Acupuncture

Evidence Reviewed as of before: 11-08-2017
Author(s)*: Tatiana Ogourtsova, PhD(c) OT; Marc-André Roy, MSc; Nicol Korner-Bitensky, PhD; Robert Teasell, MD; Norine Foley, BASc; Sanjit Bhogal, MSc; Jamie Bitensky, MSc OT; Mark Speechley, MD; Annabel McDermott, OT
Patient/Family Information Table of contents

Introduction

Acupuncture is an ancient Chinese therapy involving the stimulation of specific trigger points along the body’s 18 meridian lines to help regulate the flow of Qi (energy). The meridian lines represent the normal flow of Qi through the body. It is believed that when this energy is disrupted, disease ensues. The use of thin metal needles or other acupuncture techniques is proposed to conduct Qi through its correct paths. The trigger points used are areas of the skin where Qi flows close to the surface and thus can be reached by the various acupuncture therapies.

While the exact mechanisms are not well defined in terms of Western medicine, there are biological responses that occur directly at the stimulus point and indirectly at other parts of the body. In addition to the use of fine needles, other methods of acupuncture include:

  • electro-acupuncture (current through the needles),
    L'électro-acupuncture
    Pictures courtesy of Ricardo Miranda,L.Ac
  • cupping (suction cups on trigger points),
    les ventouses
    Pictures courtesy of Ricardo Miranda,L.Ac
  • acupressure using trigger points (applying pressure with fingers or instruments),
  • reflexology (using pressure on the soles of the feet and inferior ankle to stimulate various parts of the body),
  • moxibustion (heat at trigger points, often combined with needles),la moxibustion
    la moxibustion
    Pictures courtesy of Ricardo Miranda,L.Ac
  • auriculotherapy (stimulating trigger points on the ear to affect other parts of the body),
  • laserpuncture and sonopuncture (using sound waves over trigger points).

Acupuncture has been used to treat many types of health problems and in the past decade has been advocated by some for the treatment of stroke. Recently, a number of studies have explored the use of acupuncture in stroke rehabilitation.

Patient/Family Information

Author: Tatiana Ogourtsova, PhD(c) OT, Marc-André Roy, MSc

What is acupuncture?

Acupuncture comes from ancient Chinese medicine. It has been used to treat pain in China for about 3000 years. The Chinese explanation involves Qi (pronounced Chee), an energy that flows through the body. The belief is that when this Qi is balanced (Yin and Yang), then the body is healthy. Qi flows through different lines within your body called “meridians”. With the most common form of acupuncture, an expert puts very small needles into specific areas of your body where Qi flows close to the surface of the skin.

There is some evidence that acupuncture works after operations to stop pain, after chemotherapy to stop feeling sick and vomiting, during pregnancy to stop feeling sick and after dental surgery for dental pain. It has also been used to treat headaches, tennis elbow, fibromyalgia (general muscle pain), low back pain, carpal tunnel syndrome and asthma.

While we are not sure exactly how it works, 3 possible explanations have been given:

  • Acupuncture blocks pain from traveling in your nerves
  • Acupuncture causes your body to make chemicals that prevent pain
  • Acupuncture opens or closes your veins and arteries in important areas of the body

Are there different kinds of acupuncture?

The most popular acupuncture is performed by putting thin metal needles into the skin. Other forms of acupuncture include:

  • electro-acupuncture, which again uses needles through which very small electrical currents are passed;L'électro-acupuncturePictures courtesy of Ricardo Miranda,L.Ac
  • auriculotherapy, which uses either needles or pressure on different spots of the ear which are trigger points for the entire body;
  • moxibustion, which uses heat at different spots on the body;moxibustion moxibustionPictures courtesy of Ricardo Miranda,L.Ac
  • sonopuncture, which uses sound waves at different spots on the body
  • cupping, which uses suction cups over areas such as the back or the legs to pull blood and other fluids in the area under the skin;cuppingPictures courtesy of Ricardo Miranda,L.Ac
  • acupressure, which uses pressure on different spots on the body;
  • reflexology, which uses pressure under the feet or the back part of the ankles.

Why use acupuncture after a stroke?

Acupuncture has been used after a stroke to treat spasticity (stiffness of muscles caused by the stroke), loss of function, loss of mobility, depression, aphasia (loss of speaking and writing skills), hemiplegia (loss of feeling and/or power to move one side of the body) and for pain reduction.

Does it work for stroke?

Experts have done some experiments to compare acupuncture with other treatments to see whether acupuncture helps people who have had a stroke.

In individuals with ACUTE stroke (< 4 weeks after stroke)
Thirteen high quality studies and 7 fair quality studies found that acupuncture:

  • Was not more helpful than other treatments for improving cognitive skills (e.g. memory, language); mood (e.g. depression); self-care skills (e.g. dressing, shopping); quality of life; physical skills (e.g. strength, range of motion, sensation, motor function of arms and legs); or mobility (e.g. balance, walking speed); but
  • Was more helpful than the usual treatment for improving swallowing skills and swallowing safety.

In individuals with SUBACUTE stroke (1 to 6 months after stroke)
One high quality study found that acupuncture:

  • Was not more helpful than pretend acupuncture for improving range of motion.

In individuals with CHRONIC stroke (> 6 months after stroke)
Three high quality studies and 1 low quality study found that acupuncture:

  • Was not more helpful than pretend acupuncture for improving mood (e.g. depression); self-care skills (e.g. dressing); mobility (e.g. walking endurance); physical skills (e.g. spasticity, range of motion, strength) or pain.

What can I expect?

Most people find that having acupuncture treatment causes very little pain, if any. In most cases you feel the needle going in, but it doesn’t hurt. Some people say they feel cramping, heaviness or tingling at the needle site or up the “meridian”.

The acupuncturist may use other treatments once the needles are in place. This depends on his/her training.

Side effects/risks?

As with any other use of needles, sanitation is very important to not spread germs. All acupuncturists should use new, individually packaged, disposable needles. If these are not used, don’t agree to treatment.

There is little risk related to acupuncture if done by a qualified professional. Side effects could include dizziness, feeling sick and feeling tired after treatment. There could also be a little bleeding at the needle site and some slight bruising. There is always a slight risk of infection when putting needles in the skin.

Who provides the treatment?

Acupuncture should be practiced by a trained health professional. For example, in Quebec (Canada) the practice of acupuncture is regulated by a professional Order and only members of the Order can practice it. Different health care professionals such as physicians and physiotherapists may use the trigger point needle technique as part of their treatment.

How many treatments?

This depends on the reason you are getting acupuncture. You should discuss the treatment plan with the acupuncturist before starting treatment. You might receive anywhere from one to 15 treatment sessions.

How much does it cost? Does insurance pay for It?

Acupuncture is not paid for by provincial insurance plans. However, it is covered by some private insurance plans. The cost for each session may vary from $40.00 to $90.00.

Is acupuncture for me?

Although the benefits of acupuncture have been talked about for hundreds of years, there is no strong scientific evidence that it works to reduce spasticity, loss of function, loss of mobility, depression, aphasia or pain. Yet, there are some people who say they have found it helpful.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

The current module includes 35 RCTs including 25 high quality RCTs, nine fair quality RCTs and one poor quality RCT. Numerous outcome measures were used throughout studies and outcomes include balance, cognitive function, dexterity, depression, functional independence, motor function, quality of life, swallowing function, etc. Studies conducted with patients in one phase of stroke recovery, be it the acute, subacute, or chronic phases of stroke recovery, predominantly reported that acupuncture was not more effective than comparison interventions in improving most outcomes (with the exception of dysphagia and swallowing function). By comparison, studies that included patients across stages of stroke recovery (e.g. patients in the acute or subacute phases of stroke recovery) generally reported that acupuncture was more effective than comparison interventions in improving outcomes (especially those related to cognitive function, health related quality of life, insomnia, mobility and swallowing function).

Results Table

View results table

Outcomes

Acute Phase

Balance
Not effective
1b

One high quality RCT (Hsieh et al., 2007) and one fair quality RCT (Johansson et al., 1993) investigated the effect of acupuncture on balance in patients with acute stroke.

The high quality RCT (Hsieh et al., 2007) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Balance was measured by the Fugl-Meyer Assessment (FMA – Balance) during treatment (2 weeks), at post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). No significant between-group differences were found at any time point.

The fair quality RCT (Johansson et al., 1993) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Balance was measured by the modified Chart for Motor Capacity Assessment – Balance at mid-treatment (1 month post-stroke), and follow-up (3 months post-stroke); measures were not taken at post-treatment (10 weeks). Significant between-group differences were found at both time points, favoring electroacupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (conventional rehabilitation with no acupuncture) in improving balance in patients with acute stroke.
Note: 
However, one fair quality RCT found that acupuncture was more effective than no acupuncture in improving balance in patients with acute stroke; the studies differed in duration of the intervention (4 weeks vs. 10 weeks) and outcome measures used to assess balance.

Cognitive function
Not effective
1a

Two high quality RCTs (Rorsman & Johansson, 2006Chen et al., 2016) investigated the effect of acupuncture on cognitive function in patients with acute stroke.

The first high quality RCT (Rorsman & Johansson, 2006) randomized patients to receive acupuncture (including electroacupuncture), high intensity/low frequency transcutaneous electrical nerve stimulation TENS) or low intensity (subliminal)/high frequency TENS. Cognitive function was measured by the Mini-Mental State Examination (MMSE) at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between-group differences were found at either time point.

The second high quality RCT (Chen et al., 2016) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Cognitive function was measured by the MMSE and the Montreal Cognitive Assessment (MOCA) at baseline, at post-treatment (3 weeks) and at follow-up (7 weeks). There were no significant between-group differences on either measure at post-treatment. There were significant differences in change scores on both measures from baseline to follow-up, favoring acupuncture vs. no acupuncture.

Conclusion: There is strong evidence (Level 1a) from 2 high quality RCTs that acupuncture is not more effective than comparison interventions (TENS, conventional rehabilitation with no acupuncture) for improving cognitive function in patients with acute stroke.
Note: 
However, one of the high quality RCTs reported gains in favour of acupuncture at follow-up.

Depression
Not effective
1b

One high quality RCT (Rorsman & Johansson, 2006) investigated the effect of acupuncture on depression in patients with acute stroke. The high quality RCT randomized patients to receive acupuncture (including electroacupuncture), high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS. Depression was measured at follow-up (3- and 12-months post-stroke) by the Hospital Anxiety and Depression Scale and the Comprehensive Psychiatric Rating Scale; measures were not taken at post-treatment (10 weeks). No significant between-group differences were found on either measure at either follow-up time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than comparison interventions (high intensity/low frequency TENS, low intensity/high frequency TENS) in improving depression in patients with acute stroke.

Dexterity
Not effective
1a

Two high quality RCTs (Johansson et al., 2001Park et al., 2005) investigated the effect of acupuncture on dexterity in patients with acute stroke.

The first high quality RCT (Johansson et al., 2001) randomized patients to receive electroacupuncture, high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS; all groups received conventional rehabilitation. Dexterity was measured by the Nine Hole Peg Test (NHPT) at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between group differences were found at either follow-up time point.

The second high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Dexterity was measured by the NHPT at post-treatment (2 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than comparison interventions (TENS, sham acupuncture) in improving dexterity in patients with acute stroke.

Dysphagia
Effective
1b

One high quality RCT (Xia et al., 2016) investigated the effect of acupuncture on functional severity of dysphagia in patients with acute stroke and subsequent dysphagia. This high quality RCT randomized patients to receive acupuncture or no acupuncture; both groups received standard swallowing training. Functional severity of dysphagia was measured by the Dysphagia Outcome and Severity Scale at post-treatment (4 weeks). Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that swallowing training with acupuncture is more effective than a comparison intervention (swallowing training with no acupuncture) in improving functional severity of dysphagia in patients with acute stroke and subsequent dysphagia.

Functional independence
Not effective
1a

Ten high quality RCTs (Gosman-Hedstrom et al., 1998Johansson et al., 2001Sze et al., 2002Park et al., 2005Hsieh et al., 2007Hopwood et al., 2008Zhu et al., 2013Li et al., 2014Liu et al., 2016Xia et al., 2016) and six fair quality RCTs (Hu et al., 1993Johansson et al., 1993Wong et al., 1999Pei et al., 2001Min et al., 2008Wang et al., 2014) investigated the effect of acupuncture on functional independence in patients with acute stroke.

The first quality RCT(Gosman-Hedstrom et al., 1998) randomized patients to receive deep electroacupuncture, superficial acupuncture or no acupuncture; all groups received conventional rehabilitation. Functional independence was measured by the Barthel Index (BI) and Sunnaas Index at post-treatment (3 months) and at follow-up (12 months). No significant between-group differences were found on any measure at either time point.

The second high quality RCT(Johansson et al., 2001) randomized patients to receive electroacupuncture, high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS; all groups received conventional rehabilitation. Functional independence was measured by the BI at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between group differences were found at either follow-up time point.

The third high quality RCT(Sze et al., 2002) randomized patients to receive manual acupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI and the Functional Independence Measure (FIM) at post-treatment (10 weeks). No significant between-group differences were found on any measure.

The forth high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Functional independence was measured by the BI at post-treatment (2 weeks). No significant between-group differences were found.

The fifth high quality RCT (Hsieh et al., 2007) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the FIM (total, self-care, social, mobility, locomotion, sphincter control, communication) during treatment (2 weeks), at post-treatment (4 weeks), and follow-up (3- and 6-months post-stroke). A significant between-group difference was found on only one score (FIM – social) during treatment (2 weeks), favoring electroacupuncture vs. no acupuncture. There were no other significant between-group differences on any measure, at any time point.

The sixth high quality RCT (Hopwood et al., 2008) randomized patients to receive electroacupuncture or placebo electroacupuncture. Functional independence was measured by the BI during treatment (3 weeks) and at several follow-up time points (6, 12, 25, and 52 weeks); measures were not taken at post-treatment (4 weeks). No significant between-group differences were found at any time point.

The seventh high quality RCT(Zhu et al., 2013) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI at mid-treatment (1 month), post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at any time point.

The eighth high quality RCT (Li et al., 2014) randomized patients to receive verum acupuncture or sham acupuncture. Functional independence was measured by the modified BI and the modified Rankin Scale (mRS) at baseline, at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (12 weeks). Significant between-group differences were found at post-treatment (both measures) and at follow-up (BI only), favoring verum acupuncture vs. sham acupuncture.
Note: Differences at post-treatment reflect change scores from baseline to post-treatment; differences at follow-up reflect scores at that time point as well as change scores from baseline to follow-up.

The ninth high quality RCT (Liu et al., 2016) randomized patients to receive manual acupuncture or no acupuncture. Functional independence was measured by the BI,the mRS and the FIM at post-treatment (2 weeks: FIM) and at follow-up (3 weeks: FIM; 1 month: FIM; 3 months: MRS, BI). No significant between-group differences were found on any measure at any time point.

The tenth high quality RCT (Xia et al., 2016) randomized patients to receive acupuncture or no acupuncture; both groups received standard swallowing training. Functional independence was measured by the modified BI at post-treatment (4 weeks). Significant between group differences were found, favoring acupuncture vs. no acupuncture.

The first fair quality RCT (Hu et al., 1993) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI at post-treatment (4 weeks) and at follow-up (3 months). No significant between-group differences were found at either time point.

The second fair quality RCT (Johansson et al., 1993) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI at mid-treatment (1 month post-stroke) and at two follow-up timepoints (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). Significant between-group differences were found at all time points, favoring electroacupuncture vs. no acupuncture.

The third fair quality RCT (Wong et al., 1999) randomized patients to receive electroacupuncture or no acupuncture. Functional independence was measured by the FIM (total, self-care, locomotion, sphincter control, transfers, communication, social interaction) at post-treatment (2 weeks). Significant between-group differences were found (FIM total, self-care, locomotion), favoring electroacupuncture vs. no acupuncture.

The forth fair quality RCT (Pei et al., 2001) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI mid-treatment (1 and 2 weeks), at post-treatment (4 weeks) and at follow-up (3 months). Significant between-group differences were found at all time points, favoring electroacupuncture vs. no acupuncture.

The fifth fair quality RCT (Min et al., 2008) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the modified BI at post-treatment (3 months). Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

The sixth fair quality RCT (Wang et al., 2014) randomized patients to receive electroacupuncture or no electroacupuncture; both groups received conventional rehabilitation. Functional independence was measured by the BI at follow-up (3 and 6 months); measures were not taken at post-treatment (4 weeks). Significant between-group differences were found at 6-month follow-up only, favoring electroacupuncture vs. no electroacupuncture.

Conclusion: There is strong evidence (Level 1a) from eight high quality RCTs and one fair quality RCT that acupuncture is not more effective than comparison interventions (superficial acupuncture, no acupuncture, TENS, conventional rehabilitation, sham or placebo acupuncture) in improving functional independence in patients with acute stroke.
Note:
However, two high quality RCTs and five fair quality RCTs found that acupuncture was more effective than comparison interventions (sham acupuncture, standard swallowing training, no acupuncture, conventional rehabilitation) in improving functional independence in patients with acute stroke.

Health-related quality of life (HRQoL)
Not effective
1a

Five high quality RCTs (Gosman-Hedstrom et al., 1998; Johansson et al., 2001; Park et al., 2005; Hopwood et al., 2008Li et al., 2014) and one fair quality RCT (Johansson et al., 1993) investigated the effect of acupuncture on health-related quality of life (HRQoL) in patients with acute stroke.

The first high quality RCT (Gosman-Hedstrom et al., 1998) randomized patients to receive deep electroacupuncture, superficial acupuncture or no acupuncture; all groups received conventional rehabilitation. HRQoL was measured by the Nottingham Health Profile (NHP – energy level, pain, emotional reaction, sleep, social isolation, physical abilities) at post-treatment (3 months) and at follow-up (12 months). There were no significant between-group differences at post-treatment; there was a significant between-group difference in one component of HRQoL (physical abilities) at follow-up, favoring deep electroacupuncture vs. no acupuncture.

The second high quality RCT (Johansson et al., 2001) randomized patients to receive electroacupuncture, high intensity/low TENS or low intensity (subliminal)/high frequency TENS; all groups received conventional rehabilitation. HRQoL was measured by the NHP at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between group differences were found at both follow-up time points.

The third high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. HRQoL was measured by the EuroQoL (EuroQoL5 – Visual Analogue Scale) at post-treatment (2 weeks). No significant between-group differences were found.

The forth high quality RCT (Hopwood et al., 2008) randomized patients to receive electroacupuncture or placebo electroacupuncture. HRQoL was measured by the NHP during treatment (3 weeks) and at follow-up (6, 12, 25, and 52 weeks). There was a significant between-group difference in one score (NHP – Energy) during treatment and at all follow-up time points, favoring electroacupuncture vs. placebo acupuncture.

The fifth high quality RCT (Li et al., 2014) randomized patients to receive verum acupuncture or sham acupuncture. HRQoL was measured by the Stroke Specialization Quality of Life Scale (SS-QoL) at baseline, at mid-treatment (2 weeks), post-treatment (4 weeks), and at follow-up (12 weeks). Significant between-group differences were found at post-treatment and at follow-up, favoring verum acupuncture vs. sham acupuncture.
Note: Differences at post-treatment reflect change scores from baseline to post-treatment; differences at follow-up reflect scores at that time point as well as change scores from baseline to follow-up.

The fair quality RCT (Johansson et al., 1993) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. HRQoL was measured by the modified NHP at follow-up (3, 6 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). There were significant between-group differences in some components of HRQoL at 3 months post-stroke (energy, mobility, emotion, social isolation), at 6 months post-stroke (energy, mobility, emotion, social isolation, sleep), and at 12 months post-stroke (mobility, emotion), favoring electroacupuncture vs. no acupuncture.

Conclusion: There is strong evidence (Level 1a) from four high quality RCTs that acupuncture is not more effective than comparison interventions (superficial acupuncture, no acupuncture, TENS, sham or placebo acupuncture) in improving health-related quality of life in patients with acute stroke.
Note
: However, one high quality RCT found that acupuncture was more effective than a comparison intervention (sham acupuncture); this study used the SS-QoL to measure quality of life, rather than the NHP used by most other studies. In addition, one fair quality RCT found that acupuncture was more effective than no acupuncture in improving some components of the health-related quality of life.

Instrumental activities of daily living (IADLs)
Not effective
1b

One high quality RCT (Park et al., 2005) investigated the effect of acupuncture on IADLs in patients with acute stroke. This high quality RCT randomized patients to receive manual acupuncture or sham acupuncture. IADLs were measured by the Nottingham Extended ADL scale at post-treatment (2 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (sham acupuncture) in improving IADLs in patients with acute stroke.

Language function
Not effective
1b

One high quality RCT (Rorsman & Johansson, 2006) investigated the effect of acupuncture on language function with acute stroke. This high quality RCT randomized patients to receive acupuncture (including electroacupuncture), high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS. Language function was measured by the Token Test and FAS Word Fluency Test at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between-group differences were found on any measure at either follow-up time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than comparison interventions (TENS) in improving language function in patients with acute stroke.

Memory
Not effective
1b

One high quality RCT (Rorsman & Johansson, 2006) investigated the effect of acupuncture on memory in patients with acute stroke. This high quality RCT randomized patients to receive acupuncture (including electroacupuncture), high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS. Memory was measured by the Rey Auditory Verbal Learning Test and Facial Recognition Memory Test at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between-group differences were found on either measure of memory at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than comparison interventions (TENS) in improving memory in patients with acute stroke.

Mobility
Not effective
1b

One high quality RCT (Johansson et al., 2001) and one fair quality RCT (Johansson et al., 1993) investigated the effect of acupuncture on mobility in patients with acute stroke.

The high quality RCT (Johansson et al., 2001) randomized patients to receive electroacupuncture, high intensity/low TENS or low intensity (subliminal)/high frequency TENS; all groups received conventional rehabilitation. Mobility was measured by the Rivermead Mobility Index at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between-group differences were found at either follow-up time point.

The fair quality RCT (Johansson et al., 1993) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Mobility was measured by the modified Chart for Motor Capacity Assessment (Walking) at mid-treatment (1 month post-stroke) and at follow-up (3 months post-stroke); measures were not taken at post-treatment (10 weeks). Significant between-group differences were found at both time points, favoring electroacupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that electroacupuncture is not more effective than comparison interventions (TENS) in improving mobility in patients with acute stroke.
Note: 
However, one RCT found that acupuncture was more effective than no acupuncture in improving mobility in patients with acute stroke.

Motor function
Conflicting
4

Five high quality RCTs (Sze et al., 2002Hsieh et al., 2007Tan et al., 2013Li et al., 2014Liu et al., 2016) and three fair quality RCTs (Johansson et al., 1993Pei et al., 2001Min et al., 2008) investigated the effect of acupuncture on motor function in patients with acute stroke.

The first high quality RCT (Sze et al., 2002) randomized patients to receive manual acupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function measured by the Fugl-Meyer Assessment (FMA) at post-treatment (10 weeks). No significant between-group differences were found.

The second high quality RCT (Hsieh et al., 2007) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the FMA (total score) at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). Significant between-group differences were found at mid-treatment, post-treatment and at 3 months post-stroke, favoring electroacupuncture vs. no acupuncture.

The third high quality RCT (Tan et al., 2013) randomized patients to receive electroacupuncture or no electroacupuncture. Motor function was measured by the FMA at post-treatment (14 days). Significant between-group differences were found at post-treatment, favoring electroacupuncture vs. no electroacupuncture.

The fourth high quality RCT (Li et al., 2014) randomized patients to receive verum acupuncture or sham acupuncture. Motor function was measured by the FMA – Upper and Lower Extremity scores combined at baseline, at mid-treatment (2 weeks), at post-treatment (4 weeks), and at follow-up (12 weeks). Significant between-group differences were found at post-treatment and at follow-up, favoring verum acupuncture vs. sham acupuncture.
Note: Differences at post-treatment reflect change scores from baseline to post-treatment; differences at follow-up reflect scores at that time point as well as change scores from baseline to follow-up.

The fifth high quality RCT (Liu et al., 2016) randomized patients to receive manual acupuncture or no acupuncture. Motor function was measured by the FMA at follow-up (1 month); measures were not taken at post-treatment (2 weeks). No significant between-group differences were found.

The first fair quality RCT (Johansson et al., 1993) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the modified Chart for Motor Capacity Assessment (motor function) at 1 and 3 months post-stroke (follow-up); measures were not taken at post-treatment (10 weeks). No significant between group differences were found at either time point.

The second fair quality RCT (Pei et al., 2001) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the FMA at mid-treatment (1 and 2 weeks), post-treatment (4 weeks) and at follow-up (3 months). Significant between-group differences were found at all time points, favoring electroacupuncture vs. no acupuncture.

The third fair quality RCT (Min et al., 2008) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the FMA at post-treatment (3 months). A significant between-group difference was found at post-treatment, favoring acupuncture vs. no acupuncture.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of acupuncture on motor function. Two high quality RCTs and one fair quality RCT reported that acupuncture is not more effective than no acupuncture, whereas two other high quality RCTs and two fairquality RCTs found that acupuncture was more effective than comparison interventions (no/sham acupuncture) in improving motor function in patients with acute stroke. A fifth high quality RCT also reported of significant differences in change scores at post-treatment and follow-up.
Note:
There was significant variation between studies in type, frequency and duration of acupuncture.

Motor function - lower extremity
Not effective
1a

Three high quality RCTs (Hsieh et al., 2007Zhu et al., 2013Chen et al., 2016) and two fair quality RCTs (Wong et al., 1999Min et al., 2008) investigated the effect of acupuncture on lower extremity motor function in patients with acute stroke.

The first quality RCT (Hsieh et al., 2007) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Lower extremity motor function was measured by the Fugl Meyer Assessment (FMA – hip/knee/ankle motor function, lower extremity coordination and speed) at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). No significant between-group differences were found at any time point.

The second high quality RCT (Zhu et al., 2013) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Lower extremity motor function was measured by the Fugl-Meyer Assessment – Lower Extremity (FMA-LE) at mid-treatment (1 month), post-treatment (3 months), and at follow-up (6 months). No significant between-group differences were found at any time point.

The third high quality RCT (Chen et al., 2016) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Lower extremity motor function was measured by the FMA-LE at baseline, at post-treatment (3 weeks) and at follow-up (7 weeks). There were no significant differences at post-treatment; there were significant differences in change scores from baseline to follow-up, favoring acupuncture vs. no acupuncture.

The first fair quality RCT (Wong et al., 1999) randomized patients to receive electroacupuncture or no acupuncture. Lower extremity motor function was measured using Brunnstrom’s lower limb motor recovery at post-treatment (2 weeks). Significant between-group differences were found, favoring electroacupuncture vs. no acupuncture.

The second fair quality RCT (Min et al., 2008) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Lower extremity motor function was measured by the FMA–LE at post-treatment (3 months). Significant between-group difference were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is strong evidence (level 1a) from 3 high quality RCTs that acupuncture is not more effective than a comparison intervention (no acupuncture) for improving lower extremity motor function in patients with acute stroke.
Note: 
One of the high quality RCTs reported a significant difference in change scores at follow-up, in favour of acupuncture vs. no acupuncture. Further, two fair quality RCTs reported that acupuncture was more effective than no acupuncture. There was significant variation in the frequency and duration of interventions.

Motor function - upper extremity
Not effective
1a

Three high quality RCTs (Hsieh et al., 2007Zhu et al., 2013Chen et al., 2016) and two fair quality RCTs (Wong et al., 1999Min et al., 2008) investigated the effect of acupuncture on upper extremity motor function in patients with acute stroke.

The first high quality RCT (Hsieh et al., 2007) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Upper extremity motor function was measured by the Fugl Meyer Assessment (FMA – shoulder / elbow / wrist / hand motor function, upper extremity coordination and speed) during treatment (2 weeks), at post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). Significant between-group differences were found during treatment (FMA – hand motor function, upper extremity coordination and speed), post-treatment (FMA – wrist motor function, hand motor function, upper extremity coordination and speed), and at both follow-up time points (FMA – wrist motor function, hand motor function, upper extremity coordination and speed), favoring electroacupuncture vs. no acupuncture.

The second high quality RCT (Zhu et al., 2013) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity scale (FMA-UE) at mid-treatment (1 month), post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at any time point.

The third high quality RCT (Chen et al., 2016) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE at post-treatment (3 weeks) and follow-up (7 weeks). No significant between-group differences were found at either time point.

The first fair quality RCT (Wong et al., 1999) randomized patients to receive electroacupuncture or no acupuncture. Upper extremity motor function was measured by Brunnstrom’s upper limb motor recovery at post-treatment (2 weeks). Significant between-group differences were found, favoring electroacupuncture vs. no acupuncture.

The second fair quality RCT (Min et al., 2008) randomized patients to receive acupuncture or no acupuncture; both groups received conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE at post-treatment (3 months). A significant between-group difference was found, favoring acupuncture vs. no acupuncture.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving upper extremity motor function in patients with acute stroke.
Note: 
However; one high quality RCT and two fair quality RCTs found that acupuncture was more effective than a comparison intervention (no acupuncture) in improving upper extremity motor function in patients with acute stroke. Studies varied in terms of the intervention, frequency (2-6 times/week) and duration (2 weeks – 3 months) of the intervention, and outcome measures used.

Range of motion
No effective
1b

One high quality RCT (Hsieh et al., 2007) investigated the effect of acupuncture on range of motion in patients with acute stroke. This high quality RCT randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Range of motion was measured by the Fugl Meyer Assessment (FMA – range of motion) at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). There was a significant between-group difference in range of motion at 3 months post-stroke only, favoring electroacupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that electroacupuncture is not more effective than a comparison intervention (no acupuncture) in improving range of motion in patients with acute stroke.

Sensation
Not effective
1b

One high quality RCT (Hsieh et al., 2007) investigated the effects of acupuncture on sensation in patients with acute stroke. The high quality RCT randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Sensation was measured by the Fugl Meyer Assessment (FMA – sensation) at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (3 and 6 months post-stroke). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving sensation in patients with acute stroke.

Spasticity
Conflicting
4

Two high quality RCTs (Park et al., 2005; Li et al., 2014) investigated the effect of acupuncture on spasticity in patients with acute stroke.

The first high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Spasticity was measured by the Modified Ashworth Scale (MAS) at post-treatment (2 weeks). No significant between-group differences were found.

The second high quality RCT (Li et al., 2014) randomized patients to receive verum acupuncture or sham acupuncture. Spasticity was measured by the MAS at baseline, at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (12 weeks). Significant between-group differences in spasticity were found at post-treatment and follow-up, favoring verum acupuncture vs. sham acupuncture.
Note: Differences at post-treatment reflect change scores from baseline to post-treatment; differences at follow-up reflect scores at that time point as well as change scores from baseline to follow-up.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of acupuncture on spasticity in patients with acute stroke. While one high quality RCT found manual acupuncture (2 weeks duration) was not more effective than sham acupuncture, a second high quality RCT reported a significant difference in change scores following verum acupuncture (4 weeks duration), in improving spasticity in patients with acute stroke.

Strength
Not effective
1a

Two high quality RCTs (Park et al., 2005; Hopwood et al., 2008) investigated the effect of acupuncture on strength in patients with acute stroke.

The first high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Strength was measured by the Motricity Index (MI) at post-treatment (2 weeks). No significant between-group differences were found.

The second quality RCT (Hopwood et al., 2008) randomized patients to receive electroacupuncture or placebo electroacupuncture. Strength was measured by the MI at mid-treatment (3 weeks) and at follow-up (6, 12, 25, and 52 weeks); measures were not taken at post-treatment (4 weeks). No significant between-group differences were found at any time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than comparison interventions (sham acupuncture, placebo electroacupuncture) in improving strength in patients with acute stroke.

Stroke outcomes
Not effective
1a

Seven high quality RCTs (Gosman-Hedstrom et al., 1998; Park et al., 2005; Tan et al., 2013; Li et al., 2014; Zhang et al., 2015; Chen et al., 2016, Liu et al., 2016) and three fair quality RCTs (Si et al., 1998; Pei et al., 2001; Wang et al., 2014) investigated the effect of acupuncture on stroke outcomes in patients with acute stroke.

The first high quality RCT (Gosman-Hedstrom et al., 1998) randomized patients to receive deep electroacupuncture, superficial acupuncture or no acupuncture; all groups received conventional rehabilitation. Stroke outcomes were measured by the Scandinavian Stroke Study Group – Neurological score at post-treatment (3 months) and follow-up (12 months). No significant between-group differences were found at either time point.

The second high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Stroke outcomes were measured by the National Institutes of Health Stroke Scale (NIHSS) at post-treatment (2 weeks). No significant between-group differences were found.

The third high quality RCT (Tan et al., 2013) randomized patients to receive electroacupuncture or no electroacupuncture. Stroke outcomes were measured by the Modified Edinburg Scandinavian Stroke Scale and the NIHSS at post-treatment (14 days). Significant between-group differences were found on both measures at post-treatment, favoring electroacupuncture vs. no electroacupuncture.

The forth high quality RCT (Li et al., 2014) randomized patients to receive verum acupuncture or sham acupuncture. Stroke outcomes were measured by the NIHSS at mid-treatment (2 weeks), post-treatment (4 weeks), and follow-up (12 weeks). No significant between-group differences were found at any time point.

The fifth high quality RCT (Zhang et al., 2015) randomized patients to receive acupuncture or no acupuncture. Stroke outcomes were measured by the Scandinavian Stroke Scale at post-treatment (3 weeks). Significant between-group differences were found, favoring acupuncture vs. no acupuncture.
Note: Results were significant only for participants who had received 10 or more acupuncture sessions.

The sixth high quality RCT (Chen et al., 2016) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Stroke outcomes were measured by the NIHSS at baseline, during treatment (1 week), at post-treatment (3 weeks), and follow-up (7 weeks). There were no significant differences between groups during treatment or at post-treatment. There was a significant between-group difference in change scores from baseline to follow-up, favoring acupuncture vs. no acupuncture.

The seventh high quality RCT (Liu et al., 2016) randomized patients to receive manual acupuncture or no acupuncture. Stroke outcomes were measured by the NIHSS at post-treatment (2 weeks) and follow-up (3, 4, 12 weeks). No significant between-group differences were found at any time point.

The first fair quality RCT (Si et al., 1998) randomized patients to receive electroacupuncture or no acupuncture. Stroke outcomes were measured by the Chinese Stroke Scale (CSS – total score, motor shoulder/hand/leg, level of consciousness, extraocular movements, facial palsy, speech, walking capacity) at discharge from hospital (average of 37±12 days). Significant between group differences in some stroke outcomes (CSS – total, motor shoulder/hand/leg) were found at discharge, favoring electroacupuncture vs. no acupuncture.

The second fair quality RCT (Pei et al., 2001) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Stroke outcomes were measured by the CSS during treatment (1 and 2 weeks), at post-treatment (4 weeks) and at follow-up (3 months). Significant between-group differences in stroke outcomes were found at 2 weeks, 4 weeks and 3 months, favoring electroacupuncture vs. no acupuncture.

The third fair quality RCT (Wang et al., 2014) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Stroke outcomes were measured by the NIHSS at post-treatment (4 weeks) and at follow-up (3 months). Significant between-group differences were found at post-treatment, favoring electroacupuncture vs. no electroacupuncture. These differences were not maintained at follow-up.

Conclusion: There is strong evidence (Level 1a) from five high quality RCTs that acupuncture is not more effective than comparison interventions (superficial/no/sham acupuncture) in improving stroke outcomes in patients with acute stroke.
Note:
However, two high quality RCTs and three fair quality RCTs found that acupuncture is more effective than a comparison intervention (no acupuncture) in improving stroke outcomes in patients with acute stroke. Differences between studies, including variation in the type of acupuncture, treatment frequency/duration and outcome measures used may account for this discrepancy in findings.

Swallowing function
Effective
1a

Three high quality RCTs (Park et al., 2005; Chen et al., 2016; Xia et al., 2016) investigated the effect of acupuncture on swallowing function in patients with acute stroke.

The first high quality RCT (Park et al., 2005) randomized patients to receive manual acupuncture or sham acupuncture. Swallowing function was measured by the Bedside Swallowing Assessment (BSA) at post-treatment (2 weeks). Significant between group differences were found, favoring sham acupuncture vs. manual acupuncture (i.e. participants who received manual acupuncture presented with a higher incidence of unsafe swallow than participants who received sham acupuncture).

The second high quality RCT (Chen et al., 2016) randomized patients to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Swallowing function was measured by the BSA at post-treatment (3 weeks) and follow-up (7 weeks), and by Videofluoroscopic Swallowing Study (VFSS) at follow-up (7 weeks). Significant between-group differences were found at post-treatment (BSA) and at follow-up (BSA, VFDSS), favoring acupuncture vs. no acupuncture.

The third high quality RCT (Xia et al., 2016) randomized patients to receive acupuncture or no acupuncture; both groups received standard swallowing training. Swallowing function was measured by the Standardized Swallowing Assessment at post-treatment (4 weeks). Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is more effective than a comparison intervention (no acupuncture) in improving swallowing function in patients with acute stroke.
Note:
However, one high quality RCT found that acupuncture was LESS effective than a comparison intervention (sham acupuncture) in improving swallowing function in patients with acute stroke.

Swallowing-related quality of life
Effective
1b

One high quality RCT (Xia et al., 2016) investigated the effects of acupuncture on swallowing-related quality of life in patients with acute stroke and subsequent dysphagia. This high quality RCT randomized patients to receive acupuncture or no acupuncture; both groups received standard swallowing training. Swallowing-related quality of life was measured with the Swallowing Related Quality of Life scale at post-treatment (4 weeks). Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is more effective than a comparison intervention (no acupuncture with standard swallowing training) in improving swallowing related quality of life in patients with acute stroke and subsequent dysphagia.

Unilateral spatial neglect
Not effective
1b

One high quality RCT (Rorsman & Johansson, 2006) investigated the effect of acupuncture on unilateral spatial neglect in patients with acute stroke. This high quality RCT randomized patients to receive acupuncture (including electroacupuncture), high intensity/low frequency TENS or low intensity (subliminal)/high frequency TENS. Unilateral spatial neglect was measured by the Star Cancellation Test and Time Perception Test at follow-up (3 and 12 months post-stroke); measures were not taken at post-treatment (10 weeks). No significant between-group differences were found on any measure at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than comparison interventions (TENS) in improving unilateral spatial neglect in patients with acute stroke.

Walking speed
Not effective
1b

One high quality RCT (Park et al., 2005) investigated the effect of acupuncture on walking speed in patients with acute stroke. This high quality RCT randomized patients to receive manual acupuncture or sham acupuncture. Walking speed was measured by the 10 Meter Walk Test at post-treatment (2 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (sham acupuncture) in improving walking speed in patients with acute stroke.

Subacute phase

Range of motion
Not effective
1b

One high quality RCT (Naeser et al., 1992) investigated the effect of acupuncture on range of motion in patients with subacute stroke. This high quality RCT randomized patients to receive electroacupuncture or sham acupuncture. Isolated active range of motion was measured at post-treatment (4 weeks). No significant between-group differences were found.
Note: A subgroup analysis of patients with the lesion in half or less than half of the motor pathway areas revealed significant between-group differences, favoring electroacupuncture vs. sham acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that electroacupuncture is not more effective than a comparison intervention (sham acupuncture) in improving isolated active range of motion in patients with subacute stroke.

Chronic phase

Depression
Not effective
1a

Two high quality RCTs (Fink et al., 2004; Wayne et al., 2005) investigated the effect of acupuncture on depression in patients with chronic stroke. This first high quality RCT (Fink et al., 2004) randomized patients to receive acupuncture or placebo acupuncture. Depression was measured by the von Zerssen Depression Scale at post-treatment (4 weeks) and follow-up (3 months). No significant between-group differences were found at either time point. 

The second high quality RCT (Wayne et al., 2005) randomized patients to receive acupuncture or sham acupuncture. Depression was measured by the Center for Epidemiological Surveys Depression at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than a comparison intervention (placebo/sham acupuncture) in improving depression in patients with chronic stroke.

Functional independence
Not effective
1b

One high quality RCT (Wayne et al, 2005) investigated the effect of acupuncture on functional independence in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or sham acupuncture. Functional independence was measured by the Barthel Index at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (sham acupuncture) in improving functional independence in patients with chronic stroke.

Gait parameters
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on gait parameters in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Gait parameters (step length, cadence, mode of initial foot contact) were measured at first treatment, post-treatment (4 weeks), and follow-up (3 months). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in improving gait parameters in patients with chronic stroke.

Grip strength
Not effective
1b

One high quality RCT (Wayne et al, 2005) investigated the effect of acupuncture on grip strength in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or sham acupuncture. Grip strength was measured by Jamar dynamometer at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (sham acupuncture) in improving grip strength in patients with chronic stroke.

Health-related quality of life (HRQoL)
Not effective
1a

Two high quality RCTs (Fink et al., 2004; Wayne et al., 2005) investigated the effect of acupuncture on HRQoL in patients with chronic stroke.

This first high quality RCT (Fink et al., 2004) randomized patients to receive acupuncture or placebo acupuncture. HRQoL was measured by the Nottingham Health Profile and the Everyday Life Questionnaire at post-treatment (4 weeks) and follow-up (3 months). No significant between-group differences were found on either measure at either time point. 

The second high quality RCT (Wayne et al, 2005) randomized patients to receive acupuncture or sham acupuncture. HRQoL was measured by the Nottingham Health Profile at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than a comparison intervention (placebo/sham acupuncture) in improving health-related quality of life in patients with chronic stroke.

Impression of improvement
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on impression of improvement in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Impression of improvement was measured by the Clinical Global Impressions Scale at first treatment, post-treatment (4 weeks), and follow-up (3 months). Significant between-group differences in patients’ impression of improvement were found at post-treatment, favoring placebo acupuncture vs. acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in increasing the impression of improvement in patients with chronic stroke. In fact, patients who received acupuncture showed lower impression of improvement as compared to those who received placebo acupuncture.

Mobility
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on mobility in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Mobility was measured by the Rivermead Mobility Index at first treatment, post-treatment (4 weeks), and follow-up (3 months). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in improving mobility in patients with chronic stroke.

Motor function
Not effective
1a

Two high quality RCTs (Fink et al., 2004, Wayne et al., 2005) investigated the effect of acupuncture on motor function in patients with chronic stroke.

This first high quality RCT (Fink et al., 2004) randomized patients to receive acupuncture or placebo acupuncture. Motor function was measured by the Rivermead Motor Assessment at first treatment, post-treatment (4 weeks), and follow-up (3 months). No significant between-group differences were found at any time point.

The second high quality RCT (Wayne et al., 2005) randomized patients to receive acupuncture or sham acupuncture. Motor function was measured by the Fugl-Meyer Assessment at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than a comparison intervention (placebo/sham acupuncture) in improving motor function in patients with chronic stroke.

Pain
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on pain in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Pain was measured by Visual Analogue Scale at first treatment, post-treatment (4 weeks), and follow-up (3 months). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in improving pain in patients with chronic stroke.

Range of motion - upper extremity
Not effective
1a

Two high quality RCTs (Wayne et al., 2005, Schaechter et al., 2007) investigated the effect of acupuncture on upper extremity range of motion in patients with chronic stroke.

The first high quality RCT (Wayne et al., 2005) randomized patients to receive acupuncture or sham acupuncture. Upper extremity range of motion (shoulder, elbow, forearm, wrist, thumb, digits) was measured at post-treatment (12 weeks). No significant between-group differences were found.

The second high quality RCT (Schaechter et al., 2007) randomized patients to receive acupuncture with electroacupuncture or sham acupuncture with sham electroacupuncture. Upper extremity active assisted range of motion was measured at 2 weeks post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than comparison interventions (sham acupuncture, sham electroacupuncture) in improving upper extremity range of motion in patients with chronic stroke.

Spasticity - lower extermity
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on lower extremity spasticity in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Ankle spasticity was measured by the Modified Ashworth Scale and the Hoffman’s reflex (Hmax/Mmax ratio of the spastic leg) using the Nicolet Viking II device at first treatment, post-treatment (4 weeks), and follow-up (3 months). Significant between-group differences in spasticity (Hoffman’s reflex) were found at post-treatment, favoring placebo acupuncture vs. acupuncture. These differences were not maintained at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in reducing ankle spasticity in patients with chronic stroke. In fact, patients who received acupuncture showed greater spasticity in their affected ankle as compared to those who received placebo acupuncture.

Spasticity - upper extermity
Not effective
1a

Two high quality RCTs (Wayne et al., 2005; Schaechter et al., 2007) and one poor quality crossover RCT (Mukherjee et al., 2007) investigated the effect of acupuncture on upper extremity spasticity in patients with chronic stroke.

The first high quality RCT (Wayne et al., 2005) randomized patients to receive acupuncture or sham acupuncture. Spasticity in the elbow and wrist was measured by the Modified Ashworth Scale at post-treatment (12 weeks). No significant between-group differences were found.

The second high quality RCT (Schaechter et al., 2007) randomized patients to receive acupuncture with electroacupuncture or sham acupuncture with sham electroacupuncture. Upper extremity spasticity was measured by the Modified Ashworth Scale at 2 weeks post-treatment (12 weeks). No significant between-group differences were found.

The poor quality crossover RCT (Mukherjee et al., 2007) randomized patients to receive electroacupuncture or no electroacupuncture; both groups received strengthening exercises. Spasticity of the wrist was measured at post-treatment (6 weeks). Significant between-group differences on one measure of wrist spasticity were found, favoring electroacupuncture vs. no electroacupuncture.
Note: Other measures of spasticity were taken, however between-group analyses were not performed.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than comparison interventions (sham acupuncture, sham electroacupuncture) in reducing upper extremity spasticity in patients with chronic stroke.
Note
: However, a poor quality crossover RCT found a significant difference on one measure of wrist spasticity, in favour of electroacupuncture + strengthening exercises alone vs. strengthening exercises alone.

Walking endurance
Not effective
1b

One high quality RCT (Fink et al., 2004) investigated the effect of acupuncture on walking endurance in patients with chronic stroke. This high quality RCT randomized patients to receive acupuncture or placebo acupuncture. Walking endurance was measured by the 2-Minute Walk Test at first treatment, post-treatment (4 weeks), and follow-up (3 months). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (placebo acupuncture) in improving walking endurance in patients with chronic stroke.

Phase not specific to one period

Balance
Not effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effect of acupuncture on balance in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture or no acupuncture for 2 weeks; both groups received conventional rehabilitation. Balance was measured by the Fugl-Meyer Assessment (FMA – Balance) at discharge from hospital. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving balance in patients with stroke.

Cognitive function
Effective
1b

One high quality RCT (Jiang et al., 2016) investigated the effect of acupuncture on cognitive function in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture (AC) + conventional rehabilitation (CR), computerized cognitive rehabilitation (COG) + CR, combined AC+COG+CR, or CR alone. Cognitive function was measured by the Mini Mental State Examination and the Montreal Cognitive Assessment (MOCA) at baseline and at post-treatment (12 weeks). Significant between-group differences in change scores from baseline to post-treatment were found on both measures, favoring AC+CR vs. CR alone. There were no significant between-group differences between AC+CR vs. COG+CR.
Note: Significant between-group differences in change scores of both measures were also found in favour of COG+CR vs. CR alone; AC+COG+CR vs. CR alone; AC+COG+CR vs. AC+CR; and AC+COG+CR vs. COG+CR.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is more effective than a comparison intervention (conventional rehabilitation) in improving cognitive function in patients with stroke.
Note:
Combined acupuncture + computerized cognitive training was also found to be more effective than comparison interventions (acupuncture alone, computerized cognitive training alone, conventional rehabilitation) in improving cognitive function in patients with stroke.

Functional independence
Not effective
1a

Five high quality RCTs (Sallstrom et al., 1996 – and a follow-up by Kjendahl et al., 1997 –; Alexander et al., 2004; Schuler et al., 2005; Zhuang et al., 2012; Jiang et al., 2016) and one fair quality RCTs (Hegyi & Szigeti, 2012) investigated the effect of acupuncture on functional independence in patients with stroke.

The first high quality RCT (Sallstrom et al., 1996) randomized patients with acute/subacute stroke to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Functional independence was measured by the Sunnaas Index at post-treatment (6 weeks) and at 1 year post-discharge from hospital (Kjendahl et al., 1997, follow-up study). Significant between-group differences were found at post-treatment and at follow-up, favoring electroacupuncture vs. no acupuncture.

The second high quality RCT (Alexander et al., 2004) randomized patients with acute/subacute stroke to receive acupuncture or no acupuncture for 2 weeks; both groups received conventional rehabilitation. Functional independence was measured by the Functional Independence Measure (FIM) at discharge from hospital. A significant between-group difference was found in only one measure of functional independence (tub/shower transfer), favoring acupuncture vs. no acupuncture.

The third high quality RCT (Schuler et al., 2005) randomized patients with acute/subacute stroke to receive electroacupuncture or placebo acupuncture. Functional independence was measured by the Barthel Index at post-treatment (4 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point.

The forth high quality RCT (Zhuang et al., 2012) randomized patients with acute/subacute stroke to receive acupuncture, conventional rehabilitation or combined acupuncture with conventional rehabilitation. Functional independence was measured by the modified Barthel Index at mid-treatment (2 weeks) and at post-treatment (4 weeks). No significant between-group differences were found at either time point.

The fifth high quality RCT (Jiang et al., 2016) randomized patients with acute/subacute stroke to receive acupuncture (AC) + conventional rehabilitation (CR), computerized cognitive rehabilitation (COG) + CR, combined AC+COG+CR, or CR alone. Functional independence was measured at baseline and at post-treatment (12 weeks) by the FIM. Significant between-group differences were found in FIM change scores from baseline to post-treatment, favoring AC+CR vs. CR alone. There were no significant differences between AC+CR vs. COG+CR.
Note: Significant differences in FIM change scores were also found in favour of COG+CR vs. CR alone; AC+COG+CR vs. CR alone; AC+COG+CR vs. AC+CR; and AC+COG+CR vs. COG+CR.

The fair quality RCT (Hegyi & Szigeti, 2012) randomized patients with acute/subacute stroke to receive acupuncture or no acupuncture for the time of hospitalization (duration not specified); both groups received conventional physical therapy. Functional independence was measured by the Barthel Index at 2 years post-stroke. Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that acupuncture is not more effective than comparison interventions (no/placebo acupuncture, conventional rehabilitation) in improving functional independence in patients with stroke.
Note:
However, two high quality RCTs and one fair quality RCT found that acupuncture was more effective than a comparison intervention (no acupuncture, conventional rehabilitation alone) in improving functional independence in patients with stroke.

Health-related quality of life (HRQoL)
Effective
1b

One high quality RCT (Sallstrom et al., 1996; and Kjendahl et al., 1997 follow-up study) and one fair quality RCT (Hegyi & Szigeti, 2012) investigated the effect of acupuncture on HRQoL in patients with stroke.

The high quality RCT (Sallstrom et al., 1996) randomized patients with acute/subacute stroke to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. HRQoL was measured by the Nottingham Health Profile (NHP – Part I, Part II) at post-treatment (6 weeks) and at 1 year post-discharge from hospital (Kjendahl et al., 1997 follow-up study). Significant between-group differences were found at post-treatment (NHP Part I: sleep, energy) and at follow-up (NHP Part I: emotion, sleep, physical movement, energy; Part II), favoring electroacupuncture vs. no acupuncture.

The fair quality RCT (Hegyi & Szigeti, 2012) randomized patients with acute/subacute stroke to receive acupuncture or no acupuncture for the time of hospitalization (duration not specified); both groups received conventional physical therapy. HRQoL (general and physical statuses) was measured by Visual Analogue Scale at 2 years post-stroke. A significant between-group difference was found, favoring acupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that electroacupuncture is more effective than a comparison intervention (no acupuncture) in improving health-related quality of life in patients with stroke.

Insomnia
Effective
1b

One high quality RCT (Kim et al., 2004) investigated the effect of acupuncture on insomnia in patients with stroke. This high quality RCT randomized patients with stroke (stage of recovery not specified) and insomnia to receive intradermal acupuncture or sham acupuncture. Symptoms of insomnia were measured by the Morning Questionnaire (MQ – sleep latency, sleep quality, condition upon awakening, ability to concentrate, ease of falling asleep, morning sleepiness), the Insomnia Severity Index (ISI) and the Athens Insomnia Scale (AIS) at mid-treatment (1 day) and post-treatment (2 days). Significant between-group differences were found at both time points (MQ – sleep quality, condition upon awakening, ability to concentrate, morning sleepiness; ISI; AIS), favoring intradermal acupuncture vs. sham acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is more effective than a comparison intervention (sham acupuncture) in improving symptoms of insomnia in patients with stroke and insomnia.

Joint pain
Not effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effect of acupuncture on joint pain in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Joint pain was measured by the Fugl-Meyer Assessment (FMA – upper and lower extremity joint pain) at discharge from hospital. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving joint pain in patients with stroke.

Mobility
Effective
2a

One fair quality RCT (Hegyi & Szigeti, 2012) investigated the effect of acupuncture on mobility in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive acupuncture or no acupuncture for the time of hospitalization (duration not specified); both groups received conventional physical therapy. Mobility was measured by the Rivermead Mobility Index at 2 years post-stroke. Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that acupuncture is more effective than a comparison intervention (no acupuncture) in improving mobility in patients with stroke.

Motor function
Not effective
1a

Three high quality RCTs (Sallstrom et al., 1996; and Kjendahl et al., 1997 follow-up study), Alexander et al., 2004, Zhuang et al., 2012) investigated the effect of acupuncture on motor function in patients with stroke.

The first high quality RCT (Sallstrom et al., 1996) randomized patients with acute/subacute stroke to receive electroacupuncture or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the Motor Assessment Scale at post-treatment (6 weeks) and at 1 year post-discharge from hospital (Kjendahl et al., 1997 follow-up study). Significant between-group differences were found, at both time points, favoring electroacupuncture vs. no acupuncture.

The second high quality RCT (Alexander et al., 2004) randomized patients with acute/subacute stroketo receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Motor function was measured by the Fugl-Meyer Assessment (FMA-total) at discharge from hospital. No significant between-group differences were found.

The third high quality RCT (Zhuang et al., 2012) randomized patients with acute/subacute stroke to receive acupuncture, conventional rehabilitation or combined acupuncture with conventional rehabilitation. Motor function was measured by the FMA at mid-treatment (2 weeks) and at post-treatment (4 weeks). No significant between-group differences were found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than a comparison intervention (no acupuncture, conventional rehabilitation) in improving motor function in patients with stroke.
Note:
However, one high quality RCT found that acupuncture was more effective than a comparison intervention (no acupuncture) in improving motor function in patients with stroke.

Motor function - lower extremity
Effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effect of acupuncture on lower extremity motor function in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Lower extremity motor function was measured by the Fugl-Meyer Assessment (FMA – lower extremity motor function) at discharge from hospital. Significant between-group differences were found, favoring acupuncture vs. no acupuncture.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is more effective than a comparison intervention (no acupuncture) in improving lower extremity motor function in patients with stroke.

Motor function - upper extremity
Not effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effects of acupuncture on upper extremity motor function in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Upper extremity motor function was measured by the Fugl-Meyer Assessment (FMA – Upper extremity motor function) at discharge from hospital. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving upper extremity motor function in patients with stroke.

Range of motion
Not effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effect of acupuncture on range of motion in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Joint motion was measured by the Fugl-Meyer Assessment (FMA – upper/lower extremity joint motion) at discharge from hospital. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than no acupuncture in improving upper and lower extremity range of motion in patients with stroke.

Sensation
Not effective
1b

One high quality RCT (Alexander et al., 2004) investigated the effect of acupuncture on sensation in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive acupuncture for 2 weeks or no acupuncture; both groups received conventional rehabilitation. Sensation was measured by the Fugl-Meyer Assessment (FMA – upper/lower extremity sensation) at discharge from hospital. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that acupuncture is not more effective than a comparison intervention (no acupuncture) in improving sensation in patients with stroke.

Stroke outcomes
Not effective
1a

Two high quality RCTs (Schuler et al., 2005; Zhuang et al., 2012) investigated the effect of acupuncture on stroke outcomes in patients with stroke.

The first high quality RCT (Schuler et al., 2005) randomized patients with acute/subacute stroke to receive electroacupuncture or placebo acupuncture. Stroke outcomes were measured by the European Stroke Scale at post-treatment (4 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point.

The second high quality RCT (Zhuang et al., 2012) randomized patients with acute/subacute stroke to receive acupuncture, conventional rehabilitation or combined acupuncture with conventional rehabilitation. Stroke outcomes were measured by the Neurologic Defect Scale at mid-treatment (2 weeks) and at post-treatment (4 weeks). No significant between-group differences were found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that acupuncture is not more effective than comparison interventions (placebo acupuncture, conventional rehabilitation) in improving stroke outcomes in patients with stroke.

Swallowing function
Effective
2b

One fair quality RCT (Mao et al., 2016) investigated the effect of acupuncture on swallowing function in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke and dysphagia to receive acupuncture + standard swallowing training or standard swallowing training alone. Swallowing function was measured by the Video Fluoroscopic Swallowing Study (VFSS), Standardized Swallowing Assessment (SSA) and the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS) at post-treatment (4 weeks). Significant between-group differences were found in two measures of swallowing function (VSFF, SSA), favoring acupuncture + standard swallowing training vs. standard swallowing training alone.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that acupuncture with swallowing training is more effective than a comparison intervention (standard swallowing training alone) in improving swallowing function in patients with stroke.

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Liu, C. H., Hsieh, Y. T., Tseng, H. P., Lin, H. C., Lin, C. L., Wu, T. Y., … & Zhang, H. (2016). Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study. Acupuncture in Medicine34(5), 349-355.
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Mao, L. Y., Li, L. L., Mao, Z. N., Han, Y. P., Zhang, X. L., Yao, J. X., & Li, M. (2016). Therapeutic effect of acupuncture combining standard swallowing training for post-stroke dysphagia: A prospective cohort study. Chinese Journal of Integrative Medicine22(7), 525-531.
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Min, M., Xin, C., Yuefeng, C., Ping, R., & Jian, L. (2008). Stage-oriented comprehensive acupuncture treatment plus rehabilitation training for apoplectic hemiplegia. Journal of Traditional Chinese Medicine28(2), 90-93.
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Mukherjee M., McPeak L.K., Redford J. B., Sun C., & Liu W. (2007). The effect of electro-acupuncture on spasticity of the wrist joint in chronic stroke survivors. Archives of Physical Medicine and Rehabilitation, 88, 159-166.
https://www.ncbi.nlm.nih.gov/pubmed/17270512

Naeser M.A., Alexander M.P., Stiassny-Eder D., Galler V., Hobbs J., & Bachman D. (1992). Real versus sham acupuncture in the treatment of paralysis in acute stroke patients: a CT scan lesion site study. Journal of Neuroengineering and Rehabilitation 6(4), 163-173.
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Park J., White A.R., James M.A., Hemsley A.G., Johnson P., Chambers J., & Ernst E. (2005). Acupuncture for subacute stroke rehabilitation. A sham-controlled, subject and assessor-blind, randomized trial. Archives of Internal Medicine, 165, 2026-2031.
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Pei, J., Sun, L., Chen, R., Zhu, T., Qian, Y., & Yuan, D. (2001). The effect of electro-acupuncture on motor function recovery in patients with acute cerebral infarction: a randomly controlled trial. Journal of Traditional Chinese Medicine21(4), 270-272.
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Sallstrom S., Kjendahl A., Osten P.E., Stanghelle J.H., & Borchgrevink C.F. (1996). Acupuncture in the treatment of stroke patients in the subacute stage: a randomized, controlled study. Complementary Therapies in Medicine, 4, 193-197.
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Aerobic Exercise

Evidence Reviewed as of before: 30-05-2021
Author(s)*: Tatiana Ogourtsova, PhD OT; Adam Kagan, B.Sc; Anita Petzold, BSc OT; Nathalie Serrat, BSC PT; Amanda Ischayek BSc PT; Sabrina Ianni, BSc, PT; Caroline Labelle, BSc PT; Sukhdeep Johal, Bsc PT; Monica Trozzo BSc. PT; Elissa Sitcoff, BA BSc; Annabel McDermott, OT; Nicol Korner-Bitensky, PhD OT
Expert Reviewer: Janice Eng, PhD PT; Pamela Duncan, PhD PT(C)
Patient/Family Information Table of contents

Introduction

It has been shown that patients with stroke have been shown to have low endurance during exercise, likely due to both the event and also as a secondary reaction to forced inactivity. It is also known that there is a positive connection between aerobic capacity and functional performance (Katz-Leurer et al. 2003).

Click here to view the AEROBICS 2019 Update Best Practice Recommendations.

Click here to access the Canadian Partnership for Stroke Recovery (CPSR) 2013 Clinicians’ guide.

Click here to access the CPSR 2013 Patients’ guide.

Patient/Family Information

Authors*: Erica Kader; Adam Kagan, B.Sc.; Nathalie Serrat, BSC PT; Amanda Ischayek BSc PT; Sabrina Ianni, BSc, PT; Caroline Labelle, BSc PT; Sukhdeep Johal, Bsc PT; Monica Trozzo BSc. PT; Elissa Sitcoff, BA BSc; Nicol Korner-Bitensky, PhD OT NOTE: *The authors have no direct financial interest in any tools, tests or interventions presented in StrokEngine.

What is aerobic exercise?

Aerobic exercise refers to physical activity that requires the body to use oxygen to generate energy. Participating in aerobic exercise is important to maintain a healthy body. A major benefit of aerobic exercise is that it conditions the heart and lungs. It does so by increasing the oxygen available to the body and enabling the heart to use oxygen more efficiently. In addition, aerobic exercise can also control body fat, increase energy, decrease tension, increase stamina, and improve mood. There are several different types of aerobic exercises that can be done at different levels of intensity for varying periods of time. Any activity that lasts longer than 3 minutes is considered aerobic (such as golf, biking, walking, and swimming).
Note: While other forms of exercises (such as those focused on flexibility and muscles training) are equally important, only those focusing on aerobic exercise will be addressed in this module.

Why is exercise important after I have had a stroke?

After a stroke, it is common to experience continued difficulties in mobility, for example in walking. It is important to continue to exercise despite these challenges to avoid a vicious cycle, where difficulty in mobility leads to lack of exercise, and lack of exercise leads to further muscle weakening and reduced fitness. Inactivity can contribute to physical complications, including osteoporosis and decreased circulation. It can also lead to loss of independence, depression, and social isolation. The more inactive you are, the harder it is to maintain cardiovascular, mental, and neurological health.

How do I begin to exercise after a stroke?

Before beginning an exercise program, it is recommended that you undergo a comprehensive medical evaluation to assess your specific needs. Your medical or rehabilitation team can work with you to develop an appropriate exercise regime (including types of activities, how often you should participate in activities and for how long) based on your individual needs and abilities.

What kind of activities should I do?

You should pick an activity that you will have fun doing. Examples of aerobic exercise activities include:

  • Golf
  • Walking
  • Dancing – With permission of Dr. Patricia McKinley, McGill School of Physical and Occupational Therapy
  • Swimming
  • Cycling
  • Tennis
  • Bowling

Gardening and housework are also great forms of aerobic exercise. Try adding exercise to your daily routine, for example, parking your car further away from your destination. Any form of physical activity can be beneficial as long as it is done regularly and consistently.

When it comes to bicycling, many people find it difficult or are afraid to fall. This problem can be solved by using a stationary bicycle. Stationary bicycles are a safe and effective means of low-impact, or light, aerobic exercise, so they are a good choice for people who have had a stroke. They can also be altered to fit your individual needs.

Treadmills are also helpful for walking, providing that there is a bar to hold on to, and a way to modify speed and intensity. A treadmill is especially useful to retrain people who have had a stroke to walk again.

Can I participate in the same exercise as before?

After a stroke, it may be difficult to resume the same activities that you enjoyed before. You may need to change your previous exercise regime, which may mean discovering new exercise activities that are perhaps less physically demanding. Things that you may need to modify are:

  • The level of difficulty of exercise
  • Length of time you exercise
  • How often you exercise

These will depend on your needs and abilities and should be assessed by a rehabilitation team. Certain equipment can also be used to facilitate exercising, such as handrails and assistive devices. For example, you may enjoy swimming but may need to find a pool that has special safety equipment and adaptations.

Who can help me resume my exercise activities?

While rehabilitation staff, such as occupational therapists, physiotherapists, social workers, recreation therapists, and psychologists will start you on your new exercise program, your family and friends are an excellent source of support to help you continue with success. Exercising with a friend or family member is motivating, encouraging, and of course more fun.

How much exercise should I do?

According to the American Heart Association, the recommended frequency of training is 3 to 7 days a week, with a duration of 20 to 60 minutes per day, depending on the patient’s level of fitness. ** Once again, however, it is very important that you seek medical advice before beginning an exercise program and get advice on how often and for how long you should be doing the activities.

Where can I participate in exercise?

While in the hospital or rehabilitation centre, you will participate in exercise programs developed and assisted by your rehabilitation team. When you are ready to go home, the team may show you how to continue with this exercise on your own, may recommend that you join an exercise program, or a combination of the two. Day centers, local community centers, and gyms in your area may be able to provide appropriate programs and support that you need.

Is it effective after stroke?

Experts have done some experiments to compare aerobic exercise with other treatments to see whether it helps people who have had a stroke.

In individuals with ACUTE stroke (< 4 weeks after stroke)

Studies found that aerobic exercise:

  • Was more helpful than the other treatments for improving awareness about stroke and walking endurance (i.e. your physical tolerance when walking).
  • Was as helpful as other treatments for improving cardiovascular fitness parameters (e.g. your blood pressure); quality of life; mood and affect (e.g. symptoms of depression and/or anxiety); and physical activity.

In individuals with CHRONIC stroke (> 6 months after stroke)

Studies found that aerobic exercise:

  • Was more helpful than the other treatments for improving cognitive function (e.g. memory, attention); grip strength; quality of life; walking endurance (i.e. physical tolerance when walking); and walking speed.
  • Was as helpful as other treatments for improving balance; cardiovascular fitness parameters (e.g. your blood pressure); executive functions (e.g. your ability to plan and sequence tasks); functional independence (i.e. your ability to perform tasks of daily life such as dressing and washing); mobility (walking, going up/down the stairs); mood and affect (e.g. symptoms of depression and/or anxiety); the strength of your leg muscles; and physical activity.

In individuals with stroke (unspecified time period post-stroke)

Studies found that aerobic exercise:

  • Was more helpful than the other treatments for improving balance; cardiovascular fitness parameters (e.g. your blood pressure); functional independence (your ability to perform tasks of everyday life such as dressing and washing); quality of life; the function of your legs and overall function of your body; spasticity (the tone of your muscles); walking endurance (your physical tolerance when walking); and walking speed.
  • Was as helpful as other treatments for improving cognitive abilities (e.g. memory, attention); dexterity (ability to manipulate small objects with your fingers); capacity to exercise; executive function (e.g. your ability to plan and sequence tasks); depression; fatigue; mobility (ability to move around); muscle strength; and the quality of sleep.

Are there any side effects or risks?

While exercise is mostly risk-free, it is important to stay within your own personal threshold. As mentioned before, it is best to consult with your doctor or therapist before beginning an exercise program. They will assist you in determining how often you should exercise, what activities you should participate in, and how intense they should be. If you were physically active before the stroke, you may or may not be able to continue with the same activities. You may simply need to modify those activities so they are easier for you. If you feel dizzy, have pain (especially in your chest) or have difficulty breathing, stop exercising immediately and tell your healthcare provider.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.
Note: It is often difficult to say with absolute certainty whether a particular exercise intervention is “aerobic” in nature. In this module we include only those studies that had a clear aerobic exercise intervention. Specifically only those that included an outcome examining the effect of exercise on aerobic capacity (peak VO2, peak workload and peak heart rate during some sort of maximal aerobic test) were considered. Many of these studies also examined functional, physical and emotional outcomes and these results are included. As well, many studies to date that have examined the effect of aerobic exercise featured a “cocktail” of different types of treatment (e.g. strength training, flexibility training as well as a strong aerobic training component) so it is important to note that the effects of these interventions may be due in part to the combination of different treatments and not the aerobic component specifically.

This module focuses on aerobic exercise for people who have had a stroke. This module contains 16 studies, where 11 of them are of high quality. Three studies report effects of aerobic exercise for individuals early in their stroke recovery period (1 month or less after stroke). Nine studies report effects of aerobic exercise for individuals in their chronic stroke period (6 months or more after stroke). Four studies report effects of aerobic exercise for individuals after stroke with unspecified period.

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Results Table

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Outcomes

Acute phase

Cardiovascular fitness parameters
Not effective
1b

One high quality RCT (Wijkman et al., 2017) investigated the effect of aerobic exercise on cardiovascular fitness parameters in the acute phase of stroke recovery. This high quality RCT randomized patients to receive aerobic exercise or no scheduled physical exercise. Cardiovascular fitness parameters [Resting diastolic blood pressure, Resting systolic blood pressure (SBP), Peak SBP, Difference in SBP (peak – resting), Resting heart rate, Peak heart rate, Difference in heart rate (peak – resting), Aerobic capacity work rate] were measured by ergometer exercise test at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (usual care without scheduled physical exercise) in improving cardiovascular fitness parameters in the acute phase of stroke recovery.

Health-related quality of life
Conflicting
4

Two high quality RCTs (Faulkner et al., 2015; Moren et al., 2016) investigated the effect of aerobic exercise on health-related quality of life (HRQoL) in the acute phase of stroke recovery.

The first high quality RCT (Faulkner et al., 2015) randomized patients to receive a resistance exercise and education program or written information. HRQoL was measured by the Short-Form 36 (SF-36: Physical component score, Mental component score, Mental health, Social functioning, Global health, Role physical, Role emotional, Vitality, Bodily pain, Physical functioning) at post-treatment (8 weeks) and follow-up (12 months). Significant between-group differences were found in change scores from baseline to post-treatment in some components of HRQoL (Physical component score, Global health, Role physical, Vitality, Physical Functioning), favouring exercise + education vs. written information. Differences did not remain significant at follow-up.

The second high quality RCT (Moren et al., 2016) randomized patients to receive physical activity or no treatment; both groups received usual care. HRQoL was measured by the EuroQoL 5 Dimension Visual Analogue Scale at follow-up (3 and 6 months). No significant between-group difference was found at either time point.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of aerobic exercise on HRQoL in the acute phase of stroke recovery. While one high quality RCT found that an exercise + education program was more effective than written information alone, another high quality RCT found that physical activity was not more effective than no treatment.
Note:
Differences in outcome measures may explain the conflicting findings.

Mood and affect
Not effective
1b

One high quality RCT (Faulkner et al., 2015) investigated the effect of aerobic exercise on mood and affect in the acute phase of stroke recovery. This high quality RCT randomized patients to receive a resistance exercise and education program or written information. Mood and effect were measured by the Hospital Anxiety and Depression Scale (HADS: Anxiety, Depression) and the Profile and Mood States (PMS: Vigour, Depression, Confusion, Tension, Anger, Fatigue) at post-treatment (8 weeks) and follow-up (12 months). A significant between-group difference was found in change scores from post-treatment to follow-up in one measure (PMS: Fatigue), favouring exercise + education vs. written information. No other significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (written information) in improving mood and affect in the acute phase of stroke recovery.

Physical activity
Not Effective
1a

Two high quality RCTs (Faulkner et al., 2015; Moren et al., 2016) investigated the effect of aerobic exercise on physical activity in the acute phase of stroke recovery.

The first high quality RCT (Faulkner et al., 2015) randomized patients to receive a resistance exercise and education program or written information. Physical activity was measured by the International Physical Activity Questionnaire (IPAQ: Leisure time walk activity, Leisure time moderate activity, Leisure time vigorous activity, Total leisure time activity, Sitting time) at post-treatment (8 weeks) and follow-up (12 months). No significant between-group difference was found at either time point.

The second high quality RCT (Moren et al., 2016) randomized patients to receive physical activity or no treatment; both groups received usual care. Physical activity was measured by the Physical Activity of Moderate to Higher Intensity (MVPA) and number of steps per day at follow-up (3 and 6 months). No significant between-group differences were found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that aerobic exercise is not more effective than a comparison intervention (written information) or no treatment in improving physical activity in the acute phase of stroke recovery.

Sroke awareness
Effective
1b

One high quality RCT (Faulkner et al., 2015) investigated the effect of aerobic exercise on stroke awareness in the acute phase of stroke recovery. This high quality RCT randomized patients to receive a resistance exercise and education program or written educational material. Stroke awareness was measured by the Stanford Medical Centre Stroke Awareness Questionnaire (SMCSAQ) at post-treatment (8 weeks) and follow-up (12 months). A significant between-group difference was found in change scores from baseline to post-treatment, favouring exercise + education vs. written educational material. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (written educational material) in improving stroke awareness in the acute phase of stroke recovery.

Walking endurance
Effective
1b

One high quality RCT (Moren et al., 2016) investigated the effect of aerobic exercise on walking endurance in the acute phase of stroke recovery. This high quality RCT randomized patients to receive physical activity or no treatment; both groups received usual care. Walking endurance was measured by the 6 Minute Walk Test at follow-up (3 and 6 months). A significant between-group difference was found at 6-month follow-up, favouring physical activity vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that physical activity is more effective than no treatment in improving long-term walking endurance of patients in the acute phase of stroke recovery.

Chronic phase

Balance
Conflicting
4

Four high quality RCTs (Pang et al., 2005; Liu-Ambrose & Eng, 2015; Lee et al., 2015; Moore et al., 2015) and one fair quality RCT (Lund et al., 2018) investigated the effect of aerobic exercise on balance in the chronic stage of stroke recovery.

The first high quality RCT (Pang et al., 2005) randomized patients to receive a community-based fitness and mobility exercise program (FAME) or a seated upper extremity program. Balance was measured by the Berg Balance Scale (BBS) at post-treatment (19 weeks). No significant between group difference was found.

The second high quality RCT (Liu-Ambrose & Eng, 2015) randomized patients to receive the FAME program or usual care. Balance was measured by the BBS at mid-treatment (3 months) and post-treatment (6 months). No significant between group difference was found at either time point.

The third high quality RCT (Lee et al., 2015) randomized patients to receive aerobic + resistance exercise training or light physical activity. Balance was measured by the Chair Sit and Reach Test and the Functional Reach Test at post-treatment (16 weeks). Significant between-group differences were found in both measures of balance, favouring aerobic + resistance exercise training vs. light physical activity.

The fourth high quality RCT (Moore et al., 2015) randomized patients to receive a fitness and mobility exercise program (adapted from the FAME program) or time-matched stretching. Balance was measured by the BBS at post-treatment (19 weeks). A significant between-group difference was found, favouring the fitness and mobility exercise program vs. stretching.

The fair quality RCT (Lund et al., 2018) randomized patients to receive aerobic training, resistance training or upper extremity training. Balance was measured by the BBS at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is conflicting evidence (Level 4) regarding the effectiveness of aerobic exercise in improving balance in the chronic stage of stroke recovery. While two high quality RCTs found that the FAME exercise program was not more effective than comparison interventions (seated upper extremity program, usual care), two high quality RCTs found that other aerobic exercise programs (aerobic + resistance exercise training, exercises adapted from the FAME program) were more effective than comparison interventions (light physical activity, stretching).

Cardiovascular fitness parameters
Conflicting
4

Five high quality RCTs (Pang et al., 2005; Gordon, Wilks & McCaw-Binns, 2013; Tang et al., 2014 and 2016; Lee et al., 2015; Moore et al., 2015) and two fair quality RCTs (Severinsen et al., 2014; Lund et al., 2018) investigated the effect of aerobic exercise on cardiovascular fitness parameters in the chronic stage of stroke recovery.

The first high quality RCT (Pang et al., 2005) randomized patients to receive a community-based fitness and mobility exercise program (FAME) or a seated upper extremity program. Maximal oxygen consumption was measured by the maximal exercise test on the Excalibur cycle ergometer at post-treatment (19 weeks). A significant between-group difference was found, favouring the FAME program vs. seated upper extremity exercises.

The second high quality RCT (Gordon, Wilks & McCaw-Binns, 2013) randomized patients to receive aerobic exercise or massage. Resting heart rate was measured by heart monitor at post-treatment (12 weeks) and follow-up (3 months). A significant between-group difference was found at follow-up only, favouring aerobic exercise vs. massage.

The third high quality RCT (Tang et al., 2014; 2016) randomized patients to receive aerobic training or balance/flexibility training. Peak oxygen consumption was measured by graded maximal exercise test using a leg cycle ergometer at post-treatment (6 months). No significant between-group difference was found.

The fourth high quality RCT (Lee et al., 2015) randomized patients to receive aerobic + resistance exercise training or light physical activity. Cardiovascular parameters (peripheral systolic blood pressure (SBP) / diastolic blood pressure (DBP), central SBP / DBP, Pulse Wave Velocity (PWV), Augmentation Index – AIx@75) were measured at post-treatment (16 weeks). Significant between-group differences were found for three cardiovascular fitness parameters (central DBP, PWV, AIx@75), favouring aerobic + resistance training vs. light physical activity.

The fifth high quality RCT (Moore et al., 2015) randomized patients to receive a fitness and mobility exercise program or time-matched stretching. Cardiovascular parameters (Peak oxygen consumption, Peak work rate, SBP, DBP) were measured by the maximal progressive recumbent bicycle exercise test and the semi-automated sphygmomanometer at post-treatment (19 weeks). Significant between-group differences were found for three cardiovascular fitness parameters (Peak oxygen consumption, Peak work rate, DBP), favouring the fitness and mobility exercise program vs. stretching.

The first fair quality RCT (Severinsen et al., 2014) randomized patients to receive aerobic training, resistance training or upper extremity training. Peak aerobic capacity (VO2 peak) was measured by the maximal progressive stepwise cycle ergometer test at post-treatment (12 weeks) and at follow-up (6 months). Significant between-group differences were found at post-treatment, favouring aerobic training vs. resistance training and aerobic training vs. upper extremity training; differences were not maintained at follow-up.

The second fair quality RCT (Lund et al., 2018) randomized patients to receive aerobic training, resistance training or upper extremity training. Cardiovascular fitness parameters (peak oxygen update, resting HR, maximal HR) were measured by the maximal progressive cycle ergometer test and a heart rate monitor at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is conflicting evidence (Level 4) regarding the effectiveness of aerobic exercise programs on cardiovascular fitness in the chronic phase of stroke recovery. While three high quality RCTs and one fair quality RCT found that aerobic exercise programs were more effective than comparison interventions (seated upper extremity exercises, light physical activity, stretching, resistance training, upper extremity training), two high quality RCTs* and one fair quality RCT found that aerobic exercise programs were not more effective than comparison interventions (massage, balance/flexibility training, upper extremity training).
*Note:
One of the high quality RCTs found that aerobic exercises were more effective than massage in the long-term.

Cognition
Effective
1b

One high quality RCT (Moore et al., 2015) investigated the effect of aerobic exercise on cognition in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive a fitness and mobility exercise program or stretching. Cognition was measured by the Addenbrooke’s Cognitive Examination Revised at post-treatment (19 weeks). A significant between-group difference was found, favouring the fitness and mobility exercise program vs. stretching.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (stretching) in improving cognition in the chronic stage of stroke recovery.

Executive functions
Conflicting
4

Two high quality RCTs (Tang et al., 2014 & 2016; Liu-Ambrose & Eng, 2015) investigated the effect of aerobic exercise on executive functions in the chronic stage of stroke recovery.

The first high quality RCT (Tang et al., 2014 & 2016) randomized patients to receive aerobic training or balance/flexibility training. Executive functions were measured by the Verbal Digit Span Test Forward & Backward (working memory), Trail Making Test B (set shifting), and Colour-Word Stroop Test (selective attention and conflict resolution) at post-treatment (6 months). No significant between-group differences were found.

The second high quality RCT (Liu-Ambrose & Eng, 2015) randomized patients to receive a community-based Fitness and Mobility Exercise (FAME) program or usual care. Executive functions were measured by the Stroop Test (selective attention and conflict resolution), Trail Making Tests – Part A and B (set shifting) and verbal digit span forward/backward test (working memory) at mid-treatment (3 months) and post-treatment (6 months). At mid-treatment a significant between-group difference was found in one measure of executive functions (Trail Making Tests), favouring the FAME program vs. usual care. At post-treatment significant between-group differences were found in two measures of executive functions (Stroop Test; verbal digit span forward/backward test), favouring the FAME program vs. usual care.

Conclusion: There is conflicting evidence (Level 4) regarding the effectiveness of aerobic exercise in improving executive functions in the chronic stage of stroke recovery. One high quality RCT found that aerobic training was not more effective than a balance/flexibility program, whereas another high quality RCT found that aerobic exercise was more effective than usual care.

Functional independence
Not effective
1b

One high quality RCT (Gordon, Wilks & McCaw-Binns, 2013) investigated the effect of aerobic exercise on functional independence in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive aerobic exercise or massage. Functional independence was measured by the Barthel Index at post-treatment (12 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (massage) in improving functional independence in the chronic stage of stroke recovery.

Functional status and service use
Not effective
1b

One high quality RCT (Gordon, Wilks & McCaw-Binns, 2013) investigated the effect of aerobic exercise on functional status and service use in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive aerobic exercise or massage. Functional status and service use were measured by the Older Americans Resources and Services at post-treatment (12 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (massage) in improving functional status and service use in the chronic stage of stroke recovery.

Grip strength
Effective
1b

One high quality RCT (Lee et al., 2015) investigated the effect of aerobic exercise on grip strength in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive aerobic + resistance exercise training or light physical activity. Grip strength of the unaffected hand was measured by handheld dynamometer at post-treatment (16 weeks). A significant between-group difference was found, favouring aerobic + resistance exercise training vs. light physical activity.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise with resistance training is more effective than a comparison intervention (light physical activity) in improving grip strength of the unaffected hand in the chronic stage of stroke recovery.

Health-related quality of life
Effective
1b

One high quality RCTs (Gordon, Wilks & McCaw-Binns, 2013) investigated the effect of aerobic exercise on health-related quality of life (HRQoL) in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive aerobic exercise or massage. HRQoL was measured by the Short-Form-36 (SF-36: Physical health component, Mental health component) at post-treatment (12 weeks) and follow-up (3 months). A significant between-group difference was found at post-treatment (SF-36: Physical health component), favouring aerobic exercise vs. massage.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (massage) in improving health-related quality of life in the chronic stage of stroke recovery.
Note:
Between-group differences were only significant for one measure of health-related quality of life.

Mobility
Not effective
1b

One high quality RCT (Lee et al., 2015) investigated the effect of aerobic exercise on mobility in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive aerobic and resistance exercise training or light physical activity. Mobility was measured by the Timed Up and Go Test at post-treatment (16 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (light physical activity) in improving mobility in the chronic stage of stroke recovery.

Mood and affect
Not effective
1b

One high quality RCT (Liu-Ambrose & Eng, 2015) investigated the effect of aerobic exercise on mood and affect in the chronic stage of stroke recovery. This high quality RCT randomized patients to receive a community-based Fitness and Mobility Exercise (FAME) program or usual care. Mood and affect were measured by the 17-item Stroke Specific Geriatric Depression Scale at mid-treatment (3 months) and post-treatment (6 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is not more effective than a comparison intervention (usual care) in improving mood and affect in the chronic stage of stroke recovery.

Muscle strength - lower extremities
Conflicting
4

Three high quality RCTs (Pang et al., 2005; Gordon, Wilks & McCaw-Binns, 2013; Lee et al., 2015) and two fair quality RCTs (Severinsen et al., 2014; Lund et al., 2018) investigated the effect of aerobic exercise on lower extremities muscle strength in the chronic stage of stroke recovery.

The first high quality RCT (Pang et al., 2005) randomized patients to receive a community-based fitness and mobility exercise program (FAME) or a seated upper extremity program. Isometric knee extension (paretic, non-paretic) was measured by dynamometer at post-treatment (19 weeks). A significant between group difference was found, favouring the FAME program vs. seated upper extremity exercises.

The second high quality RCT (Gordon, Wilks & McCaw-Binns, 2013) randomized patients to receive aerobic exercise or massage. Lower extremity strength (paretic, non-paretic) was measured by the Motricity Index at post-treatment (12 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

The third high quality RCT (Lee et al., 2015) randomized patients to receive aerobic + resistance exercise training or light physical activity. Lower extremity strength was measured by the 30-sec Chair Stand Test at post-treatment (16 weeks). A significant between-group difference was found, favouring aerobic + resistance exercise training vs. light physical activity.

The first fair quality RCT (Severinsen et al., 2014) randomized patients to receive aerobic training, resistance training or upper extremity training. Maximal isometric knee strength (paretic, non-paretic) was measured by dynamometer at post-treatment (12 weeks) and follow-up (6 weeks). A significant between-group difference in knee strength (paretic, non-paretic) was found at post-treatment, favouring resistance training vs. aerobic training; this between-group difference was maintained at follow-up. There was no significant difference in knee strength between aerobic training vs. upper extremity training.
Note: A significant between-group difference in knee strength (non-paretic only) was found at post-treatment, favouring resistance training vs. upper extremity exercises; this difference was maintained at follow-up.

The second fair quality RCT (Lund et al., 2018) randomized patients to receive aerobic training, resistance training or upper extremity training. Knee strength (paretic, non-paretic) was measured by dynamometer at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is conflicting evidence (Level 4) regarding the effectiveness of aerobic exercise on lower extremity strength in the chronic stage of stroke recovery. While two high quality RCTs found that aerobic exercise was more effective than comparison interventions (seated upper extremity program, light physical activity), one high quality RCT and two fair quality RCTs found that aerobic exercise was not more effective than comparison interventions (massage, upper extremity training, resistance training).
Note
: In fact, one of the fair quality RCTs found that resistance training was more effective than aerobic training for improving knee strength.

Physical activity
Not effective
1b

One high quality RCT (Pang et al., 2005) and one fair quality RCT (Shaughnessy, Michael & Resnick, 2012) investigated the effect of aerobic exercise on physical activity in the chronic stage of stroke recovery.

The high quality RCT (Pang et al., 2005) randomized patients to receive a community-based fitness and mobility exercise program (FAME) or a seated upper extremity program. Physical activity was measured by the Physical Activity Scale for Individuals with Physical Disabilities at post-treatment (19 weeks). No significant between group difference was found.

The fair quality RCT (Shaughnessy, Michael & Resnick, 2012) randomized patients to receive aerobic treadmill training or stretching. Physical activity was measured by the Yale Physical Activity Survey (YPAS: Housework, Yard work, Caretaking, Moderate physical activity, Recreational activities) at post-treatment (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that aerobic exercise is not more effective than comparison interventions (seated upper extremity program, stretching) in improving physical activity in the chronic stage of stroke recovery.

Self-efficacy and expectations
Not effective
2a

One fair quality RCT (Shaughnessy, Michael & Resnick, 2012) investigated the effect of aerobic exercise on self-efficacy & expectations in the chronic stage of stroke recovery. This fair quality RCT randomized patients to receive aerobic treadmill training or stretching. Self-efficacy & expectations were measured by Short Self-Efficacy and Outcomes Expectations for Exercises (Outcome expectations; Self-efficacy) at post-treatment (6 months). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (stretching) in improving self-efficacy & expectations in the chronic stage of stroke recovery.

Stroke outcomes
Not effective
1b

One high quality RCT (Moore et al., 2015) and one fair quality RCT (Shaughnessy, Michael & Resnick, 2012) investigated the effect of aerobic exercise on stroke outcomes in the chronic stage of stroke recovery.

The high quality RCT (Moore et al., 2015) randomized patients to receive a fitness and mobility exercise program or time-matched stretching. Stroke outcomes were measured by the Stroke Impact Scale (SIS: Stroke recovery, Mood, Strength, Memory, Communication, Activities of daily living, Community mobility, Hand function, Participation, Physical total) at post-treatment (19 weeks). A significant between-group difference was found in only one measure (SIS: Mood), favouring the fitness and mobility exercise program vs. stretching.

The fair quality RCT (Shaughnessy, Michael & Resnick, 2012) randomized patients to receive aerobic treadmill training or stretching. Stroke outcomes were measure by the SIS (Strength, Hand function, Activities of daily living, Mobility, Communication, Emotion, Memory and thinking, Participation, Overall sum, Recovery visual analogue scale) at post-treatment (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (stretching) in reducing stroke outcomes in the chronic stage of stroke recovery.

Walking endurance
Effective
1a

Six high quality RCTs (Pang et al., 2005; Gordon, Wilks & McCaw-Binns, 2013; Tang et al., 2014 & 2016; Lee et al., 2015; Liu-Ambrose & Eng, 2015; Moore et al., 2015) and 2 fair quality RCTs (Severinsen et al., 2014; Lund et al., 2018) investigated the effect of aerobic exercise on walking endurance in the chronic stage of stroke recovery.

The first high quality RCT (Pang et al., 2005) randomized patients to receive a community-based fitness and mobility exercise program (FAME) or a seated upper extremity program. Walking endurance was measured by the 6-Minute Walk Test (6MWT) at post-treatment (19 weeks). A significant between-group difference was found, favouring the FAME program vs. seated upper extremity exercises.

The second high quality RCT (Gordon, Wilks & McCaw-Binns, 2013) randomized patients to receive aerobic exercise or massage. Walking endurance was measured by the 6MWT at post-treatment (12 weeks) and follow-up (3 months). No significant between-group differences were found at either time point.

The third high quality RCT (Tang et al., 2014; 2016) randomized patients to receive aerobic training or balance/flexibility training. Walking endurance was measured by the 6MWT at post-treatment (6 months). No significant between-group difference was found.

The fourth high quality RCT (Lee et al., 2015) randomized patients to receive aerobic + resistance exercise training or light physical activity. Walking endurance was measured by the 6MWT at post-treatment (16 weeks). A significant between-group difference was found, favouring aerobic + resistance exercise training vs. light physical activity.

The fifth high quality RCT (Liu-Ambrose & Eng, 2015) randomized patients to receive the FAME program or usual care. Walking endurance was measured by the 6MWT at mid-treatment (3 months) and post-treatment (6 months). A significant between-group difference was found at post-treatment, favouring the FAME program vs. usual care.

The sixth high quality RCT (Moore et al., 2015) randomized patients to receive a fitness and mobility exercise program or time-matched stretching. Walking endurance was measured by the 6MWT at post-treatment (19 weeks). A significant between-group difference was found, favouring the fitness and mobility exercise program vs. stretching.

The first fair quality RCT (Severinsen et al., 2014) randomized patients to receive aerobic training, resistance training or upper extremity training. Walking endurance was measured by the 6MWT at post-treatment (12 weeks) and at follow-up (6 months). No significant between-group differences were found.

The second fair quality RCT (Lund et al., 2018) randomized patients to receive aerobic training, resistance training or upper extremity training. Walking endurance was measured by the 6MWT at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from four high quality RCTs that aerobic exercise is more effective than comparison interventions (seated upper extremity program, light physical activity, usual care, stretching) in improving walking endurance in the chronic stage of stroke recovery.
Note
: However, two high quality RCTs and two fair quality RCTs found that aerobic exercise was not more effective than comparison interventions (massage, balance/flexibility training, resistance training, upper extremity training).

Walking speed
Effective
1a

Two high quality RCTs (Lee et al., 2015; Moore et al., 2015) and two fair quality RCTs (Severinsen et al., 2014; Lund et al., 2018) investigated the effect of aerobic exercise on walking speed in the chronic stage of stroke recovery.

The first high quality RCT (Lee et al., 2015) randomized patients to receive aerobic + resistance exercise training or light physical activity. Walking speed was measured by the 10 Meter Walk Test (10mWT) at post-treatment (16 weeks). A significant between-group difference was found, favouring aerobic + resistance exercise training vs. light physical activity.

The second high quality RCT (Moore et al., 2015) randomized patients to receive a fitness and mobility exercise program or time-matched stretching. Walking speed was measured by the 10mWT at post-treatment (19 weeks). A significant between-group difference was found, favouring the fitness and mobility exercise program vs. stretching.

The first fair quality RCT (Severinsen et al., 2014) randomized patients to receive aerobic training, resistance training or upper extremity training. Walking speed was measured by the 10mWT at post-treatment (12 weeks) and at follow-up (6 months). No significant between-group differences were found at post-treatment. Significant between-group differences were found at follow-up, favouring resistance training vs. aerobic training, and upper extremity training vs. aerobic training.

The second fair quality RCT (Lund et al., 2018) randomized patients to receive aerobic training, resistance training or upper extremity training. Walking speed was measured by the 10mWT at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that aerobic exercise is more effective than comparison interventions (light physical activity, stretching) in improving walking speed in the chronic stage of stroke recovery.
Note: Two fair quality RCTs found that aerobic exercise was not more effective than comparison interventions (resistance training, upper extremity training). In fact, one fair quality RCT found that both resistance training and upper extremity training were more effective than aerobic exercise for improving walking speed.

Phase not specific to one period

Balance
Effective
1b

One high quality RCT (Sandberg et al., 2016) and one quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on balance in patients with stroke.

The high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. Balance was measured by the Single Leg Stance Test (SLST: Right/left with eyes closed/open) at post-treatment (12 weeks). A significant between-group difference was found for three measures of balance (SLST: Right leg eyes open, Right leg eyes closed, Left leg eyes open), favouring aerobic exercise program vs. no exercise program.

The quasi-experimental design study (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Balance was measured by the Step Test (Right, Left) at post-treatment (12 weeks). A significant between-group difference was found on both measures of balance, favouring the aerobic exercise program vs. usual care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one quasi-experimental study that aerobic exercise is more effective than comparison interventions (no exercise program, usual care) in improving balance in patients with stroke.

Cardiovascular fitness parameters
Effective
1a

Two high-quality RCTs (Wang et al., 2014; Sandberg et al., 2016) and one quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on cardiovascular fitness parameters in patients with stroke.

The first high quality RCT (Wang et al., 2014) randomized patients with subacute/chronic stroke to receive low-intensity aerobic training or no training; both groups received conventional rehabilitation. Cardiovascular fitness parameters (Resting heart rate (RHR), Peak heart rate (PHR), Exercise test time) were measured at post-treatment (6 weeks). A significant between-group difference was found on one measure (exercise test time), in favour of aerobic training vs. no aerobic training.

The second high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. A cardiovascular fitness parameter (Peak work rate) was measured by the symptom-limited graded cycle ergometer test at post-treatment (12 weeks). A significant between-group difference was found, favouring aerobic exercise program vs. no exercise program.

The quasi-experimental design study (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Cardiovascular fitness parameters (Vo2peak absolute, Vo2peak relative, HR, R-value) were measured during the 6 Minute Walk Test (6MWT), Shuttle Walk Test and Cycle Progressive Exercise Test (also Duration, Workload measures) at post-treatment (12 weeks). A significant between-group difference was found in one parameter (6MWT: Vo2peak absolute, relative), favouring an aerobic exercise program vs. usual care.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and one quasi-experimental study that aerobic exercise is more effective than no treatment for improving some cardiovascular fitness parameters (e.g. exercise test time, peak work rate, peak oxygen uptake) in patients with stroke.

Cognition
Not effective
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on cognition in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Cognition was measured by the Montreal Cognitive Assessment at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between group difference was found at any time point.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving cognition in patients with stroke.

Depression
Not effective
2b

One fair quality RCT (Nave et al., 2019) and one quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on depression in patients with stroke.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Depression was measured by the Centre for Epidemiological Studies Depression at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group differences were found at any time points.

The quasi-experimental design study (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Depression was measured by the Patient Health Questionnaire-9 at post-treatment (12 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT and one quasi-experimental study that aerobic exercise is not more effective than comparison interventions (relaxation, usual care) in reducing depression in patients with stroke.

Dexterity
Not effective
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on dexterity in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Dexterity was measured by the Box and Block Test at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group differences were found at any time points.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving dexterity in patients with stroke.

Executive functions
Not effective
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on executive functions in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Executive functions were measured by the Trail Making Test (TMT – A, B) at post-treatment (4 weeks) and follow-up (3, 6 months) and the Regensburger Wort-Flüssigkeits-Test at follow-up (3 months). No significant between group differences were found on any of the measures at any time point.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving executive functions in patients with stroke.

Exercise capacity
Not effective
2b

One quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on exercise capacity in patients with stroke. This quasi-experimental design study assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Exercise capacity was measured by the Shuttle Walk Test at post-treatment (12 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental study that aerobic exercise is not more effective than a comparison intervention (usual care) in improving exercise capacity in patients with stroke.

Fatigue
Not effective
2b

One quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on fatigue in patients with stroke. This quasi-experimental study assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Fatigue was measured by the Fatigue Assessment Scale at post-treatment (12 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental study that aerobic exercise is not more effective than a comparison intervention (usual care) in reducing fatigue in patients with stroke.

Functional independence
Effective
1b

One high quality RCT (Wang et al., 2014) and one fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on functional independence in patients with stroke.

The high quality RCT (Wang et al., 2014) randomized patients with subacute/chronic stroke to receive low-intensity aerobic training or no training; both groups received conventional rehabilitation. Functional independence was measured by the Barthel Index at post-treatment (6 weeks). A significant between-group difference was found in favour of aerobic training vs. no training.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Functional independence was measured by the Barthel Index (change scores) and the modified Rankin Scale at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group differences were found at any time points.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than no training in improving functional independence in patients with stroke.

Gait parameters
Not effective
2a

One fair quality RCT (Nave et al., 2019) investigated the effects of aerobic exercise in improving gait parameters in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Gait parameters (Number of steps/day, Step length, Step Cadence, Gait Energy Cost) were measured at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group differences were found at any time points.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving gait parameters in patients with stroke.

Health-related quality of life
Effective
1b

One high quality RCT (Sandberg et al., 2016), one fair quality RCT (Nave et al., 2019) and one quasi-experimental design study (Marsden et al., 2016) investigated the effect of aerobic exercise on health-related quality of life (HRQoL) in patients with stroke.

The high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. HRQoL was measured by the European Quality of Life Scale (EQ-5D: Total score; Visual analogue Scale) at post-treatment (12 weeks). A significant between-group difference was found for one measure of HRQoL (EQ-5D: Visual analogue scale), favouring aerobic exercise program vs. no exercise program.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. HRQoL was measured by the EuroQoL Quality of Life Questionnaire 5D-5L at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group differences were found at any time points.

The quasi-experimental study (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. HRQoL was measured by the Stroke and Aphasia Quality of Life-39 at post-treatment (12 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (no exercise program) in improving health-related quality of life in patients with stroke.

Mobility
Not effective
1b

One high quality RCT (Sandberg et al., 2016) and one fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on mobility in patients with stroke.

The high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. Mobility was measured by the Timed Up and Go test at post-treatment (12 weeks). A significant between-group difference was found, favouring aerobic exercise program vs. no exercise program.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Mobility was measured by the Rivermead Mobility Index, Use of walking aids and Functional Ambulation Category, at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between group differences were found on any of the measures at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (no exercise program) in improving mobility in patients with stroke.

Motor function
Effective
1b

One high quality RCT (Wang et al., 2014) investigated the effect of aerobic exercise on motor function in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive low-intensity aerobic training or no training; both groups received conventional rehabilitation. Motor function was measured by the Fugl Meyer Assessment (FMA: Total motor score) at post-treatment (6 weeks). A significant between-group difference was found, favouring aerobic exercise vs. no training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than no training (conventional rehabilitation alone) in improving motor function in patients with stroke.

Motor function - lower extremity
Effective
1b

One high quality RCT (Wang et al., 2014) investigated the effect of aerobic exercise on lower extremity motor function in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive low-intensity aerobic training or no training; both groups received conventional rehabilitation. Lower extremity motor function was measured by the Fugl Meyer Assessment (FMA: Lower extremity score) at post-treatment (6 weeks). A significant between-group difference was found, favouring aerobic exercise vs. no training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than no training in improving lower extremity motor function in patients with stroke.

Motor function - upper extremity
Not effective
1b

One high quality RCT (Wang et al., 2014) and one fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on upper extremity motor function in patients with stroke.

The high quality RCT (Wang et al., 2014) randomized patients with subacute/chronic stroke to receive low-intensity aerobic training or no training; both groups received conventional rehabilitation. Upper extremity motor function was measured by the Fugl Meyer Assessment (FMA: Upper extremity score) at post-treatment (6 weeks). No significant between-group difference was found.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Upper extremity motor function was measured by the Rivermead Mobility Index (RMI – arm score) at post-treatment (4 weeks) and follow-up (3, 6 months). A significant between-group differences was found at 6-month follow up only, favouring aerobic physical fitness training vs. relaxation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that aerobic exercise is not more effective than comparison interventions (no training, relaxation) in improving upper extremity motor function in patients with stroke.

Muscle strength
Not effective
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on muscle strength in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Muscle strength was measured by the Medical Research Council (MRC) Scale at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group difference was found at any time points.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving muscle strength in patients with stroke.

Sleep quality
Not effective
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on sleep quality in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Sleep quality was measured by the Pittsburgh Sleep Quality Score at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group difference was found at any time point.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is not more effective than a comparison intervention (relaxation) in improving sleep quality in patients with stroke.

Spasticity
Effective*
2b

One fair quality RCT (Nave et al., 2019) investigated the effect of aerobic exercise on spasticity in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Spasticity was measured by the Resistance to Passive Movement Scale (REPAS) at post-treatment (4 weeks) and follow-up (3, 6 months). A significant between-group differences was found at follow up (6 months), favouring aerobic physical fitness training vs. relaxation.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that aerobic exercise is more effective, in the long term*, than a comparison intervention (relaxation) in reducing spasticity in patients with stroke.

Stroke outcomes
Effective
1b

One high quality RCT (Sandberg et al., 2016) investigated the effect of aerobic exercise on stroke outcomes in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. Stroke outcomes were measured by the Stroke Impact Scale (SIS: Daily activities, Recovery) at post-treatment (12 weeks). A significant between-group difference was found in one measure (SIS: Recovery), favouring aerobic exercise program vs. no exercise.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than a comparison intervention (usual care) in reducing some stroke outcomes in patients with stroke.

Walking endurance
Effective
1b

One high-quality RCT (Sandberg et al., 2016), one fair quality RCT (Nave et al., 2019) and one quasi-experimental study (Marsden et al., 2016) investigated the effect of aerobic exercise on walking endurance in patients with stroke.

The high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. Walking endurance was measured by the  6 Minute Walk Test (6MWT) at post-treatment (12 weeks). A significant between-group difference was found, favouring aerobic exercise vs. no exercise.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Walking endurance was measured by the 6MWT at post-treatment (4 weeks) and follow-up (3, 6 months). No significant between-group difference was found at any time points.

The quasi-experimental study design (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Walking endurance was measured by the 6MWT at post-treatment (12 weeks). A significant between-group difference was found, favouring aerobic exercise vs. usual care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one quasi-experimental study design that aerobic exercise is more effective than comparison interventions (no exercise, usual care) in improving walking endurance in patients with stroke.

Walking speed
Effective
1b

One high quality RCT (Sandberg et al., 2016), one fair quality RCT (Nave et al., 2019) and one quasi-experimental study design (Marsden et al., 2016) investigated the effect of aerobic exercise on walking speed in patients with stroke.

The high quality RCT (Sandberg et al., 2016) randomized patients with acute/subacute stroke to receive an aerobic exercise program or no exercise program. Walking speed was measured by the  10 Minute Walk Test (10MWT) at post-treatment (12 weeks). A significant between-group difference was found, favouring aerobic exercise vs. no exercise.

The fair quality RCT (Nave et al., 2019) randomized patients with acute/subacute stroke to receive aerobic physical fitness training using the PHYS-STROKE program or relaxation. Walking speed was measured by the 10MWT post-treatment (4 weeks) and follow-up (3, 6 months). No significant between group difference was found at any time point.

The quasi-experimental study design (Marsden et al., 2016) assigned patients with acute, subacute or chronic stroke to receive a home- and community-based exercise program with aerobic content or usual care. Walking speed was measured by the 10MWT (Fast, Self-selected speed) at post-treatment (12 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that aerobic exercise is more effective than no exercise in improving walking speed in patients with stroke.

References

Faulkner, J., McGonigal, G., Woolley, B., Stoner, L., Wong, L., & Lambrick, D. (2015). A randomized controlled trial to assess the psychosocial effects of early exercise engagement in patients diagnosed with transient ischaemic attack and mild, non-disabling stroke. Clinical Rehabilitation29(8), 783-794.
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Gordon, C. D., Wilks, R., & McCaw-Binns, A. (2013). Effect of aerobic exercise (walking) training on functional status and health-related quality of life in chronic stroke survivors: a randomized controlled trial. Stroke, 44(4), 1179-1181.
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Lee, Y. H., Park, S. H., Yoon, E. S., Lee, C. D., Wee, S. O., Fernhall, B., & Jae, S. Y. (2015). Effects of combined aerobic and resistance exercise on central arterial stiffness and gait velocity in patients with chronic poststroke hemiparesis. American Journal of Physical Medicine & Rehabilitation94(9), 687-695.
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Liu-Ambrose, T., & Eng, J. J. (2015). Exercise training and recreational activities to promote executive functions in chronic stroke: a proof-of-concept study. Journal of Stroke and Cerebrovascular Diseases24(1), 130-137.
https://www.sciencedirect.com/science/article/abs/pii/S1052305714004169

Lund, C., Dalgas, U., Grønborg, T. K., Andersen, H., Severinsen, K., Riemenschneider, M., & Overgaard, K. (2018). Balance and walking performance are improved after resistance and aerobic training in persons with chronic stroke. Disability and rehabilitation, 40(20), 2408-2415.
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Marsden, D. L., Dunn, A., Callister, R., McElduff, P., Levi, C. R., & Spratt, N. J. (2016). A home-and community-based physical activity program can improve the cardiorespiratory fitness and walking capacity of stroke survivors. Journal of Stroke and Cerebrovascular Diseases, 25(10), 2386-2398.
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Moore, S. A., Hallsworth, K., Jakovljevic, D. G., Blamire, A. M., He, J., Ford, G. A., … & Trenell, M. I. (2015). Effects of community exercise therapy on metabolic, brain, physical, and cognitive function following stroke: a randomized controlled pilot trial. Neurorehabilitation and neural repair, 29(7), 623-635.
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Morén, C., Welmer, A. K., Hagströmer, M., Karlsson, E., & Sommerfeld, D. K. (2016). The effects of “physical activity on prescription” in persons with transient ischemic attack: a randomized controlled study. Journal of Neurologic Physical Therapy40(3), 176-183.
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Nave, A. H., Rackoll, T., Grittner, U., Bläsing, H., Gorsler, A., Nabavi, D. G., … & Flöel, A. (2019). Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial. BMJ, 366.
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Pang, M. Y., Eng, J. J., Dawson, A. S., McKay, H. A., & Harris, J. E. (2005). A community‐based fitness and mobility exercise program for older adults with chronic stroke: A randomized, controlled trial. Journal of the American Geriatrics Society, 53(10), 1667-1674.
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Sandberg, K., Kleist, M., Falk, L., & Enthoven, P. (2016). Effects of twice-weekly intense aerobic exercise in early subacute stroke: a randomized controlled trial. Archives of physical medicine and rehabilitation, 97(8), 1244-1253.
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Severinsen, K., Jakobsen, J. K., Pedersen, A. R., Overgaard, K., & Andersen, H. (2014). Effects of resistance training and aerobic training on ambulation in chronic stroke. American journal of physical medicine & rehabilitation, 93(1), 29-42.
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Shaughnessy, M., Michael, K., & Resnick, B. (2012). Impact of treadmill exercise on efficacy expectations, physical activity, and stroke recovery. The Journal of neuroscience nursing: journal of the American Association of Neuroscience Nurses, 44(1), 27.
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Tang, A., Eng, J. J., Krassioukov, A. V., Madden, K. M., Mohammadi, A., Tsang, M. Y., & Tsang, T. S. (2014). Exercise-induced changes in cardiovascular function after stroke: a randomized controlled trial. International Journal of Stroke, 9(7), 883-889.
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Tang, A., Eng, J. J., Tsang, T. S., & Liu-Ambrose, T. (2016). High-and low-intensity exercise do not improve cognitive function after stroke: A randomized controlled trial. Journal of rehabilitation medicine, 48(10), 841-846.
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Wijkman, M. O., Sandberg, K., Kleist, M., Falk, L., & Enthoven, P. (2018). The exaggerated blood pressure response to exercise in the sub‐acute phase after stroke is not affected by aerobic exercise. The Journal of Clinical Hypertension20(1), 56-64.
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Wang, Z., Wang, L., Fan, H., Lu, X., & Wang, T. (2014). Effect of low-intensity ergometer aerobic training on glucose tolerance in severely impaired nondiabetic stroke patients. Journal of Stroke and Cerebrovascular Diseases, 23(3), e187-e193.
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Excluded studies:

Bo, W., Lei, M., Tao, S., Jie, L. T., Qian, L., Lin, F. Q., & Ping, W. X. (2019). Effects of combined intervention of physical exercise and cognitive training on cognitive function in stroke survivors with vascular cognitive impairment: a randomized controlled trial. Clinical Rehabilitation, 33(1), 54-63.
Reason for exclusion: The main part of the treatment focused on endurance, strength and balance (30-35 minutes) and aerobic exercise was provided only for the first 5 minutes as warm-up (cycling, jogging).

Jin, H., Jiang, Y., Wei, Q., Chen, L., & Ma, G. (2013). Effects of aerobic cycling training on cardiovascular fitness and heart rate recovery in patients with chronic stroke. NeuroRehabilitation32(2), 327-335.
Reason for exclusion: Included in treadmill module.

Jin, H., Jiang, Y., Wei, Q., Wang, B., & Ma, G. (2012). Intensive aerobic cycling training with lower limb weights in Chinese patients with chronic stroke: discordance between improved cardiovascular fitness and walking ability. Disability and Rehabilitation34(19), 1665-1671.
Reason for exclusion: Included in treadmill module.

Aquatic interventions

Evidence Reviewed as of before: 26-02-2021
Author(s)*: Annabel McDermott, OT; Tatiana Ogourtsova, PhD OT
Patient/Family Information Table of contents

Introduction

Aquatic interventions are considered applicable to post-stroke rehabilitation as the properties of water support the effects of exercise on recovery.

An early Cochrane review (Merholz, Kugler & Pohl, 2011) that looked at the effect of water-based exercise on activities of daily living (ADLs) and other clinical outcomes (walking speed, postural control, muscle strength, aerobic fitness) after stroke included 4 studies (all studies are included in this review) and concluded that there was not enough evidence at that time to determine whether water-based exercise reduced disability after stroke.

Since that time there have been several systematic reviews and meta-analyses of aquatic interventions specific to the stroke population. Recent reviews have concluded that aquatic interventions are useful for improving balance (Iatridou et al., 2018; Xie et al., 2019; Nascimento et al., 2020) and walking skills (Xie et a., 2019; Nascimento et al., 2020). A positive effect has not been found in relation to ADLs (Xie et al., 2019).

Most recently, Veldema & Jansen’s (2020) analysis of 28 studies (all studies are included in this review) concluded that aquatic therapies are more effective than no treatment for improving walking, balance, emotional status/health-related quality of life, spasticity and physiological indicators; and are more effective than land-based therapies for improving walking, balance, muscular strength, proprioception, health-related quality of life, physiological indicators and cardiorespiratory fitness.

This Stroke Engine review includes 31 studies comprised of 11 high quality RCTs, 17 fair quality RCTs and 3 quasi-experimental studies. Most studies (N=26) were conducted with participants in the chronic phase of stroke recovery; all other studies were conducted with individuals in the subacute phase of recovery. For the purpose of this review, aquatic therapy interventions are defined as any stroke rehabilitation program conducted in controlled water environments. Aquatic programs encompass lower-extremity exercises, trunk exercises, balance activities, obstacle courses, dual-task training, hydrokinesitherapy, hydrotherapy, proprioceptive exercises, treadmill training, task-oriented training, and programs that draw on defined methods (e.g. Bad Ragaz Ring method and programs using Proprioceptive Neuromuscular Facilitation, Halliwick method, Ai Chi method). Control groups include no treatment and on-land programs (e.g. conventional rehabilitation, physical therapy, upper extremity function exercises, proprioceptive exercise, aerobic exercise, obstacle training, PNF lower extremity exercises, treadmill training/backward treadmill training, task-oriented training, trunk exercises, motor dual task training).

Overall, the results from this review found strong evidence (level 1a – from two or more high quality RCTs) to indicate that that aquatic interventions improve* lower extremity muscle strength and gait during the subacute phase of recovery; and balance, mobility and walking speed in the chronic phase of stroke recovery. Further, there was moderate evidence (level 1b – from at least one high quality RCT) that aquatic interventions improve* cardiovascular fitness parameters, gait parameters, muscle activity, pain and walking endurance in the chronic phase of stroke recovery.

* More than land-based interventions or no treatment.

Patient/Family Information

What are aquatic interventions?

 Aquatic interventions are exercise programs performed in a controlled water environment (e.g. in a pool).

Aquatic therapy is also referred to as:

  • water-based therapy
  • pool therapy
  • hydrotherapy
  • hydrokinesiotherapy

Why are aquatic interventions used for?

 It is common to experience physical difficulties after a stroke, such as difficulty with walking and balance. Exercise after a stroke is very important to recovery. It is necessary to continue to exercise after a stroke, to avoid further muscle weakness and reduced fitness. Exercise can also have a positive effect on mental health and neurological health.

Aquatic interventions can be suitable for different levels of ability and recovery after stroke. Aquatic therapy is used in stroke rehabilitation because water provides a safe and comfortable environment for exercise. There are several ways in which aquatic therapy assists recovery:

  • The density and viscosity (thickness) of water provides buoyancy to support body weight. This reduces the impact of movement on joints, allows for increased mobility, and reduces the risk of falls when exercising.
  • The hydrostatic pressure of water provides resistance for muscle strengthening. This pressure also provides increased sensory input to the muscles and joints.
  • Water can provide relief for muscles and joints.

Are there different types of aquatic interventions?

 Yes, there are different types of aquatic therapy used in stroke rehabilitation. Rehabilitation clinicians may choose a specific program because of:

  • the method (e.g. task-oriented training, Halliwick method, Ai Chi method)
  • the equipment (e.g. obstacle courses, treadmills)
  • the goal (e.g. improving upper body strength, lower body strength, balance or proprioception)

How do I do aquatic therapy?

 Your stroke rehabilitation team will talk with you to determine whether aquatic therapy is available, safe, and suitable for your recovery. Your rehabilitation clinician will develop a program that addresses your specific recovery needs and goals. Your clinician will supervise your session and will instruct you on the exercises and movements. They may assist you in the pool or direct you from beside the pool, depending on safety.

Do aquatic interventions work?

Researchers have done studies to see if aquatic therapy helps people who have had a stroke. There is good evidence that aquatic therapy can improve balance and walking skills.

There is strong evidence that aquatic therapy is helpful in the subacute phase of stroke recovery (1-6 months after the stroke) for improving:

  • lower extremity muscle strength
  • gait

There is moderate to strong evidence that aquatic therapy is helpful in the chronic phase of stroke recovery (more than 6 months after the stroke) for improving:

  • balance
  • mobility
  • walking speed
  • gait
  • walking endurance
  • cardiovascular fitness
  • muscle activity
  • pain

Other studies show that aquatic therapy is also helpful for improving emotional status and quality of life (related to health).

Note: These studies showed that aquatic interventions were more effective than land-based interventions or no treatment.

Are there any side effects or risks?

There are safety risks to consider when starting aquatic therapy after stroke. Risks include:

  • Slips and falls on wet surfaces around pools. The clinician will assess the individual’s safety and mobility before starting the program. The clinician will supervise or assist the individual to enter and exit the pool safely.
  • Drowning and heat exhaustion. The clinician will closely supervise the individual when doing exercises. The clinician will monitor the pool temperature and the individual’s wellness during the session.
  • Skin irritation and infection. Aquatic therapy should be done in a pool with controlled pH levels and an environment with frequent cleaning routines. The clinician should follow hygiene and infection control procedures.

Aquatic therapy should be done under supervision of a rehabilitation clinician. The clinician will choose a program that is safe and that suits the person’s recovery.

Who provides the treatment?

Aquatic interventions are performed under the supervision of a trained clinician. The clinician will choose specific exercises that use the physical properties of water to benefit the patient. The program and exercises will be selected according to each person’s recovery stage, abilities, needs and rehabilitation goals.

Who can help me?

 It is important to obtain medical clearance from your physician before starting an exercise program after stroke. Talk with your rehabilitation team if you are interested in aquatic therapy for stroke recovery.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

 

Results Table

View results table

Outcomes

Subacute phase

Activities of Daily Living
Conflicting
4

Three high quality RCTs (Zhang et al., 2016; Han & Im, 2018; Lee et al., 2018) investigated the effect of aquatic interventions on Activities of Daily Living (ADLs) in the subacute phase of stroke recovery.

The first high quality RCT (Zhang et al., 2016) randomized participants to receive aquatic therapy or land-based physiotherapy. ADLs were measured using the Barthel Index at post-treatment (8 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. land-based physiotherapy.

The second high quality RCT (Han & Im, 2018) randomized participants to receive aquatic treadmill training or land-based aerobic exercise. ADLs were measured using the Korean modified Barthel Index at post-treatment (6 weeks). No significant between-group difference was found.

The third high quality RCT (Lee et al., 2018) randomized participants to receive aquatic treadmill training or on-land aerobic exercise. ADLs were measured using the Korean modified Barthel Index at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of aquatic interventions on Activities of Daily Living in the subacute phase of stroke recovery. While one high quality RCT found that aquatic interventions were more effective than on-land programs, two other high quality RCTs found that an aquatic therapy program was no more effective than a land-based aerobic program.

Arterial stiffness
Not effective
1b

One high quality RCT (Lee et al., 2018) investigated the effect of aquatic interventions on arterial stiffness in the subacute phase of stroke recovery. The high quality RCT randomized participants to receive aquatic treadmill training or on-land aerobic exercise. Arterial stiffness (paretic/non-paretic) was measured using an oscillometric method at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are not more effective than on-land interventions for reducing arterial stiffness in the subacute phase of stroke recovery.

Balance
Conflicting
4

Two high quality RCTs (Tripp & Krakow, 2014; Lee et al., 2018) and one fair quality RCT (Chan et al., 2017) investigated the effect of aquatic interventions on balance in the subacute phase of stroke recovery.

The first high quality RCT (Tripp & Krakow, 2014) randomized participants to receive aquatic therapy using the Halliwick method, or time-matched conventional physiotherapy; both groups received additional physiotherapy. Balance was measured using the Berg Balance Scale (BBS) and the Functional Reach Test at post-treatment (2 weeks). A significant between-group difference was found on one measure (BBS), in favour of aquatic therapy vs. conventional physiotherapy.

The second high quality RCT (Lee et al., 2018) randomized participants to receive aquatic treadmill training or on-land aerobic exercise. Balance was measured using the BBS at post-treatment (4 weeks). No significant between-group difference was found.

The fair quality RCT (Chan et al., 2017) randomized participants to receive aquatic therapy or conventional rehabilitation; both groups received additional conventional rehabilitation. Balance was measured using the BBS at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of aquatic interventions on balance in the subacute phase of stroke recovery. While one high quality RCT found that a 2-week aquatic therapy program was more effective than physiotherapy, a second high quality RCT and a fair quality RCT found that aquatic interventions (4-week aquatic treadmill training, 6-week aquatic therapy) were not more effective than on-land rehabilitation programs.

Cardiorespiratory fitness parameters
Conflicting
4

Two high quality RCTs (Han & Im, 2018; Lee et al., 2018) investigated the effect of aquatic interventions on cardiorespiratory fitness parameters in the subacute phase of stroke recovery.

The first high quality RCT (Han & Im, 2018) randomized participants to receive aquatic treadmill training or land-based aerobic exercise. Cardiorespiratory fitness parameters (Peak oxygen uptake, Peak rate pressure product, Resting heart rate, Peak heart rate, Age-predicted maximum heart rate, Exercise tolerance test duration, Respiratory exchange ratio) were measured at post-treatment (6 weeks). Significant between-group differences were found on four of seven measures (Oxygen uptake, Peak heart rate, Age-predicted maximum heart rate, Exercise tolerance test duration), in favour of aquatic therapy vs. land-based aerobic exercise.

The second high quality RCT (Lee et al., 2018) randomized participants to receive aquatic treadmill training or on-land aerobic exercise. Cardiorespiratory fitness parameters (Resting heart rate, Resting systolic/diastolic blood pressure, Maximal heart rate, Maximal systolic/diastolic blood pressure, Maximal rate pressure product, Respiratory exchange ratio, Maximal oxygen consumption) were measured at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of aquatic interventions on cardiorespiratory fitness parameters in the subacute phase of stroke recovery. While both interventions compared aquatic treadmill training with on-land aerobic exercise, the 6-week program found between-group differences on some measures of cardiorespiratory fitness whereas the 4-week program found no differences between groups.

Gait
Effective
1a

Two high quality RCTs (Tripp & Krakow, 2014; Zhang et al., 2016) investigated the effect of aquatic interventions on gait in the subacute phase of stroke recovery.

The first high quality RCT (Tripp & Krakow, 2014) randomized participants to receive aquatic therapy using the Halliwick method, or time-matched conventional physiotherapy; both groups received additional physiotherapy. Gait was measured using the Functional Ambulation Categories at post-treatment (2 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. conventional physiotherapy.

The second high quality RCT (Zhang et al., 2016) randomized participants to receive aquatic therapy or land-based physiotherapy. Gait was measured using the Functional Ambulation Categories at post-treatment (8 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. land-based physiotherapy.

Conclusion: There is strong evidence (level 1a) from two high quality RCTs that aquatic interventions are more effective than on-land interventions for improving gait in the subacute phase of stroke recovery.

Mobility
Not effective
1b

One high quality RCT (Tripp & Krakow, 2014) and one fair quality RCT (Chan et al., 2017) investigated the effect of aquatic interventions on mobility in the subacute phase of stroke recovery.

The high quality RCT (Tripp & Krakow, 2014) randomized participants to receive aquatic therapy using the Halliwick method, or time-matched conventional physiotherapy; both groups received additional physiotherapy. Mobility was measured using the Rivermead Mobility Index at post-treatment (2 weeks). No significant between-group difference was found.

The fair quality RCT (Chan et al., 2017) randomized participants to receive aquatic therapy or conventional rehabilitation; both groups received additional conventional rehabilitation. Mobility was measured using the Timed Up and Go test and ambulatory skills were measured using the Community Balance and Mobility Test at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and one fair quality RCT that aquatic interventions are not more effective than on-land interventions for improving mobility in the subacute phase of stroke recovery.

Motor function - lower extremity
Not effective
1b

One high quality RCT (Lee et al., 2018) investigated the effect of aquatic interventions on motor function in the subacute phase of stroke recovery. The high quality RCT randomized participants to receive aquatic treadmill training or on-land aerobic exercise. Lower extremity motor function was measured using the Fugl-Meyer Assessment (FMA, FMA – Lower Limb score) at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are not more effective than on-land interventions for improving lower extremity motor function in the subacute phase of stroke recovery.

Muscle strength - lower extremity
Effective
1a

Two high quality RCTs (Zhang et al., 2016; Lee et al., 2018) investigated the effect of aquatic interventions on lower extremity muscle strength in the subacute phase of stroke recovery.

The first high quality RCT (Zhang et al., 2016) randomized participants to receive aquatic therapy or land-based physiotherapy. Muscle activity (Knee extension/flexion torque/cocontraction ratio, Ankle dorsiflexion/plantarflextion torque/cocontraction ratio) was measured at post-treatment (8 weeks). Significant between-group differences were found in some measures (Knee extension torque, Knee extension cocontraction ratio, Ankle plantarflextion torque), in favour of aquatic therapy vs. land-based physiotherapy.

The second high quality RCT (Lee et al., 2018) randomized participants with subacute stroke to receive aquatic treadmill training or on-land aerobic exercise. Muscle strength was measured by dynamometer (isometric knee flexion/extension – paretic/non-paretic limb) at post-treatment (4 weeks). A significant between-group difference in muscle strength of the paretic limb (knee flexion, knee extension) was found, in favour of aquatic therapy vs. on-land aerobic exercise.

Conclusion: There is strong evidence (level 1a) from two high quality RCTs that aquatic interventions are more effective than on-land interventions for improving lower extremity muscle strength in the subacute phase of stroke recovery.

Quality of life
Not effective
1b

One high quality RCT (Lee et al., 2018) investigated the effect of aquatic interventions on quality of life in the subacute phase of stroke recovery. The high quality RCT randomized participants to receive aquatic treadmill training or on-land aerobic exercise. Health-related quality of life was measured using the EQ-5D-3L at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are not more effective than on-land interventions for improving quality of life in the subacute phase of stroke recovery.

Spasticity
Not effective
1b

One high quality RCT (Zhang et al., 2016) investigated the effect of aquatic interventions on spasticity in the subacute phase of stroke recovery. The high quality RCT randomized participants to receive aquatic therapy or land-based physiotherapy. Spasticity was measured using the Modified Ashworth Scale (Knee flexion, Ankle dorsiflexion) at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are not more effective than on-land interventions for reducing spasticity in the subacute phase of stroke recovery.

Walking endurance
Not effective
1b

One high quality RCT (Han & Im, 2018) and one fair quality RCT (Chan et al., 2017) investigated the effect of aquatic interventions on walking endurance in the subacute phase of stroke recovery.

The high quality RCT (Han & Im, 2018) randomized participants to receive aquatic treadmill training or land-based aerobic exercise. Walking endurance was measured using the Six Minute Walk Test at post-treatment (6 weeks). No significant between-group difference was found.

The fair quality RCT (Chan et al., 2017) randomized participants to receive aquatic therapy or conventional rehabilitation; both groups received additional conventional rehabilitation. Walking endurance was measured using the Two-Minute Walking Test at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and one fair quality RCT that aquatic interventions are not more effective than on-land interventions for improving walking endurance in the subacute phase of stroke recovery.

Chronic phase

Balance
Effective
1a

Six high quality RCTs (Chu et al., 2004; Zhu et al., 2016; Cha, Shin & Kim, 2017; Saleh, Rehab & Aly, 2019; Perez-de la Cruz, 2020; Perez-de la Cruz, 2021), ten fair quality RCTs (Noh et al., 2008; Lee, Ko & Cho, 2010; Park & Roh, 2011b; Park et al., 2014; Jung et al., 2014; Kim, Lee & Kim, 2015; Kim, Lee & Jung, 2015; Kim, Lee & Kim, 2016; Eyvaz, Dundar & Yesil, 2018; Aidar et al., 2018) and three quasi-experimental studies (Han, Kim & An, 2013; Montagna et al., 2014; Morer et al., 2020) investigated the effect of aquatic therapy interventions on balance in the chronic phase of stroke recovery.

The first high quality RCT (Chu et al., 2004) randomized participants to receive an aquatic lower extremity program or a land-based upper extremity training program. Balance was measured using the Berg Balance Scale (BBS) at post-treatment (8 weeks). No significant between-group difference was found.

The second high quality RCT (Zhu et al., 2016) randomized participants to receive hydrotherapy or land-based exercises. Balance was measured using the BBS and the Functional Reach Test (FRT) at post-treatment (4 weeks). A significant between-group difference was found on one measure (FRT), in favour of hydrotherapy vs. land-based exercise.

The third high quality RCT (Cha, Shin & Kim, 2017) randomized participants to receive aquatic therapy using the Bad Ragaz Ring method or time-matched conventional physical therapy; both groups received additional physical therapy. Balance was measured using the Biodex Balance Master (a balance measurement system) at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. physical therapy.

The fourth high quality RCT (Saleh, Rehab & Aly, 2019) randomized participants to receive aquatic motor dual task training or land-based motor dual task training. Dynamic balance was measured using the Biodex Balance System (Overall Stability Index, Anteroposterior Stability Index, Mediolateral Stability Index) at post-treatment (6 weeks). A significant between-group difference was found on all measures of dynamic balance, in favour of aquatic therapy vs. land-based training.

The fifth high quality RCT (Perez-de la Cruz, 2020) randomized participants to receive Ai-Chi aquatic therapy, on-land exercises, or combined aquatic therapy + on-land exercises. Balance was measured using the Tinetti test (Total score), the 360 degree turn test, and single-leg stance balance tests (Right/Left leg) at post-treatment (12 weeks) and one-month follow-up. Significant between-group differences were found on two measures (Tinetti test, 360-degree turn test) at both timepoints, in favour of aquatic therapy vs. on-land therapy.
Note: Significant between-group differences were also found (Tinetti test, 360-degree turn test) at both timepoints, in favour of combined therapy vs. on-land exercises. There was a significant between-group difference (360 degree turn test) at both timepoints, in favour of combined therapy vs. aquatic therapy.

The sixth high quality RCT (Perez-de la Cruz, 2021) randomized participants to receive aquatic therapy, on-land exercises, or combined aquatic therapy + on-land exercises. Balance was measured using the BBS and tandem stance (eyes open) at post-treatment (12 weeks) and one-month follow-up. There were significant between-group differences on both measures at both timepoints, in favour of aquatic therapy vs. on-land exercises.
Note: There was a significant between-group difference in one measure (BBS) at both timepoints, in favour of aquatic therapy vs. combined therapy; in one measure (tandem stance) at follow-up only, in favour of combined therapy vs. aquatic therapy; and in one measure (tandem stance) at both timepoints, in favour of combined therapy vs. on-land exercises.

The first fair quality RCT (Noh et al., 2008) randomized participants to receive aquatic therapy or conventional rehabilitation. Balance was measured using the BBS at post-treatment (8 weeks). A significant difference in change scores from baseline to post-treatment was found, in favour of aquatic therapy vs. conventional rehabilitation.

The second fair quality RCT (Lee, Ko & Cho, 2010) randomized participants to receive aquatic task-oriented training or on-ground task-oriented training. Balance was measured using the Good Balance System to measure static balance (Anteroposterior/mediolateral sway velocity – eyes open, eyes closed) and dynamic balance (Time, Distance) at post-treatment (12 weeks). A significant between-group difference was found in dynamic balance only (time, distance), in favour of aquatic vs. on-ground task-oriented training.

The third fair quality RCT (Park & Roh, 2011b) randomized participants to receive aquatic exercises or land exercises. Static balance was measured using the Good Balance System (Mediolateral sway velocity – eyes open/eyes closed; Anteroposterior sway velocity – eyes open/eyes closed; Velocity movement – eyes open/eyes closed) at post-treatment (6 weeks). Significant between-group differences were seen in static balance measures (Mediolateral sway velocity – eyes open, Anteroposterior sway velocity – eyes open, Velocity movement – eyes open), in favour of aquatic exercises vs. land exercises.

The fourth fair quality RCT (Park et al., 2014) randomized participants to receive aquatic treadmill training or no additional training; both groups received conventional rehabilitation. Balance was measured using the Balance System SD (Static balance – anteroposterior sway, mediolateral sway, total; Dynamic balance) at post-treatment (4 weeks). No significant between-group differences were found.

The fifth fair quality RCT (Jung et al., 2014) randomized participants to receive aquatic obstacle training or land-based obstacle training. Static balance was measured using the Good Balance system (Mediolateral sway velocity – eyes closed, Anteroposterior sway velocity – eyes closed, Sway area) at post-treatment (12 weeks). Significant between-group differences were found on all measures, in favour of aquatic therapy vs. land-based obstacle training.

The sixth fair quality RCT (Kim, Lee & Kim, 2015) randomized participants to receive aquatic proprioceptive neuromuscular facilitation (PNF) lower extremity exercises or on-ground PNF lower extremity exercises. Balance was measured using the BBS, FRT and One Leg Stand Test at post-treatment (6 weeks). Significant between-group differences were found on all measures of balance, in favour of aquatic PNF exercises vs. on-ground PNF exercises.

The seventh fair quality RCT (Kim, Lee & Jung, 2015) randomized patients to receive aquatic coordination movement using Proprioceptive Neuromuscular Facilitation (PNF) and Neurodevelopmental Therapy (NDT) or NDT alone. Balance was measured using the BBS and the FRT at post-treatment (6 weeks). Significant between-group differences were found on both measures of balance, in favour of aquatic PNF vs. no aquatic therapy.

The eighth fair quality RCT (Kim, Lee & Kim, 2016) randomized participants to receive aquatic dual-task training or no aquatic therapy; both groups received neurodevelopmental therapy. Balance was measured using the BBS and FRT at post-treatment (6 weeks). A Significant between-group difference was found on both measures, in favour of aquatic therapy vs. no aquatic therapy.

The ninth fair quality RCT (Eyvaz, Dundar & Yesil, 2018) randomized participants to receive water-based exercises or land-based exercises; both groups received additional land-based exercises. Balance was measured using the BBS and the Sportak Balance Device (Static balance index, Dynamic balance index) at post-treatment (6 weeks). A significant difference was found on one measure (BBS), in favour of land-based exercise vs. water-based exercise.

The tenth fair quality RCT (Aidar et al., 2018) randomized participants to receive an aquatic exercise program or no treatment. Balance was measured using the BBS at post-treatment (12 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. no treatment.

The first non-randomized study (Han, Kim & An, 2013) allocated participants to receive an aquatic proprioceptive exercise program or a land-based proprioceptive exercise program. Balance was measured using the BBS and sway area was measured using the Good Balance system (eyes open, eyes closed) at post-treatment (6 weeks). Significant between-group differences were found on all measures, in favour of aquatic therapy vs. land-based therapy.

The second non-randomized study (Montagna et al., 2014) assigned participants to receive aquatic physiotherapy using the Halliwick method. Balance was measured using the BBS at post-treatment (18 sessions). A significant improvement was found.

The third non-randomized study (Morer et al., 2020) assigned participants to receive aquatic therapy + thalassotherapy. Balance was measured using the BBS at post-treatment (2 weeks). A significant improvement was found.

Conclusion: There is strong evidence (level 1a) from five high quality RCTs, nine fair quality RCTs and one quasi-experimental study that aquatic therapy interventions are more effective than land-based interventions or no treatment for improving balance in the chronic phase of stroke recovery.
Note
: However, one high quality RCT found that an aquatic lower extremity intervention program was no more effective than a comparative land-based upper extremity program; one fair quality RCT found that aquatic treadmill training was no more effective than no treatment; and another fair quality RCT found that water-based exercises were less effective than land-based exercises for improving balance. In contrast, two other quasi-experimental studies noted a significant improvement in balance following aquatic interventions.

Cardiovascular fitness parameters
Effective
1b

One high quality RCT (Chu et al., 2004) investigated the effect of an aquatic intervention on cardiovascular fitness in the chronic phase of stroke recovery. The high quality RCT randomized participants to receive an aquatic lower extremity program or a land-based upper extremity training program. Maximal oxygen uptake (VO2max) and maximal workload (watts) were measured using a cycle ergometer test at post-treatment (8 weeks). A significant between-group difference was found on both measures, in favour of aquatic therapy lower extremity training vs. land-based upper extremity training.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic therapy intervention is more effective than a land-based intervention (upper extremity training) for improving cardiovascular fitness parameters in the chronic phase of stroke recovery.

Functional independence
Conflicting
4

Two fair quality RCTs (Kim, Lee & Kim, 2015; Eyvaz, Dundar & Yesil, 2018) have investigated the effect of aquatic therapy interventions on functional independence in the chronic phase of stroke recovery.

The first fair quality RCT (Kim, Lee & Kim, 2015) randomized participants to receive aquatic proprioceptive neuromuscular facilitation (PNF) lower extremity exercises or on-ground PNF lower extremity exercises. Functional independence was measured using the Functional Independence Measure (FIM) at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic PNF exercises vs. on-ground PNF exercises.

The second fair quality RCT (Eyvaz, Dundar & Yesil, 2018) randomized participants to receive water-based exercises or land-based exercises; both groups received additional land-based exercises. Functional independence was measured using the FIM at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of aquatic therapy on functional independent in chronic phase of stroke recovery. While one fair quality RCT found that aquatic therapy was more effective than land-based exercises, another fair quality RCT found that it was not more effective.
Note:
Differences in outcomes may relate to the different forms of aquatic intervention and/or intervention intensity: aquatic exercises performed for 60 mins/session for 3 days/week were not more effective than land-based exercises; aquatic PNF performed for 30 mins/session, 5 sessions/week were more effective than land-based PNF exercises.

Gait ability
Not effective
2a

One fair quality RCT (Noh et al., 2008) has investigated the effect of aquatic interventions on gait ability in the chronic phase of stroke recovery. The fair quality RCT randomized participants to receive aquatic therapy or conventional rehabilitation. Gait ability was measured using the Modified Motor Assessment Scale at post-treatment (8 weeks). No significant difference was found.

Conclusion: There is limited evidence (level 2a) from one fair quality RCT that aquatic interventions are not more effective than land-based interventions for improving gait ability in the chronic phase of stroke recovery.

Gait parameters
Effective
1b

One high quality RCT (Saleh, Rehab & Aly, 2019) and three fair quality RCTs (Park et al., 2012; Furnari et al., 2014; Park et al., 2016) have investigated the effect of aquatic interventions on gait parameters in the chronic phase of stroke recovery.

The high quality RCT (Saleh, Rehab & Aly, 2019) randomized participants to receive aquatic motor dual task training or land-based motor dual task training. Gait parameters (Walking speed, Step length – paretic/non-paretic limb, Time of support on the paretic limb) were measured using the Biodex Gait Trainer at post-treatment (6 weeks). A significant between-group difference was found on all gait parameters, in favour of aquatic training vs. land-based training.

The first fair quality RCT (Park et al., 2012) randomized participants to receive aquatic treadmill training or land-based treadmill training. Gait parameters (Joint angles on heel contact and toe off the ground [hip flexion, knee extension, plantarflexion/dorsiflexion]) were measured at post-treatment (6 weeks). Significant between-group differences were found (hip flexion – heel contact, toe off; knee extension – heel contact, toe-off), in favour of aquatic treadmill training vs. land-based treadmill training.

The second fair quality RCT (Furnari et al., 2014) randomized participants to receive hydrokinesytherapy or conventional physical therapy; both groups received additional physical therapy. Gait parameters (gait speed, cadence, stance phase, swing phase, double support phase, semistep length) were measured using a Modular Clinical Electronic Baropodometer at post-treatment (8 weeks). Significant between-group differences were found on most measures (gait speed, cadence, stance phase, swing phase, double support phase), in favour of aquatic therapy vs. physical therapy.

The third fair quality RCT (Park et al., 2016) randomized participants to receive aquatic trunk exercises or land-based trunk exercises. Gait parameters were measured using the Gait trainer 2 analysis system (Walking speed, Walking cycle, Stance phase, Stride length, Symmetry index – stance phase/stride length) at post-treatment (4 weeks). Significant between-group differences were found on two gait parameters (Walking cycle, Stride length – paretic limb), in favour of land-based trunk exercises vs. aquatic trunk exercises.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and two fair quality RCTs that aquatic interventions are more effective than land-based interventions for improving gait parameters in the chronic phase of stroke recovery.
Note
: However, one fair quality RCT found that land-based exercises were more effective than water-based trunk exercises for improving some gait parameters.

Mobility
Conflicting
4

Three high quality RCTs (Zhu et al., 2016; Cha, Shin & Kim, 2017; Perez-de la Cruz, 2021), six fair quality RCTs (Park et al., 2011a; Kim, Lee & Jung, 2015; Kim, Lee & Kim, 2015; Kim, Lee & Kim, 2016; Eyvaz, Dundar & Yesil, 2018; Aidar et al., 2018) and two quasi-experimental studies (Montagna et al., 2014; Morer et al., 2020) investigated the effect of aquatic interventions on mobility in the chronic phase of stroke recovery.

The first high quality RCT (Zhu et al., 2016) randomized participants to receive hydrotherapy or land-based exercises. Mobility was measured using the Timed Up and Go Test (TUG) at post-treatment (4 weeks). No significant between-group difference was found.

The second high quality RCT (Cha, Shin & Kim, 2017) randomized patients to receive aquatic therapy using the Bad Ragaz Ring method or time-matched conventional physical therapy; both groups received additional physical therapy. Mobility was measured using the TUG at post-treatment (6 weeks). No significant between-group difference was found.

The third high quality RCT (Perez-de la Cruz, 2021) randomized participants to receive aquatic therapy, on-land exercises, or combined aquatic therapy + on-land exercises. Mobility was measured using the TUG and Five Times Sit-to-Stand test (FTSTS) at post-treatment (12 weeks) and one-month follow-up. There were significant between-group differences in both measures at both timepoints, in favour of aquatic therapy vs. on-land exercises.
Note: There was a significant between-group difference in one measure (FTSTS) at both timepoints, in favour of combined therapy vs. aquatic therapy; there were significant between-group differences in both measures at both timepoints, in favour of combined therapy vs. on-land exercises.

The first fair quality RCT (Park et al., 2011a) randomized participants to receive aquatic exercises or land exercises. Mobility was measured using the Performance-Oriented Mobility Assessment at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic exercise vs. land exercise.

The second fair quality RCT (Kim, Lee & Jung, 2015) randomized patients to receive aquatic coordination movement using Proprioceptive Neuromuscular Facilitation (PNF) and Neurodevelopmental Therapy (NDT) or NDT alone. Mobility was measured using the TUG at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic PNF vs. no aquatic therapy.

The third fair quality RCT (Kim, Lee & Kim, 2015) randomized participants to receive aquatic proprioceptive neuromuscular facilitation (PNF) lower extremity exercises or on-ground PNF lower extremity exercises. Mobility was measured using the TUG at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic PNF exercises vs. on-ground PNF exercises.

The fourth fair quality RCT (Kim, Lee & Kim, 2016) randomized participants to receive aquatic dual-task training or no aquatic therapy; both groups received neurodevelopmental therapy. Mobility was measured using the TUG and the Five Times Sit-to-Stand Test at post-treatment (6 weeks). A significant between-group difference was found on both measures, in favour of aquatic therapy vs. no therapy.

The fifth fair quality RCT (Eyvaz, Dundar & Yesil, 2018) randomized participants to receive water-based exercises or land-based exercises; both groups received additional land-based exercises. Mobility was measured using the TUG test at post-treatment (6 weeks). No significant between-group difference was found.

The sixth fair quality RCT (Aidar et al., 2018) randomized participants to receive an aquatic exercise program or no treatment. Mobility was measured using the TUG and a test of getting up from a sitting position at post-treatment (12 weeks). A significant between-group difference was found on both measures of mobility, in favour of aquatic therapy vs. no treatment.

The first non-randomized study (Montagna et al., 2014) assigned participants to receive aquatic physiotherapy using the Halliwick method. Mobility was measured using the TUG at post-treatment (18 sessions). A significant improvement was found.

The second non-randomized study (Morer et al., 2020) assigned participants to receive aquatic therapy + thalassotherapy. Mobility was measured using the TUG at post-treatment (2 weeks). A significant improvement was found.

Conclusion: There is conflicting evidence (level 4) regarding the effect of aquatic therapy on mobility in the chronic phase of stroke recovery. While one high quality RCT and five fair quality RCTs found that aquatic interventions were more effective than land-based interventions or no treatment, two high quality RCTs and one fair quality RCT found that aquatic interventions were not more effective than comparison interventions (land-based exercises, conventional physical therapy).

Mood
Effective
2a

Two fair quality RCTs (Aidar et al., 2013; Aidar et al., 2018) investigated the effect of aquatic interventions on mood in the chronic phase of stroke recovery.

The first fair quality RCT (Aidar et al., 2013) randomized participants to receive an aquatic exercise program or no treatment. Anxiety was measured using the State Trait Anxiety Inventory (IDATE – I Anxiety Trait; II Anxiety State) and depression was measured using the Beck Depression Inventory at post-treatment (12 weeks). A significant between-group difference was found on all measures of mood, in favour of aquatic therapy vs. no treatment.

The second fair quality RCT (Aidar et al., 2018) randomized participants to receive an aquatic exercise program or no treatment. Anxiety was measured using the State Trait Anxiety Inventory (IDATE – I Anxiety state, II Anxiety trait) and depression was measured using the BDI at post-treatment (12 weeks). A significant between-group difference was found on all measures of mood, in favour of aquatic therapy vs. no treatment.

Conclusion: There is limited evidence (level 2a) from two fair quality RCTs that aquatic interventions are more effective than no treatment in improving mood in the chronic phase of stroke recovery.

Muscle activity
Effective
1b

One high quality RCT (Cha, Shin & Kim, 2017) investigated the effect of aquatic interventions on muscle activity in the chronic phase of stroke recovery. The high quality RCT randomized patients to receive aquatic therapy using the Bad Ragaz Ring method or time-matched conventional physical therapy; both groups received additional physical therapy. Muscle activity was measured using electromyography (EMG – Tibialis anterior, Gastrocnemius) at post-treatment (6 weeks). A significant between-group difference was found in favour of aquatic therapy vs. physical therapy.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are more effective than land-based interventions for improving muscle activity in the chronic phase of stroke recovery.

Pain
Effective
1b

One high quality RCT (Perez-de la Cruz, 2020) and one quasi-experimental study (Morer et al., 2020) investigated the effect of aquatic interventions on pain in the chronic phase of stroke recovery.

The high quality RCT (Perez-de la Cruz, 2020) randomized participants to receive Ai-Chi aquatic therapy, on-land exercises, or combined aquatic therapy + on-land exercises. Pain was measured using a visual analogue scale at post-treatment (12 weeks) and one-month follow-up. A significant between-group difference was found at both timepoints, in favour of aquatic therapy vs. on-land exercises.
Note: A significant between-group difference in pain was found at both timepoints, in favour of combined therapy vs. on-land exercises.

The non-randomized study (Morer et al., 2020) assigned participants to receive aquatic therapy + thalassotherapy. Pain was measured using a visual analogue scale at post-treatment (2 weeks). A significant improvement was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are more effective than on-land interventions for reducing pain in the chronic phase of stroke recovery. A non-randomized study also reported reduced pain following aquatic intervention.

Postural stability - dynamic
Conflicting
4

Two fair quality RCTs (Kim, Lee & Kim, 2016; Kum & Shin, 2017) investigated the effect of aquatic interventions on dynamic postural stability in the chronic phase of stroke recovery.

The first fair quality RCT (Kim, Lee & Kim, 2016) randomized participants to receive aquatic dual-task training or no aquatic therapy; both groups received neurodevelopmental therapy. Postural stability when walking was measured using the Functional Gait Assessment at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. no aquatic therapy.

The second fair quality RCT (Kum & Shin, 2017) randomized participants to receive underwater backward treadmill training or on-ground backward treadmill training. Postural stability when walking was measured using the Functional Gait Assessment at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (level 4) between two fair quality RCTs regarding the effectiveness of aquatic interventions on dynamic postural stability in the chronic phase of stroke recovery. One study found that aquatic dual-task training was more effective than no training whereas a second study found that underwater backward treadmill training was no more effective than on-ground training.

Postural stability - static
Not effective
2a

One fair quality RCT (Furnari et al., 2014) and one quasi-experimental study (Montagna et al., 2014) investigated the effect of aquatic interventions on static postural stability in the chronic phase of stroke recovery.

The fair quality RCT (Furnari et al., 2014) randomized participants to receive hydrokinesytherapy or conventional physical therapy; both groups received additional physical therapy. Static postural stability was measured using baropodometry (plantar surface, plantar load – paretic/non-paretic) and stabilometry (length of the ball – eyes open/closed) at post-treatment (8 weeks). A significant between-group difference was found on one measure (length of ball – eyes open/closed), in favour of aquatic therapy vs. conventional physical therapy.

The non-randomized study (Montagna et al., 2014) assigned participants to receive aquatic physiotherapy using the Halliwick method. Plantar pressure distribution was measured using baropodometry (anterioposterior/mediolateral – eyes open, eyes closed, sit-to-stand) at post-treatment (18 sessions). No significant improvement was found.

Conclusion: There is limited evidence (level 2a) from one fair quality RCT that aquatic interventions are not more effective than on-ground interventions for improving static postural stability in the chronic phase of stroke recovery. A quasi-experimental study also reported no significant improvement in static postural stability following aquatic physiotherapy.

Proprioception
Effective
2a

Two fair quality RCTs (Park et al., 2011a; Kum & Shin, 2017) and one quasi-experimental study (Han, Kim & An, 2013) investigated the effect of aquatic interventions on proprioception in the chronic phase of stroke recovery.

The first fair quality RCT (Park et al., 2011a) randomized participants to receive aquatic exercises or land exercises. Proprioception of knee movements was measured using the Biometrics Motion Analysis System at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic exercise vs. land exercise.

The second fair quality RCT (Kum & Shin, 2017) randomized participants to receive underwater backward treadmill training or on-ground backward treadmill training. Proprioception was measured using the joint angle recurrence method by smartphone protractor application while the participant was in one-legged stance (paretic hip flexion/extension, paretic knee flexion/extension), at post-treatment (6 weeks). Significant between-group differences were found on all measures, in favour of underwater backward treadmill training vs. on-ground backward treadmill training.

The non-randomized study (Han, Kim & An, 2013) allocated participants to receive an aquatic proprioceptive exercise program or a land-based proprioceptive exercise program. Proprioception was measured using the Biometrics motion analysis system at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. land-based therapy.

Conclusion: There is limited evidence (level 2a) from two fair quality RCTs and one quasi-experimental study that aquatic interventions are more effective than on-land interventions for improving proprioception in the chronic phase of stroke recovery.

Quality of life
Conflicting
4

One high quality RCT (Matsumoto et al., 2016), one fair quality RCT (Eyvaz, Dundar & Yesil, 2018) and two quasi-experimental studies (Montagna et al., 2014; Morer et al., 2020) investigated the effect of aquatic interventions on quality of life in the chronic phase of stroke recovery.

The high quality RCT (Matsumoto et al., 2016) randomized participants to receive aquatic therapy or no aquatic therapy; both groups received conventional rehabilitation. Quality of life was measured using the Short-Form 36 (SF-36: Physical functioning; Role physical; Bodily pain; General health; Vitality; Social functioning; Role-emotional; Mental health) at post-treatment (12 weeks). A significant between-group difference was found in change scores on all measures of quality of life in favour of aquatic therapy vs. no aquatic therapy.

The fair quality RCT (Eyvaz, Dundar & Yesil, 2018) randomized participants to receive water-based exercises or land-based exercises; both groups received additional land-based exercises. Quality of life was measured using the SF-36 (Vitality; Physical functioning; Role physical; Pain; General health; Social functioning; Role emotional; Mental health) at post-treatment (6 weeks). A significant between-group difference was found in one measure of quality of life (SF-36: Vitality), in favour of water-based exercises vs. land-based exercises. No other between-group differences were found.

The first non-randomized study (Montagna et al., 2014) assigned participants to receive aquatic physiotherapy using the Halliwick method. Quality of life was measured using the Stroke-Specific Quality of Life questionnaire (SS-QoL – Energy, Family roles, Language, Mobility, Mood, Personality, Self-care, Social roles, Thinking, Upper extremity function, Vision, Work/productivity, Total scores) at post-treatment (18 sessions). A significant improvement was found in one score only (Mobility).

The second non-randomized study (Morer et al., 2020) assigned participants to receive aquatic therapy + thalassotherapy. Health-related quality of life was measured using the EQ-5D (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression scores) at post-treatment (2 weeks). A significant improvement was found on one measure (Mobility).

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of aquatic interventions on quality of life in the chronic phase of stroke recovery. One high quality RCT found that aquatic therapy was more effective than no aquatic therapy. One fair quality RCT found that water-based exercises were no more effective than comparable land-based exercises. Two quasi-experimental studies found an improvement in only one measure of quality of life (mobility) following aquatic interventions.

Self-perception of Health and Well-being
Effective
2b

One quasi-experimental study (Morer et al., 2020) investigated the effect of aquatic interventions on well-being in the chronic phase of stroke recovery. The non-randomized study assigned participants to receive aquatic therapy + thalassotherapy. Psychological well-being was measured using the WHO 5-item Well-Being Index and self-perception of health was measured using the EQ-VAS at post-treatment (2 weeks). A significant improvement was found on both measures.

Conclusion: There is limited evidence (level 2b) from one quasi-experimental study that aquatic interventions are effective for improving well-being following stroke.

Spasticity
Effective
1b

One high quality RCT (Matsumoto et al., 2016) investigated the effect of aquatic interventions on spasticity in the chronic phase of stroke recovery. This high quality RCT randomized participants to receive aquatic therapy or no aquatic therapy; both groups received conventional rehabilitation. Spasticity was measured using the Modified Ashworth Scale at post-treatment (12 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. no aquatic therapy.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic therapy is more effective than no aquatic therapy for reducing spasticity in the chronic phase of stroke recovery.

Strength - lower extremity
Not effective
1a

One high quality RCT (Perez-de la Cruz, 2020) and four fair quality RCTs (Noh et al., 2008; Park et al., 2012; Kum & Shin, 2017; Eyvaz, Dundar & Yesil, 2018) investigated the effect of aquatic interventions on lower extremity strength in the chronic phase of stroke recovery.

The high quality RCT (Perez-de la Cruz, 2020) randomized participants to receive Ai-Chi aquatic therapy, on-land exercises, or combined aquatic therapy + on-land exercises. Lower extremity functional strength was measured using the 30-second chair stand test at post-treatment (12 weeks) and one-month follow-up. No significant between-group difference was found at either timepoint between aquatic therapy vs. on-land exercises.
Note: Significant between-group differences were found at both timepoints in favour of combined therapy vs. aquatic therapy, and in favour of combined therapy vs. on-land exercises.

The first fair quality RCT (Noh et al., 2008) randomized participants to receive aquatic therapy or conventional rehabilitation. Muscle strength was measured using an isokinetic device (knee flexors/extensors – paretic/nonparetic, lumbar flexors/extensors) at post-treatment (8 weeks). A significant difference was found on one measure of muscle strength (paretic knee flexor – change score from baseline to post-treatment), in favour of aquatic therapy vs. conventional rehabilitation.

The second fair quality RCT (Park et al., 2012) randomized participants to receive aquatic treadmill training or land-based treadmill training. Muscle strength was measured using the Short Physical Performance Battery at post-treatment. No significant between-group difference was found.

The third fair quality RCT (Kum & Shin, 2017) randomized participants to receive underwater backward treadmill training or on-ground backward treadmill training. Knee flexor and extensor Isokinetic strength (paretic, non-paretic) was measured by handheld dynamometer (maximal peak torque at 90-degrees/second, 120-degrees/second) at post-treatment (6 weeks). No significant between-group differences were found.

The fourth fair quality RCT (Eyvaz, Dundar & Yesil, 2018) randomized participants to receive water-based exercises or land-based exercises; both groups received additional land-based exercises. Lower extremity muscle strength (paretic, non-paretic sides) was measured at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (level 1a) from one high quality RCT and four fair quality RCTs that aquatic interventions are not more effective than on-land interventions for improving lower extremity strength in the chronic phase of stroke recovery.

Walking endurance
Effective
1b

One high quality RCT (Zhu et al., 2016) and one quasi-experimental study (Morer et al., 2020) investigated the effect of aquatic interventions on walking endurance in the chronic phase of stroke recovery.

The high quality RCT (Zhu et al., 2016) randomized participants to receive hydrotherapy or land-based exercises. Walking endurance was measured using the Two-Minute Walk Test at post-treatment (4 weeks). A significant between-group difference was found, in favour of hydrotherapy vs. land-based exercise.

The non-randomized study (Morer et al., 2020) assigned participants to receive aquatic therapy + thalassotherapy. Walking endurance was measured using the Six-Minute Walk Test at post-treatment (2 weeks). A significant improvement was found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that aquatic interventions are more effective than on-land interventions for improving walking endurance in the chronic phase of stroke recovery. A quasi-experimental study also reported improved walking endurance following aquatic therapy.

Walking speed
Effective
1a

Two high quality RCTs (Chu et al., 2004; Matsumoto et al., 2016), three fair quality RCTs (Kim, Lee & Jung, 2015; Kim, Lee & Kim, 2016; Aidar et al., 2018) and one quasi-experimental study (Morer et al., 2020) investigated the effect of aquatic interventions on walking speed in the chronic phase of stroke recovery.

The first high quality RCT (Chu et al., 2004) randomized participants to receive an aquatic lower extremity program or a land-based upper extremity training program. Self-selected gait speed (m/sec) was measured over an 8-meter walking test at post-treatment (8 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. upper extremity training.

The second high quality RCT (Matsumoto et al., 2016) randomized participants to receive aquatic therapy or no aquatic therapy; both groups received conventional rehabilitation. Walking speed was measured using the 10-Meter Walk Test (Speed, Cadence) at post-treatment (12 weeks). A significant between-group difference was found on both measures of walking speed, in favour of aquatic therapy vs. no aquatic therapy.

The first fair quality RCT (Kim, Lee & Jung, 2015) randomized patients to receive aquatic coordination movement using Proprioceptive Neuromuscular Facilitation (PNF) and Neurodevelopmental Therapy (NDT) or NDT alone. Walking speed was measured using the 10-Meter Walk Test at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic PNF vs. no therapy.

The second fair quality RCT (Kim, Lee & Kim, 2016) randomized participants to receive aquatic dual-task training or no aquatic therapy; both groups received neurodevelopmental therapy. Walking speed was measured using the 10-Meter Walk Test at post-treatment (6 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. no therapy.

The third fair quality RCT (Aidar et al., 2018) randomized participants to receive an aquatic exercise program or no treatment. Walking speed was measured using the Timed 7.62-Meter Walk test at post-treatment (12 weeks). A significant between-group difference was found, in favour of aquatic therapy vs. no treatment.

The non-randomized study (Morer et al., 2020) assigned participants with chronic stroke to receive aquatic therapy + thalassotherapy. Walking speed was measured using the 10-Meter Walk Test at post-treatment (2 weeks). No significant improvement was found.

Conclusion: There is strong evidence (level 1a) from two high quality RCTs and three fair quality RCTs that aquatic therapy is more effective than on-land interventions or no therapy for improving walking speed in the chronic phase of stroke recovery.

Walking skills
Not effective
2a

One fair quality RCT (Kum & Shin, 2017) investigated the effect of aquatic interventions on walking skills in the chronic phase of stroke recovery. The fair quality RCT randomized participants to receive underwater backward treadmill training or on-ground backward treadmill training. Walking skills were measured using the Figure-of-Eight Walk test at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (level 2a) from one fair quality RCT that aquatic interventions are not more effective than on-land interventions for improving walking skills in the chronic phase of stroke recovery.

Weight-bearing
Effective
2a

Two fair quality RCTs (Noh et al., 2008; Park et al., 2012) investigated the effect of aquatic interventions on weight-bearing in the chronic phase of stroke recovery.

The first fair quality RCT (Noh et al., 2008) randomized participants to receive aquatic therapy or conventional rehabilitation. Weight-bearing ability was measured using an mtd-Balance system (Rising from a chair, Lateral weight-shift, Forward weight-shift, Backward weight-shift – paretic/non-paretic limbs) at post-treatment (8 weeks). A significant difference in change scores from baseline to post-treatment was found on two measures of weight-shift (forward, backward – paretic limb only), in favour of aquatic therapy vs. conventional rehabilitation.

The second fair quality RCT (Park et al., 2012) randomized participants to receive aquatic treadmill training or land-based treadmill training. Weight-bearing ability was measured using the SmartStep System (entire foot, forefoot, hindfoot) at post-treatment. Significant between-group differences were found (entire foot, hindfoot), in favour of aquatic treadmill training vs. land-based treadmill training.

Conclusion: There is limited evidence (level 2a) from two fair quality RCTs that aquatic interventions are more effective than on-land interventions for improving weight-bearing in the chronic phase of stroke recovery.

References

Aidar, F.J., Garrido, N.D., Silva, A.J., Reis, V.M., Marinho, D.A., & Faco de Oliveira, R.J. (2013). Effects of aquatic exercise on depression and anxiety in ischemic stroke subjects. Health, 5(2), 222-8.
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Aidar, F.J., Faco de Oliveira, R., Gama de Matos, D., Chilibeck, P.D., de Souza, R.F., Carneiro, A.L., & Machado Reis, V. (2017). A randomized trial of the effects of an aquatic exercise program on depression, anxiety levels, and functional capacity of people who suffered an ischemic stroke. The Journal of Sports Medicine and Physical Fitness, 58, 1171-7
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Cha, H-.G., Shin, Y-.J., & Kim, M-.K. (2017). Effects of the Bad Ragaz Ring method on muscle activation of the lower limbs and balance ability in chronic stroke: a randomised controlled trial. Hong Kong Physiotherapy Journal, 37, 39-45.
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Chu, K.S., Eng, J.J., Dawson, A.S., Harris, J.E., Ozkaplan, A., & Gylfadottir, S. (2004). Water-based exercise for cardiovascular fitness in people with chronic stroke: a randomized controlled trial. Archives of Physical Medicine & Rehabilitation, 85, 870-4.
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Eyvaz, N., Dundar, U., & Yesil, H. (2018). Effects of water-based and land-based exercises on walking and balance functions of patients with hemiplegia. NeuroRehabilitation, 43(2), 237-46.
DOI: 10.3233/NRE-182422

Furnari, A., Calabro, R.S., Gervasi, G., La Fauci-Belponer, F., Marzo, A., Berbiglia, F., Paladina, G., De Cola, M.C., & Bramanti, P. (2014). Is hydrokinesitherapy effective on gait and balance in patients with stroke? A clinical and baropodometric investigation. Brain Injury, 28(8), 1109-14.
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Han, S.K., Kim, M.C., & An, C.S. (2013). Comparison of effects of a proprioceptive exercise program in water and on land the balance of chronic stroke patients. The Journal of Physical Therapy Science, 25(10), 1219-22.
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Han, E.Y. & Im, S.H. (2018). Effects of a 6-week aquatic treadmill exercise program on cardiorespiratory fitness and walking endurance in subacute stroke patients: a pilot trial. Cardiovascular Disease, 38, 314-9.
DOI: 10.1097/HCR.0000000000000243

Iatridou, G., Pelidou, H.S., Varvarousis, D., Stergiou, A., Beris, A., Givissis, P., & Ploumis, A. (2018). The effectiveness of hydrokinesiotherapy on postural balance of hemiplegic patients after stroke: a systematic review and meta-analysis. Clinical Rehabilitation, 32(5):583-593.
DOI: 10.1177/0269215517748454.

Jung, J.H., Lee, J.Y., Chung, E.J., & Kim, K. (2014). The effect of obstacle training in water on static balance of chronic stroke patients. The Journal of Physical Therapy Science, 26, 437-40.
DOI: 10.1589/jpts.26.437

Kim, K., Lee, D-.K., & Jung, S-.I. (2015). Effect of coordination movement using the PNF pattern underwater on the balance and gait of stroke patients. The Journal of Physical Therapy Science, 27, 3699-3701.
DOI: 10.1589/jpts.27.3699

Kim, E-.K., Lee, D-.K., & Kim, Y-.M. (2015). Effects of aquatic PNF lower extremity patterns on balance and ADL of stroke patients. The Journal of Physical Therapy Science, 27, 213-5.
DOI: 10.1589/jpts.27.213

Kim, K., Lee, D-.K. & Kim, E-.K. (2016). Effect of aquatic dual-task training on balance and gait in stroke patients. The Journal of Physical Therapy Science, 28, 2044-7.
DOI: 10.1589/jpts.28.2044

Kum, D-.M. & Shin, W-.S. (2017). Effect of backward walking training using an underwater treadmill on muscle strength, proprioception and gait ability in persons with stroke. Physical Therapy Rehabilitation Science, 6(3), 120-6.
DOI: 10.14474/ptrs.2017.6.3.120

Lee, D., Ko, T., & Cho, Y. (2010). Effects on static and dynamic balance of task-oriented training for patients in water or on land. The Journal of Physical Therapy Science, 22, 331-6.
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Lee, S.Y., Im, S.H., Kim, B.R., & Han, E.Y. (2018). The effects of a motorized aquatic treadmill exercise program on muscle strength, cardiorespiratory fitness, and clinical function in subacute stroke patients: a randomized controlled pilot trial. American Journal of Physical Medicine and Rehabilitation, 97, 533-40.
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Matsumoto, S., Uema, T., Ikeda, K., & Miyara, K. (2016). Effect of underwater exercise on lower-extremity function and quality of life in post-stroke patients: a pilot controlled clinical trial. The Journal of Alternative and Complementary Medicine, 22(8), 635-41.
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Mehrholz, J., Kugler, J, & Pohl, M. (2011). Water-based exercises for improving activities of daily living after stroke. Cochrane Database of Systematic Reviews, Issue 1. Art. No.: CD008186.
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Montagna, J.C., Santos, B.C., Battistuzzo, C.R., & Loureiro, A.P.C. (2014). Effects of aquatic physiotherapy on the improvement of balance and corporal symmetry in stroke survivors. International Journal of Clinical and Experimental Medicine, 7(4), 1182-7.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4057885/

Morer, C., Michan-Dona, A., Zuluaga, P., & Maraver, F. (2020). Evaluation of the feasibility of a two-week course of aquatic therapy and thalassotherapy in a mild post-stroke population. International Journal of Environmental Research and Public health, 17, 8163.
DOI: 10.3390/ijerph17218163

Nascimento, L.R., Flores, L.C., de Menezes, K.K.P., & Teixeira-Salmela, L.F. (2020). Water-based exercises for improving walking speed, balance, and strength after stroke: a systematic review with meta-analyses of randomized trials. Physiotherapy, 107, 110-10.
DOI: 10.1016/j.physio.2019.10.002

Noh, D.K., Lim, J-.Y., Shin, H-.I., & Paik, N-.J. (2008). The effect of aquatic therapy on postural balance and muscle strength in stroke survivors: a randomized controlled pilot trial. Clinical Rehabilitation, 22, 966-76.
DOI: 10.1177/0269215508091434

Park, J., Lee, D., Lee, S., Lee, C., Yoon, J., Lee, M., Lee, J., Choi, J., & Roh, H. (2011). Comparison of the effects of exercise by chronic stroke patients in aquatic and land environments. The Journal of Physical Therapy Science, 23, 821-4.
DOI: 10.1589/jpts.23.821

Park S-.E., Kim, S-.H., Lee, S-.B., An, H-.J., Choi, W-.S., Moon, O-.G., Kim, J-.S., Shin, H-.J., Choi, Y-.R., & Min, K-.O. (2012). Comparison of underwater and overground treadmill walking to improve gait pattern and muscle strength after stroke. The Journal of Physical Therapy Science, 24, 1087-90.
DOI: 10.1589/jpts.24.1087

Park, S.W., Lee, K.J., Shin, D.C., Shin, S.H., Lee, M.M., & Song, C.H. (2014). The effect of underwater gait training on balance ability of stroke patients. The Journal of Physical Therapy Science, 26, 899-903.
DOI: 10.1589/jpts.26.899

Park, B-.S., Noh, J-.W., Kim, M-.K., Lee, L-.K., Yang, S-.M., Lee, W-.D., Shin, Y-.S., Kim, J-.H., Lee, J-.U., Kwak, T-.Y., Lee, T-.H., Park, J., & Kim, J. (2016). A comparative study of the effects of trunk exercise program in aquatic and land-based therapy on gait in hemiplegic stroke patients. The Journal of Physical Therapy Science, 28, 1904-8.
DOI: 10.1589/jpts.28.1904

Park, J. & Roh, H. (2011b). Postural balance of stroke survivors in aquatic and land environments. The Journal of Physical Therapy Science, 23, 905-8.
DOI: 10.1589/jpts.23.905

Perez-de la Cruz, S. (2020). Comparison of aquatic therapy vs. dry land therapy to improve mobility of chronic stroke patients. International Journal of Environmental Research and Public Health, 17(13), 4728 pp1-12.
DOI: 10.3390/ijerph17134728

Perez-de la Cruz, S. (2021). Comparison between three therapeutic options for the treatment of balance and gait in stroke: a randomized controlled trial. International Journal of Environmental Research and Public Health, 18, 426 pp1-11.
DOI: 10.3390/ijerph18020426

Saleh, M.S.M., Rehab, N.I., & Aly, S.M.A. (2019). Effect of aquatic versus land motor dual task training on balance and gait of patients with chronic stroke: a randomized controlled trial. NeuroRehabilitation, 44, 485-92.
DOI: 10.3233/NRE-182636

Tripp, F. & Krakow, K. (2014). Effects of an aquatic therapy approach (Halliwick-Therapy) on functional mobility in subacute stroke patients: a randomized controlled trial. Clinical Rehabilitation, 28(5), 432-9.
DOI: 10.1177/0269215513504942

Veldema, J. & Jansen, P. (2020). Aquatic therapy in stroke rehabilitation: systematic review and meta-analysis. Acta Neurologica Scandinavica, 43(3), 221-41.
DOI: 10.1111/ane.13371

Xie, G., Wang, T., Jiang, B., Su, Y., Tang, X., Guo, Y., & Liao, J. (2019). Effects of hydrokinesitherapy on balance and walking ability in stroke survivors: a systematic review and meta-analysis of randomized controlled studies. European Review of Aging and Physical Activity, 16, Art. No. 21.
DOI: 10.1186/x11556-019-0227-0

Zhang, Y., Wang, Y-.Z., Huang, L-.P., Bai, B., Zhou, S., Yin, M-.M., Zhao, H., Zhou, X-.N., & Wang, H-.T. (2016). Aquatic therapy improves outcomes for subacute stroke patients by enhancing muscular strength of paretic lower limbs without increasing spasticity: a randomized controlled trial. American Journal of Physical Medicine & Rehabilitation, 95(11), 840-9.
DOI: 10.1097/PHM.0000000000000512

Zhu, Z., Cui, L., Yin, M., Yu, Y., Zhou, X., Wang, H., & Yan, H. (2015). Hydrotherapy vs. conventional land-based exercise for improving walking and balance after stroke: a randomized controlled trial. Clinical Rehabilitation, 30(6), 587-93.
DOI: 10.1177/0269215515593392

Excluded Studies

Lee, J-.Y., Park, J-.S., & Kim, K. (2011). The effect of aquatic task training on gait and balance ability in stroke patients. The Journal of Korean Society of Physical Therapy, 23(3), 29-35.
Reason for exclusion: Between-group differences were not reported.

Lim, C-.G. (2020). Effect of underwater treadmill gait training with water-jet resistance on balance and gait ability in patients with chronic stroke: a randomized controlled pilot trial. Frontiers in Neurology, 10: 1246.
Reason for exclusion: Both groups received a form of aquatic treadmill training.

Park, B-.S., Noh, J-.W., Kim, M-.Y., Lee, L-,K., Yang, S-.M., Lee, W-.D., Shin, Y-.S., Kim, J-.H., Lee, J-.U.., Kwak, T-.Y., Lee, T-.H., Kim, J-.Y., Park, J., & Kim, J. (2015). The effects of aquatic trunk exercise on gait and muscle activity in stroke patients: a randomized controlled pilot study. Journal of Physical Therapy Science, 27, 3549-53.
Reason for exclusion: No between-group comparisons.

Temperoni, G., Curcio, A., Iosa, M., Mangiarotti, M.A., Morelli, D., De Angelis, S., Vergano, S., & Tramontano, M. (2020). A water-based sequential preparatory approach vs. conventional aquatic training in stroke patients: a randomized controlled trial with a 1-month follow-up. Frontiers in Neurology, 11: 466.
Reason for exclusion: Both groups received a form of aquatic training.

Balance Training

Evidence Reviewed as of before: 09-06-2012
Author(s)*: Annabel McDermott, OT; Nicol Korner-Bitensky, PhD OT; Norine Foley, BASc; Mark Speechley, PhD; Nancy M. Salbach, PhD, PT; Maxim Ben Yakov, BSc. PT; Robert Teasell, MD
Patient/Family Information Table of contents

Introduction

Balance problems are caused by motor, sensory and cognitive impairments and are one of the most common issues after stroke. Impaired postural control contributes to difficulties with recovery of mobility and functional independence among patients with stroke. Most rehabilitation therapies aim for the restoration of balance in sitting, as well as in standing, reaching, and rising to stand.

Additional support from undergraduate students, School of Physical and Occupational Therapy, McGill University: Natasha Alloul, Julie Parent -Taillon, Nadia Boule-Laghzali, Genevieve Larivee, Ang Li, Zahra Adl-Zarabi, Michael Dyck

Patient/Family Information

Author: Maxim Ben Yakov, BSc. PT

What is balance training?

To sit and to walk safely you need to have good balance. Balance training focuses on practicing and improving the body’s ability to perform coordinated movement (of arms and legs) while maintaining a balanced posture, i.e. without falling, stumbling, or feeling wobbly. This is usually achieved through rehearsal of tasks, such as reaching for objects while holding the body straight. Training in sitting and standing should be initiated as soon as possible after a stroke, as these are basic, necessary tasks in daily life.

Why train balance after a stroke?

Balance is a basic requirement for active, independent, and safe movement of our bodies in daily life. Before your stroke, you probably balanced your body when sitting and standing automatically, without thinking about it. After a stroke, you may have balance problems that require you to concentrate a great deal to do simple things, such as putting on your socks, or standing at a sink to brush your teeth. Even people who experience only small problems with balance may have difficulty when walking outside on uneven ground or when crossing the street.

Are there different kinds of balance training?

Yes, there are different ways to retrain balance after a stroke.

  • Functional balance training: Recently, balance training has been focusing more on functional, task-specific training. In functional training, the individual who has had a stroke works on typical tasks that people perform in their daily lives, such as reaching into a cupboard for a cup or plate, or trying to carry a grocery bag.
  • Body weight support: After a stroke, some individuals are too weak and have difficulty sitting, standing, or walking in therapy. If this is the case, your body weight may be supported while you stand or walk either  by your therapist or by a body harness.
  • Hydrotherapy: Sometimes, balance training is done in a therapeutic pool, using a technique called Hydrotherapy. Water makes your limbs lighter, since you are not moving against gravity. Water also provides support and stimulation so that you can work on your balance in a safe environment. Your therapist will usually work in the water with you to make sure that you are well supported and safe.
  • Proprioception training: Balance training can also include something called proprioception training, which can help you to be aware of where your arms and legs are in space. For example, after a stroke some people have difficulty knowing where their hand is when their eyes are closed. Proprioception is important to achieve proper balance, and the good news is that as we work on improving balance, we are training proprioception as well.Other types of balance training you might hear about are:
  • “Bobath approach”: Bobath was a physiotherapist who developed a treatment approach that analyzes and interprets how you move after your stroke. After a stroke, many people move in a way that is different from before. Your therapist will work on training and modifying your movements to help you accomplish daily tasks. Usually a therapist will guide your arms, legs or trunk through the correct movements so that you can re-learn to do the activities correctly.
  • “Visual feedback” or “Biofeedback for trunk control”: This technique uses a mirror in front of you or a video camera system to track your body, arms, or legs while doing activities like catching a ball or placing objects on a shelf. This allows you to see how you are moving so that you can try to correct your movements.
  • “Vision-deprived training”: With your eyes covered, your therapist will help you do activities like standing on one or both legs, trying to sit on a pillow, or simply getting up from a chair and sitting down. This challenges your balance more than when your eyes are open. This is an activity you should try doing as you get better.
  • “Independent practice”: You can work on your balance on your own. For example, during your independent exercise, you could have as a goal to stand on both legs with equal weight, or to try and sit on both buttocks with equal pressure.
    NOTE: You should only try this once your therapist tells you that it is safe for you to do so.
  • “Balance biofeedback”: After a stroke, it is typical to put more weight on your “good” leg when you are standing. However, it is important that you also put weight on your weaker leg. While you are standing, your therapist will use a computer screen with a special mat that will sense how much pressure goes through each foot. The amount of weight put through your weaker leg will then be recorded and will show up on the computer screen. Training in this way gives you immediate feedback about how well you are doing. At first, the goal may be to increase the amount of weight you put on your weaker leg. Next, it may be to put an equal amount of weight on both legs while standing. Eventually, you may try to put more weight on your weaker leg. This is important because as we walk, we need to put our body weight through one leg at a time.
  • “Perceptual training”: This technique focuses on training the awareness of your arms, legs, and trunk in space. For example you might be asked to touch your knee and then your forehead while your eyes are closed.
  • “Multisensorial Training”: Following a stroke, you may become overly reliant on visual cues to help maintain your balance. Multisensorial training is a form of rehabilitation conducted while restricting the amount that you see. It focuses on the amount and intensity of your movements and exercise without placing emphasis on how well you perform them.

Does balance training work after a stroke?

Researchers have done experiments to see if balance training helps people who have had a stroke.

  • Task-oriented interventions: One high quality study looked at task-oriented interventions for walking. The results showed that this treatment can improve a person’s confidence in balance.
  • Perceptual exercises: After a stroke, it is common to have more body sway, and this makes you more unsteady on your feet. In one high quality study, results showed that perceptual exercises reduced the amount of body sway.
    NOTE: Even without a stroke, everyone has a certain normal amount of body sway that we are not aware of.
  • Bobath Therapy Approach: One high quality study showed that the Bobath approach did not improve independence in normal daily living, sitting balance, standing balance, or the amount of weight put on the weaker leg.
  • Task-specific reaching training: One high quality study found that task-specific reaching does not improve how evenly you distribute your body weight through both buttocks when sitting. The same study results showed that such training does not improve how equally you put your body weight through both feet while standing.
  • Independent-practice training: There is limited research from one fair quality study that showed that when independent-practice training is combined with therapy based on the Bobath approach it does not improve balance after a stroke.
  • Visual feedback training: There is limited research based on two fair quality studies suggesting that visual feedback training does not result in improvements in balance. It is worth noting that one study did find important gains in the ability to perform self-care activities (such as washing, toileting, dressing, and grooming).
  • Balance biofeedback training: There are conflicting findings in this area. Three fair quality studies found no real gains in balance after using this training method. In contrast, two high quality studies on balance biofeedback training found that balance did improve after a stroke. Another high quality study demonstrated that biofeedback for trunk control training can improve significantly standing balance (not when walking or reaching).
  • Multisensorial Training: One high quality study found that multisensorial training (a form of therapy conducted while restricting what you see and focusing on the amount and intensity of movement and exercise) is not more effective than neurodevelopmental therapy (a form of therapy which focuses on quality of movement and exercise) in improving standing balance. However, it is more effective at improving your balance when walking and moving around, as well as increasing independence in functional activities and improving quality of life.

Side effects/risks?

Balance is important to prevent you from falling. During balance training, you should always be supervised by an individual who knows about practicing balance training safely. Eventually, you will probably begin practicing balance exercises with your family or friends. Before you do so, your therapist should show them safe ways of working with you.

Who provides the treatment?

Balance training should be performed or supervised by a trained health professional. A variety of health professionals provide balance training as part of their treatment, including occupational therapists, physical therapists, and exercise therapists.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

Of the 42 studies included in this module that have investigated interventions to improve balance post-stroke, 25 are high quality randomized controlled trials. Interventions reviewed in this module include aquatic therapy, Bobath therapy, force platform or mechanical balance training devices, multisensory training, perceptual exercises, task-specific exercises, trunk exercises, vibration therapy and virtual reality. Although a majority of the studies demonstrated a positive benefit of balance training, the heterogeneity of intervention and outcomes measures does not allow us to make definite conclusions regarding any one most efficacious intervention method for balance re-training post-stroke.

Lubetzky-Vilnai & Kartin (2010) conducted a systematic review of recent studies on balance training interventions that comprised 22 RCTs, pilot studies and case series from January 2006 to February 2010. Comparison among studies was limited by diversity in balance training interventions (type, duration, intensity and progression), control interventions (conventional physiotherapy, standard interdisciplinary care, conventional gait training, patient-initiated training, body-weight supported training, standard rehabilitation and neurodevelopmental treatment) and outcomes measured. Most studies reported that balance training programs were not more effective than control therapies as both experimental and control groups demonstrated improved balance following intervention.

An & Shaughnessy (2011) conducted a systematic review of exercise interventions used to improve balance and/or gait following stroke. The authors reviewed 17 English-language RCTs published from 2001 to January 2010, 10 of which included balance as an outcome (5 of these were also included in the 2010 systematic review by Lubetzky-Vilnai & Kartin). This systematic review concluded that multisensory programs do not seem to be effective in improving balance following stroke. However, early initiation of exercise after stroke was reported to be effective in improving balance, and aerobic exercise was positively associated with improved balance in subacute and chronic stroke. The systematic review concluded that exercise performed for at least 20-60 minutes, 3-4 times a week for 6-12 weeks can improve balance following stroke.

Results Table

View results table

Outcomes

Aquatic therapy
Effective
2A

One fair quality RCT (Noh et al., 2008) has investigated the effectiveness of aquatic therapy in improving balance in patients with stroke.

The fair quality RCT (Noh et al., 2008) randomized patients with chronic stroke and unilateral limb weakness to an aquatic therapy program or a conventional gym exercise program. At one month post-treatment there were significant between-group differences, with those in the aquatic group having better balance (Berg Balance Scale) and weight-bearing ability on the affected side (vertical ground reaction force during forward and backward weight-shift). There was no significant group difference in weight-bearing ability during sit-to-stand or lateral weight-shift.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that aquatic therapy is more effective than a gym exercise program for improving balance, forward/backward weight shift and knee flexor strength of the affected limb in patients with stroke.

Note: however, the fair quality RCT found no significant difference between groups in weight shift during lateral movements and when rising from a chair, or strength of knee extensor and trunk muscles.

Bobath therapy
Effective
2a

One fair quality RCT (Mudie et al., 2002) has investigated the use of the Bobath approach in improving balance following stroke.

The fair quality study (Mudie et al., 2002) randomly assigned patients with acute stroke to one of four treatment groups: (1) task-specific reaching; (2) Bobath therapy interventions; (3) BPM biofeedback interventions; or (4) conventional physiotherapy and occupational therapy (control). The Bobath group demonstrated a significant improvement in seated symmetry of weight distribution at post-treatment (2 weeks), although results did not remain significant at follow-up time point (12 weeks). At 12 weeks post-study 29% of the Bobath group were able to distribute weight to both sides, in comparison to the BPM group (83%), task-specific group (38%) and the control group (0%).

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that Bobath therapy is effective for improving balance (seated weight distribution) following stroke. However, between-group differences were not reported.

Cycling training
Effective
1B

One high quality RCT (Katz-Leurer et al., 2006) has investigated the effectiveness of cycling training in improving balance in patients with stroke.

The high quality RCT (Katz-Leurer et al., 2006) randomized patients with subacute stroke to receive cycling training and conventional rehabilitation or conventional rehabilitation training alone. At post-treatment (6 weeks) there were significant group-time interactions in favour of the cycling group compared to the control group for balance on the Postural Assessment Scale for Stroke Patients total, static and dynamic scores. However, no significant between-group differences were seen for standing balance as measured using the Standing Balance Test.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that cycling training is more effective than conventional rehabilitation alone for improving balance in patients with stroke.

Note: However, the high quality RCT showed no significant between-group differences on the Standing Balance test.

Force platform training
Effective
1a

Two high quality RCTs (Sackley & Lincoln, 1997; Cheng et al., 2001), 6 fair quality RCTs (Shumway-Cook et al., 1988;Wong et al., 1997; Grant et al., 1997; Walker et al., 2000; Chen et al., 2002; Mudie et al., 2002) and 1 poor quality RCT (Geiger et al., 2001) have investigated the effect of force platform biofeedback training on balance following stroke.

The first high quality RCT (Sackley & Lincoln, 1997) randomized patients with subacute or chronic stroke to receive balance training using the Nottingham Balance Platform with visual feedback regarding weight distribution and weight shift activity, or a placebo balance intervention. Balance measures were taken at baseline, 4 weeks (post-treatment) and 12 weeks (follow-up) using assessment of stance symmetry and sway. Significant between-group differences were seen in favour of the treatment group compared to the placebo group for stance symmetry at post-treatment, but these differences did not remain significant at follow-up. There were no significant differences in sway.

The second high quality RCT (Cheng et al., 2001) assigned patients with hemiplegia following stroke to balance training using a dual force platform standing biofeedback trainer with visual and auditory feedback, or conventional physical therapy. Significant between-group differences were noted in favour of the force platform group compared to the control group on balance measures of mediolateral sway, rate of rise in force when rising from a chair, and frequency of falls post-stroke. There were no significant between-group differences in sit-to-stand or stand-to-sit performance at post-treatment, but at 6-month follow-up a significant difference in sit-to-stand performance was reported in favour of the force platform group compared to the control group.

The first fair quality RCT (Shumway-Cook et al., 1988) randomly assigned individuals with subacute stroke to standing balance retraining using a static force platform biofeedback device, or standing balance training without biofeedback. A significant between-group difference in lateral sway displacement was reported in favour of the force platform group compared to the control group. There was no significant difference in total sway area between groups.

The second fair quality RCT (Wong et al., 1997) randomised patients with acute stroke to training using a Standing Biofeedback Training (SBT) device that provides real-time visual and auditory weight bearing biofeedback, or a Standing Training Table (STT) worktable. Significant between-group differences in postural symmetry were seen at week 1, week 2 and week 4, in favour of the SBT group compared to the STT group. Note: significant between-group differences in postural symmetry were not seen at day 1 or week 3.

The third fair quality RCT (Grant et al., 1997) reported preliminary findings from a study by Walker et al., 2000 (see below), whereby 16 patients with stroke were randomly assigned to visual biofeedback balance training and physiotherapy, or standard balance training and physiotherapy. No significant differences were noted on measures of balance (Berg Balance Scale, postural sway, standing symmetry).

The fourth fair quality RCT (Walker et al., 2000) randomly assigned 54 patients with stroke to one of three treatment groups: (1) balance training using the dual force platform Balance Master with visual feedback and conventional physiotherapy and occupational therapy; (2) ‘standard’ balance training and conventional physiotherapy and occupational therapy; or (3) conventional physiotherapy and occupational therapy alone. There were no significant differences on measures of balance (Berg Balance Scale, postural sway) when comparing either intervention group with the control group.

The fifth fair quality RCT (Chen et al., 2002) randomly assigned patients with stroke to balance training using the Smart Balance Master with visual feedback in combination with conventional physical and occupational therapy, or physical and occupational therapy alone. Significant differences were observed between groups on one of three measures of static balance (absence of sway but not maximum stability or center of gravity alignment) and all three measures of dynamic balance (axis velocity, directional control, end-point excursion).

The sixth fair quality RCT (Mudie et al., 2002) randomly assigned individuals with recent stroke to one of four treatment groups: (1) task-specific reaching; (2) Bobath therapy interventions; (3) Balance Performance Monitor (BPM) weight-distribution training in sitting and standing with visual feedback; or (4) conventional physiotherapy and occupational therapy (control). The BPM group demonstrated a significant improvement in seated symmetry of weight distribution at post-treatment (2 weeks) but these results did not remain significant at follow-up time points (4 weeks, 12 weeks). At 12 weeks post-study 83% of the BPM group was distributing weight to both sides, as compared to 38% of the task-specific reaching group, 29% of the Bobath group and 0% of the control group. The BPM group also demonstrated some generalization of symmetry training in sitting to standing.

The poor quality study (Geiger et al., 2001) assigned patients with stroke to balance training using the forceplate Neurocom Balance Master with visual feedback, or regular balance training. There were no significant differences in balance (Berg Balance Scale) at post-treatment (4 weeks).

Conclusion: There is strong evidence (level 1a) from 2 high quality RCTs and 3 fair quality RCTs that force platform biofeedback training is more effective than control therapies for improving balance (e.g. symmetry, mediolateral sway, dynamic balance, frequency of falls) following stroke.

Note: However, numerous studies reported that force platform biofeedback training was not more effective than control therapies for improving other measures of balance (e.g. Berg Balance Scale, postural sway, seated weight-distribution).

Independent practice
Not Effective
2A

One fair quality RCT (Pollock et al. 2002) has investigated the efficacy of independent-practice training for improving balance post-stroke.

The fair quality RCT (Pollock et al. 2002) randomly assigned patient with stroke to 1 of 2 treatment groups: (1) Independent practice with balance-focused exercise in combination with conventional therapy; or (2) conventional therapy alone (control). No significant difference was found between groups. It was concluded that performance of postural control and weight distribution did not increase for individuals in either group post-stroke.

Conclusion: There is limited evidence (level 2a) from 1 fair quality study that independent-practice training with conventional therapy is not more effective than conventional therapy alone for improving balance post-stroke.

Mechanical balance training devices
Not Effective
1b

One high quality RCT (Goljar et al., 2010) and one controlled clinical trial (Byun et al., 2011) have investigated the effect of a mechanical balance training device on balance in patients with stroke.

The high quality RCT (Goljar et al., 2010) randomized patients with subacute or chronic stroke to receive physiotherapy and balance training using a mechanical device, or physiotherapy and conventional balance training. There was no significant between-group difference in balance (Berg Balance Scale; one-leg standing) at post-treatment.

The controlled clinical trial (non-randomized crossover design) (Byun et al., 2011) divided patients with chronic stroke into two groups to receive conventional rehabilitation in addition to balance training using a sliding rehabilitation machine for 2 weeks (experimental period), preceded (group B) or followed (group A) by 2 weeks of conventional rehabilitation alone (control period). There was a significant difference in favour of the experimental period as compared to the control period in improving balance (Berg Balance Scale).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that a mechanical balance training device is not more effective than physiotherapy and conventional training for improving balance among patients with subacute and chronic stroke.

Note: However, 1 controlled clinical trial found that a balance trainer (sliding rehabilitation machine) is more effective than conventional rehabilitation alone in improving balance among patients with chronic stroke. Variations in the type of mechanical balance training devices used may account for differences in results between studies.

Multisensory training
Effective
1B

Two high quality RCTs (Yelnik et al., 2008; Gok et al., 2008), one fair quality RCT (Bayouk et al., 2006) and one poor quality RCT(Onigbinde et al., 2009) have investigated the use of multisensorial training on balance in patients with stroke.

The first high quality RCT (Yelnik et al., 2008) randomised patients with subacute and chronic stroke to receive multisensorial therapy or neurodevelopmental therapy (control group). No significant between-group differences in balance (Berg Balance Scale*; self reported perception of security) were seen at post treatment (30 days) or follow-up (60 days). However, a significant between-group difference in dynamic balance (percentage of double-limb stance time) was seen at follow-up, in favour of the multisensorial group compared to the control group.

*Note: Differences in standing balance may not have been detected due to the ceiling effect of the Berg Balance Scale. The authors also questioned the clinical meaning of the improvements to the patients due to the small values.

The second high quality RCT (Gok et al., 2008) randomized patients with chronic stroke to receive balance training using a kinaesthetic ability training (KAT) device and conventional rehabilitation, or conventional rehabilitation alone. The KAT device held a centrally-pivoted balance platform with a pressure bladder that allowed adjustments in weight shift in response to visual feedback. At 4 weeks (post-treatment) the KAT group showed significantly greater improvement in balance (Fugl-Meyer Stroke Assessment [FMA] balance subscore; KAT static and dynamic balance indices) than the control group.

The fair quality RCT (Bayouk et al., 2006) randomised hemiparetic patients with chronic stroke to a task-oriented exercise program with manipulation of sensory input (eyes open/closed; soft/firm surface) or a task-oriented program under normal conditions. Outcomes were taken as a measure of the center of pressure (COP) displacement during double-legged stance and sit-to-stand with eyes open or closed and on normal or soft surfaces, as well as the 10-m walking test. Although between-group differences were not reported*, a significant difference in pre- and post-test balance (COP displacement during double-leg stance with eyes open on normal and soft surfaces) was seen for the experimental group but not the control group. Both groups demonstrated a significant difference in pre- and post-test results in other balance measures (COP displacement during sit-to-stand with eyes open on a soft surface) and walking speed (10-m walking test).

*Note: as between-group differences are not reported, this study is not used to determine level of evidence regarding the effectiveness of multisensorial training in the conclusion below.

The poor quality RCT (Onigbinde et al., 2009) randomised patients with stroke (time since stroke not specified) to perform wobble board exercises with visual feedback and conventional physiotherapy, or conventional physiotherapy alone. At post-treatment (6 weeks) there were significant between-group differences in static balance (eyes closed) and dynamic balance (Four Square Step Test time), in favour of the experimental group compared to the control group. There were no significant between-group differences in static balance (eyes open) at post-treatment.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT and 1 poor quality RCT that multisensorial training is more effective than conventional rehabilitation for improving balance following stroke. One fair quality RCT also reported a significant improvement in balance following multisensory training.

Note: One high quality RCT reported no significant difference in balance between multisensory training and conventional rehabilitation, although noted a potential ceiling effect of the instrument used to measure balance (Berg Balance Scale). The same RCT saw a significant between-group difference in dynamic balance at follow-up (but not at post-treatment), in favour of the multisensorial training group.

Perceptual exercises
Effective
1B

One high quality RCT (Morioka et al. 2003) has investigated the use of perceptual training for balance retraining post-stroke.

The high quality RCT (Morioka et al., 2003) randomly assigned patients with stroke to receive rehabilitation including perceptual learning exercises or standard rehabilitation (control). Significant improvements were reported in the length, the enveloped area and the rectangular area of the parameter of postural sway in the group receiving the perceptual exercises compared to the control group.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that perceptual exercises are more effective than standard rehabilitation for improving balance measures post-stroke.

Speed-dependent treadmill training
Not Effective
1B

One high quality RCT (Lau et al., 2011) has investigated the use of speed-dependent treadmill training for improving balance following stroke.

The high quality RCT (Lau et al., 2011) randomised patients with subacute stroke to a speed-dependent treadmill training group or a steady-speed treadmill training group. At post-treatment (10 x 30-minute sessions) there was no significant between-group difference in balance (Berg Balance Scale).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that speed-dependent treadmill training is not more effective than steady-speed treadmill training for improving balance following stroke.

Standing practice
Not Effective
1b

One high quality RCT (Allison & Dennett, 2007) has investigated the effectiveness of standing practice to improve balance among patients with stroke.

The high quality RCT (Allison & Dennett, 2007) randomized patients with acute or subacute stroke to receive standing practice and conventional physiotherapy or physiotherapy alone. There were no significant between-group differences in balance or trunk control (Berg Balance Scale; Trunk Control Test; Rivermead Motor Assessment – Gross Functional Tool Section) at weeks 1, 2 or 12.

Note: However, a significant difference in change in Berg Balance Scale scores from week 1 to week 12 was seen in favour of the standing practice group compared to the control group.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that standing practice is not more effective than conventional physiotherapy alone for improving balance and trunk control in patients with acute or subacute stroke.

Tai chi
Effective
1B

One high quality RCT (Au-Yeung et al., 2009) has investigated the effect of tai chi on balance in patients with stroke.

The high quality RCT (Au-Yeung et al., 2009) randomized patients with chronic stroke to a tai chi group or a control group that performed general exercises for breathing, stretching, mobilization, memory and reasoning. Dynamic standing balance was measured by center of gravity (COG) excursion during self-initiated body leaning forward, backward and towards the affected and non-affected sides using the Limit of Stability test; and standing equilibrium was measured by the Sensory Organization test. A significant between-group difference was seen in COG excursion amplitude when leaning forward, backward and toward the nonaffected side from week 6 (mid-treatment), and also toward the affected side from week 12 (post-treatment), in favour of the tai chi group compared to the control group. These results were maintained at 18 weeks (follow-up). A significant between-group difference in reaction time during voluntary weight shift towards the non-affected side was seen at 12 weeks and 18 weeks in favour of the tai chi group compared to the control group. There was a significant difference in standing equilibrium with vestibular input at 12 weeks (post-treatment), in favour of the tai chi group compared to the control group.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that tai chi is more effective than regular exercises for improving balance in patients with chronic stroke.

Task-oriented walking
Not Effective
1A

Five high quality RCTs (Richards et al., 1993; McClellan & Ada, 2004; Salbach et al., 2004 and Salbach et al., 2005; Marigold et al., 2005; Outermans et al., 2010), 1 fair quality RCT (Dean et al., 2000) and 1 quasi-experimental study (Rose et al., 2011) have investigated the use of task-oriented interventions targeting walking for balance retraining post-stroke.

The first high quality RCT (Richards et al., 1993) randomised patients with acute stroke to receive intensive gait-focused task-oriented physical therapy, or one of two control groups that received different intensities of standard physical therapy. No significant difference in balance (Berg Balance Scale, Fugl Meyer Assessment balance subscale) was seen between groups at 6 weeks (post-treatment) or 3 months (follow-up).

The second high quality RCT (McClellan & Ada, 2004) randomised patients with chronic stroke to receive home-based task-oriented mobility training or home-based task-oriented upper extremity training exercises. There was a significant between-group difference in standing balance (Functional Reach Test) at 6 weeks (post-treatment) and at 2-month follow-up, in favour of the task-oriented mobility group compared to the task-oriented upper extremity group.

The third high quality RCT (Salbach et al., 2004; Salbach et al., 2005) randomised patients with subacute or chronic stroke to receive task-oriented mobility training or task-oriented upper extremity training. There was a significant between-group difference in balance confidence (Activities-specific Balance Confidence scale), but not balance (Berg Balance Scale) at 6 weeks (post-treatment), in favour of the task-oriented mobility group compared to the task-oriented upper extremity group.

The fourth high quality RCT (Marigold et al., 2005) randomised patients with chronic stroke to receive a task-oriented mobility training program or a program that emphasized slow stretching and weight-shift. No significant differences in balance (Berg Balance Scale), balance confidence (Activities-specific Balance Confidence Scale) or falls (unforced falls during reaching transferring; induced falls during platform translation) were seen at 10 weeks (post-treatment) or 1-month follow-up.

The fifth high quality RCT (Outermans et al., 2010) randomised patients with subacute stroke to receive high intensity task-oriented mobility training or low intensity standard therapy. No significant between-group differences in balance (Berg Balance Test; Functional Reach Test) were seen at 4 weeks (post-treatment).

The fair quality RCT (Dean et al., 2000) randomised patients with chronic stroke and residual hemiplegia to receive task-oriented mobility training or task-oriented upper extremity training. A significant between-group difference in balance during stepping (Step Test) was seen in favour of the task-oriented mobility group compared to the upper extremity group at 4 weeks (post-treatment) and 2 months (follow-up).

The quasi-experimental study (Rose et al., 2011) assigned patients with acute stroke to receive task-oriented mobility training or conventional rehabilitation. No significant between-group difference in balance (Berg Balance Scale) was seen at hospital discharge (post-treatment).

Conclusion 1 (balance): There is strong evidence (level 1a) from 4 high quality RCTs and 1 quasi-experimental study that task-oriented mobility training is not more effective than control therapies (conventional rehabilitation, physiotherapy) for improving balance following stroke.

Note: however, 1 high quality RCT found a significant difference in standing balance, and 1 fair quality RCT found a significant difference in stepping balance, in favour of task-oriented mobility training compared to control therapies.

Conclusion 2 (balance confidence): There is conflicting evidence (level 4) between 2 high quality RCTs regarding the effectiveness of task-oriented mobility training for improving balance confidence following stroke.

One fair quality RCT (Mudie et al. 2002) has investigated the use of task-specific reaching for balance retraining post-stroke.

The fair quality RCT (Mudie et al., 2002) randomly assigned patients with recent stroke to one of four treatment groups: (1) task-specific reaching; (2) Bobath therapy interventions; (3) BPM biofeedback interventions; or (4) conventional physiotherapy and occupational therapy (control). The task-specific reaching group did not demonstrate a significant improvement in seated weight distribution at post-treatment (2 weeks) or follow-up time points (4 weeks, 12 weeks), whereas all other groups demonstrated significantly improved sitting symmetry at post-treatment. At 12 weeks post-study, 38% of the task-specific reaching group were distributing weight to both sides, as compared to 83% of the BPM group, 29% of the Bobath group and 0% of the conventional therapy group.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that task specific reaching is not effective for improving balance post-stroke. However, between-group differences were not reported.

Task-specific reaching
Not Effective
2A

One fair quality RCT (Mudie et al. 2002) has investigated the use of task-specific reaching for balance retraining post-stroke.

The fair quality RCT (Mudie et al., 2002) randomly assigned patients with recent stroke to one of four treatment groups: (1) task-specific reaching; (2) Bobath therapy interventions; (3) BPM biofeedback interventions; or (4) conventional physiotherapy and occupational therapy (control). The task-specific reaching group did not demonstrate a significant improvement in seated weight distribution at post-treatment (2 weeks) or follow-up time points (4 weeks, 12 weeks), whereas all other groups demonstrated significantly improved sitting symmetry at post-treatment. At 12 weeks post-study, 38% of the task-specific reaching group were distributing weight to both sides, as compared to 83% of the BPM group, 29% of the Bobath group and 0% of the conventional therapy group.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that task specific reaching is not effective for improving balance post-stroke. However, between-group differences were not reported.

Thermal therapy
Not Effective
1B

One high quality RCT (Chen et al., 2011) investigated the effect of thermal therapy on balance in patients with stroke.

The high quality RCT (Chen et al., 2011) randomized patients with acute stroke to receive thermal stimulation and conventional rehabilitation or conventional rehabilitation alone. No significant between-group differences in balance (Berg Balance Scale; Postural Assessment Scale for Stroke Trunk Control) were seen post-treatment (6 weeks).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that thermal therapy is not more effective than conventional rehabilitation for improving balance in patients with acute stroke.

Trunk exercises
Conflicting
4

Five high quality RCTs (de Seze et al., 2001; Howe et al., 2005; Verheyden et al., 2009; Karthikbabu et al., 2011; Saeys et al., 2011) have investigated the effect of trunk exercises on balance in patients with stroke.

The first high quality RCT (de Seze et al., 2001) randomly assigned patients with stroke to receive trunk control training with visual and auditory feedback using the Bon Saint Come device, or conventional rehabilitation training. Significant between-group differences were noted for balance (Upright Equilibrium Index; Trunk Control Test) at 30 days (post-treatment) and remained at 90 day follow-up (Upright Equilibrium Index only). No significant between-group differences were found for sitting balance (Sitting Equilibrium Index) at post-treatment or follow-up.

The second high quality RCT (Howe et al., 2005) randomized patients with acute stroke to receive lateral weight transference training in sitting and standing and conventional rehabilitation, or conventional rehabilitation alone. There were no significant between-group differences in balance (weight displacement during lateral reaching in sitting and standing; time taken to transfer from sit-to-stand and stand-to-sit) at post-treatment (4 weeks) or follow-up (8 weeks).

The third high quality RCT (Verheyden et al., 2009) randomized patients with acute and subacute stroke to receive conventional rehabilitation and individualized trunk exercises (intervention group) or conventional rehabilitation alone (control group). At 5 weeks (post-treatment) there was a significant between-group difference in dynamic sitting balance (Trunk Impairment Scale dynamic sitting balance), in favour of the intervention group compared to the control group. There were no significant between-group differences on other measures of balance and coordination (Trunk Impairment Scale total, static sitting balance, coordination).

The fourth high quality RCT (Karthikbabu et al., 2011) randomised patients with acute stroke to perform trunk exercises on an unstable surface (intervention group) or on a stable surface (control group), in addition to conventional physiotherapy. At 3 weeks (post-treatment) there were significant between-group differences in balance and coordination (Trunk Impairment Scale [TIS] total, dynamic sitting balance, coordination; Brunel Balance Assessment [BBA] total and stepping subtest scores), in favour of the intervention group compared to the control group. However, no significant between-group differences were seen for static sitting balance (TIS) or standing balance (BBA).

The fifth high quality RCT (Saeys et al., 2011) randomised patients with acute or subacute stroke to receive conventional training and exercises to improve trunk muscle strength, coordination and movement (intervention group), or conventional training and sham treatment that comprised passive mobilization and TENS to the hemiplegic shoulder (control group). At 8 weeks (post-treatment) there were significant differences in balance (Berg Balance Scale; Four Test Balance Scale; Tinetti Test; Trunk Impairment Scale [TIS] total, dynamic sitting, coordination). No significant between-group differences were seen in static sitting balance (TIS static sitting) or proprioception (Romberg tests).

Conclusion: There is conflicting evidence (level 4) among 5 high quality RCTs regarding the effect of trunk exercises on balance following stroke. While studies reported better outcomes than conventional rehabilitation on several balance measures (e.g. Berg Balance Scale, Brunel Balance Assessment, Trunk Control Test, Tinetti Test, Four Test Balance Scale, Upright Equilibrium Index, Trunk Impairment Scale – dynamic balance), all studies also reported no significant between-group differences on other balance measures (Sitting Equilibrium Index, Trunk Impairment Scale – static sitting balance, Romberg tests, weight displacement during lateral reaching, and time taken to transfer between sit and stand).

Note: Most participants were in the acute or subacute stages of stroke recovery. Variation in outcome measures used, as well as the type, frequency and duration of trunk exercises, are likely to account for these differences in outcomes between studies.

Vibration therapy
Not Effective
1B

One high quality RCT (van Nes et al., 2006) and 1 fair quality RCT (Merkert et al., 2011) have investigated the effect of vibration therapy on balance in patients with stroke.

The first high quality RCT (van Nes et al., 2006) randomized patients with subacute stroke to receive whole-body vibration using a commercially-available platform vibration device, or exercise therapy on music at the same frequency and duration (sham stimulation). No significant between-group differences in balance (Berg Balance Scale; Trunk Control Test) were seen at 6 weeks (post-treatment) or 12 weeks (follow-up).

The fair quality RCT (Merkert et al., 2011) randomized patients with stroke to receive balance training and vibration therapy using a Vibrosphere® vibrating platform, or conventional rehabilitation alone. There were no significant differences between groups for balance (Berg Balance Scale) at 15 days (post-treatment).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT and 1 fair quality RCT that vibration therapy is not more effective than control therapies (e.g. conventional therapy, sham stimulation) for improving balance following stroke.

Virtual reality
Not Effective
2A

One fair quality RCT (Yang et al., 2011) has investigated the effect of virtual reality training programs on balance in patients following stroke.

The fair quality RCT (Yang et al., 2011) randomised patients with chronic stroke to receive virtual reality treadmill training or traditional treadmill training. Virtual reality treadmill training comprised level walking while watching interactive scenes that simulated turns, whereas the control group completed level treadmill walking with a garden view. At post-treatment (3 weeks) there was a significant between-group difference in center of pressure (COP) displacement in the medial-lateral direction during quiet stance. There were no other significant differences between groups in measures taken in quiet stance or sit-to-stand transfers (COP displacement in the anterior-posterior direction, COP total path excursion, COP sway area, symmetry index, COP path excursion under the paretic limb) or during level walking (stance time of the paretic limb, contact area of the paretic foot, and number of steps of the paretic limb).

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that virtual reality treadmill training is not more effective than traditional treadmill training for improving static or dynamic balance in patients following stroke.

Note: However, the fair quality RCT did find a significant between-group difference in COP displacement in the medial-lateral direction during quiet stance, in favour of the virtual reality treadmill training group.

Vision-deprived training
Effective
1B

One high quality RCT (Bonan et al. 2004) has investigated the efficacy of vision-deprived training for the improvement of balance post-stroke.

The high quality RCT (Bonan et al., 2004) randomly assigned patients with stroke to receive vision-deprived training (intervention group) or free vision training (control group). At post-treatment significant between-group differences were noted in balance (Sensory Organization Test), in favour of the intervention group compared to the control group.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that vision-deprived training is more effective than free vision training for improving balance post-stroke.

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Body Weight Supported Treadmill Training

Evidence Reviewed as of before: 23-11-2010
Author(s)*: Angela Kim, BSc; Adam Kagan, BSc; Anita Menon MSc. erg; Robert Teasell; Sanjit Bhogal MSc; Norine Foley BSc; Mark Speechley; Chelsea Hellings; Nicol Korner-Bitensky; Geoffroy Hubert BSc; Geoffroy Hubert BSc. Lic. K
Patient/Family Information Table of contents

Introduction

Restoring walking ability is one of the primary goals of stroke rehabilitation. Failure to walk following a stroke can lead to serious long-term disability. About one-third of individuals surviving an acute stroke are unable to walk three months after being admitted to hospital (Wade et al. 1987). Walking can be affected by residual impairments and disabilities including impaired balance, muscle stiffness, and decreased motor function. One method for retraining walking has been through partial body weight support (BWS) combined with treadmill training. The person is partially suspended in a harness either from the ceiling or from an apparatus frame (see photograph), in order to reduce weight bearing and provide postural support for treadmill walking. The amount of support can be gradually decreased as postural control, balance, and coordination begin to improve.

Patient/Family Information

Author: Marc-André Roy, MSc

What is body weight supported treadmill training?

Body weight supported (BWS) treadmill training is a method for retraining walking. A person using BWS is supported by a harness that is suspended from a metal frame or from the ceiling (see photograph here below). The harness and BWS provide support and reduce the weight on your feet while you walk on the treadmill. The amount of support can be gradually increased or decreased according to your particular needs. For example, if your therapist increases the treadmill speed, you might need more BWS for a short time as you try to keep your balance and posture while walking faster.

Front view of a body weight support system with an overhead suspension and harness that supports the subject on the treadmill.

Body Weight Supported Treadmill

Why use body weight supported treadmill training after a stroke?

Some people have difficulty walking after a stroke. BWS treadmill training may be a safe way for you to begin walking when you are not able to walk safely by yourself. BWS allows some people to start walking earlier after a stroke, especially if they currently require two people to help them walk over ground. It also allows some people to practice walking when they are not ready to do so over ground.

Does it work for stroke?

The best research studies on BWS and treadmill training have shown differing results depending on the severity of the walking deficit. In general, benefits have been found in people who have serious problems walking after a stroke. The benefits are less certain for individuals who only have mild difficulty walking after a stroke.

  • For those with serious walking deficits, a number of high quality research studies have shown that BWS treadmill training is more effective than usual walking training for improving speed of walking, endurance, balance, motor recovery, and functional walking.
  • For those with mild walking deficits, high quality studies have not found that BWS treadmill training is more effective than usual walking training.

What can I expect?

BWS treadmill training is a fairly new treatment. You may be receiving rehabilitation in a setting that has the equipment and if so, you may be offered this treatment. Many different harnesses have been designed to support the body. However, there are some aspects of this intervention that are common to all the equipment used:

  • You will wear a harness over your clothes.
  • The harness is then fastened to an overhead suspension system.
  • The therapist providing the therapy will decide on how much of your body weight is supported by the harness and how much is supported by your legs.
  • When the therapist adjusts the BWS it will feel like you are being lifted slightly off the floor.
  • The therapist will then start the treadmill at a very low speed. The therapist can then increase the speed as your walking ability improves.

Side effects/risks?

There are no specific side effects of BWS treadmill training. In fact, research has shown that it is easier on your heart if you walk with your body weight supported – so after a stroke it may be easier for you to practice walking using BWS as compared to walking over ground.

Generally, people who have used BWS tell us that they feel more confident because they are supported by the harness and can practice walking without the risk of a fall.

However, there are some patients who have told us that they find the harness uncomfortable to wear – and some who do not enjoy walking on a treadmill.

Who provides the treatment?

BWS treadmill training is typically performed by a physical therapist. An assistant may be present to help you get ready by putting on your harness and staying with you during rest periods. This equipment is quite costly and it is quite a labor-intensive treatment, so the rehabilitation center where you are receiving rehabilitation may not have a BWS system. If further research continues to show benefits for those with severe walking difficulties, it is likely that more rehabilitation centers will purchase the equipment.

How many treatments?

The best exercise program design is unknown. However, in most of the studies that have found BWS treadmill training effective, the patients received the therapy 20 to 40 minutes (with rest periods in-between), 4-to-5 days a week, for at least 2 weeks, and sometimes as long as 6 weeks.

How much does it cost? Does insurance pay for it?

In Canada, BWS treadmill training is covered if you are receiving care in a rehabilitation setting that offers this form of treatment. If you are receiving private rehabilitation you will have to verify that your insurance covers the cost of BWS treadmill training.

Is body weight supported treadmill training for me?

If your gait has been seriously affected by a stroke, BWS treadmill training could help you regain endurance, control of your lower limbs, and cardiovascular health. However, further studies are needed to better understand who can benefit most from this type of training.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

Of the 12 studies investigating the effect of BWS treadmill training on gait recovery of patients, eight were fair quality, and two were not scored as they were not RCTs.

A systematic Cochrane review investigating the effectiveness of BWS treadmill training post-stroke concluded that there are no statistically significant differences between patients receiving BWS treadmill training as compared to over-ground gait therapy on functional ambulation and other gait parameters. They did however report that patients who walked independently at baseline showed a trend towards greater improvement than those with more severe impairments (Moseley et al. 2003).

Since that time new studies have found significant post-intervention differences on a number of gait parameters between those who received BWS and those who received treadmill training without BWS.

Only studies that compare BWS treadmill to either overground walking, or treadmill training with no BWS are reviewed in this module. Studies that involve comparisons with electromechanical gait trainers (the “electromechanical gait trainers” involves a harness-secured patient putting his feet on two motorized footplates that simulate stance and swing movements of gait) are presented in the module entitled “Electromechanical gait trainers”.
*Although no significant between-group differences were found, results indicated a potential benefit of using BWS treadmill training compared to other therapies.

Results Table

View results table

Outcomes

Acute Phase of Stroke Recovery

Balance
Not Effective
1B

Results from one high quality RCT (Nilsson et al. 2001) reported no significant difference in balance at post-treatment and at the 10 month follow-up assessment (as assessed by the Berg Balance Scale) between those with acute stroke who received BWS treadmill training or over-ground gait therapy, in addition to their usual therapy.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training does not improve balance during ambulation for acute patients post-stroke.

Endurance
Not Effective
2A

One fair quality RCT (da Cunha IT Jr et al. 2001) involving patients with acute stroke, reported no significant differences in endurance at post-treatment for those who received BWS treadmill training versus over-ground gait therapy – both in addition to usual physical therapy.

Conclusion: There is limited evidence (level 2a) from one fair quality RCT that BWS treadmill training does not improve endurance in patients with an acute stroke.

Functional ambulation
Not Effective
1B

One high quality RCT (Nilsson et al. 2001) and one fair quality RCT(da Cunha IT Jr et al. 2001a) involving patients with an acute stroke receiving either BWS treadmill training or over-ground gait therapy in addition to their usual therapy, have reported no significant differences in functional ambulation between the two groups at post-treatment, as measured by the Functional Ambulation Categories (FAC). In addition, the study by (Nilsson et al. 2001) found no significant differences between the two groups on the FAC at 10-month follow-up.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and one fair quality RCT that BWS treadmill training does not improve functional ambulation in patients with an acute stroke.

Functional independence
Not Effective
1B

Results from one high quality RCT (Nilsson et al. 2001) reported no significant difference in activities of daily living as assessed by the Functional Independence Measure (FIM) at post-treatment and at the 10 month follow-up assessment, between acute patients who received BWS treadmill training versus over-ground gait therapy.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training does not improve functional independence in acute stroke.

Motor recovery
Not Effective
1B

Results from one high quality RCT(Nilsson et al. 2001) reported no significant improvements in motor recovery as assessed by the Fugl-Meyer Motor Assessment (FMA) at post-treatment and at 10 month follow-up, for acute patients with a stroke who received BWS treadmill training as compared to over-ground gait therapy.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training does not improve motor recovery in patients with an acute stroke

Walking speed
Not Effective
1B

Results from one high quality RCT (Nilsson et al. 2001) and one fair quality RCT (da Cunha IT Jr et al. 2001) reported no significant difference in walking speed at post-treatment between acute patients with stroke who received BWS treadmill training or over-ground gait therapy. Only 12 subjects were studied by da Cunha IT Jr et al.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and one fair quality RCT that BWS treadmill training does not improve walking speed in patients with an acute stroke.

Subacute Phase of Stroke Recovery - Low Ambulatory Status

Balance
Effective
1b

One high quality RCT (Visintin et al. 1998) investigated the effect of BWS treadmill training on balance in patients with subacute stroke. The study found significant between-group differences in balance (as measured by the Berg Balance Scale) at post-treatment in favour of patients who received BWS treadmill training as compared to treadmill training without BWS, but these significant differences were not seen at the 3 month follow-up. Further sub-analyses of the data (Barbeau and Visintin (2003) suggested significant differences in balance on the Berg Balance Scale at post-treatment and at 3-month follow-up assessment, in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS. Such differences were not observed between patients with high ambulatory status in the two groups at post-treatment and at 3-month follow-up.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training is better than overground walking for improving balance in patients with subacute stroke and low initial ambulatory status post-stroke.

Discharge destination
Effective
1B

One high quality RCT (Ada et al. 2010) investigated the effect of BWS treadmill training on discharge destination in patients with low ambulatory status and subacute stroke. Within 6 months, the study found a significant between-group difference in the number of patients who were discharged home or in supported accomodation in favour of the group that received up to 6 months* of BWS treadmill training group compared to a control group that received up to 6 months* of assisted overground walking.
* Patients received up to 6 months training, where training ended at discharge or when the patient was able to walk unassisted for 15 meters.
Note: Fewer patients in intervention group required assisted accommodation following discharge.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that BWS treadmill training improves the number of patients discharged to their home environments, compared to assisted overground walking in patients with subacute stroke and low ambulatory status.

Functional ambulation
Not Effective
1B

One high quality RCT (Franceschini et al., 2009) has investigated the effect of BWS treadmill training on functional ambulation in patients with subacute stroke.

The high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in functional ambulation (as measured by the Functional Ambulation Categories) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training is not more effective than overground gait training in improving functional ambulation in patients with subacute stroke.

Functional independence
Not Effective
1B

One high quality RCT (Franceschini et al., 2009) investigated the effect of BWS treadmill training on functional independence in patients with subacute stroke.

One high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in functional independence (as measured by the Barthel Index) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training is not more effective than overground gait training in improving functional independence in patients with subacute stroke.

Motor recovery
Conflicting
4

Three high quality RCTs (Franceschini et al., 2009, Werner et al. 2002, Visintin et al. 1998) investigated the effect of BWS gait training on motor recovery in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in motor recovery (as measured by the Motricity Index) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

The second high quality RCT (Werner et al. 2002) investigated patients with a subacute stroke receiving either BWS treadmill training or BWS and “gait trainer”. The “gait trainer” involves a harness-secured patient putting his feet on 2 motorized footplates that simulate stance and swing movements of gait (both groups also received usual physical therapy). No significant differences were found on the Rivermead Motor Assessment (gross function, trunk and leg subscales) at post-treatment and 6-month follow-up between the two groups of patients with subacute stroke and low ambulatory status. NOTE: As both groups received BWS this study is not included in determining levels of evidence for BWS in patients with a subacute stroke.

The third high quality RCT (Visintin et al. 1998) indicated significant improvement in motor recovery (as measured by the STREAM- STroke REhabilitation Assessment of Movement) at post-treatment and at 3-month follow-up assessment, for patients with subacute stroke who received BWS treadmill training as compared to treadmill training without BWS.

Further sub-group analyses of the data (Barbeau and Visintin, 2003) indicated significant improvements in motor recovery at post-treatment and at 3-month follow-up assessment, in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS. Such differences were not observed at post-treatment and at 3-month follow-up between groups with high ambulatory status.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of BWS treadmill training on motor recovery in patients with subacute stroke and low ambulatory status. While one high quality RCT reported no significant difference between BWS treadmill training and overground gait training, another high quality RCT found BWS was more effective than overground walking training in improving motor recovery in patients with subacute stroke.

Self-rated walking perception and community participation
Not Effective
1B

One high quality RCT (Ada et al. 2010) investigated the effect of BWS treadmill training on community participation in patients with low ambulatory status and subacute stroke. At 6 months, no significant between-group differences were found for self-rated walking perception (10 point Likert Scale), self-rated number of falls over 6 months, or community participation (Adelaide Activities Profile) between the group that received up to 6 months* of BWS treadmill training group compared to the group that received up to 6 months* of assisted overground walking.
* Patients received up to 6 months training, where training ended at discharge or when the patient was able to walk unassisted for 15 meters.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that BWS treadmill training does not improve self-rated walking perception and community participation in patients with subacute stroke and low initial ambulatory status.

Trunk control
Not Effective
1B

One high quality RCT (Franceschini et al., 2009) investigated the effect of BWS treadmill training on trunk control in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in trunk control (as measured by the Trunk Control Test) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training is not more effective than overground gait training in improving trunk control in patients with subacute stroke.

Walking endurance
Conflicting
4

Two high quality RCTs (Franceschini et al., 2009, Dean et al. 2010) examined the effect of BWS treadmill training on walking endurance in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke and low ambulatory status to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in walking endurance (as measured by the 6-minute Walk Test) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

The second high quality RCT (Dean et al. 2010) investigated the effect of BWS treadmill training on walking endurance in patients with low ambulatory status and subacute stroke. The study found a significant difference at 6 months in walking endurance (as measured by the 6-Minute Walking Test) in favour of the group that received BWS treadmill training for up to 6 months* compared to the group that received assisted overground walking training for up to 6 months*.
* Patients received up to 6 months training, where training ended at discharge or when the patient was able to walk unassisted for 15 meters.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of BWS treadmill training on walking endurance in patients with subacute stroke and low ambulatory status. While one high quality RCT reported no significant difference between BWS treadmill training and overground gait training, another high quality RCT found BWS was more effective than overground walking training in improving walking endurance in patients with subacute stroke.

Walking independence
Not Effective
1a

Two high quality RCTs (Franceschini et al., 2009, Ada et al. 2010) examined the effect of BWS treadmill training on walking independence in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke and low ambulatory status to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in walking independence (as measured by the Walking Handicap Scale) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

The second high quality RCT (Ada et al. 2010) investigated the effect of BWS treadmill training on walking independence in patients with low ambulation. At 6 months, a non-significant between-group difference was found in the number of patients to reach independent walking, in favor of the group that received up to 6 months* of BWS treadmill training compared to a group that received up to 6 months* of assisted overground walking. The BWS treadmill group achieved independent walking 2 weeks earlier than the control group (median of 5 weeks for BWS vs. 7 weeks for control). However, this between-group difference was not statistically significant.
* Patients received up to 6 months training, where training ended at discharge or when the patient was able to walk unassisted for 15 meters.

Conclusion: There is high evidence (level 1a) from 2 high quality RCTs that BWS treadmill training does not improve walking independence compared to control therapies (assisted overground walking or overground gait training) in patients with sub acute stroke and low ambulatory status.
Note: One high quality RCT showed clinically important differences in favor of BWS training for the number of patients to achieve independent walking and for time until independent walking.

Walking speed
Conflicting
4

Three high quality RCTs (Franceschini et al., 2009, Visintin et al. 1998, Dean et al. 2010) and one fair quality RCT (Kosak et al. 2000) examined the effect of BWS treadmill training on walking speed in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke and low ambulatory status to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in walking speed (as measured by the 10-meter Walk Test) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

The second high quality RCT (Visintin et al. 1998) indicated significant differences in walking speed at post-treatment and at 3-month follow-up assessment, for patients with subacute stroke who received BWS treadmill training as compared to treadmill training without BWS. Further sub-analyses of the data (Barbeau and Visintin, 2003) indicated significant differences in walking speed at post-treatment and at 3-month follow-up assessment in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS, but no differences between groups in those with high ambulatory status.

The third high quality RCT (Dean et al. 2010) found no significant differences at 6 months in walking speed (as measured by the 10 Meter Walking Test) in the group treated for up to 6 months* with BWS treadmill training as compared to the group treated for up to 6 months* with assisted overground walking. All patients in this study had low ambulatory status at baseline.
* Patients received up to 6 months training, where training ended at discharge or when the patient was able to walk unassisted for 15 meters.

The one fair quality RCT (Kosak et al. 2000) reported a significant between-group difference in walking speed at post-treatment in favor of patients receiving BWS treadmill training as compared to aggressive bracing assisted overground walking over ground for those with a low ambulatory status. However, no significant between- group differences were found for those with high initial ambulatory status.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of BWS treadmill training on walking speed in patients with subacute stroke and low ambulatory status. While two high quality RCTs reported no significant difference between BWS treadmill training and overground gait training, another high quality RCT found BWS was more effective than overground walking training in improving walking speed in patients with subacute stroke.

Subacute Phase of Stroke Recovery - High Ambulatory Status

Balance
Not Effective
1B

One high quality RCT (Visintin et al. 1998) investigated the effect of BWS treadmill training on balance in patients with subacute stroke. The study found significant between-group differences in balance (as measured by the Berg Balance Scale) at post-treatment in favour of patients who received BWS treadmill training as compared to treadmill training without BWS, but these significant differences were not seen at the 3 month follow-up. Further sub-analyses of the data (Barbeau and Visintin (2003) suggested significant differences in balance on the Berg Balance Scale at post-treatment and at 3-month follow-up assessment, in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS. Such differences were not observed between patients with high ambulatory status in the two groups at post-treatment and at 3-month follow-up.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training does not improve balance during ambulation compared to overground walking for patients with subacute stroke and high initial ambulatory status.

Motor recovery
Not Effective
1B

Three high quality RCTs (Franceschini et al., 2009, Werner et al. 2002, Visintin et al. 1998) investigated the effect of BWS gait training on motor recovery in patients with subacute stroke.

The first high quality RCT (Franceschini et al., 2009) randomized patients with subacute stroke to an intervention group that received BWS treadmill training or a control group that received overground gait training. No significant difference in motor recovery (as measured by the Motricity Index) was found at 2 weeks (mid-intervention), 4 weeks (post-intervention), 6 weeks (follow-up) or at 6 months post-stroke.

The second high quality RCT (Werner et al. 2002) investigated patients with a subacute stroke receiving either BWS treadmill training or BWS and “gait trainer”. The “gait trainer” involves a harness-secured patient putting his feet on 2 motorized footplates that simulate stance and swing movements of gait (both groups also received usual physical therapy). No significant differences were found on the Rivermead Motor Assessment (gross function, trunk and leg subscales) at post-treatment and 6-month follow-up between the two groups of patients with subacute stroke and low ambulatory status. NOTE: As both groups received BWS this study is not included in determining levels of evidence for BWS in patients with a subacute stroke.

The third high quality RCT (Visintin et al. 1998) indicated significant improvement in motor recovery (as measured by the STREAM- STroke REhabilitation Assessment of Movement) at post-treatment and at 3-month follow-up assessment, for patients with subacute stroke who received BWS treadmill training as compared to treadmill training without BWS.

Further sub-group analyses of the data (Barbeau and Visintin, 2003) indicated significant improvements in motor recovery at post-treatment and at 3-month follow-up assessment, in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS. Such differences were not observed at post-treatment and at 3-month follow-up between groups with high ambulatory status.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that BWS treadmill training is not more effective than treadmill training without BWS for improving motor recovery in patients with subacute stroke and high ambulatory status.

Walking speed
Not Effective
1B

Results from one high quality RCT (Visintin et al. 1998) indicated significant differences in walking speed at post-treatment and at 3-month follow-up assessment, for patients with subacute stroke who received BWS treadmill training as compared to treadmill training without BWS. Further sub-analyses of the data (Barbeau and Visintin, 2003) indicated significant differences in walking speed at post-treatment and at 3-month follow-up assessment in patients with low ambulatory status who received BWS treadmill training as compared to treadmill training without BWS, but no differences between groups in those with high ambulatory status.

One fair quality RCT (Kosak et al. 2000) reported a significant between-group difference in walking speed at post-treatment in favor of patients receiving BWS treadmill training as compared to aggressive bracing assisted overground walking over ground for those with a low ambulatory status. However, no significant between- group differences were found for those with high initial ambulatory status.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT and one fair quality RCT that BWS treadmill training is not more effective than either treadmill training with no BWS, or assisted over ground walking in improving walking speed in patients with subacute stroke and high initial ambulatory status.

Chronic Phase of Stroke Recovery - High Ambulatory Status

Cardiac/respiratory status
Effective
2B

Danielsson et al. 2000 conducted a within-subject study of 18 chronic patients with stroke who were ambulatory with or without an assistive device. Subjects walked on a treadmill with 0% and 30% BWS at their self-selected maximum walking speed. VO2 and heart rate of patients were lower during walking with 30% BWS as compared to 0% BWS when tested at various walking velocities. Although BWS during treadmill training can decrease the O2 consumption and cardiac output required for the task, the actual cardiac/respiratory status of the client may not be necessarily improved as a result of this intervention.

Conclusion: There is limited evidence (level 2b) from one non-randomized study that body weight supported treadmill training can decrease the O2 consumption and cardiac input required for the task by lowering VO2 and heart rate in ambulatory patients with a chronic stroke.

References

Ada L, Dean CM, Morris M, et al. (2010). Randomised trial of treadmill walking with body weight support to establish walking in subacute stroke: the MOBILISE trial. Stroke, 41, 1237-1242.

Barbeau H., & Visintin, M. (2003). Optimal outcomes obtained with body-weight support combined with treadmill training in stroke subjects. Arch Phys Med Rehabil, 84(10), 1458-1465.

da Cunha I. T., Jr., Lim P. A., Qureshy H., Henson H., Monga T., & Protas, E. J. (2002). Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study. Arch Phys Med Rehabil, 83(9), 1258-1265.

Danielsson A., & Sunnerhagen, K. S. (2000). Oxygen consumption during treadmill walking with and without body weight support in patients with hemiparesis after stroke and in healthy subjects. Arch Phys Med Rehabil, 81(7), 953-957.

Dean CM, Ada L, Bampton J, Morris ME, Katrak PH, Potts S. (2010). Treadmill walking with body weight support in subacute non-ambulatory stroke improves walking capacity more than overground walking: a randomised trial. Journal of Physiotherapy, 56, 97–103.

Franceschini M., Carda S., Agosti M., Antenucci R., Malgrati D., & Cisari C (2009). Walking after stroke: What does treadmill training with body weight support add to overground gait training in patients early after stroke? Stroke, 30, 3079-3085.

Hesse S., Bertelt C., Jahnke M. T., Schaffrin A., Baake P., Malezic M., et al. (1995). Treadmill training with partial body weight support compared with physiotherapy in nonambulatory hemiparetic patients. Stroke, 26(6), 976-981.

Kosak M. C., & Reding, M. J. (2000). Comparison of partial body weight-supported treadmill gait training versus aggressive bracing assisted walking post stroke. Neurorehabil Neural Repair, 14(1), 13-19.

Ng M.F.W., Tong R.K.Y., & Li, L.S.W. (2008). A pilot study of randomized clinical controlled trial of gait training in subacute stroke patients with partial body-weight support electromechanical gait trainer and functional electrical stimulation: six-month follow-up. Stroke. 39(1):154-60

Nilsson L., Carlsson J., Danielsson A., Fugl-Meyer A., Hellstrom K., Kristensen L., et al. (2001). Walking training of patients with hemiparesis at an early stage after stroke: a comparison of walking training on a treadmill with body weight support and walking training on the ground. Clin Rehabil, 15(5), 515-527.

Visintin M., Barbeau H., Korner-Bitensky N., & Mayo, N. E. (1998). A new approach to retrain gait in stroke patients through body weight support and treadmill stimulation. Stroke, 29(6), 1122-1128.

Werner C., Von Frankenberg S., Treig T., Konrad M., & Hesse, S. (2002). Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study. Stroke, 33(12), 2895-2901.

Electromechanical Gait Trainers

Evidence Reviewed as of before: 14-02-2020
Author(s)*: Annabel McDermott (BOccThy); Adam Kagan, BSc; Nicol Korner-Bitensky, PhD OT
Content consistency: Gabriel Plumier
Patient/Family Information Table of contents

Introduction

Electromechanical gait trainers have been developed as an alternative to conventional gait training methods such as assisted overground walking and treadmill training. Electromechanical gait trainers differ from traditional treadmill training in that the device guides the lower limbs through the gait motion. Electromechanical devices can enable intensive repetition of movement with reduced physical assistance from clinicians. The two most common types of electromechanical gait trainers are ‘end-effector’ trainers and exoskeleton trainers.

Patient/Family Information

What is an electromechanical gait trainer and what is it for?

An electromechanical gait trainer – also called a Gait Trainer – is a piece of equipment that is used to help regain walking skills (gait) after a stroke. Gait Trainers are used in stroke rehabilitation centers instead of, or as well as other types of walking training such as walking on a treadmill or walking over obstacles. Gait Trainers help move the leg through the stepping motion. They provide a way for patients to practice walking in a natural pattern.

Two main types of Gait Trainers are:

  1. End-effector gait trainers look similar to a large treadmill. The patient stands on a treadmill surface or on footplates. The patient wears a harness around his/her upper legs and torso for support. The treadmill or footplates are motor-driven to move the patient’s legs through the correct position and movements of walking.
  2. Exoskeleton gait trainers use a treadmill or a walking frame on wheels. The exoskeleton is a robotic orthosis that attaches to the patient’s legs. The patient stands on a treadmill surface and is supported by a harness, or stands within a walking frame on wheels. The orthosis guides the legs through the correct walking patterns. These are also called robotic gait trainers.

Why do we use a Gait Trainer after a stroke?

A stroke can affect aspects of walking such as:

  • How fast you walk
  • How long you walk for before tiring
  • The length of your step
  • The number of steps you take
  • The symmetry of your leg movements
  • Your risk of falling
  • Your confidence when walking.

If you have difficulty walking after a stroke, your rehabilitation will probably include gait (walking) training. Gait Trainers may be a safe way for you to begin walking training if you are not able to walk safely by yourself, because:

  • The harness supports your body and takes some of the weight off your legs,
  • The Gait Trainer guides your legs through the walking patterns.

Gait Trainers can be used to help some patients walk sooner after a stroke, especially if they require help from two people to walk over ground. It also allows some patients to practice walking when they are not ready to walk over ground.

Do electromechanical gait trainers work for stroke?

Gait Trainers enable patients to practice repetitive walking movements. It is believed that this repetition may help rewire the area of the brain affected by the stroke. When the patient performs repetitive walking movements, the brain cells form new ‘pathways’ to repair the damage from the stroke.

Research shows that Gait Trainers are as good as usual gait rehabilitation (e.g. normal walking training, treadmill training) after stroke. Gait Trainers may be more useful than usual gait training methods for improving:

  • Leg motor function in the very early stage of recovery (up to one month post-stroke)
  • Activities of daily living, functional walking skills, leg muscle strength and walking endurance in the rehabilitation phase (1-6 months post-stroke)
  • Functional walking skills, gait patterns, general mobility and leg muscle strength more than 6 months post-stroke.

Further studies are needed to better understand who can benefit most from this type of training. Gait Trainers are best used in conjunction with standard physical therapy.

What can I expect?

There are many different types of Gait Trainers. Here is what you can expect when using most types of Gait Trainer:

  • You will wear a harness over your clothes
  • The harness is fastened to an overhead suspension system. This harness supports your upper body and reduces the amount of weight you carry through your legs while you walk. Your therapist will decide how much of your body weight is supported by the harness and how much is carried through your legs
  • Your therapist will start the Gait Trainer at a very low speed. As your walking skills improve, your therapist can (a) increase your walking speed slowly, and (b) increase the amount of weight you are taking through your legs
  • The device will guide your legs through walking movements.

Are there any side effects or risks?

There are no specific side effects from using Gait Trainers. In fact, research has shown that it is easier on your heart if you walk with your body weight supported. As such, it may be easier for some patients who have had a stroke to use the gait trainer than walking on the ground.

Who provides the treatment?

Gait Trainers are usually used by a physical therapist at a rehabilitation center. An assistant may be present to help you get ready by putting on your harness and staying with you during rest periods.

Gait Trainers are a fairly new treatment device and are labor-intensive. It requires specific equipment that is quite costly. As such, Gait Trainers may not be available in all rehabilitation centers.

How much does it cost?

Gait Trainers are very expensive pieces of equipment and are only suitable for use in rehabilitation centers under supervision of a trained rehabilitation professional. They are not suitable for private use.

Is a Gait Trainer suitable for me?

Gait Trainers have been shown to be as good as other walking rehabilitation approaches for most outcomes after stroke. Factors such as time since stroke, the severity of your stroke, and your rehabilitation center’s access to a Gait Trainer may affect your ability to use this form of rehabilitation. Ask your rehabilitation specialist if this is a suitable intervention for you.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (Level 1a) for an outcome.

Electromechanical gait trainers have been developed as an alternative to conventional gait training methods such as assisted overground walking and treadmill training. Electromechanical gait trainers differ from traditional treadmill training in that the device guides the lower limbs through the gait motion, which enables intensive repetition of movement with reduced physical assistance from clinicians. Gait trainers use automated mechanical forces to drive movements of the lower extremity (Morone et al., 2017). This motor-driven stepping may improve the symmetry of walking patterns as it forces timing between the lower limbs, promotes hip extension and discourages compensatory movement patterns (Regneaux et al., 2008; Polese et al., 2013).

The two common types of electromechanical gait trainers are end-effector devices and exoskeleton devices. Both devices move the lower limbs through kinematically repetitive stepping patterns in the sagittal plane. Both systems adopt a ‘forced use’ motor learning approach to promote task-oriented training of walking. This enables intensive, repetitive practice of typical walking patterns that simulate stance and swing phases of gait training (Bruni et al., 2018; Kim & You, 2017; Polese et al., 2013; Regneaux et al., 2008).

End-effector devices use footplates to facilitate stance and swing phases during locomotor training (Bruni et al., 2018). The most common electromechanical gait trainers are the Reha-Stim Gait Trainers (GT1, GT2), G-EO system, Lokohelp and the Haptik walker. This StrokEngine review of end-effector devices includes ten high quality RCTs, three fair quality RCTs and two non-randomized studies; most studies were conducted with patients in the subacute or chronic phases of recovery. In this review, end-effector gait trainers are compared with interventions including conventional physiotherapy, conventional rehabilitation, conventional gait training, overground gait training and body-weight supported treadmill training. While end-effector gait trainers were no more effective than comparison interventions for most outcomes, findings from this review provide at least moderate evidence (Level 1b) end-effector gait trainers were more effective than comparison interventions for improving:

  • Activities of daily living, functional ambulation, lower extremity muscle strength and walking endurance in the subacute phase of stroke recovery;
  • Functional ambulation, gait parameters, mobility and lower extremity muscle strength in the chronic phase of stroke recovery; and
  • Disability in a sample of patients across the stroke recovery continuum.

Exoskeleton devices facilitate movement of the hips and knees during the phases of gait (Bruni et al., 2018). Examples of exoskeleton devices include the Lokomat and the LOPES. The Lokomat uses a harness-supported body weight system in conjunction with a treadmill. This StrokEngine review of exoskeleton devices includes eight high quality RCTs, nine fair quality RCTs and two non-randomized studies; most studies were conducted with patients in the subacute or chronic phases of stroke recovery. In this review, exoskeleton gait trainers are compared with interventions including conventional physical therapy, treadmill training, therapist-assisted gait training, or no additional gait training. While exoskeleton devices were no more effective than comparison interventions for most functional outcomes, findings from this review provide at least moderate evidence (Level 1b) that exoskeleton gait trainers were more effective than comparison interventions for improving:

  • Lower extremity motor function in the acute phase of stroke recovery; and
  • Functional independence, functional ambulation, neurological recovery, and stair climbing in a sample of patients across the stroke recovery continuum.

Results Table

View results table

Outcomes

Acute Phase - End-effector gait trainers

Functional ambulation
Not Effective
2A

One fair quality RCT (Peurala et al., 2009) examined the effect of an end-effector gait trainer on functional ambulation in the acute phase of stroke recovery. This fair quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) time-matched overground walking training, or (3) conventional rehabilitation alone. Functional ambulation was measured using the Functional Ambulation Category at post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found at either time point.
Note: The end-effector gait training group showed significantly lower perceived exertion during training (measured by the Borg scale) compared to the other groups, and achieved the required 20 minutes of walking per 1-hour session in less time than the overground walking training group, which often required the full 1 hour before achieving 20 minutes of walking.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that end-effector gait trainers are not more effective than comparison interventions (overground walking training, conventional rehabilitation alone) in improving functional ambulation in the acute phase of stroke recovery.

Mobility
Not Effective
2A

One fair quality RCT (Peurala et al., 2009) examined the effect of an end-effector gait trainer on mobility in the acute phase of stroke recovery. This fair quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) time-matched overground walking training, or (3) conventional rehabilitation alone. Mobility was measured using the Rivermead Mobility Index and the Rivermead Motor Assessment Scale (RMA – Gross motor function, Lower extremity function and trunk control) at post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found on either measure at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that end-effector gait trainers are not more effective than comparison interventions (overground walking training, conventional rehabilitation alone) in improving mobility in the acute phase of stroke recovery.

Motor function
Effective
2A

One fair quality RCT (Peurala et al., 2009) examined the effect of an end-effector gait trainer on motor function in the acute phase of stroke recovery. This fair quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) time-matched overground walking training, or (3) conventional rehabilitation alone. Motor function was measured using the Modified Motor Assessment Scale (MMAS) at post-treatment (3 weeks) and follow-up (6 months). A significant between-group difference was seen at post-treatment, in favour of end-effector gait training vs. conventional rehabilitation alone. Differences did not remain significant at follow-up. There were no significant differences between end-effector gait training vs. overground walking training.
Note: A significant between-group difference was found at post-treatment in favour of overground walking vs. conventional rehabilitation; differences did not remain significant at follow-up.

Conclusion: There is limited evidence (Level 2a) from 1 fair quality RCT that end-effector gait trainers are more effective, in short-term, than a comparison intervention (conventional rehabilitation) in improving motor function in the acute phase of stroke recovery.
Note: End-effector gait trainers were not more effective than overground walking training.

Walking endurance
Not Effective
2A

One fair quality RCT (Peurala et al., 2009) examined the effect of an end-effector gait trainer on walking endurance in the acute phase of stroke recovery. This fair quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) time-matched overground walking training, or (3) conventional rehabilitation alone. Walking endurance was measured using the 6 Minute Walk Test at post-treatment (3 weeks) and follow-up (6 months). A significant difference was found at follow-up, in favour of end-effector gait training vs. overground walking.
Note: Insufficient data was gathered from the conventional rehabilitation group at either time point and no between-group comparisons were made.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that end-effector gait trainers are not more effective than a comparison intervention (overground walking training) in improving walking endurance in the acute phase of stroke recovery.
Note: End-effector gait trainers were more effective than overground walking in the long term.

Walking speed
Not Effective
2A

One fair quality RCT (Peurala et al., 2009) examined the effect of an end-effector gait trainer on walking speed in the acute phase of stroke recovery. This fair quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) time-matched overground walking training, or (3) conventional rehabilitation alone. Walking speed was measured using the 10-meter walking test at post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that end-effector gait trainers are not more effective than comparison interventions (overground walking training, conventional rehabilitation alone) in improving walking speed in the acute phase of stroke recovery.

Acute Phase - Exoskeleton gait trainers

Cardiopulmonary fitness
Not Effective
1B

One high quality RCT (Chang et al., 2012) investigated the effect of exoskeleton gait trainers on cardiopulmonary fitness in the acute phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy; both groups received additional physical therapy. Cardiopulmonary fitness was measured according to aerobic capacity (peak VO2, respiratory exchange ratio), cardiovascular response (oxygen pulse, peak heart rate, systolic/diastolic blood pressure, rate of perceived exertion) and ventilatory response (minute ventilation, ventilatory efficiency) at post-treatment (2 weeks). There was a significant between-group difference in aerobic capacity only (peak VO2), in favour of exoskeleton gait training vs. conventional physical therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for improving cardiopulmonary fitness in the acute phase of stroke recovery.

Functional ambulation
Not Effective
1B

One high quality RCT (Chang et al., 2012) investigated the effect of exoskeleton gait trainers on functional ambulation in the acute phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy; both groups received additional physical therapy. Functional ambulation was measured using the Functional Ambulation Categories at post-treatment (2 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for improving functional ambulation in the acute phase of stroke recovery.

Motor function – lower extremity
Effective
1B

One high quality RCT (Chang et al., 2012) investigated the effect of exoskeleton gait trainers on lower extremity motor function in the acute phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy; both groups received additional physical therapy. Lower extremity motor function was measured using the Fugl-Meyer Assessment – Lower Extremity score (FMA-LE) at post-treatment (2 weeks). There was a significant between-group difference, in favour of exoskeleton gait training vs. conventional physical therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is more effective than a comparison intervention (conventional physical therapy) for improving lower extremity motor function in the acute phase of stroke recovery.

Motor power – lower extremity
Not Effective
1B

One high quality RCT (Chang et al., 2012) investigated the effect of exoskeleton gait trainers on lower extremity motor power in the acute phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy; both groups received additional physical therapy. Lower extremity motor power was measured using the Motricity Index – Leg score at post-treatment (2 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for improving lower extremity motor power in the acute phase of stroke recovery.

Subacute Phase - End-effector gait trainers

Activities of daily living
Effective
1B

One high quality RCT (Pohl et al., 2007) investigated the effect of end-effector gait trainers on activities of daily living (ADLs) in the subacute phase of stroke recovery. This high quality RCT randomized patients to receive gait training using the GT1 device or time-matched physical therapy. ADLs were measured using the Barthel Index (BI) at post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference in the number of patients who achieved BI scores > 75 was seen at post-treatment, in favour of end-effector gait training vs. physical therapy. This difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers are more effective, in short-term, than a comparison intervention (time-matched physical therapy) in improving Activities of daily living in the subacute phase of stroke recovery.

Balance
Not Effective
2B

One non-randomized study (Iacovelli et al., 2018) examined the effect of end-effector gait trainers on balance in the subacute phase of stroke recovery. This non-randomized controlled trial assigned patients to receive gait training using the G-EO device or conventional gait training. Balance was measured using the Tinetti Scale at post-treatment (20 sessions). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that end-effector gait trainers are not more effective than a comparison intervention (conventional gait training) in improving balance in the subacute phase of stroke recovery.

Functional ambulation
Effective
1A

Two high quality RCTs (Werner et al., 2002; Pohl et al., 2007) and two non-randomized studies (Hesse et al., 2012; Iacovelli et al., 2018) investigated the effect of end-effector gait trainers on functional ambulation in the subacute phase of stroke recovery.

The first high quality cross-over design RCT (Werner et al., 2002) randomized patients to receive gait training using the GT1 device or body-weight supported treadmill training (BWS-TT). Interventions were provided using an A-B-A or B-A-B design, with each block lasting 2 weeks (6 weeks total). Functional ambulation was measured by the Functional Ambulation Category (FAC) at post-treatment (6 weeks) and follow-up (6 months). A significant between-group difference was found at post-treatment, in favour of end-effector gait training vs. BWS-TT; the difference did not remain significant at follow-up.

The second high quality RCT (Pohl et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched physical therapy. Functional ambulation was measured by the FAC at post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference was found at both time points in the number of patients to achieve independent walking (FAC > 4) at post-treatment, in favour of end-effector gait training vs. physical therapy.

The first non-randomized controlled trial (Hesse et al., 2012) assigned non-ambulatory patients to receive gait training using the G-EO device or time-matched physical therapy. Functional ambulation was measured using the FAC at post-treatment (4 weeks) and follow-up (3 months). A significant between-group difference was found at both time points, in favour of end-effector gait training vs. physical therapy.

The second non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Functional ambulation was measured using the FAC and the Walking Handicap Scale at post-treatment (20 sessions). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from 2 high quality RCTs and one non-randomized study that end-effector gait trainers are more effective than comparison interventions (body-weight supported treadmill training or physical therapy) for improving functional ambulation in the subacute phase of stroke recovery.

Gait parameters
Not Effective
2B

One non-randomized study (Iacovelli et al., 2018) examined the effect of end-effector gait trainers on gait parameters in the subacute phase of stroke recovery. This non-randomized controlled trial assigned patients to receive gait training using the G-EO device or conventional gait training. Gait parameters were measured using the SMART0D500 optoelectronic system (stride time, stride length, step length, cadence, velocity, swing velocity, mean velocity) and five measures (step length, swing time, stance time, double support time, intra-limb ratio of swing: stance time) were used to calculate the symmetry index (symmetry ratio, symmetry index, gait asymmetry, symmetry angle) at post-treatment (20 sessions). Significant between-group differences were found in only two gait parameters (symmetry ratio – step length, symmetry angle – step length), in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that end-effector gait trainers are not more effective than a comparison intervention (conventional gait training) for improving gait parameters in the subacute phase of stroke recovery.

Mobility
Conflicting
4

Two high quality RCTs (Werner et al., 2002; Pohl et al., 2007) and two non-randomized studies (Hesse et al., 2012; Iacovelli et al., 2018) investigated the effect of end-effector gait trainers on mobility in patients with subacute stroke.

The first high quality cross-over design RCT (Werner et al., 2002) randomized patients to receive gait training using the GT1 device or body-weight supported treadmill training (BWS-TT). Interventions were provided using an A-B-A or B-A-B design, with each block lasting 2 weeks (6 weeks total). Mobility was measured using the Rivermead Motor Assessment (RMA – Gross function, Trunk and leg subscales) at post-treatment (6 weeks). No significant between-group differences were found.

The second high quality RCT (Pohl et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched physical therapy. Mobility was measured using the Rivermead Mobility Index (RMI) at post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference was found at post-treatment in favour of end-effector gait training vs. physical therapy. Differences did not remain significant at follow-up.

The first non-randomized controlled trial (Hesse et al., 2012) assigned non-ambulatory patients to receive gait training using the G-EO device or time-matched physical therapy. Mobility was measured using the RMI at post-treatment (4 weeks) and follow-up (3 months). A significant between-group difference was found at post-treatment in favour of end-effector gait training vs. physical therapy. Differences did not remain significant at follow-up.

The second non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Mobility was measured using the Timed Up and Go (TUG) test and the Trunk Control Test at post-treatment (20 sessions). A significant between-group difference was found in one measure of mobility (TUG) in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on mobility in the subacute phase of stroke recovery. One high quality RCT and two non-randomized studies found that end-effector gait trainers are more effective than comparison interventions (physical therapy, conventional gait training); a second high quality RCT found no significant difference compared with body-weight supported treadmill training.
Note: Differences in results may relate to the variation in outcome measures used.

Motor function - lower extremity
Not Effective
2B

One non-randomized study (Iacovelli et al., 2018) examined the effect of end-effector gait trainers on lower extremity motor function in the subacute phase of stroke recovery. This non-randomized controlled trial assigned patients to receive gait training using the G-EO device or conventional gait training. Lower extremity motor function was measured using the Fugl-Meyer Assessment – Lower Extremity at post-treatment (20 sessions). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that end-effector gait trainers are not more effective than a comparison intervention (conventional gait training) for improving lower extremity motor function in the subacute phase of stroke recovery.

Muscle strength - lower extremity
Effective
1B

One high quality RCT (Pohl et al., 2007) and two non-randomized studies (Hesse et al., 2012; Iacovelli et al., 2018) examined the effect of end-effector gait trainers on lower extremity muscle strength in the subacute phase of stroke recovery.

The high quality RCT (Pohl et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched physical therapy. Lower extremity muscle strength was measured using the Motricity Index (MI) and post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference was seen at post-treatment in favour of end-effector gait training vs. physical therapy. Differences did not remain significant at follow-up.

The first non-randomized controlled trial (Hesse et al., 2012) assigned non-ambulatory patients to receive gait training using the G-EO device or time-matched physical therapy. Lower extremity muscle strength was measured using the MI at post-treatment (4 weeks) and follow-up (3 months). A significant between-group difference was found at both time points in favour of end-effector gait training vs. physical therapy.

The second non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Lower extremity muscle strength was measured using the MI and the Medical Research Council Scale (MRC Scale – Hip extension, Knee flexion, Ankle flexion) at post-treatment (20 sessions). Significant between-group differences were found on two measures of muscle strength (MRC scale – Hip extension, Ankle flexion), in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and two non-randomized studies that end-effector gait trainers are more effective than comparison interventions (time-matched physical therapy, conventional gait training) for improving lower extremity muscle strength in the subacute phase of stroke recovery.

Muscle tone/Spasticity - lower extremity
Not Effective
1b

One high quality RCT (Werner et al., 2002) and two non-randomized studies (Hesse et al., 2012; Iacovelli et al., 2018) examined the effect of end-effector gait trainers on lower extremity muscle tone/spasticity in the subacute phase of stroke recovery.

The high quality cross-over design RCT (Werner et al., 2002) randomized patients to receive gait training using the GT1 device or body-weight supported treadmill training (BWS-TT). Interventions were provided using an A-B-A or B-A-B design, with each block lasting 2 weeks (6 weeks total). Spasticity was measured by the Modified Ashworth Scale at post-treatment (6 weeks). No significant between-group difference was found.

The first non-randomized controlled trial (Hesse et al., 2012) assigned non-ambulatory patients to receive gait training using the G-EO device or time-matched physical therapy. Lower extremity muscle tone was measured using the Resistance to Passive Movement Scale at post-treatment (4 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

The second non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Lower extremity spasticity was measured using the Ashworth Scale (Total score, Hip, Knee) at post-treatment (20 sessions). Significant between-group differences were found on all measures of Ahsworth Scale, in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one non-randomized study that end-effector gait trainers are not more effective than comparison interventions (body-weight supported treadmill training, time-matched physical therapy) in improving lower extremity muscle tone/spasticity in the subacute phase of stroke recovery.
Note: However, a second non-randomized study found that end-effector gait trainers were more effective than conventional gait training.

Range of motion - lower extremity
Not Effective
2B

One non-randomized study (Iacovelli et al., 2018) examined the effect of end-effector gait trainers on lower extremity range of motion in the subacute phase of stroke recovery. This non-randomized controlled trial assigned patients to receive gait training using the G-EO device or conventional gait training. Lower extremity range of motion (Hip, Knee, Ankle) was measured in the sagittal plane at post-treatment (20 sessions). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that end-effector gait trainers are not more effective than a comparison intervention (conventional gait training) for improving lower extremity range of motion in the subacute phase of stroke recovery.

Walking endurance
Effective
1B

One high quality RCT (Pohl et al., 2007) and one non-randomized study (Iacovelli et al., 2018) examined the effect of end-effector gait trainers on walking endurance in the subacute phase of stroke recovery.

The high quality RCT (Pohl et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched physical therapy. Walking endurance was measured using the 6 Minute Walk Test (6MWT) at post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference was seen at post-treatment in favour of end-effector gait training vs. physical therapy. Results did not remain significant at follow-up.

The non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Walking endurance was measured using the 6MWT at post-treatment (20 sessions). A significant between-group difference was found in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one non-randomized study that end-effector gait trainersare more effective than comparison interventions (physical therapy, conventional gait training) for improving walking endurance in the subacute phase of stroke recovery.

Walking speed
Conflicting
4

Two high quality RCTs (Werner et al., 2002; Pohl et al., 2007) and two non-randomized studies (Hesse et al., 2012; Iacovelli et al., 2018) investigated the effect of end-effector gait trainers on walking speed in the subacute phase of stroke recovery.

The first high quality cross-over design RCT (Werner et al., 2002) randomized patients to receive gait training using the GT1 device or Body-Weight Supported Treadmill Training (BWS-TT) using an A-B-A or B-A-B format, with each block lasting 2 weeks (6 weeks total). Walking speed was measured using the 10-meter walking test each week for 6 weeks (post-treatment). No significant between-group difference was found.

The second high quality RCT (Pohl et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched physical therapy. Walking speed was measured using the 10-meter walking test at post-treatment (4 weeks) and follow-up (6 months). There was a significant between-group difference at post-treatment in favour of end-effector gait training vs. physical therapy. Between-group differences did not remain significant at follow-up.

The first non-randomized controlled trial (Hesse et al., 2012) assigned non-ambulatory patients to receive gait training using the G-EO device or time-matched physical therapy. Walking speed was measured using the 10-meter walking test at post-treatment (4 weeks) and follow-up (3 months). A significant between-group difference was found at post-treatment in favour of end-effector gait training vs. physical therapy. Differences did not remain significant at follow-up.

The second non-randomized controlled trial (Iacovelli et al., 2018) assigned patients to receive gait training using the G-EO device or conventional gait training. Walking speed was measured using the 10-meter walking test at post-treatment (20 sessions). A significant between-group difference was found in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on walking speed in the subacute phase of stroke recovery. One high quality RCT and two non-randomized studies found that end-effector gait trainers are more effective than comparison interventions (physical therapy, conventional gait training), whereas a second high quality RCT found no significant difference between end-effector gait trainers and Body-Weight Supported Treadmill Training.

Subacute Phase - Exoskeleton gait trainers

Activities of daily living (ADLs)/Instrumental ADLs
Not Effective
1B

One high quality RCT (Husemann et al., 2007), two fair quality RCT (Hidler et al., 2009; Han et al., 2016) and one non-randomized study (Chung, 2017) investigated the effect of exoskeleton gait trainers on ADLs or IADLs in the subacute phase of stroke recovery.

The high quality RCT (Husemann et al., 2007) randomized patients to receive gait training using the Lokomat device or conventional physical therapy. ADLs were measured by the Barthel Index (BI) at post-treatment (4 weeks). No significant between-group difference was found.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. IADLs were measured using the Frenchay Activities Index at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (Han et al., 2016) randomized patients to receive gait training using the Lokomat device or conventional physical therapy; both groups received additional physical therapy and occupational therapy. ADLs were measured by the Korean modified Barthel Index at post-treatment (4 weeks). No significant between-group difference was found.

The non-randomized case-controlled study (Chung, 2017) provided patients with gait training using the Lokomat device and physical therapy or time-matched physical therapy. ADLs were measured by the modified BI at discharge (approximately 5 weeks). No significant between-group difference in change scores was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT, two fair quality RCTs and one non-randomized study that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training) for improving ADLs or IADLs in the subacute phase of stroke recovery.

Balance
Not Effective
1B

One high quality RCT (Taveggia et al., 2016), three fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015; Han et al., 2016) and one non-randomized study (Chung, 2017) investigated the effect of exoskeleton gait trainers on balance in the subacute phase of stroke recovery.

The high quality RCT (Taveggia et al., 2016) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Balance was measured by the Tinetti Balance Scale at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Balance was measured using the Berg Balance Scale (BBS) at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Balance was measured by the BBS at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any timepoint.

The third fair quality RCT (Han et al., 2016) randomized patients to receive gait training using the Lokomat device or conventional physical therapy; both groups received additional physical therapy and occupational therapy. Balance was measured by the BBS at post-treatment (4 weeks). No significant between-group difference was found.

The non-randomized case-controlled study (Chung, 2017) provided patients with gait training using the Lokomat device and physical therapy or time-matched physical therapy. Balance was measured by the BBS at baseline and at discharge (approximately 5 weeks). A significant between-group difference in change scores from baseline to discharge was found, in favour of exoskeleton gait training + physical therapy vs. physical therapy alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and three fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training, overground gait training) for improving balance in the subacute phase of stroke recovery.
Note: The non-randomized study found that the exoskeleton gait trainer was more effective than time-matched physical therapy.

Functional ambulation
Not Effective
1B

One high quality RCT (Husemann et al., 2007), three fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015; Han et al., 2016) and one non-randomized study (Chung, 2017) investigated the effect of exoskeleton gait trainers on functional ambulation in the subacute phase of stroke recovery.

The high quality RCT (Husemann et al., 2007) randomized patients to receive gait training using the Lokomat device or conventional physical therapy. Functional ambulation was measured by the Functional Ambulation Category (FAC) at post-treatment (4 weeks). No significant between-group difference was found.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Functional ambulation was measured using the FAC at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Functional ambulation was measured by the FAC at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any timepoint.

The third fair quality RCT (Han et al., 2016) randomized patients to receive gait training using the Lokomat device or conventional physical therapy; both groups received additional physical therapy and occupational therapy. Functional ambulation was measured by the FAC at post-treatment (4 weeks). No significant between-group difference was found.

The non-randomized case-controlled study (Chung, 2017) provided patients with gait training using the Lokomat device and physical therapy or time-matched physical therapy. Functional ambulation was measured by the modified FAC at baseline and at discharge (approximately 5 weeks). A significant between-group difference in change scores from baseline to discharge was found, in favour of exoskeleton gait training + physical therapy vs. physical therapy alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and three fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training, overground gait training) for improving functional ambulation in the subacute phase of stroke recovery.
Note: The non-randomized study found that the exoskeleton gait trainer was more effective than time-matched physical therapy.

Functional independance
Not Effective
1B

One high quality RCT (Taveggia et al., 2016) investigated the effect of an exoskeleton gait trainer on functional independence in the subacute phase of stroke recovery. This high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Functional independence was measured by the Functional Independence Measure at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for improving functional independence in the subacute phase of stroke recovery.

Gait parameters
Not Effective
1B

One high quality RCT (Husemann et al., 2007) and one fair quality RCT (Hidler et al., 2009) investigated the effect of exoskeleton gait trainers on gait parameters in the subacute phase of stroke recovery.

The high quality RCT (Husemann et al., 2007) randomized patients to receive gait training using the Lokomat device or conventional physical therapy. Gait parameters were measured by the Parotec system (Cadence, Stride duration, Stance duration – affected/unaffected leg, Single support time – affected/unaffected leg) at post-treatment (4 weeks). A significant between-group difference in one measure (Single support time – affected leg) was found, in favour of exoskeleton gait training vs. conventional physical therapy.

The fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. One gait parameter was measured using the GAITRite system (Cadence) at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training) for improving gait parameters in the subacute phase of stroke recovery.

Health related quality of life
Not Effective
1B

One high quality RCT (Taveggia et al., 2016) and two fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015) investigated the effect of exoskeleton gait trainers on health related quality of life (HRQoL) in the subacute phase of stroke recovery.

The high quality RCT (Taveggia et al., 2016) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. HRQoL was measured by the Medical Outcomes Study Short Form 36 (SF-36) at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. HRQoL was measured using the SF-36 at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. HRQoL was measured by the SF-36 (General health, Social functioning scores) and the Stroke Impact Scale (SIS 3.0 – Activities of Daily Living, Mobility scores) at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group differences were found on either measure at any timepoint.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and two fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training, overground gait training) for improving quality of life in the subacute phase of stroke recovery.

Mobility
Not Effective
2A

Two fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015) and one non-randomized study (Chung, 2017) investigated the effect of exoskeleton gait trainers on mobility in the subacute phase of stroke recovery.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Mobility was measured using the Rivermead Mobility Index (RMI) at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Mobility was measured by the RMI at post-treatment (10 weeks) and follow-up (week 24, week 36); the Timed Up and Go test was also used with patients with a Functional Ambulation Category of or greater than 3. No significant between-group differences were found on either measure at any timepoint.

The non-randomized case-controlled study (Chung, 2017) provided patients with gait training using the Lokomat device and physical therapy or time-matched physical therapy. Mobility was measured by the modified RMI at baseline and at discharge (approximately 5 weeks). A significant between-group difference in change scores from baseline to discharge was found, in favour of exoskeleton gait training + physical therapy vs. physical therapy alone.

Conclusion: There is limited evidence (Level 2a) from two fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional gait training, overground gait training) for improving mobility in the subacute phase of stroke recovery.
Note: A non-randomized study found that the exoskeleton gait trainer was more effective than physical therapy alone.

Motor function - lower extremity
Not Effective
2A

Three fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015; Han et al., 2016) investigated the effect of exoskeleton gait trainers on lower extremity motor function in the subacute phase of stroke recovery.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Lower extremity motor function was measured using the Motor Assessment Scale at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Lower extremity motor function was measured by the Fugl-Meyer Assessment – Lower Extremity (FMA-LE) at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any timepoint.

The third fair quality RCT (Han et al., 2016) randomized patients to receive gait training using the Lokomat device or conventional physical therapy; both groups received additional physical therapy and occupational therapy. Lower extremity motor function was measured by the FMA-LE at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from three fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional gait training, overground gait training, conventional physical therapy) for improving lower extremity motor function in the subacute phase of stroke recovery.

Muscle strength - lower extremity
Not Effective
1B

One high quality RCT (Husemann et al., 2007) and one fair quality RCT (van Nunen et al., 2015) investigated the effect of exoskeleton gait trainers on lower extremity muscle strength in the subacute phase of stroke recovery.

The high quality RCT (Husemann et al., 2007) randomized patients to receive gait training using the Lokomat device or conventional physical therapy. Muscle power was measured by the Motricity Index at post-treatment (4 weeks). No significant between-group difference was found.

The fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Muscle strength was measured according to maximal voluntary isometric torque of bilateral knee extensors and flexors at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any timepoint.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, overground gait training) for improving lower extremity muscle strength in the subacute phase of stroke recovery.

Spasticity
Not Effective
1B

One high quality RCT (Husemann et al., 2007) investigated the effect of an exoskeleton gait trainer on spasticity in the subacute phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or conventional physical therapy. Spasticity was measured by the Modified Ashworth Scale at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for reducing spasticity in the subacute phase of stroke recovery.

Stroke impact
Not Effective
2A

One fair quality RCT (van Nunen et al., 2015) investigated the effect of exoskeleton gait trainers on stroke impact the subacute phase of stroke recovery. The fair quality RCT randomized patients to receive gait training using the Lokomat device or dose-matched overground gait training; both groups received additional physical therapy. Stroke impact was measured by the Stroke Impact Scale (SIS 3.0 – Activities of Daily Living, Mobility scores) at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (overground gait training) for reducing the impact of stroke in the subacute phase of stroke recovery.

Stroke severity
Not Effective
2A

One fair quality RCT (Hidler et al., 2009) investigated the effect of an exoskeleton gait trainer on stroke severity in the subacute phase of stroke recovery. The fair quality RCT randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Stroke severity was measured using the National Institute of Health Stroke Scale (NIHSS) at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). No significant between-group difference was found at any timepoint.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional gait training) for reducing stroke severity in the subacute phase of stroke recovery.

Walking endurance
Not Effective
1B

One high quality RCT (Taveggia et al., 2016) and one fair quality RCT (Hidler et al., 2009) investigated the effect of exoskeleton gait trainers on walking endurance in the subacute phase of stroke recovery.

The high quality RCT (Taveggia et al., 2016) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Walking endurance was measured by the 6 Minute Walk Test (6MWT) at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Walking endurance was measured using the 6MWT at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). A significant between-group difference was found at mid-treatment and post-treatment, in favour of conventional gait training vs. exoskeleton gait training. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training) for improving walking endurance in the subacute phase of stroke recovery.
Note: The fair quality RCT found that conventional gait training was more effective than exoskeleton gait training.

Walking speed
Not Effective
1A

Two high quality RCTs (Husemann et al., 2007; Taveggia et al., 2016) and two fair quality RCTs (Hidler et al., 2009; van Nunen et al., 2015) investigated the effect of exoskeleton gait trainers on walking speed in the subacute phase of stroke recovery.

The first high quality RCT (Husemann et al., 2007) randomized patients to receive gait training using the Lokomat device or conventional physical therapy. Walking speed was measured by the 10-meter walking test at post-treatment (4 weeks). No significant between-group difference was found.

The second high quality RCT (Taveggia et al., 2016) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Walking speed was measured by the 10-meter walking test at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The first fair quality RCT (Hidler et al., 2009) randomized patients to receive gait training using the Lokomat device or time-matched conventional gait training. Walking speed was measured using the 5 meter walking test at mid-treatment (12 sessions), post-treatment (24 sessions) and follow-up (3 months). A significant between-group difference was found at all timepoints, in favour of conventional gait training vs. exoskeleton gait training.

The second fair quality RCT (van Nunen et al., 2015) randomized patients to receive gait training using the Lokomat device, or dose-matched overground gait training; both groups received additional physical therapy. Walking speed was measured by the 10-meter walking test at post-treatment (10 weeks) and follow-up (week 24, week 36). No significant between-group difference was found at any timepoint.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and two fair quality RCTs that exoskeleton gait trainers are not more effective than comparison interventions (conventional physical therapy, conventional gait training, overground gait training) for improving walking speed in the subacute phase of stroke recovery.
Note: One fair quality RCT found that conventional gait training was more effective than exoskeleton gait training.

Chronic Phase - End-effector gait trainers

Activities of daily living
Not Effective
2A

One fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on Activities of daily living (ADLs) in patients with chronic stroke. The fair quality RCT randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. ADLs were measured using the Barthel Index (BI) at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that end-effector gait trainers are not more effective than a comparison intervention (conventional rehabilitation) for improving Activities of daily living in the chronic phase of stroke recovery.

Balance
Not Effective
1B

One high quality RCT (Peurala et al., 2005) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on balance in the chronic phase of stroke recovery.

The high quality RCT (Peurala et al., 2005) randomized patients to receive (1) gait training using the GT1 device, (2) gait training + Functional Electrical Stimulation (GT1+FES), or (3) overground walking training. Postural sway was measured using a force plate at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found at any time point.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Balance was measured using the Toulouse Motor Scale (Balance: items 1-10; items 11-20; total), Berg Balance Scale (BBS) and the Step Test at post-treatment (5 weeks) and follow-up (3 months). No significant between-group differences were found on either measure at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that end-effector gait trainers are not more effective than comparison interventions (overground walking training, conventional rehabilitation) for improving balance in the chronic phase of stroke recovery.
Note: The high quality RCT also found that GT1+FES is not more effective than overground walking training for improving balance in the chronic phase of stroke recovery. There was no significant difference between end-effector gait training with/without FES.

Functional ambulation
Effective
1b

One high quality RCT (Geroin et al., 2011), one fair quality RCT (Dias et al., 2007) and one fair non-randomized study (Park et al., 2015) examined the effect of end-effector gait trainers on functional ambulation in the chronic phase of stroke recovery.

The high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Functional ambulation was measured using the Functional Ambulation Category (FAC) at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found in favour of GT1+tDCS vs. conventional walking exercises at both time points. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Functional ambulation was measured using the FAC at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

The fair non-randomized controlled trial (Park et al., 2015) assigned patients to receive gait training using the GT2 device or conventional overground gait training. Functional ambulation was measured using the FAC at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers are more effective than a comparison intervention (conventional overground walking exercises) in improving functional ambulation in the chronic phase of stroke recovery. However, one fair quality RCT and fair one non-randomized study found that end-effector gait trainers are not more effective than comparison interventions (conventional rehabilitation, overground gait training).
Note: The high quality RCT also found that GT1+tDCS was more effective than conventional overground walking exercises. There was no significant difference between end-effector gait training with/without tDCS.

Functional independance
Not Effective
1B

One high quality RCT (Peurala et al., 2005) investigated the effect of end-effector gait trainers on functional independence in patients with chronic stroke. This high quality RCT randomized patients to receive (1) gait training using the GT1 device, (2) gait training + Functional Electrical Stimulation (GT1+FES), or (3) overground walking training. Functional independence was measured using the Functional Independence Measure at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers are not more effective than a comparison intervention (overground walking training) for improving functional independence in the chronic phase of stroke recovery.
Note: This high quality RCT found that GT1+FES was not more effective than overground walking training. There was no significant difference between end-effector gait training with/without FES.

Gait parameters
Effective
1B

One high quality RCT (Geroin et al., 2011) and one fair non-randomized study (Park et al., 2015) examined the effect of end-effector gait trainers on gait parameters in the chronic phase of stroke recovery.

The high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Gait parameters were measured using the GAITRite system (Cadence, Temporal symmetry ratio of swing time to stance phase, Single to double support duration ratio) at post-treatment (2 weeks) and follow-up (4 weeks). Significant between-group differences were found on all gait parameters at both time points, in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: Significant between-group differences were found on all gait parameters at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant differences were found between GT1 + sham stimulation vs. GT1+tDCS.

The fair non-randomized controlled trial (Park et al., 2015) assigned patients to receive gait training using the GT2 device or conventional overground gait training. Spatiotemporal gait parameters were measured using the GAITRite system (Walking speed, Walking cycle, Stance phase and stride length of affected side, Symmetry index of stance phase and stride length) at post-treatment (4 weeks). No significant between-group differences were found on either measure.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers (+ sham stimulation) are more effective than a comparison intervention (conventional overground walking exercises) for improving gait parameters in the chronic phase of stroke recovery.
Note: The high quality RCT also found that GT1+tDCS was more effective than conventional overground walking exercises for improving gait parameters. There was no significant difference between end-effector gait training with/without tDCS.
Note: A fair non-randomized study found that end-effector gait training was not more effective than conventional overground gait training.

Mobility
Effective
1B

One high quality RCT (Geroin et al., 2011) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on mobility in the chronic phase of stroke recovery.

The high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Mobility was measured using the Rivermead Mobility Index (RMI) at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Mobility was measured using the RMI and the Timed Up and Go test at post-treatment (5 weeks) and follow-up (3 months). No significant between-group differences were found on either measure at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers (+ sham stimulation) are more effective than a comparison intervention (conventional overground walking exercises) for improving mobility in the chronic phase of stroke recovery.
Note: However, one fair quality RCT found that end-effector gait trainers are not more effective than conventional gait training.
Note: The high quality RCT found that GT1+tDCS is more effective than conventional walking exercises. There is no significant difference between end-effector gait training with/without tDCS.

Motor function
Not Effective
1B

One high quality RCT (Peurala et al., 2005) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on motor function in the chronic phase of stroke recovery.

The high quality RCT (Peurala et al., 2005) randomized patients to receive (1) gait training using the GT1 device, (2) gait trainer + Functional Electrical Stimulation (GT1+FES) group, or (3) overground walking training. Motor function was measured using the Modified Motor Assessment Scale at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant differences were found at any time point.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Motor function was measured using the Fugl-Meyer Stroke Scale at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that end-effector gait trainers are not more effective than comparison interventions (overground walking training, conventional rehabilitation) for improving motor function in the chronic phase of stroke recovery.
Note: The high quality RCT also found that GT1+FES was not more effective than overground walking training. There was no significant difference between end-effector gait training with/without FES.

Muscle strength - lower extremity
Effective
1B

One high quality RCT (Geroin et al., 2011) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on lower extremity muscle strength in the chronic phase of stroke recovery.

The high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Muscle strength was measured using the Motricity Index (MI – Leg score) at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Muscle strength was measured using the MI at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that end-effector gait trainers (+ sham stimulation) are more effective than a comparison intervention (conventional overground walking exercises) for improving lower extremity muscle strength in the chronic phase of stroke recovery.
Note: One fair quality RCT found that end-effector gait trainers are not more effective than conventional rehabilitation.
Note: The high quality RCT found that GT1+tDCS is more effective than conventional walking exercises. There is no significant difference between end-effector gait training with/without tDCS.

Spasticity
Conflicting
4

Two high quality RCTs (Peurala et al., 2005; Geroin et al., 2011) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on spasticity in the chronic phase of stroke recovery.

The first high quality RCT (Peurala et al., 2005) randomized patients to receive (1) gait training using the GT1 device, (2) gait training + Functional Electrical Stimulation (GT1+FES), or (3) overground walking training. Lower extremity spasticity was measured by the Modified Ashworth Scale (MAS) at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant differences were found at any time point.

The second high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Spasticity was measured using the MAS (hip adductors, quadriceps femoris, ankle plantiflexors) at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Spasticity was measured using the MAS at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on spasticity in the chronic phase of stroke recovery. One high quality RCT found that end-effector gait trainers were more effective than conventional walking exercises, whereas a second high quality RCT and a fair quality RCT found that end-effector gait trainers were not more effective than comparison interventions (overground walking training, conventional rehabilitation).
Note: A high quality RCT found that GT1+tDCS was more effective than conventional overground walking training. There was no significant difference between end-effector gait training with/without tDCS.

Walking endurance
Conflicting
4

Two high quality RCTs (Peurala et al., 2005; Geroin et al., 2011) and one fair quality RCT (Dias et al., 2007) investigated the effect of end-effector gait trainers on walking endurance in the chronic phase of stroke recovery.

The first high quality RCT Peurala et al., 2005) randomized patients to receive (1) gait training using the GT1 device, (2) gait training + Functional Electrical Stimulation (GT1+FES) group, or (3) overground walking training. Walking endurance was measured by the 6 Minute Walk Test (6MWT) at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were found at any time point.

The second high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Walking endurance was measured using the 6MWT at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS at either time point.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device, or time-matched conventional rehabilitation. Walking endurance was measured using the 6MWT at post-treatment (5 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on walking endurance in the chronic phase of stroke recovery. One high quality RCT and one fair quality RCT found that end-effector gait trainers were not more effective than comparison interventions (overground walking training, conventional rehabilitation), whereas a second high quality RCT found that end-effector gait trainers were more effective than conventional walking exercises.
Note: One high quality RCT found that GT1+FES is not more effective than overground walking training, whereas a second high quality RCT found that GT1+tDCS is more effective than conventional overground walking exercises. There is no significant difference between end-effector gait training with/without FES, nor between end-effector gait training with/without tDCS.

Walking speed
Conflicting
4

Two high quality RCTs (Peurala et al., 2005; Geroin et al., 2011), two fair quality RCTs (Dias et al., 2007) and a fair non-randomized study (Park et al., 2015) investigated the effect of end-effector gait trainers on walking speed in the chronic phase of stroke recovery.

The first high quality RCT (Peurala et al., 2005) randomized patients to receive (1) gait training using the GT1 device, (2) gait training + Functional Electrical Stimulation (GT1+FES), or (3) overground walking training. Walking speed was measured using a 10-meter walking test at mid-treatment (2 weeks), post-treatment (3 weeks) and follow-up (6 months). No significant between-group differences were seen at any time point.

The second high quality RCT (Geroin et al., 2011) randomized patients to receive (1) gait training using the GT1 device + sham stimulation (GT1 + sham stimulation), (2) gait training + transcranial direct current stimulation (GT1+tDCS), or (3) conventional overground walking exercises. Walking speed was measured using a 10-meter walking test at post-treatment (2 weeks) and follow-up (4 weeks). A significant between-group difference was found at both time points in favour of GT1 + sham stimulation vs. conventional walking exercises.
Note: A significant between-group difference was found at both time points in favour of GT1+tDCS vs. conventional walking exercises. No significant difference was found between GT1 + sham stimulation vs. GT1+tDCS.

The fair quality RCT (Dias et al., 2007) randomized patients to receive gait training using the GT1 device or time-matched conventional rehabilitation. Walking speed was measured using a 10-meter walking test (Velocity, Step length, Step cadence with and without gait aid) at post-treatment (5 weeks) and follow-up (3 months). No significant between-group differences were found at either time point.

The fair non-randomized controlled trial (Park et al., 2015) assigned patients to receive gait training using the GT2 device or conventional overground gait training. Walking speed was measured using a 10-meter walking test at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on walking speed in the chronic phase of stroke recovery. One high quality RCT, one fair quality RCT and one fairnon-randomized study found that end-effector gait trainers were not more effective than comparison interventions (overground walking training, conventional rehabilitation, overground gait training), whereas a second high quality RCT found end-effector gait trainers were more effective than conventional overground walking exercises.
Note: One high quality RCT found that GT1+FES is not more effective than overground walking training; a second high quality RCT found that GT1+tDCS is more effective than conventional overground walking exercises. There is no significant difference between end-effector gait training with/without FES, nor between end-effector gait training with/without tDCS.

Chronic Phase - Exoskeleton gait trainers

Activities of daily living (ADLs)/Instrumental ADLs
Not Effective
1B

One high quality RCT (Kelley et al., 2013) and two fair quality RCTs (Hornby et al., 2008; Cho et al., 2015) investigated the effect of exoskeleton gait trainers on ADLs or IADLs in patients with chronic stroke.

The high quality RCT (Kelley et al., 2013) randomized patients to receive gait training using the Lokomat device or overground gait training. ADLs were measured by the Barthel Index (BI) at post-treatment (8 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The first fair quality RCT (Hornby et al., 2008) randomized patients to receive locomotor training using the Lokomat device or therapist-assisted locomotor treadmill training. IADLs were measured using the Frenchay Activities Index at post-treatment (12 sessions) and follow-up (6 months). No significant between-group difference was found at either timepoint.

The second fair quality (crossover) RCT (Cho et al., 2015) randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. ADLs were measured using the modified BI (mBI – Total, Transfers, Ambulation scores) at post-treatment (4 weeks, 8 weeks). A significant between-group difference was found in one measure (mBI – Transfers), in favour of exoskeleton gait training vs. no gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and two fair quality RCTs that exoskeleton gait trainers are not more effective than no gait training or comparison interventions (overground gait training, treadmill training, no gait training) for improving ADLs/IADLs in the chronic phase of stroke recovery.

Ataxia
Not Effective
2A

One fair quality RCT (dos Santos et al., 2018) investigated the effect of an exoskeleton gait trainer on ataxia in the chronic phase of stroke recovery. The fair quality RCT randomized patients with chronic stroke and ataxia to receive gait training using the Lokomat 5.0 or therapist-assisted gait training. Ataxia was measured using the Scale for the Assessment and Rating of Ataxia at post-treatment (5 months). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (therapist-assisted gait training) for improving ataxia in the chronic phase of stroke recovery.

Balance
Conflicting
4

Two high quality RCTs (Westlake & Patten, 2009; Bang & Shin, 2016) and three fair quality RCTs (Hornby et al., 2008; Cho et al., 2015; dos Santos et al., 2018) investigated the effect of exoskeleton gait trainers on balance in the chronic phase or stroke recovery.

The first high quality RCT (Westlake & Patten, 2009) randomized patients to receive gait training using the Lokomat device or time-matched manually-assisted body-weight supported treadmill training. Balance was measured by the Berg Balance Scale (BBS) at post-treatment (4 weeks). No significant between-group difference was found.

The second high quality RCT (Bang & Shin, 2016) randomized patients to receive gait training using the Lokomat device or treadmill gait training. Balance was measured using the BBS at post-treatment (4 weeks). A significant between-group difference was found, in favour of exoskeleton gait training vs. treadmill gait training.

The first fair quality RCT (Hornby et al., 2008) randomized patients to receive locomotor training using the Lokomat device or therapist-assisted locomotor treadmill training. Balance was measured using the BBS at post-treatment (12 sessions) and follow-up (6 months). No significant between-group difference was found at either timepoint.

The second fair quality (crossover) RCT (Cho et al., 2015) randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. Balance was measured using the BBS and the modified Functional Reach Test (Forward, Lateral) at post-treatment (4 weeks, 8 weeks). No significant between-group differences were found on either measure.

The third fair quality RCT (dos Santos et al., 2018) randomized patients with chronic stroke and ataxia to receive gait training using the Lokomat 5.0 or therapist-assisted gait training. Balance was measured using the BBS at post-treatment (5 months). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of exoskeleton gait trainers on balance in the chronic phase of stroke recovery. One high quality RCT and three fair quality RCTs found that the Lokomat device was not more effective than comparison interventions (manually-assisted body-weight supported treadmill training, therapist-assisted locomotor treadmill training, no gait training, therapist-assisted gait training), whereas one high quality RCT found that the Lokomat device was more effective than treadmill gait training.

Balance confidence
Effective
1B

One high quality RCT (Bang & Shin, 2016) investigated the effect of an exoskeleton gait trainer on balance confidence in the chronic phase or stroke recovery. This high quality RCT randomized patients to receive gait training using the Lokomat device or treadmill gait training. Balance confidence was measured using the Activities-Specific Balance Confidence scale at post-treatment (4 weeks). Significant between-group difference was found, in favour of exoskeleton gait training vs. treadmill gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exoskeleton gait trainers are more effective than a comparison intervention (treadmill gait training) for improving balance confidence in the chronic phase of stroke recovery.

Functional ambulation
Not Effective
2A

Two fair quality RCTs (Hornby et al., 2008; Cho et al., 2015) investigated the effect of exoskeleton gait trainers on functional ambulation in the chronic phase of stroke recovery.

The first fair quality RCT (Hornby et al., 2008) randomized patients to receive locomotor training using the Lokomat device or therapist-assisted locomotor treadmill training. Functional ambulation was measured using the modified Emory Functional Ambulation Profile at post-treatment (12 sessions) and follow-up (6 months). No significant between-group difference was found at either timepoint.

The second fair quality (crossover) RCT (Cho et al., 2015) randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. Functional ambulation was measured using the Functional Ambulation Category at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from two fair quality RCTs that exoskeleton gait trainers are not more effective than no gait training or a comparison intervention (therapist-assisted treadmill training) for improving functional ambulation in the chronic phase of stroke recovery.

Functional independence
Not Effective
1B

One high quality RCT (Kelley et al., 2013) and one fair quality RCT (dos Santos et al., 2018) investigated the effect of exoskeleton gait trainers on functional independence in the chronic phase of stroke recovery.

The high quality RCT (Kelley et al., 2013) randomized patients to receive gait training using the Lokomat device or overground gait training. Functional independence was measured by the Functional Independence Measure (FIM – Locomotion subtest) at post-treatment (8 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The fair quality RCT (dos Santos et al., 2018) randomized patients with chronic stroke and ataxia to receive gait training using the Lokomat 5.0 or therapist-assisted gait training. Functional independence was measured using the FIM at post-treatment (5 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (overground gait training, therapist-assisted gait training) for improving functional independence in the chronic phase of stroke recovery.

Gait parameters
Conflicting
4

Two high quality RCTs (Westlake & Patten 2009,; Bang & Shin, 2016) and one fair quality RCT (Hornby et al., 2008) investigated the effect of exoskeleton gait trainers on gait parameters in the chronic phase of stroke recovery.

The first high quality RCT (Westlake & Patten, 2009) randomized patients to receive gait training using the Lokomat device or time-matched manually-assisted body-weight supported treadmill training. Gait parameters were measured using the GAITRite system (Self-selected walking speed, Fast walking speed, Step length ratio of paretic limb) at post-treatment (4 weeks). No significant between-group differences were found.

The second high quality RCT (Bang & Shin, 2016) randomized patients to receive gait training using the Lokomat device or treadmill gait training. Gait parameters was measured using the GAITRite system (Gait speed, Cadence, Step length, Double limb support period) at post-treatment (4 weeks). Significant between-group differences were found on all measures, in favour of exoskeleton gait training vs. treadmill gait training.

The fair quality RCT (Hornby et al., 2008) randomized patients to receive gait training using the Lokomat device or therapist-assisted locomotor treadmill training. Gait parameters (% Single limb stance, Step asymmetry: self-selected velocity/fast velocity) were measured at post-treatment (12 sessions) and follow-up (6 months). A significant between-group difference in one measure (% Single limb stance – Fast velocity) was found at post-treatment, in favour of therapist-assisted locomotor treadmill training vs. exoskeleton gait training. Results did not remain significant at follow-up.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of exoskeleton gait trainers on gait parameters in the chronic phase of stroke recovery. One high quality RCT and one fair quality RCT found that the Lokomat gait trainer was not more effective than comparison interventions (body-weight supported treadmill training, therapist-assisted treadmill training), whereas a second high quality RCT found that the Lokomat gait trainer was more effective than treadmill training.

Kinematics - lower extremity
Not Effective
1B

One high quality RCT (Lewek et al., 2009) investigated the effect of an exoskeleton gait trainer on lower extremity kinematics in the chronic phase of stroke recovery. The high quality RCT randomized patients to receive gait training using the Lokomat device or therapist-assisted treadmill training. Kinematic coordination was measured according to the consistency of intralimb hip and knee angular trajectories over gait cycles (average coefficient of correspondence (ACC): Hip – involved/uninvolved; Knee – involved/uninvolved) at post-treatment (4 weeks). No between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (treadmill training) for improving lower extremity kinematics in the chronic phase of stroke recovery.

Mobility
Conflicting
4

Two fair quality RCTs (Ukar, Paker, & Bugdayci, 2014; dos Santos et al., 2018) investigated the effect of exoskeleton gait trainers on mobility in the chronic phase of stroke recovery.

The first fair quality RCT (Ukar, Paker, & Bugdayci, 2014) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy home exercises. Mobility was measured using the Timed Up and Go test (TUG) at post-treatment (2 weeks) and follow-up (8 weeks). A significant between-group difference was found at both time points, in favour of exoskeleton gait training vs. conventional home exercises.

The second fair quality RCT (dos Santos et al., 2018) randomized patients with chronic stroke and ataxia to receive gait training using the Lokomat 5.0 or therapist-assisted gait training. Mobility was measured using the TUG at post-treatment (5 months). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of exoskeleton gait trainers on mobility in the chronic phase of stroke recovery. One fair quality RCT found that the Lokomat gait trainer was more effective than home exercises, whereas a second fair quality RCT found that the Lokomat device was not more effective than therapist-assisted gait training.

Motor function - lower extremity
Not Effective
1a

Two high quality RCTs (Westlake & Patten, 2009; Kelley et al., 2013) and one fair quality RCT (Cho et al., 2015) investigated the effect of exoskeleton gait trainers on lower extremity motor function in the chronic phase of stroke recovery.

The first high quality RCT (Westlake & Patten, 2009) randomized patients to receive gait training using the Lokomat device or time-matched manually-assisted body-weight supported treadmill training. Lower extremity motor function was measured using the Fugl-Meyer Assessment – Lower Extremity (FMA-LE) and the short physical performance battery at post-treatment (4 weeks). No significant between-group differences were found.

The second high quality RCT (Kelley et al., 2013) randomized patients to receive gait training using the Lokomat device or overground gait training. Lower extremity motor function was measured by the FMA-LE at post-treatment (8 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The fair quality (crossover) RCT (Cho et al., 2015) randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. Lower extremity motor function was measured using the FMA-LE at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (body-weight supported treadmill training, overground gait training, no additional gait training) for improving lower extremity motor function in the chronic phase of stroke recovery.

Muscle strength - lower extremity
Not Effective
2a

One fair quality RCT (Cho et al., 2015) investigated the effect of an exoskeleton gait trainer on lower extremity muscle strength in the chronic phase of stroke recovery. This fair quality (crossover) RCT randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. Lower extremity muscle strength was measured using the Motricity Index at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that exoskeleton gait trainers are not more effective than no additional training for improving lower extremity strength in the chronic phase of stroke recovery.

Participation in life events
Not Effective
1b

One high quality RCT (Westlake & Patten, 2009) investigated the effect of an exoskeleton gait trainer on participation in life events in the chronic phase of stroke recovery. This high quality RCT randomized patients to receive gait training using the Lokomat device or time-matched manually-assisted body-weight supported treadmill training. Participation in life events was measured using the Late Life Function and Disability Instrument (LLFDI: Disability Frequency, Disability Limitation, Function) at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (body-weight supported treadmill training) for improving participation in life events in the chronic phase of stroke recovery.

Quality of life
Not Effective
2A

One fair quality RCT (Hornby et al., 2008) investigated the effect of an exoskeleton gait trainer on quality of life in the chronic phase of stroke recovery. This fair quality RCT randomized patients to receive gait training using the Lokomat device or therapist-assisted locomotor treadmill training. Quality of life was measured using the Medical Outcomes Questionnaire Short Form – 36 (SF-36 – Physical component summary score) at post-treatment (12 sessions) and follow-up (6 months). A significant between-group difference was found at post-treatment in a subgroup of participants with severe gait deficits (walking velocity ≤ 0.5m/s), in favour of therapist-assisted locomotor treadmill training vs. exoskeleton gait training. Results did not remain significant at follow-up.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (therapist-assisted treadmill training) for improving quality of life in the chronic phase of stroke recovery.
Note: In fact, the fair quality RCT found that therapist-assisted treadmill training was more effective than the Lokomat gait trainer.

Spasticity
Not Effective
2A

One fair quality RCT (Cho et al., 2015) investigated the effect of an exoskeleton gait trainer on muscle tone in the chronic phase of stroke recovery. The fair quality (crossover) RCT randomized patients to receive gait training using the Lokomat device or no additional gait training; both groups received conventional physical therapy. Spasticity was measured using the Modified Ashworth Scale at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that an exoskeleton gait trainer is not more effective no additional gait training for reducing spasticity in the chronic phase of stroke recovery.

Stroke impact
Not Effective
1B

One high quality RCT (Kelley et al., 2013) investigated the effect of an exoskeleton gait trainer on stroke outcomes in the chronic phase of stroke recovery. This high quality RCT randomized patients to receive gait training using the Lokomat device or overground gait training. Stroke impact was measured by the Stroke Impact Scale (SIS – Strength, Mobility, ADL/IADL, Social participation, Total recovery scores) at post-treatment (8 weeks) and follow-up (3 months). No significant between-group differences were found at either timepoint.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (overground gait training) for reducing the impact of stroke in the chronic phase of stroke recovery.

Walking endurance
Not Effective
1A

Two high quality RCTs (Westlake & Patten, 2009; Kelley et al., 2013) and one fair quality RCT (Hornby et al., 2008) investigated the effect of exoskeleton gait trainers on walking endurance in the chronic phase of stroke recovery.

The first high quality RCT (Westlake & Patten, 2009) randomized patients to receive gait training using the Lokomat device or time-matched manually-assisted body-weight supported treadmill training. Walking endurance was measured by the 6 Minute Walk Test (6MWT) at post-treatment (4 weeks). No significant between-group difference was found.

The second high quality RCT (Kelley et al., 2013) randomized patients to receive gait training using the Lokomat device or overground gait training. Walking endurance was measured by the 6MWT at post-treatment (8 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The fair quality RCT (Hornby et al., 2008) randomized patients to receive gait training using the Lokomat device or therapist-assisted treadmill training. Walking endurance was measured using the 6MWT at post-treatment (12 sessions) and follow-up (6 months). No significant between-group difference was found at either timepoint.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (body-weight supported treadmill training, overground gait training, treadmill training) for improving walking endurance in the chronic phase of stroke recovery.

Walking speed
Not Effective
1B

One high quality RCT (Kelley et al., 2013) and two fair quality RCTs (Hornby et al., 2008; Ukar, Paker, & Bugdayci, 2014) investigated the effect of exoskeleton gait trainers on walking speed in the chronic phase of stroke recovery.

The high quality RCT (Kelley et al., 2013) randomized patients to receive gait training using the Lokomat device or overground gait training. Walking speed was measured by the 10-meter walking test at post-treatment (8 weeks) and follow-up (3 months). No significant between-group difference was found at either timepoint.

The first fair quality RCT (Hornby et al., 2008) randomized patients to receive gait training using the Lokomat device, or therapist-assisted treadmill training. Walking speed was measured by the 10-meter walking test using the GaitMat device (Self-selected velocity, Fast velocity) at post-treatment (12 sessions) and follow-up (6 months). Significant between-group differences on all measures were found at post-treatment, in favour of therapist-assisted treadmill training vs. exoskeleton gait training. Results did not remain significant at follow-up.

The second fair quality RCT (Ukar, Paker, & Bugdayci, 2014) randomized patients to receive gait training using the Lokomat device or time-matched conventional physical therapy home exercises. Walking speed was measured using the 10-meter walking test at post-treatment (2 weeks) and follow-up (8 weeks). A significant between-group difference was found at both time points, in favour of exoskeleton gait training vs. home exercises.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are not more effective than comparison interventions (overground gait training, treadmill training) for improving walking speed in the chronic phase of stroke recovery. In fact, the fair quality RCT found that therapist-assisted treadmill training was more effective than gait training using the Lokomat device.
Note: However, a second fair quality RCT found that gait training with the Lokomat device was more effective than home exercises.

Phase not specific to one period - End-effector gait trainers

Activities of daily living
Not Effective
1A

Four high quality RCTs (Tong et al., 2006; Ng et al., 2008; Morone et al., 2011; Chua, Culpan & Menon, 2016) examined the effect of end-effector gait trainers on activities of daily living (ADLs) following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. ADLs were measured using the Barthel Index (BI) at post-treatment (4 weeks). No significant between-group differences were found.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. ADLs were measured using the BI at post-treatment (4 weeks) and follow-up (6 months). No significant between-group differences were found at either timepoint.

The third high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤29: low motricity, > 29: high motricity). ADLs were measured using the BI at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

The fourth high quality RCT (Chua, Culpan & Menon, 2016) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or time-matched conventional physical therapy. ADLs was measured by the BI at mid-treatment (4 weeks), post-treatment (8 weeks) and follow-up (12 weeks, 24 weeks, 48 weeks). No significant between-group difference was found at any time point.

Conclusion: There is strong evidence (Level 1a) from four high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional overground gait training, physical therapy) for improving ADLs following stroke.
Note: One high quality RCT found that end-effector gait training is more effective than conventional gait training for improving ADLs in patients with low motricity (MI score ≤29).
Note: Two high quality RCTs found that end-effector gait training + Functional Electrical Stimulation is not more effective than conventional overground gait training. There is no significant difference between end-effector gait training with/without FES.

Balance
Not Effective
1a

Four high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011) investigated the effect of end-effector gait trainers on balance following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. Balance was measured using the Berg Balance Scale (BBS) at mid-treatment (2 weeks) and post-treatment (4 weeks). No significant between-group differences were found at either time point.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Balance was measured by the BBS at post-treatment (4 weeks) and follow-up (6 months). No significant between-group differences were found at either timepoint.

The third high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Balance was measured using the BBS at post-treatment (6 weeks). No significant between-group difference was found.

The fourth high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤29: low motricity, > 29: high motricity). Balance was measured using the Trunk Control Test at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is strong evidence (Level 1a) from four high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional overground gait training, conventional treadmill training) following stroke.
Note: One high quality RCT found that end-effector gait training is more effective than conventional gait training for improving balance in patients with low motricity (MI score ≤ 29).
Note: Two high quality RCTs found that end-effector gait training with Functional Electrical Stimulation (FES) is not more effective than conventional overground gait training. There is no difference between end-effector gait training with/without FES.

Disability
Effective
1b

One high quality RCT (Morone et al., 2011) investigated the effect of an end-effector gait trainer on disability following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤ 29: low motricity, > 29: high motricity). Disability was measured using the Rankin Scale at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait training is more effective than a comparison intervention (conventional gait training) for reducing disability among patients with low motricity following stroke.
Note: End-effector gait training is not more effective than conventional gait training for improving disability among patients with high motricity.

Functional ambulation
Conflicting
4

Five high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011; Chua, Culpan & Menon, 2016) and one non-randomized study (Hesse et al., 2001) investigated the effect of end-effector gait trainers on functional ambulation following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait Training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. Functional ambulation was measured using the Functional Ambulation Categories (FAC) at mid-treatment (2 weeks) and post-treatment (4 weeks). Significant between-group differences were found at both time points, in favour of end-effector gait training vs. conventional overground gait training.
Note: Significant between-group differences in functional ambulation were found at both time points, in favour of GT1+FES vs. conventional overground gait training. There were no significant differences between end-effector gait training vs. GT1+FES.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Functional ambulation was measured by the FAC at post-treatment (4 weeks) and follow-up (6 months). A significant difference was found at follow-up only, in favour of end-effector gait training vs. conventional gait training.
Note: A significant difference was found at both timepoints, in favour of GT2+FES vs. conventional gait training. No significant difference was found between end-effector gait training vs. GT2+FES at either timepoint.

The third high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Functional ambulation was measured using the FAC at post-treatment (6 weeks). No significant between-group difference was found.

The fourth high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤ 29: low motricity, > 29: high motricity). Functional ambulation was measured using the FAC at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

The fifth high quality RCT (Chua, Culpan & Menon, 2016) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or time-matched conventional physical therapy. Functional ambulation was measured using the FAC at mid-treatment (4 weeks), at post-treatment (8 weeks), and follow-up (12 weeks, 24 weeks, 48 weeks). No significant between-group difference was found at any time point.

The non-randomized controlled trial (Hesse et al., 2001) assigned patients with subacute/chronic stroke who were wheelchair-dependent to receive gait training using the GT1 device in addition to conventional physical therapy. Functional ambulation was measured using the FAC at post-treatment (4 weeks). No significant improvement was seen.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on functional ambulation following stroke. One high quality RCT found that end-effector gait trainers are more effective than conventional overground gait training at mid-treatment and post-treatment; another high quality RCT found that end-effector gait trainers are more effective than conventional gait training in the long term; and a third high quality RCT found that end-effector gait trainers are more effective than conventional gait training in patients with low motricity but not those with high motricity. However, two high quality RCTs and one non-randomized study found that end-effector gait trainers are not more effective than comparison interventions (conventional treadmill/overground gait training, conventional physical therapy).
Note: Two high quality RCTs found that end-effector gait training + Functional Electrical Stimulation (FES) is more effective than overground gait training. There is no difference between end-effector gait training with/without FES.

Functional independence
Not Effective
1a

Two high quality RCTs (Tong et al., 2006; Ng et al., 2008) investigated the effect of end-effector gait trainers on functional independence following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. Functional independence was measured using the Functional Independence Measure (FIM) at post-treatment (4 weeks). No significant between-group differences were found.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Functional independence was measured by the Functional Independence Measure (FIM) at post-treatment (4 weeks) and follow-up (6 months). No significant differences were found at either timepoint.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional overground gait training) for improving functional independence following stroke.
Note: Two high quality RCTs found that end-effector gait training with Functional Electrical Stimulation (FES) is not more effective than conventional overground gait training. There is no difference between end-effector gait training with/without FES.

Gait parameters
Effective
2b

One non-randomized study (Hesse et al., 2001) investigated the effect of end-effector gait trainers on gait parameters following stroke. The non-randomized controlled trial assigned patients with subacute/chronic stroke who were wheelchair-dependent to receive gait training using the GT1 device in addition to conventional physical therapy. Gait parameters (velocity, cadence, stride length) and limb-dependent cycle parameters (single-stance period, double-stance phase, stance duration, swing duration, swing symmetry, stance symmetry) were measured at post-treatment (4 weeks). Significant improvements were seen (velocity, cadence, stride length, single-stance period, terminal double-stance phase, swing symmetry).

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that end-effector gait trainers are effective for improving gait parameters following stroke.

Mobility
Conflicting
4

Four high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011) and one non-randomized study (Hesse et al., 2001) investigated the effect of end-effector gait trainers on mobility following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. Mobility was measured using the Elderly Mobility Scale at mid-treatment (2 weeks) and post-treatment (4 weeks). A significant between-group difference was found at post-treatment, in favour of end-effector gait training vs. conventional overground gait training.
Note: A significant between-group differences was found at post-treatment in favour of GT1+FES vs. conventional overground gait training. No significant difference between end-effector gait training vs. GT1+FES was found at either timepoint.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Mobility was measured by the Elderly Mobility Scale at post-treatment (4 weeks) and follow-up (6 months). Significant between-group differences were found at both timepoints, in favour of end-effector gait training vs. conventional gait training.
Note: Significant between-group differences were found at both timepoints, in favour of GT2+FES vs. conventional gait training. No significant difference was found between end-effector gait training vs. GT2+FES at either timepoint.

The third high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Mobility was measured using the Rivermead Mobility Index (RMI) at post-treatment (6 weeks). No significant between-group difference was found.

The fourth high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤29: low motricity, > 29: high motricity). Mobility was measured using the RMI at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

The The non-randomized controlled trial (Hesse et al., 2001) assigned patients with subacute/chronic stroke who were wheelchair-dependent to receive gait training using the GT1 device in addition to conventional physical therapy. Functional mobility was measured using the Rivermead Motor Assessment (Gross function, Legs and trunk scores) at post-treatment (4 weeks). No significant improvement was seen.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on mobility following stroke. Two high quality RCTs found that end-effector gait trainers are more effective than conventional overground gait training, whereas another high quality RCT found that end-effector gait trainers are not more effective than conventional treadmill/overground gait training; these studies used different devices and outcome measures. A fourth high quality RCT found that an end-effector gait trainer was more effective than conventional gait training among patients with low motricity but not those with high motricity.
Note: Two high quality RCTs found that end-effector gait training with Functional Electrical Stimulation (FES) is more effective than conventional overground gait training. There is no difference between end-effector gait training with/without FES.

Muscle strength - lower extremity
Not Effective
1A

Four high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011) investigated the effect of end-effector gait trainers on lower extremity muscle strength following stroke.

Four high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011) investigated the effect of end-effector gait trainers on lower extremity muscle strength following stroke.

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Note: A significant between-group difference was found at post-treatment in favour of GT1+FES vs. conventional overground gait training. There was no significant difference between end-effector gait training vs. GT1+FES.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Muscle strength was measured by the MI (Leg score) at post-treatment (4 weeks) and follow-up (6 months). No significant between-group differences were found at either timepoint.

The third high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Muscle strength was measured using the MI (Leg score) at post-treatment (6 weeks). No significant between-group difference was found.

The fourth high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (MI score ≤29: low motricity, > 29: high motricity). Muscle strength was measured using the Motricity Index at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. No significant between-group differences were found at either timepoint.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional overground/treadmill gait training) for improving lower extremity muscle strength following stroke.
Note: However, one high quality RCT found that end-effector gait training is more effective than conventional overground gait training.
Note: One high quality RCT found that end-effector gait training with Functional Electrical Stimulation (FES) is more effective than conventional overground gait training. Two high quality RCTs found no significant difference between end-effector gait training with/without FES.

Neurological status
Not Effective
1B

One high quality RCT (Morone et al., 2011) investigated the effect of end-effector gait training on neurological status following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤29: low motricity, > 29: high motricity). Neurological status was measured using the Canadian Neurological Scale at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers are not more effective than a comparison intervention (conventional gait training) for improving neurological status following stroke.

Spasticity
Not Effective
1A

Two high quality RCTs (Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011) and one non-randomized study (Hesse et al., 2001) investigated the effect of end-effector gait training on spasticity following stroke.

The first high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Spasticity was measured using the Modified Ashworth Scale at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤ 29: low motricity, > 29: high motricity). Spasticity was measured using the Ashworth Scale at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. No significant between-group differences were found at either time point.

The non-randomized controlled trial (Hesse et al., 2001) assigned patients with subacute/chronic stroke who were wheelchair-dependent to receive gait training using the GT1 device in addition to conventional physical therapy. Spasticity was measured using the Modified Ashworth Scale at post-treatment (4 weeks). No significant improvement was seen.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional overground/treadmill gait training,conventional gait training) for reducing spasticity following stroke. A non-randomized study also reported no significant improvement in spasticity following end-effector gait training.

Stroke impact
Not Effective
1B

One high quality RCT (Chua, Culpan & Menon, 2016) investigated the effect of end-effector gait training on stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the GT1 device or time-matched conventional physical therapy. Stroke impact was measured by the Stroke Impact Scale (SIS – Physical, Memory and thinking, Mood and emotion, Communication, Participation, Recovery domains) at mid-treatment (4 weeks), post-treatment (8 weeks) and follow-up (12 weeks, 24 weeks, 48 weeks). No significant between-group difference was found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that end-effector gait trainers are not more effective than a comparison intervention (conventional physical therapy) for reducing the impact of stroke.

Walking endurance
Not Effective
1A

Two high quality RCTs (Morone et al., 2011; Chua, Culpan & Menon, 2016) investigated the effect of end-effector gait training on walking endurance following stroke.

The first high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤29: low motricity, > 29: high motricity). Walking endurance was measured using the 6 Minute Walk Test (6MWT) at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. A significant difference was found between low motricity groups only, in favour of end-effector gait training vs. conventional gait training.

The second high quality RCT (Chua, Culpan & Menon, 2016) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or time-matched conventional physical therapy. Walking endurance was measured by the 6MWT at mid-treatment (4 weeks), post-treatment (8 weeks) and follow-up (12 weeks, 24 weeks, 48 weeks). No significant between-group difference was found at any time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that end-effector gait trainers are not more effective than comparison interventions (conventional gait training, conventional physical therapy) in improving walking endurance following stroke.
Note: However, one of these studies found that end-effector gait trainers are more effective than conventional gait training among patients with low motricity (but not those with high motricity).

Walking speed
Conflicting
4

Five high quality RCTs (Tong et al., 2006; Ng et al., 2008; Freivogel, Schmalohr & Mehrholz, 2009; Morone et al., 2011; Chua, Culpan & Menon, 2016) investigated the effect of end-effector gait training on walking speed following stroke.

The first high quality RCT (Tong et al., 2006) randomized patients with acute/subacute stroke to receive (1) gait training using the GT1 device, (2) gait training and Functional Electrical Stimulation (GT1+FES), or (3) conventional overground gait training. Walking speed was measured using the 5-meter walking test at mid-treatment (2 weeks) and post-treatment (4 weeks). A significant between-group difference was found at post-treatment, in favour of end-effector gait training vs. conventional overground gait training.
Note: Significant between-group differences in walking speed were found at both timepoints, in favour of GT1+FES vs. conventional overground gait training. There were no significant differences between end-effector gait training vs. GT1+FES.

The second high quality RCT (Ng et al., 2008) randomized patients with acute/subacute stroke to receive (1) gait training using the GT2 device, (2) gait training + Functional Electrical Stimulation (GT2+FES), or (3) conventional gait training. Walking speed was measured using the 5 meter walking test at post-treatment (4 weeks) and follow-up (6 months). A significant between-group difference was found at both timepoints, in favour of end-effector gait training vs. conventional gait training.
Note: A significant between-group difference was found at both timepoints, in favour of GT2+FES vs. conventional gait training. No significant difference was found between end-effector gait training vs. GT2+FES at either timepoint.

The third high quality cross-over RCT (Freivogel, Schmalohr & Mehrholz, 2009) randomized patients with subacute/chronic stroke to receive gait training using the LokoHelp electromechanical device or conventional treadmill/overground gait training. Walking speed was measured using the 10-meter walking test at post-treatment (6 weeks). No significant between-group difference was found.

The fourth high quality RCT (Morone et al., 2011) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or conventional gait training. Patients were stratified by level of motor impairment (Motricity Index score ≤ 29: low motricity, > 29: high motricity). Walking speed was measured using the 10-meter walking test at post-treatment (4 weeks) and at discharge (average 86-102 days post-stroke according to level of impairment); discharge results were reported. No significant between-group difference was found at any time point.

The fifth high quality RCT (Chua, Culpan & Menon, 2016) randomized patients with acute/subacute stroke to receive gait training using the GT1 device or time-matched conventional physical therapy. Walking speed was measured by the 10-meter walking test at mid-treatment (4 weeks), post-treatment (8 weeks) and follow-up (12 weeks, 24 weeks, 48 weeks). No significant between-group difference was found at any time point.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of end-effector gait trainers on walking speed following stroke. Two high quality RCTs found that end-effector gait trainers are more effective than a comparison intervention (conventional overground gait training), whereas three high quality RCTs found that end-effector gait trainers are not more effective than comparison interventions (conventional treadmill/overground gait training, conventional physical therapy).
Note: Two high quality RCTs found that end-effector gait training + FES is more effective than conventional overground gait training. There is no difference between end-effector gait training with/without FES.

Phase not specific to one period - Exoskeleton gait trainers

Activities of daily living
Not Effective
2A

One fair quality RCT (Kim et al., 2015) investigated the effect of an exoskeleton gait trainer on ADLs following stroke. The fair quality RCT randomized patients with subacute/chronic stroke to receive gait training using the WALKBOT device or time-matched conventional locomotor training; both groups received additional conventional locomotor training. ADLs were measured using the Korean modified Barthel Index (Grooming, Bathing, Feeding, Toilet use, Stairs, Dressing, Bowels, Bladder, Ambulation, Transfers, Total scores) at post-treatment (4 weeks) and follow-up (8 weeks). Significant between-group differences were found on only three ADL scores at both timepoints (Dressing, Ambulation, Total score), in favour of exoskeleton gait training vs. conventional locomotor training.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional locomotor training) for improving Activities of daily living following stroke.

Balance
Effective
2a

One fair quality RCT (Kim et al., 2015) and one non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on balance following stroke.

The fair quality RCT (Kim et al., 2015) randomized patients with subacute/chronic stroke to receive gait training using the WALKBOT device or time-matched conventional locomotor training; both groups received additional conventional locomotor training. Balance was measured using the Berg Balance Scale (BBS) at post-treatment (4 weeks) and follow-up (8 weeks). A significant between-group difference was found at both timepoints, in favour of exoskeleton gait training vs. conventional locomotor training.

The non-randomized retrospective study (Dundar et al., 2014) compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Balance was measured using the BBS at post-treatment (minimum 30 sessions). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that an exoskeleton gait trainer is more effective than a comparison intervention (conventional locomotor training) for improving balance following stroke.
Note: However, a non-randomized study found that the Lokomat device was not more effective than conventional physical therapy.

Cognition
Effective
2B

One non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on cognition following stroke. The non-randomized retrospective study compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Cognition was measured using the Mini Mental Status Examination at post-treatment (minimum 30 sessions). A significant between-group difference was found, in favour of exoskeleton gait training vs. physical therapy.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that an exoskeleton gait trainer is more effective than a comparison intervention (physical therapy) for improving cognition following stroke.

Functional ambulation
Effective
1B

One high quality RCT (Schwartz et al., 2009), one fair quality RCT (Kim et al., 2015) and one non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on functional ambulation following stroke.

The high quality RCT (Schwartz et al., 2009) randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Functional ambulation was measured by the Functional Ambulation Category (FAC) at post-treatment (6 weeks). A significant between-group difference was found, in favour of Lokomat training vs. conventional physical therapy.

The fair quality RCT (Kim et al., 2015) randomized patients with stroke to receive gait training using the WALKBOT device or time-matched conventional locomotor training; both groups received additional conventional locomotor training. Functional ambulation was measured using the FAC at post-treatment (4 weeks) and follow-up (8 weeks). A significant between-group difference was found at both timepoints, in favour of exoskeleton gait training vs. conventional locomotor training.

The non-randomized retrospective study (Dundar et al., 2014) compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Functional ambulation was measured using the FAC at post-treatment (minimum 30 sessions). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that exoskeleton gait trainers are more effective than comparison interventions (physical therapy, conventional locomotor training) for improving functional ambulation following stroke.

Functional independence
Effective
1b

One high quality RCT (Schwartz et al., 2009) and one non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on functional independence following stroke.

The high quality RCT (Schwartz et al., 2009) randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Functional independence was measured by the Functional Independence Measure (FIM – Motor, Cognition) at post-treatment (6 weeks). A significant between-group difference was found in one measure (FIM – Motor), in favour of Lokomat training vs. conventional physical therapy.

The non-randomized retrospective study (Dundar et al., 2014) compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Functional independence was measured using the FIM at post-treatment (minimum 30 sessions). A significant between-group difference was found, in favour of exoskeleton gait training vs. physical therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one non-randomized study that exoskeleton gait trainers are more effective than comparison interventions (physical therapy) for improving functional independence following stroke.

Health related quality of life
Not Effective
2A

One fair quality RCT (Kim et al., 2015) and one non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on Health related quality of life (HRQoL) following stroke.

The fair quality RCT (Kim et al., 2015) randomized patients with subacute/chronic stroke to receive gait training using the WALKBOT device, or time-matched conventional locomotor training; both groups received additional conventional locomotor training. HRQoL was measured using the EuroQoL 5-dimension (EQ-5D) at post-treatment (4 weeks) and follow-up (8 weeks). No significant between-group difference was found at either timepoint.

The non-randomized retrospective study (Dundar et al., 2014) compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. HRQoL was measured using the Medical Outcomes Study Short Form 36 (SF-36 – Physical functioning, Physical role limitations, Pain, General health, Social functioning, General mental health, Emotional role limitations, Vitality, Physical component, Mental component) at post-treatment (minimum 30 sessions). Significant between-group differences were found on all SF-36 scores, in favour of exoskeleton gait training vs. physical therapy.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (conventional locomotor training) for improving quality of life following stroke.
Note: However, a non-randomized study found that the Lokomat device was more effective than physical therapy.

Mobility
Not Effective
1B

One high quality RCT (Schwartz et al., 2009) investigated the effect of an exoskeleton gait trainer on mobility following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Mobility was measured by the Timed Up and Go test and the Stroke Activity Scale (Walking, Standing scores) at post-treatment (6 weeks). No significant between-group differences were found on either measure.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (conventional physical therapy) for improving mobility following stroke.

Motor recovery
Effective
2B

One non-randomized study (Dundar et al., 2014) investigated the effect of an exoskeleton gait trainer on motor recovery following stroke. The non-randomized retrospective study compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Motor recovery was measured using the Brunnstrom Recovery Scale (Lower extremity categories) at post-treatment (minimum 30 sessions). Significant between-group differences were found on all lower extremity categories, in favour of exoskeleton gait training vs. physical therapy.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that exoskeleton gait trainers are more effective than a comparison intervention (physical therapy) for improving motor recovery following stroke.

Spasticity
Not Effective
2A

One fair quality RCT (Kim et al., 2015) and one non-randomized study (Dundar et al., 2014) investigated the effect of exoskeleton gait trainers on spasticity following stroke.

The fair quality RCT (Kim et al., 2015) randomized patients with subacute/chronic stroke to receive gait training using the WALKBOT device or time-matched conventional locomotor training; both groups received additional conventional locomotor training. Spasticity was measured using the Modified Ashworth Scale at post-treatment (4 weeks) and follow-up (8 weeks). No significant between-group difference was found at either timepoint.

The non-randomized retrospective study (Dundar et al., 2014) compared patients with subacute/chronic stroke who had received gait training using the Lokomat device with those who had received physical therapy. Spasticity was measured using the Modified Ashworth Scale at post-treatment (minimum 30 sessions). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT and one non-randomized study that exoskeleton gait trainers are not more effective than comparison interventions (conventional locomotor training, physical therapy) for reducing spasticity following stroke.

Stair climbing
Effective
1B

One high quality RCT (Schwartz et al., 2009) investigated the effect of an exoskeleton gait trainer on stair climbing following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Stair climbing was measured according to number of stairs climbed at post-treatment (6 weeks). A significant between-group difference was found in a subgroup of patients with high functional ambulation (Functional Ambulation Category score ≥ 3), in favour of Lokomat training vs. conventional physical therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is more effective than a comparison intervention (physical therapy) for improving stair climbing following stroke, among patients with high functional ambulation.

Stroke severity
Effective
1B

One high quality RCT (Schwartz et al., 2009) investigated the effect of exoskeleton gait trainers on stroke severity following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the Lokomat device, or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Stroke severity was measured by the National Institute of Health Stroke Scale at post-treatment (6 weeks). A significant between-group difference was found, in favour of exoskeleton gait training vs. conventional physical therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is more effective than a comparison intervention (physical therapy) for reducing stroke severity following stroke.

Walking endurance
Not Effective
1B

One high quality RCT (Schwartz et al., 2009) investigated the effect of exoskeleton gait trainers on walking endurance following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Walking endurance was measured by the 2 Minute Walk Test at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an exoskeleton gait trainer is not more effective than a comparison intervention (physical therapy) for improving walking endurance following stroke.

Walking speed
Not Effective
1B

One high quality RCT (Schwartz et al., 2009) investigated the effect of exoskeleton gait trainers on walking speed following stroke. The high quality RCT randomized patients with acute/subacute stroke to receive gait training using the Lokomat device or time-matched conventional physical therapy for gait retraining; both groups received additional physical therapy. Walking speed was measured by the 10-meter walking test at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exoskeleton gait trainers are not more effective than a comparison intervention (physical therapy) for improving walking speed following stroke.

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Tong, R.K., Ng, M.F., & Li, L.S. (2006). Effectiveness of gait training using an electromechanical gait trainer, with and without Functional Electric Stimulation, in subacute stroke: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 87, 1298-1304.
DOI:10.1016/j.apmr.2006.06.016

Ukar, D.E., Paker, N., & Bugdayci, D. (2014). Lokomat: a therapeutic chance for patients with chronic hemiplegia. NeuroRehabilitation, 34, 447-53.
DOI: 10.3233/NRE-141054

van Nunen, M.P.M., Gerrits, K.H.L., Konijnenbelt, M., Janssen, T.W.J., & de Haan, A. (2015). Recovery of walking ability using a robotic device in subacute stroke patients: a randomized controlled study. Disability and Rehabilitation: Assistive Technology, 10(2), 141-8.
DOI: 10.3109/17483107.2013.873489

Werner, C., Von Frankenberg, S., Treig, T., Konrad, M., & Hesse, S. (2002). Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study. Stroke, 33(12), 2895-2901.
http://www.ncbi.nlm.nih.gov/pubmed/12468788

Westlake, K.P. & Patten, C. (2009). Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. Journal of NeuroEngineering and Rehabilitation, 6(18), 1-11.
DOI: 10.1186/1743-0003-6-18

Excluded Studies

Bae, Y.-H., Kim, Y.-H., & Fong, S.S.M. (2016). Comparison of heart rate reserve-guided and ratings of perceived exertion-guided methods for high-intensity robot-assisted gait training in patients with chronic stroke. Topics in Geriatric Rehabilitation, 32(2), 119-26.

Reason for exclusion: Both groups received gait training using an exoskeleton device (Lokomat).

Bonnyaud, C., Zory, R., Boudarham, J., Pradon, D., Bensmail, D., & Roche, N. (2014). Effect of a robotic restraint gait training versus robotic conventional gait training on gait parameters in stroke patients. Experimental Brain Research, 232, 31-42.

Reason for exclusion: Single session; all groups received gait training using an exoskeleton device (Lokomat).

Calabro, R.S., Reitano, S., Leo, A., De Luca, R., Melegari, C., & Bramanti, P. (2014). Can robot-assisted movement training (Lokomat) improve functional recovery and psychological well-being in chronic stroke? Promising findings from a case study. Functional Neurology, 29(2), 139-141.

Reason for exclusion: Case study.

Calabro, R.S., De Cola, M.C., Leo, A., Reitano, S., Balletta, T., Trombetta, G., Naro, A., Russo, M., Berte, F., De Luca, R., & Bramanti, P. (2015). Robotic neurorehabilitation in patietns with cnronic stroke: psychological well-being beyond motor improvement. International Journal of Rehabilitation Research, 38, 219-225.

Reason for exclusion: Non-randomized study, between-group differences not reported.

Conesa, L., Costa, U., Morales, E., Edwards, D.J., Cortes, M., Leon, D., Bernabeu, M., & Medina, J. (2012). An observational report of intensive robotic and manual gait training in sub-acute stroke. Journal of NeuroEngineering and Rehabilitation, 9(1), 13. DOI: 10.1186/1743-0003-9-13.

Reason for exclusion: All participants received Gait Training using the Reha-Stim Gait Trainer followed by conventional overground gait training; between-group comparisons were not conducted.

Delussu, A.S., Morone, G., Iosa, M., Bargoni, M., Traballesi, M., & Paolucci, S. (2014). Physiological responses and energy cost of walking on the Gait Trainer with and without body weight support in subacute stroke patients. Journal of Neuroengineering and Rehabilitation, 11, 54-63.

Reason for exclusion: The intervention group was compared with healthy subjects.

Krewer, C., Muller, F., Husemann, B., Heller, S., Quintern, J., & Koenig, E. (2007). The influence of different Lokomat walking conditions on the energy expenditure of hemiparetic patients and healthy subjects. Gait & Posture, 26, 372-7.

Reason for exclusion: Comparison of patients with healthy subjects using Lokomat under different walking conditions over a single session.

Krewer, C., Rie, K., Bergmann, J., Muller, F., Jahn, K., & Koenig, E. (2013). Immediate effectiveness of single-session therapeutic interventions in pusher behaviour. Gait & Posture, 37(2), 246-50.

Reason for exclusion: Single session; study was specifically examining pusher behaviour.

Mayr, A., Kofler, M., Quirbach, E., Matzak, H., Frohlich, K., & Saltuari, L. (2007). Prospective, blinded, randomized crossover study of gait rehabilitation in stroke patients using the Lokomat gait orthosis. Neurorehabilitation and Neural Repair, 21(4), 307-14.

Reason for exclusion: Between-group differences not reported.

Ochi, M., Wada, F., Saeki, S., & Hachisuka, K. (2015). Gait training in subacute non-ambulatory stroke patients using a full weight-bearing gait-assistance robot: a prospective, randomized, open, blinded-endpoint trial. Journal of the Neurological Sciences, 353, 130-6.

Reason for exclusion: The device used was a robot arm control system.

Picelli, A., Bacciga, M., Melotti, C., La Marchina, E., Verzini, E., Ferrari, F., Pontillo, A., Corradi, J., Tamburin, S., Saltuari, L., Corradini, C., Waldner, A., & Smania, N. (2016). Combined effects of robot-assisted gait training and botulinum toxin type A on spastic equinus foot in patients with chronic stroke: a pilot, single blind, randomized controlled trial. European Journal of Physical and Rehabilitation Medicine, 52(6), 759-66.

Reason for exclusion: Study incorporated use of botulinum toxin type A.

Regnaux, J.P., Saremi, K., Marehbian, J., Bussel, B., & Dobkin, B.H. (2008). An accelerometry-based comparison of 2 robotic assistive devices for treadmill training of gait. Neurorehabilitation and Neural Repair, 22(4), 348-54.

Reason for exclusion: Single case study; comparison of Gait Trainer and Lokomat over single session.

Stoller, O., de Bruin, E.D., Schindelholz, M., Schuster-Amft, C., de Bie, R.A., & Hunt, K.J. (2015). Efficacy of feedback-controlled robotics-assisted treadmill exercise to improve cardiovascular fitness early after stroke: a randomized controlled pilot trial. Journal of Neurologic Physical Therapy, 39, 156-65.

Reason for exclusion: Both groups received gait training using the Lokomat device.

Fatigue

Evidence Reviewed as of before: 28-08-2019
Author(s)*: Tatiana Ogourtsova, PhD OT; Annabel McDermott, OT
Content consistency: Gabriel Plumier
Patient/Family Information Table of contents

Introduction

Fatigue is a multidimensional, motor-perceptive, cognitive and emotional experience. It is described as “a feeling of early exhaustion with weariness, lack of energy and aversion to effort that develops during physical or mental activity and is usually not ameliorated by rest” (Staub & Bogousslavsky, 2001). Post-stroke fatigue can be distinguished into three types:

1) Physical fatigue (i.e. inability to perform activities at physical lengths and intensities);
2) Cognitive fatigue (i.e. inability to perform activities at concentration, multitasking and/or cognitive load stressors lengths and intensities); and
3) Emotional fatigue (i.e. getting tired when facing demanding interactions or relationships) (Terrill, Schwartz & Belagaje, 2018).

Post-stroke fatigue is a prevalent stroke consequence, affecting more than 50% of stroke survivors (Cumming et al. 2016). Prevalence cannot be explained by type of stroke, side of stroke or lesion location. Prevalence is also not associated to stroke severity, meaning that prevalence is the same in mild stroke as compared to severe stroke (Acciarresi et al., 2014). Fatigue is associated with depressive symptoms but can be present without depression. Its association to cognitive deficits and gender remains unclear. However, higher levels of fatigue are found to be associated with female sex, depression, longer post-stroke time period and greater disability (Cumming et al., 2018).

A documentary (lasting 40 minutes) presenting how fatigue impacts daily life of five individuals and what strategies they use to effectively cope with fatigue was produced in March 2019. The documentary (in French) can be viewed by clicking here.

Patient/Family Information

Author: Tatiana Ogourtsova, PhD OT; Annabel McDermott, OT

Since my stroke I feel tired. Am I normal?

Fatigue is common in patients with stroke. Approximately 50% of stroke survivors will experience fatigue after having a stroke, no matter what the severity of the stroke is.

What is fatigue after stroke?

Fatigue is a feeling of early tiredness, lack of energy and aversion to effort. Fatigue occurs during or after activity that is physically demanding, mentally demanding (i.e. requiring attention and concentration) or emotionally demanding (e.g. conflict with another person). The main difference with regular fatigue is that post-stroke fatigue usually does not get better as fast with rest.

Are there different types of fatigue?

Fatigue after stroke is usually distinguished into three types: 1) physical, 2) mental or cognitive, and 3) emotional.

Physical fatigue is when a person is unusually tired after physical activity, or is unable to perform a physical activity that requires more effort or strength (e.g. walking, going up the stairs) or for a long period of time.

Mental or cognitive fatigue is when a person is unusually tired after or unable to perform an activity that requires attention, concentration or multitasking (e.g. reading, following a movie).

Emotional fatigue is when a person is unusually tired after difficult interactions or conflicts with close ones (e.g. marital conflict, being uncomfortable with someone, difficulty managing emotions).

When would fatigue appear after a stroke?

Fatigue after stroke can appear at different times. Some people experience fatigue shortly after the stroke. Others experience fatigue much later after stroke, even 1 year after stroke.

Is fatigue caused by my stroke?

It is possible that the fatigue you are experiencing is an effect of your stroke. Here is one possible explanation:

Injury to your brain

There are debates on whether the site of the lesion (stroke location) is related to symptoms of fatigue. Some research shows that people who have a stroke in specific parts of the brain (basal ganglia, internal capsule, brain stem, thalamus) are more likely to experience post-stroke fatigue. Other research argues that it is the number of strokes that matter, where fatigue is more common in people who have had several strokes rather than in those who had a stroke for the first time.

How do I know if I have post-stroke fatigue? What are the common signs of fatigue after a stroke?

People who have fatigue after stroke share some common traits such as:

  • Low energy
  • Feeling weary soon after starting a physical activity (e.g. walking, exercise), an activity that is mentally demanding (e.g. reading, social event) or an activity that is emotionally demanding (e.g. conflict with another person).
  • Feeling a loss of self-control
  • Feeling emotional instability
  • Feeling of tiredness that becomes greater during physical exercise, during activities that require concentration and/or with stress.

Is it easy to detect fatigue after a stroke?

It is often easy to detect fatigue in a person that has had a stroke. However, it can be difficult to identify the type of fatigue you are experiencing and what causes you to feel tired. Your rehabilitation therapist may often ask about your level of fatigue. However, sometimes people who had a stroke have problems speaking or understanding words; this makes it more difficult to share information about fatigue symptoms.

How is the diagnosis of fatigue after a stroke made?

Your therapist may ask you a series of questions or have you or your caregiver fill out a questionnaire. This will help to identify presence of fatigue.

Are there different kinds of therapies for fatigue?

There are many different therapies available for fatigue after stroke. This module includes the following interventions:

  • Mindfulness-based stress reduction (MBSR): a program that helps you to calm you mind and body to help cope with illness, pain, and stress.
  • Inspiratory muscle training (IMT): breathing exercises using a breathing device.
  • Game-based team therapy: playing games in groups that are competitive in nature (e.g. playing ball with scores).
  • Multimodal interventions: rehabilitation that combines physical exercises and cognitive exercises together.
  • Psychoeducation: education, advice, recommendations, and strategies to help change your thoughts and behavior.

There is no known ‘cure’ for post-stroke fatigue. However, when we asked individuals who have had a stroke for their key strategies to cope with fatigue post-stroke, they told us:

  • To accept that you may need to reduce the frequency or intensity of an activity;
  • To plan rest periods into your daily routine;
  • To organise your environment and routine;
  • To conserve your energy when doing everyday activities by making a task simpler;
  • To identify the type of fatigue you are prone to and the activities that trigger your fatigue;
  • To prioritise activities that are meaningful to you and your well-being;
  • To communicate with your close-ones about your level of fatigue;
  • To engage in planned exercise such as aerobics to increase endurance;
  • To practice good sleep patterns.

What fatigue therapies work for stroke?

Fatigue therapies have been examined using high and fair quality research studies. Some therapies were shown to improve mental fatigue and other important domains such as independence in self-care activities, depression, sleep, endurance and respiratory function in some patients after stroke.

In particular, for patients with chronic stroke (more than 6 months after stroke), mindfulness-based stress reduction therapy has been shown to be useful to improve mental fatigue, depression, anxiety, and cognitive abilities (e.g. attention).

For patients with stroke across the recovery continuum (acute, subacute and/or chronic), inspiratory muscle training, game-based team therapy, and multimodal interventions have been shown to be useful to improve fatigue, independence in everyday activities (e.g. dressing, walking), respiratory function (e.g. inspiration and expiration lung capacities), depression, and sleep.

What can I expect in terms of therapy for fatigue?

Your therapist will discuss with you what fatigue therapy is most suitable for you. How often and for how long the therapy is provided for depends on the nature of therapy.

Who provides the treatment?

Different health-care providers can administer fatigue therapies: occupational therapists, physiotherapists, psychologists, neuropsychologists and nurses.

Are there any side effects or risks?

Fatigue therapies are usually administered by a trained health professional at a rehabilitation clinic or at home. Your therapist will monitor your reactions to the therapy closely. It is important to report to your therapist any changes in your state (e.g. more or less fatigue, sleep quality, independence for daily tasks). Your therapist will adjust the nature, intensity and the duration of therapy according to your ability, endurance and progress.

Is it possible to speak to someone who had a stroke?

Support groups are available in some regions for people who have had a stroke. You can also find stories about people who have had problems similar to yours. Consult your National Stroke Association.

How does my fatigue impact on my recovery?

Fatigue after stroke may make you feel less motivated, more tired, and also may cause you to have trouble concentrating. All these symptoms of fatigue will slow down your recovery. Studies have shown that people who have fatigue after stroke do not get better as quickly as people who do not have fatigue.

I would like to know more about fatigue and stroke?

Understanding how fatigue and stroke happen can reassure you. There are many resources online. Your health care provider can help answer your specific questions.

A documentary (lasting 40 minutes) presenting how fatigue impacts daily life of five individuals and what strategies they use to effectively cope with fatigue was produced in March 2019. The documentary (in French) can be viewed by clicking here.

Please click here to access a video on fatigue posted by Canadian Partnership for stroke recovery.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

The current module includes studies examining interventions specific for post-stroke fatigue. Studies were excluded based on the following exclusion criteria: i) fatigue is a secondary outcome and intervention is not fatigue-specific; and ii) the type of intervention is represented by an existing Stroke Engine module. Please see the following Stroke Engine modules for more information on the effects of these intervention on fatigue: Cognitive Rehabilitation, Robotics, Aerobic Exercise, Transcranial Direct Current Stimulation/Transcranial Magnetic Stimulation, Task-Oriented Upper Extremity, Video Games, Balance Training, and Task-Oriented Lower Extremities. The current module includes eight studies: two high quality RCTs, three fair quality RCTs and three non-RCTs design studies. Of these, seven studies included patients with stroke not defined to one specific post-stroke time period (e.g. participants in the subacute or chronic stage of stroke recovery). The following five types of interventions for post-stroke fatigue emerged and are included in the present module: Mindfulness-based stress reduction, Inspiratory muscle training, Group sports, Multimodal intervention (cognitive and physical training), and Fatigue management psychoeducation.

No studies on interventions for post-stroke fatigue were found for patients specifically in the acute and subacute phase of stroke recovery.

Results Table

View results table

Outcomes

Chronic phase - Mindfulness

Anxiety
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on anxiety in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Anxiety was measured by the Comprehensive Psychopathological Rating Scale (CPRS: Anxiety) at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in reducing anxiety in patients with chronic stroke.

Depression
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on depression in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Depression was measured by the Comprehensive Psychopathological Rating Scale (CPRS: Depression) at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in reducing depression in patients with chronic stroke.

Executive function
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on executive functions in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Executive function was measured by the Trail Making Test (TMT: A, B, C, D) and the Wechsler Adult Intelligence Scale-III: Digit Symbol-Coding Test at post-treatment (8 weeks). A significant between-group difference was found on only one measure of executive function (TMT – A) in favour of MBSR treatment vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in improving executive function in patients with chronic stroke.
Note: Significant between-group differences in TMT-A were also found at baseline, favoring MBSR vs. no treatment. Significant between-group differences in TMT-B and TMT-C scores were found at post-treatment, but differences did not remain significant when adjusted with TMT-A scores.

Mental fatigue
Effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on mental fatigue in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Mental fatigue was measured by the Self-Evaluation Questionnaire for Mental Fatigue at post-treatment (8 weeks). A significant between-group difference was found in favour of MBSR treatment vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is more effective than no treatment in reducing mental fatigue in patients with chronic stroke.

Reading speed
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on reading speed in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Reading speed was measured by a Reading Speed Dyslexia Screening test at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in improving reading speed in patients with chronic stroke.

Verbal fluency
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on verbal fluency in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Verbal fluency was measured by the FAS Verbal Fluency Test at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in improving verbal fluency in patients with chronic stroke.

Working memory
Not effective
2a

One fair quality RCT (Johansson, Bjuhr & Ronnback, 2012) investigated the effect of mindfulness-based stress reduction (MBSR) treatment on working memory in patients with chronic acquired brain injury (62% of participants with stroke). This fair quality RCT randomized patients to receive MBSR treatment or delayed MBSR treatment (no treatment). Working memory was measured by the Wechsler Adult Intelligence Scale-III: Digit Span Test at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mindfulness-based stress reduction treatment is not more effective than no treatment in improving working memory in patients with chronic stroke.

Phase not specific to one period - Fatigue management education

Activities of daily living
Not effective
2a

One fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) investigated the effect of fatigue management education on activities of daily living (ADLs) in patients with stroke. This fair quality RCT randomized patients with subacute/chronic stroke to receive post-stroke fatigue management psychoeducation or general stroke psychoeducation. ADLs were measured by the Barthel Index and the modified Rankin Scale at post-treatment (6 weeks) and follow-up (3 months). No significant between-group differences were found on any measure at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that post-stroke fatigue management education is not more effective than a comparison intervention (general stroke education) in improving activities of daily living in patients with stroke.

Anxiety
Not effective
2a

One fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) investigated the effect of fatigue management education on anxiety in patients with stroke. This fair quality RCT randomized patients with subacute/chronic stroke to receive post-stroke fatigue management psychoeducation or general stroke psychoeducation. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS: Anxiety) at post-treatment (6 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that post-stroke fatigue management education is not more effective than a comparison intervention (general stroke education) in reducing anxiety in patients with stroke.

Depression
Not effective
2a

One fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) and one non-randomized study (Wu et al., 2017) investigated the effect of fatigue management education on anxiety in patients with stroke.

The fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) randomized patients with subacute/chronic stroke to receive post-stroke fatigue management psychoeducation or general stroke psychoeducation. Depression was measured by the Hospital Anxiety and Depression Scale (HADS: Depression) at post-treatment (6 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

The non-randomized pre-post design study (Wu et al., 2017) allocated patients with subacute/chronic stroke to receive psychoeducation for post-stroke fatigue. Depression was measured by the Patient Health Questionnaire (PHQ-9) at post-treatment (6 sessions) and follow-up (1 month, 3 months). A significant improvement was found at one follow-up time point only (1 month).

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that post-stroke fatigue management education is not more effective than a comparison intervention (general stroke education) in reducing depression in patients with stroke. Similarly, a pre-post design study found no significant immediate or long-term benefits from a psychoeducation program.

Fatigue
Not effective
2a

One fair quality RCT (Clarke, Baker-Collo & Feigin, 2012), and two non-randomized studies (Wu et al., 2017; Boehm, Muehlberg & Stube, 2015) investigated the effect aof fatigue management education on fatigue in patients with stroke.

The fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) randomized patients with subacute/chronic stroke to receive post-stroke fatigue management psychoeducation or general stroke psychoeducation. Fatigue was measured by the Fatigue Severity Scale, a Visual Analogue Scale for Fatigue (Fatigue, Vigor), and the Checklist of Individual Strength at post-treatment (6 weeks) and follow-up (3 months). No significant between-group differences were found on any measure at either time point.

A non-randomized pre-post design study (Wu et al., 2017) allocated patients with subacute/chronic stroke to receive psychoeducation for post-stroke fatigue. Fatigue was measured by the Fatigue Assessment Scale at post-treatment (6 sessions) and follow-up (1 month, 3 months). A significant improvement was found at one follow-up time point only (3 months).

A case report (Boehm, Muehlberg & Stube, 2015) allocated one patient with stroke and post-stroke fatigue (time since stroke not specified) to receive a fatigue management course. Fatigue was measured by the Fatigue Impact Scale (FIS: Physical Fatigue, Cognitive Fatigue, Social Fatigue) at post-treatment (5 weeks). Improvements were noted on all measures of fatigue, however no statistical results were provided. This study is not used in the conclusion below.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that post-stroke fatigue management education is not more effective than a comparison intervention (general stroke education) in reducing fatigue in patients with stroke. A non-randomized also reported no significant improvements in fatigue immediately following a psychoeducation program.

Health-related quality of life
Not effective
2a

One fair quality RCT (Clarke, Baker-Collo & Feigin, 2012) investigated the effect of fatigue management education on health-related quality of life in patients with stroke. This fair quality RCT randomized patients with subacute/chronic stroke to receive post-stroke fatigue management psychoeducation or general stroke psychoeducation. Health-related quality of life was measured by the Short Form-36 (SF-36: Physical functioning, Role physical, Role emotional, Energy/Fatigue, Emotional wellbeing, Social functioning, Pain, General Health) at post-treatment (6 weeks) and follow-up (3 months). No significant between-group differences were found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that post-stroke fatigue management education is not more effective than a comparison intervention (general stroke education) in improving health-related quality of life in patients with stroke.

Instrumental activities of daily living
Insufficient evidence
5

One non-randomized study (Wu et al., 2017) investigated the effect of fatigue management education on instrumental activities of daily living (IADLs) in patients with stroke. This pre-post design study allocated patients with subacute/chronic stroke to receive psychoeducation for post-stroke fatigue. IADLs were measured by the Nottingham Extended Activities of Daily Living at post-treatment (6 sessions) and follow-up (1 month, 3 months). No significant improvements were found at any time point.

Conclusion: There is insufficient evidence (Level 5) regarding the effect of post-stroke fatigue management education on instrumental activities of daily living in patients with stroke. However, one pre-post design study found no significant improvements in instrumental activities of daily living following an psychoeducation program.

Occupational performance
Insufficient evidence
5

One case-report (Boehm, Muehlberg & Stube, 2015) investigated the effect of fatigue management education on occupational performance in a patient with stroke. This case-reported allocated one patient with stroke and post-stroke fatigue (time since stroke not specified) to receive a fatigue management course. Occupational performance was measured by the Canadian Occupational Performance Measure (COPM: Perceived performance, Satisfaction) at post-treatment (5 weeks). No improvements were noted and no statistical results were provided.

Conclusion: There is insufficient evidence (Level 5) regarding the effect of post-stroke fatigue management education on occupational performance in patients with stroke. However, one case report found no improvement in occupational performance following a fatigue management course.

Stroke outcomes
Insufficient evidence
5

One non-randomized study (Wu et al., 2017) investigated the effect of fatigue management education on stroke outcomes in patients with stroke. This pre-post design study allocated patients with subacute/chronic stroke to receive psychoeducation for post-stroke fatigue. Stroke outcomes were measured by the Stroke Impact Scale (SIS: General recovery, Physical strength, Memory and thinking, Emotion, Communication, Daily activities, Mobility, Hand function, Social activity) at post-treatment (6 sessions) and follow-up (1 month, 3 months). Significant improvements were noted in some stroke outcomes at post-treatment (SIS: Mobility, Social activity), 1-month follow-up (SIS: Mobility, Social activity), and 3-month follow-up (SIS: General recovery, Memory and thinking, Emotion, Mobility, Social activity).

Conclusion: There is insufficient evidence (Level 5) regarding the effect of post-stroke fatigue management education on stroke outcomes in patients with stroke. However, one pre-post design study found significant improvements in some stroke outcomes following a psychoeducation program.

Phase not specific to one period - Group sports

Depression
Effective
2b

One quasi-experimental design study (Kim, 2012) investigated the effect of group sports on depression in patients with stroke. This quasi-experimental design study allocated patients with acute/subacute/chronic stroke to engage in group sports (ball games) or no treatment; both groups received conventional rehabilitation. Depression was measured by the Korean version of the State Depression Scale at post-treatment (2 weeks). A significant between-group differences was found, favoring group sports vs. no treatment.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that group sports are more effective than no treatment in reducing depression in patients with stroke.

Fatigue
Effective
2b

One quasi-experimental design study (Kim, 2012) investigated the effect of group sports on fatigue in patients with stroke. This quasi-experimental design study allocated patients with acute/subacute/chronic stroke to engage in group sports (ball games) or no treatment; both groups received conventional rehabilitation. Fatigue was measured by the Brief Fatigue Inventory at post-treatment (2 weeks). A significant between-group difference was found, favoring group sports vs. no treatment.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that group sports are more effective than no treatment in reducing fatigue in patients with stroke.

Functional independence
Effective
2b

One quasi-experimental design study (Kim, 2012) investigated the effect of group sports on functional independence in patients with stroke. This quasi-experimental design study allocated patients with acute/subacute/chronic stroke to engage in group sports (ball games) or no treatment; both groups received conventional rehabilitation. Functional independence was measured by the Functional Independence Measure (FIM: Motor, Cognition, Total scores) at post-treatment (2 weeks). Significant between-group differences were found in two measures of functional independence (FIM: Motor, Total scores), favoring group sports vs. no treatment.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that group sports are more effective than no treatment in improving functional independence in patients with stroke.

Sleep quality
Effective
2b

One quasi-experimental design study (Kim, 2012) investigated the effect of group sports on sleep quality in patients with stroke. This quasi-experimental design study allocated patients with acute/subacute/chronic stroke to engage in group sports (ball games) or no treatment; both groups received conventional rehabilitation. Sleep quality was measured by the Pittsburgh Sleep Quality Index at post-treatment (2 weeks). A significant between-group difference was found, favoring group sports vs. no treatment.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that group sports are more effective than no treatment in improving sleep quality in patients with stroke.

Phase not specific to one period - Inspiratory muscle training

Activities of daily living
Effective
2a

One fair quality RCT (Chen et al., 2016) investigated the effect of inspiratory muscle training (IMT) on activities of daily living (ADLs) in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive IMT or no treatment; both groups received conventional rehabilitation. ADLs were measured by the Barthel Index at post-treatment (10 weeks). A significant between-group difference was found, favoring IMT vs. no treatment. Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that inspiratory muscle training is more effective than no treatment in improving activities of daily living in patients with stroke.

Fatigue
Not effective
1b

One high quality RCT (Cho et al., 2018) and one fair quality RCT (Chen et al., 2016) investigated the effect of inspiratory muscle training (IMT) on fatigue in patients with stroke.

The high quality RCT (Cho et al., 2018) randomized patients with subacute/chronic stroke to receive IMT or no treatment; both groups received conventional physical therapy. Fatigue was measured by the Fatigue Severity Scale at post-treatment (6 weeks). No significant between-group difference was found.

The fair quality RCT (Chen et al., 2016) randomized patients with acute/subacute stroke to receive IMT or no treatment; both groups received conventional rehabilitation. Fatigue was measured by the Fatigue Assessment Scale at post-treatment (10 weeks). No significant between-group difference was found. Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that inspiratory muscle training is not more effective than no treatment in reducing fatigue in patients with stroke.

Perceived exertion
Not effective
2a

One fair quality RCT (Chen et al., 2016) investigated the effect of inspiratory muscle training (IMT) on perceived exertion in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive IMT or no treatment; both groups received conventional rehabilitation. Perceived exertion was measured by the modified Borg Scale at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that inspiratory muscle training is not more effective than no treatment in improving perceived exertion in patients with stroke.

Respiratory function
Effective
1b

One high quality RCT (Cho et al., 2018) and one fair quality RCT (Chen et al., 2016) investigated the effect of inspiratory muscle training (IMT) on respiratory function in patients with stroke.

The high quality RCT (Cho et al., 2018) randomized patients with subacute/chronic stroke to receive IMT or no treatment; both groups received conventional physical therapy. Respiratory function (MIP, IME, affected/non-affected DT at rest/contraction, affected/non-affected DT thickness ratio) was measured by the inspiratory muscle training device PowerBreath K5 (2010, HaB International LtD, UK) at post-treatment (6 weeks). Significant between-group differences were found in some measures of respiratory function (MIP, IME, affected DT at contraction, affected DT thickness ratio), favoring IMT vs. no treatment.

The fair quality RCT (Chen et al., 2016) randomized patients with acute/subacute stroke to receive IMT or no treatment; both groups received conventional rehabilitation. Respiratory function (FVC, FEV1, ratio FEV1/FVC, MIP, MEP, MMEF, SpO2) was measured by standard spirometer and a finger pulse oximeter at post-treatment (10 weeks). A significant between-group difference was found in one measure of respiratory function (MIP), favoring IMT vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that inspiratory muscle training is more effective than no treatment in improving respiratory function in patients with stroke. In addition, one fair quality RCT found a significant between-group difference in one measure of respiratory function, favoring inspiratory muscle training compared to no treatment.
DT: Diaphragm thickness IME: Inspiratory muscle endurance FVC: Forced Vital Capacity FEV1: Forced Expiratory Volume in 1 sec MIP: Maximal inspiratory pressure MEP: Maximal expiratory pressure MMEF: Maximal mid-expiratory flow SpO2: Resting oxyhemoglobin saturation.

Walking endurance
Not effective
1b

One high quality RCT (Cho et al., 2018) investigated the effect of inspiratory muscle training (IMT) on endurance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive IMT or no treatment; both groups received conventional physical therapy. Walking endurance was measured by the 6-Minute Walk Test at post-treatment (6 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that inspiratory muscle training is not more effective than no treatment in improving walking endurance in patients with stroke.

Phase not specific to one period - Multimodal intervention

Fatigue
Not effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on fatigue in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. Fatigue was measured by the Checklist Individual Strength (CIS: Fatigue) and the Fatigue Self-Observation List at post-treatment (3 months) and follow-up (6 months). There were no significant between-group differences on either measure at either time point.
Note: The authors noted a significant clinically relevant improvement in CIS: Fatigue scores at follow-up, for the cognitive therapy group with graded activity training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is not more effective than a comparison intervention (cognitive therapy alone) in reducing fatigue in patients with stroke.

Health-related quality of life
Not effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. HRQoL was measured by the Stroke-Adapted Sickness Impact Profile at post-treatment (3 months) and follow-up (6 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is not more effective than a comparison intervention (cognitive therapy alone) in improving health-related quality of life in patients with stroke.

Mood and affect
Not effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on mood and affect in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. Mood and affect were measured by the Hospital Anxiety and Depression Scale (HADS: Anxiety, Depression) at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is not more effective than a comparison intervention (cognitive therapy alone) in improving mood and affect in patients with stroke.

Pain
Not effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on pain in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. Pain was measured by the Pain Self-Observation List at post-treatment (3 months) and follow-up (6 months). No significant between-group difference found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is not more effective than a comparison intervention (cognitive therapy alone) in reducing pain in patients with stroke.

Sleep quality
Not effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on sleep quality in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. Sleep quality was measured by the Sleep Quality Self-Observation List at post-treatment (3 months) and follow-up (6 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is not more effective than a comparison intervention (cognitive therapy alone) in improving sleep quality in patients with stroke.

Walking endurance
Effective
1b

One high quality RCT (Zedlitz et al., 2012) investigated the effect of a multimodal intervention on walking endurance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive cognitive therapy with graded activity training or cognitive therapy alone. Walking endurance was measured by the 6 Minute Walk Test at post-treatment (3 months) and follow-up (6 months). A significant between-group difference was found at post-treatment, favoring cognitive therapy with graded activity vs. cognitive therapy alone. This between-group difference remained significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention of cognitive therapy with graded activity training is more effective than a comparison intervention (cognitive therapy alone) in improving walking endurance in patients with stroke.

References

Acciarresi, M., Bogousslavsky, J., & Paciaroni. M. (2014). Post-stroke fatigue: epidemiology, clinical characteristics and treatment. European Neurology, 72, 255-61

Boehm, N., Muehlberg, H., & Stube, J.E. (2015). Managing poststroke fatigue using telehealth: a case report. American Journal of Occupational Therapy, 69(6), 6906350020p1-6906350020p7.
https://ajot.aota.org/article.aspx?articleid=2465091

Carlsson, G.E., Möller, A., & Blomstrand, C. (2003). Consequences of mild stroke in persons. Cerebrovascular Diseases, 16(4), 383-388.

Chen PC, Liaw MY, Wang LY, Tsai YC, Hsin YJ, Chen YC, Chen SM, Lin MC. (2016). Inspiratory muscle training in stroke patients with congestive heart failure: A CONSORT-compliant prospective randomized single-blind controlled trial. Medicine (Baltimore). Sep;95(37):e4856. doi: 10.1097/MD.0000000000004856.
https://www.ncbi.nlm.nih.gov/pubmed/27631248

Cho JE, Lee HJ, Kim MK, Lee WH. (2018). The improvement in respiratory function by inspiratory muscle training is due to structural muscle changes in patients with stroke: a randomized controlled pilot trial.Top Stroke Rehabil. Jan;25(1):37-43. doi: 10.1080/10749357.2017.1383681.
https://www.ncbi.nlm.nih.gov/pubmed/29061084

Clarke, A., Barker-Collo, S.L., & Feigin, V.L. (2012). Poststroke fatigue: does group education make a difference? A randomized pilot trial. Topics in Stroke Rehabilitation, 19(1), 32-39.
https://www.tandfonline.com/doi/abs/10.1310/tsr1901-32

Cumming, T.B., Packer, M., Kramer, S.F., & English, C. (2016). The prevalence of fatigue after stroke: a systematic review and meta-analysis. International Journal of Stroke, 11, 968-77.

Cumming, T.B., Yeo, A.B., Marquez, J., Churilov, L., Annoni, J.M., Badaru, U., … & Mills, R. (2018). Investigating post-stroke fatigue: An individual participant data meta-analysis. Journal of Psychosomatic Research, 113, 107-112.

Glader, E.L., Stegmayr, B., & Asplund, K. (2002). Poststroke fatigue: a 2-year follow-up study of stroke patients in Sweden., 33(5), 1327-1333.

Johansson, B., Bjuhr, H., & Rönnbäck, L. (2012). Mindfulness-based stress reduction (MBSR) improves long-term mental fatigue after stroke or traumatic brain injury. Brain Injury, 26(13-14), 1621-1628.
https://www.tandfonline.com/doi/abs/10.3109/02699052.2012.700082

Kim, I. (2012). Effects of an enjoyable nurse-led intervention to promote movement in poststroke inpatients. Clinical Nursing Research, 21(4), 390-405.
https://journals.sagepub.com/doi/abs/10.1177/1054773812439204

Paul, L., Wyke, S., Brewster, S., Sattar, N., Gill, J. M., Alexander, G., … & Dybus, A. (2016). Increasing physical activity in stroke survivors using STARFISH, an interactive mobile phone application: a pilot study. Topics in Stroke Rehabilitation, 23(3), 170-177.
https://www.tandfonline.com/doi/abs/10.1080/10749357.2015.1122266

Schepers, V.P., Visser-Meily, A.M., Ketelaar, M., & Lindeman, E. (2006). Poststroke fatigue: course and its relation to personal and stroke-related factors. Archives of Physical Medicine and Rehabilitation, 87(2), 184-188.

Staub, F. & Bogousslavsky, J. (2001). Fatigue after stroke: a major but neglected issue. Cerebrovascular Diseases, 12(2), 75-81.

Terrill, A.L., Schwartz, J.K., & Belagaje, S.R. (2018). Best Practices for The Interdisciplinary Rehabilitation Team: A Review of Mental Health Issues in Mild Stroke Survivors. Stroke Research and Treatment, Volume 2018, Article ID 6187328.

Wu, S., Chalder, T., Anderson, K.E., Gillespie, D., Macleod, M.R., & Mead, G.E. (2017). Development of a psychological intervention for fatigue after stroke. PloS One, 12(8), e0183286.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183286

Zedlitz, A.M., Rietveld, T.C., Geurts, A.C., & Fasotti, L. (2012). Cognitive and graded activity training can alleviate persistent fatigue after stroke: a randomized, controlled trial. Stroke, STROKEAHA-111.
https://repository.ubn.ru.nl//bitstream/handle/2066/102380/M_346855.pdf?sequence=1

Motor Imagery / Mental Practice

Evidence Reviewed as of before: 01-06-2017
Author(s)*: Tatiana Ogourtsova, MSc BSc OT; Annabel McDermott, OT; Angela Kim, B.Sc.; Adam Kagan, B.Sc.; Emilie Belley B.A. Psychology, B.Sc PT; Mathilde Parent-Vachon Bsc PT; Josee-Anne Filion; Alison Nutter; Marie Saulnier; Stephanie Shedleur, Bsc PT; Tsz Ting Wan, BSc PT; Elissa Sitcoff, BA BSc; Nicol Korner-Bitensky, PhD OT
Expert Reviewer: Stephen Page, PhD (C)
Patient/Family Information Table of contents

Introduction

Motor imagery or mental practice/mental imagery/mental rehearsal involves activation of the neural system while a person imagines performing a task or body movement without actually physically performing the movement. Motor imagery has been used after a stroke to attempt to treat loss of arm, hand and lower extremity movement, to help improve performance in activities of daily living, to help improve gait, and to minimize the effects of unilateral spatial neglect. Motor imagery can be used in the acute phase, subacute phase or chronic phase of rehabilitation. It has been shown that while motor imagery is beneficial by itself, it is most effective when used in addition to physical practice. In fact, many of the first studies on motor imagery were designed to investigate whether motor imagery improved motor performance in athletes. Brain scanning techniques have shown that similar areas of the brain are activated during motor imagery and physical movement. In addition, motor imagery has been shown in one study to help the brain reorganize its neural pathways, which may help promote learning of motor tasks after a stroke.

Patient/Family Information

Authors: Tatiana Ogourtsova, MSc BSc OT, Annabel McDermott, OT, Erica Kader; Emilie Belley, BA Psychology, BSc PT; Josee-Anne Filion; Alison Nutter; Mathilde Parent-Vachon; Marie Saulnier; Stephanie Shedleur, Bsc PT; Tsz Ting Wan, BSc PT; Elissa Sitcoff, BA BSc; Nicol Korner-Bitensky, PhD OT

What is motor imagery?

Motor imagery is a form of therapy that can be used to strengthen the arms, hands, feet and legs which may be weakened by stroke. In motor imagery, we mentally rehearse the movement of the affected body parts, without ever actually attempting to perform the movement. In other words, you imagine doing the motion in your mind. For example, you may imagine hitting a golf ball or drinking a cup of tea. Researchers have shown that this “mental rehearsal” actually works, as it stimulates the brain areas responsible for making the weaker arm or leg move.

Courtesy of Dr. Stephen Page and his team at Drake Center and University of Cincinnati

What is motor imagery used for?

It has been used to improve strength, increase hip movements, and improve postural control in the elderly, as well as treat people who have health problems, including injury to the spinal cord, Parkinson’s disease, or fibromyalgia (general muscle pain). It is especially useful for people with problems with the arms, legs, and hands.

Are there different types of motor imagery?

There are two distinct types of motor imagery:

  • Kinaesthetic motor imagery – imagining the feeling associated with performing a movement.
  • Visual motor imagery – imagining the movement itself.

What can I expect from a motor imagery session?

An example of a motor imagery session for a person with a weakened arm might include:

  • 5 minutes of listening to a tape recording of relaxation techniques
  • 20 minutes of exercises related to motor imagery. In week one the mental imagery training involves using computer images and movies to analyze steps and sequences required to successfully complete a task ie. reaching for a cup or turning a page in a book. In week two, patients are trained to identify problems they are having with the tasks and correct them using mental imagery. In the third week, they practice the corrected tasks mentally as well as perform the actual tasks.
  • The session concludes with time given to the individual to refocus on the room around them.

Does it Work for Stroke?

Experts have done experiments to compare mental imagery with other treatments, to see if mental imagery helps people who have had a stroke.

In individuals with ACUTE stroke (up to 1 month after stroke), 1 high quality study and one fair quality study found that mental imagery:

  • Was more helpful than the usual treatment alone for improving self-care skills (e.g. dressing and shopping);
  • Was as helpful as other treatments for improving thinking skills (e.g. attention) and motor function of the arms and legs.

In individuals with SUBACUTE stroke (1 month to 6 months after stroke), 2 high quality studies and 1 fair quality study found that mental imagery:

  • Was more helpful than the usual treatment alone for improving walking speed;
  • Was as helpful as other treatments for improving self-care skills (e.g. dressing) and physical skills of the arms and legs, including mobility, dexterity and grip strength.

In individuals with CHRONIC stroke (more than 6 months after stroke), 10 high quality studies, 6 fair quality studies in 1 poor quality study found that mental imagery:

  • Was more helpful than the usual treatment alone for improving balance, walking speed, and motor function of the arms and legs;
  • Was as helpful as other treatments for improving self-care skills (e.g. dressing and shopping) and spasticity.

When can motor imagery be used after stroke?

Motor imagery techniques can be started at any time following a stroke. However, it is believed that the treatments would be most useful in the first 6 to 18 months after a stroke when the majority of post-stroke recovery occurs.

Are there any risks to me?

There are no specific risks involved in participating in motor imagery. Motor imagery is actually quite easy to do at home, and many people find it a fun and relaxing way of having additional therapy.

How do I begin?

Your rehabilitation therapist should be able to provide you with a program to meet your individual needs. She/He can guide you as to:

  • how many times a week you should do motor imagery exercises,
  • what specific activities and movements you should do,
  • what activities you should not do,
  • how long each motor imagery session should be,
  • how to change activities as you improve.

How much does it cost? Do I need special equipment?

Motor imagery is inexpensive and accessible. Insurance will cover the services that you will receive in the hospital or rehabilitation centre. Once you are home you can continue this treatment on your own. No special equipment is required.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

The present module compiled results from 30 RCTs – 16 high quality RCTs, 12 fair quality RCTs and two low quality RCTs – and one non-randomized quasi experimental study. A Cochrane review by Barclay-Goddard et al. (2011) and three systematic reviews by Harris & Hebert (2015), Nilsen, Gillen & Gordon (2010), and Braun et al. (2006) were also reviewed to ensure completeness of results.

Studies were excluded if: (1) they were not RCTs and outcomes within those studies could be found in RCTs; (2) both groups were receiving a form of mental imagery training; and/or (3) no between-group analyses were performed.

Studies included in this review used mental imagery across all stages of stroke recovery, although most studies included individuals in the chronic phase or mixed phases of recovery (acute/subacute/chronic). Overall, mental imagery was often provided in combination with other interventions (e.g. conventional rehabilitation, physical therapy, occupational therapy, electrical stimulation or modified-Constraint Induced Movement Therapy – mCIMT). While in many instances it was found to achieve similar results to other interventions, mental imagery was shown to be more effective than comparison interventions in improving outcomes such as:

  • Acute stroke – functional independence and instrumental activities of daily living;
  • Subacute stroke – gait speed;
  • Chronic stroke – balance, gait speed, lower extremity motor function, mobility and stroke outcomes.

Note: Mental imagery, motor imagery or mental rehearsal are used interchangeably in this module.

Results Table

View results table

Outcomes

Acute phase

Functional independence
Effective
1b

One high quality RCT (Liu et al., 2004) investigated the effect of mental imagery on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive mental imagery + activity of daily living (ADL) training or ADL training alone. Functional independence of trained and untrained tasks was measured by a 7-point Likert Scale at post-treatment (3 weeks) and at follow-up (1 month). Significant between-group differences in functional independence (trained and untrained tasks) were found at post-treatment, favoring mental imagery + ADL training vs. ADL training alone. Significant between-group differences in functional independence (trained tasks only) were found at follow-up, favoring mental imagery + ADL training vs. ADL training alone.
Note: In this study, mental imagery training was aimed at creating a strategy to correct ADLs in general, rather than to improve a particular movement.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + ADL training is more effective than a comparison intervention (ADL training alone) in improving functional independence in patients with acute stroke.

Instrumental activities of daily living (IADLs)
Effective
2a

One fair quality RCT (Liu et al., 2009) investigated the effect of mental imagery on instrumental activities of daily living (IADLs) in patients with acute stroke. This fair quality RCT randomized patients to receive mental imagery training or conventional functional rehabilitation. IADLs (trained: sweeping, tidying, cooking, going outdoors, going to a shop; untrained: cooking, cleaning, visiting a resource center) were measured at post-treatment (3 weeks). There were significant between-group differences in performance of 3/5 trained tasks (tidying, cooking, going outdoors) and 2/3 untrained tasks (cleaning, visiting a resource center) at post-treatment, favoring mental imagery training vs. conventional functional rehabilitation.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mental imagery training is more effective than a comparison intervention (conventional functional rehabilitation) in improving IADLs in patients with acute stroke.

Motor function - lower extremity
Not effective
1b

One high quality RCT (Liu et al., 2004) investigated the effect of mental imagery on lower extremity motor function in patients with acute stroke. This high quality RCT randomized patients to receive mental imagery + activity of daily living (ADL) training or ADL training alone. Lower extremity motor function was measured by the Fugl-Meyer Assessment – Lower Extremity at post-treatment (3 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + ADL training is not more effective than a comparison intervention (ADL training alone) in improving lower extremity motor function in patients with acute stroke.

Motor function - upper extremity
Not effective
1b

One high quality RCT (Liu et al., 2004) investigated the effects of mental imagery on upper extremity motor function in patients with acute stroke. This high quality RCT randomized patients to receive mental imagery + activity of daily living (ADL) training or ADL training alone. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity at post-treatment (3 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + ADL training is not more effective than a comparison intervention (ADL training alone) in improving upper extremity motor function in patients with acute stroke.

Sensation
Not effective
1b

One high quality RCT (Liu et al., 2004) investigated the effect of mental imagery on sensation in patients with acute stroke. This high quality RCT randomized patients to receive mental imagery + activity of daily living (ADL) training or ADL training alone. Sensation was measured by the Fugl-Meyer Assessment – Sensation subtest at post-treatment (3 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + ADL training is not more effective than a comparison intervention (ADL training) in improving sensation in patients with acute stroke.

Sustained visual attention
Not effective
1b

One high quality RCT (Liu et al., 2004) investigated the effects of mental imagery on sustained visual attention in patients with acute stroke. This high quality RCT randomized patients to receive mental imagery + activity of daily living (ADL) training or ADL training alone. Sustained attention was measured by the Color Trails Test at post-treatment (3 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + ADL training is not more effective than a comparison intervention (ADL training alone) in improving sustained attention in patients with acute stroke.

Subacute phase

Dexterity
Not effective
1b

One high quality RCT (Ietswaart et al., 2011) investigated the effect of mental imagery on dexterity in patients with subacute stroke. This high quality RCT randomized patients to receive mental rehearsal training, non-motor mental rehearsal training or conventional rehabilitation. Dexterity was measured by a timed manual dexterity task at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental rehearsal training is not more effective than comparison interventions (non-motor mental rehearsal training, conventional rehabilitation) in improving dexterity in patients with subacute stroke.

Functional independence
Not effective
1b

One high quality RCT (Ietswaart et al., 2011) investigated the effect of mental imagery on functional independence in patients with subacute stroke. This high quality RCT randomized patients to receive mental rehearsal training, non-motor mental rehearsal training or conventional rehabilitation. Functional independence was measured by the Barthel Index and the Modified Functional Limitations Profile at post-treatment (4 weeks). No significant between-group differences were found on any of the measures.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental rehearsal training is not more effective than comparison interventions (non-motor mental rehearsal training, conventional rehabilitation) in improving functional independence in patients with subacute stroke.

Gait speed
Effective
1b

One high quality RCT (Oostra et al., 2015) investigated the effect of mental imagery on gait speed in patients with subacute stroke. This high quality RCT randomized patients to receive lower extremity mental imagery practice or muscle relaxation. Gait speed was measured by the 10 Meter Walking Test at post-treatment (6 weeks). Significant between-group differences were found at post-treatment, favoring lower extremity mental imagery practice vs. muscle relaxation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that lower extremity mental imagery practice is more effective than a comparison intervention (muscle relaxation) in improving gait speed in patients with subacute stroke.

Grip strength
Not effective
1b

One high quality RCT (Ietswaart et al., 2011) investigated the effect of mental imagery on grip strength in patients with subacute stroke. This high quality RCT randomized patients to receive mental rehearsal training, non-motor mental rehearsal training or conventional rehabilitation. Grip strength was measured with a dynamometer at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental rehearsal training is not more effective than comparison interventions (non-motor mental rehearsal training, conventional rehabilitation) in improving grip strength in patients with subacute stroke.

Motor function - lower extremity
Not effective
1b

One high quality RCT (Oostra et al., 2015) investigated the effect of mental imagery on lower extremity motor function in patients with subacute stroke. This high quality RCT randomized patients to receive lower extremity mental imagery practice or muscle relaxation. Lower extremity motor function was measured by the Fugl-Meyer Assessment – Lower Extremity (far transfer) at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that lower extremity mental imagery practice is not more effective than a comparison intervention (muscle relaxation) in improving lower extremity motor function in patients with subacute stroke.

Motor function - upper extremity
Not effective
1b

One high quality RCT (Ietswaart et al., 2011) and one fair quality RCT (Riccio et al., 2010) investigated the effect of mental imagery on upper extremity motor function in patients with subacute stroke.

The high quality RCT (Ietswaart et al., 2011) randomized patients to receive mental rehearsal training, non-motor mental rehearsal training or conventional rehabilitation. Upper extremity motor function was measured by the Action Research Arm Test at post-treatment (4 weeks). No significant between-group differences were found.

The fair quality RCT (Riccio et al., 2010) randomized patients to receive mental rehearsal training + conventional rehabilitation or conventional rehabilitation alone, in a cross-over design study. Upper extremity motor function was measured by the Motricity Index – Upper Extremity subscale (MI-UE) and the Arm Functional Test – Functional Ability Scale and Time score (AFT-FAS, AFT-T) score at post-treatment of Phase 1 (3 weeks) and post-treatment of Phase 2 (6 weeks). Significant between-group differences were found on all measures of upper extremity motor function at both time points, in favour of the group that had just undergone mental rehearsal training + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental rehearsal training is not more effective than comparison interventions (non-motor mental rehearsal training, conventional rehabilitation) in improving upper extremity motor function in patients with subacute stroke.
Note:
However, one cross-over fair quality RCT found that mental rehearsal training + conventional rehabilitation was more effective than conventional rehabilitation alone in improving upper extremity motor function in patients with subacute stroke.

Motor imagery ability
Not effective
1b

One high quality RCT (Oostra et al., 2015) investigated the effect of mental imagery on motor imagery ability in patients with subacute stroke. This high quality RCT randomized patients to receive lower extremity mental imagery practice or muscle relaxation. Motor imagery ability was measured by the Movement Imagery Questionnaire Revised – Visual and Kinesthetic scales, and the Walking Trajectory Test (imagery/actual walking time) at post-treatment (6 weeks). There was a significant between-group difference on only one measure (Movement Imagery Questionnaire Revised – kinesthetic scale) at post-treatment, favoring lower extremity mental imagery practice vs. muscle relaxation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that lower extremity mental imagery practice is not more effective than a comparison intervention (muscle relaxation) in improving motor imagery ability in patients with subacute stroke.
Note:
However, there was a significant difference in kinaesthetic motor imagery, in favour of lower extremity mental imagery practice vs. muscle relaxation.

Chronic phase

Balance
Effective
1a

Four high quality RCTs (Hwang et al., 2010; Cho et al., 2012; Hosseini et al., 2012; Kim & Lee, 2013) investigated the effect of mental imagery on balance in patients with chronic stroke.

The first high quality RCT (Hwang et al., 2010) randomized patients to receive videotape-based locomotor imagery training or sham imagery training. Balance was measure by the Berg Balance Scale (BBS) at post-treatment (4 weeks). Significant between-group differences were found in balance, favoring videotape-based locomotor imagery training vs. sham imagery training.

The second high quality RCT (Cho et al., 2012) randomized patients to receive mental imagery + gait training or gait training alone. Balance was measured by the Functional Reach Test (FRT) at post-treatment (6 weeks). Significant between-group differences were found in balance, favoring mental imagery + gait training vs. gait training alone.

The third high quality RCT (Hosseini et al., 2012) randomized patients to receive mental imagery + occupational therapy or occupational therapy alone. Balance was measured by the BBS at post-treatment (5 weeks) and at follow-up (7 weeks). Significant between-group differences were found in balance at post-treatment, favoring mental imagery + occupational therapy vs. occupational therapy alone. Differences did not remain significant at follow-up.

The forth high quality RCT (Kim & Lee, 2013) randomized patients to receive mental imagery + physical therapy, action observation training + physical therapy or physical therapy alone. Balance was measured by the FRT at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that mental imagery training is more effective than comparison interventions (sham imagery training, gait training alone, occupational therapy alone) in improving balance in patients with chronic stroke. However, a fourth high quality RCT reported no significant between-group differences when comparing mental imagery + physical therapy, action observation training + physical therapy or physical therapy alone in improving balance in patients with chronic stroke.

Balance confidence
Conflicting
4

Two high quality RCTs (Hwang et al., 2010 Dickstein et al., 2013) investigated the effect of mental imagery on balance confidence in patients with chronic stroke.

The first high quality RCT (Hwang et al., 2010) randomized patients to receive videotape-based locomotor imagery training or sham imagery training. Balance confidence was measure by the Activities Specific Balance Confidence Scale at post-treatment (4 weeks). Significant between-group differences were found, favoring videotape-based locomotor imagery training vs. sham imagery training.

The second high quality RCT (Dickstein et al., 2013) randomized patients to receive mental imagery training or physical therapy. Balance confidence was measured by the Falls Efficacy Scale at post-treatment (4 weeks) and at follow-up (6 weeks). No significant between-group differences were found at either time point.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of mental imagery on balance confidence in patients with chronic stroke. While one high quality RCT found that videotape-based locomotor imagery training was more effective than sham mental imagery training, one second high quality RCT found that mental imagery training was not more effective than physical therapy in improving balance confidence in patients with chronic stroke.
Note:
Studies used different measures of balance confidence.

Functional independence
Not effective
1a

Two high quality RCTs (Bovend’Eerdt et al., 2010; Hong et al., 2012) investigated the effect of mental imagery on functional independence in patients with chronic stroke.

The first high quality RCT (Bovend’Eerdt et al., 2010) randomized patients to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Functional independence was measured by the Barthel Index (BI) at post-treatment (6 weeks). No significant between-group differences were found.

The second high quality RCT (Hong et al., 2012) randomized patients to receive mental imagery with electromyogram-triggered electric stimulation or functional electric stimulation to the affected forearm. Functional independence was measured by the modified BI at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that mental imagery is not more effective than comparison interventions (conventional rehabilitation alone, functional electric stimulation) in improving functional independence in patients with chronic stroke.

Gait parameters
Conflicting
4

Two high quality RCTs (Hwang et al., 2010 Kim & Lee, 2013) and one fair quality RCT (Lee et al., 2011) investigated the effect of mental imagery on gait parameters in patients with chronic stroke.

The first high quality RCT (Hwang et al., 2010) randomized patients to receive videotape-based locomotor imagery training or sham imagery training. Gait parameters (cadence, joint motion, stride length) were measured by a 3D motion capture system at post-treatment (4 weeks). Significant between-group differences in some gait parameters (joint motion, stride length) were found, favoring videotape-based locomotor imagery training vs. sham imagery training.

The second high quality RCT (Kim & Lee, 2013) randomized patients to receive mental imagery + physical therapy, action observation training + physical therapy or physical therapy alone. Gait parameters (cadence, speed, single/double limb support, step/stride length) were measured by the GAITRite system at post-treatment (4 weeks). There were significant between-group differences in three gait parameters (cadence, speed, single limb support) at post-treatment, favoring action observation training + physical therapy vs. physical therapy alone.

The fair quality RCT (Lee et al., 2011) randomized patients to receive mental imagery + treadmill training or treadmill training alone. Gait parameters (cadence, speed, single/double limb support, step/stride length) were measured at post-treatment (2 weeks following a 6-week treatment block). No significant between-group differences were found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of mental imagery training on gait parameters in patients with chronic stroke. While one high quality RCT found that videotape-based locomotor imagery training is more effective than a comparison intervention (sham mental imagery training) in improving some gait parameters in patients with chronic stroke, another high quality RCT and one fair quality RCT found that mental imagery training is not more effective than comparison interventions (action observation training with physical therapy, physical therapy alone, treadmill training alone) in improving gait parameters in patients with chronic stroke.

Gait speed
Effective
1a

Three high quality RCTs (Hwang et al., 2010; Cho et al., 2012;Dickstein et al., 2013) investigated the effect of mental imagery on gait speed in patients with chronic stroke.

The first high quality RCT (Hwang et al., 2010) randomized patients to receive videotape-based locomotor imagery training or sham imagery training. Gait speed was measured by the 10 Meter Walk Test (10MWT) at post-treatment (4 weeks). Significant between-group differences were found, favoring videotape-based locomotor imagery training vs. sham imagery training.

The second high quality RCT (Cho et al., 2012) randomized patients to receive mental imagery + gait training or gait training alone. Gait speed was measured by the 10MWT at post-treatment (6 weeks). Significant between-group differences were found in gait speed at post-treatment, favoring mental imagery + gait training vs. gait training alone.

The third high quality RCT (Dickstein et al., 2013) randomized patients to receive mental imagery training or physical therapy. Gait speed was measured by the 10MWT at post-treatment (4 weeks) and at follow-up (6 weeks). Significant between-group differences were found at both time points, favoring mental imagery training vs. physical therapy.
Note: Further, all participants who received physical therapy crossed-over to receive mental imagery training for 4 weeks. A significant improvement in gait speed was reported among those participants at both time points.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that mental imagery training is more effective than comparison interventions (sham imagery training, gait training alone, physical therapy) in improving gait speed in patients with chronic stroke.

Goal attainment
Not effective
1b

One high quality RCT (Bovend’Eerdt et al., 2010) investigated the effect of mental imagery training on goal attainment in patients with chronic stroke. This high quality RCT randomized patients to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Goal attainment was measured by the Goal Attainment Scale at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery is not more effective than a comparison intervention (conventional rehabilitation alone) in improving goal attainment in patients with chronic stroke.

Instrumental activities of daily living (IADLs)
Not effective
1b

One high quality RCT (Bovend’Eerdt et al., 2010) investigated the effect of mental imagery training on instrumental activities of daily living (IADLs) in patients with chronic stroke. This high quality RCT randomized patients to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. IADLs were measured by the Nottingham Extended Activities of Daily Living at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery is not more effective than a comparison intervention (conventional rehabilitation alone) in improving IADLs in patients with chronic stroke.

Mobility
Conflicting
4

Seven high quality RCTs (Malouin et al., 2009Bovend’Eerdt et al., 2010Hwang et al., 2010; Cho et al., 2012Hosseini et al., 2012Dickstein et al., 2013Kim & Lee, 2013) investigated the effect of mental imagery training on mobility in patients with chronic stroke.

The first high quality RCT (Malouin et al., 2009) randomized patients to receive mental imagery + physical practice, cognitive training + physical practice, or no training. Mobility was measured by the change scores in leg loading of the affected leg as a percent of body weight during the rising-to-sitting action at baseline, post-treatment (4 weeks) and follow-up (7 weeks). Significant between-group differences in change scores from baseline to post-treatment were found, favoring mental imagery training + physical practice vs. cognitive training + physical practice; and favoring mental imagery training + physical practice vs. no training. Significant between-group differences were not maintained at follow-up.

The second high quality RCT (Bovend’Eerdt et al., 2010) randomized patients to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Mobility was measured by the Timed Up and Go Test (TUGT) and the Rivermead Mobility Index at post-treatment (6 weeks). No significant between-group differences were found on any of the measures.

The third high quality RCT (Hwang et al., 2010) randomized patients to receive videotape-based locomotor imagery training or sham imagery training. Mobility was measured by the Dynamic Gait Index and the Modified Emory Functional Ambulation Profile at post-treatment (4 weeks). Significant between-group differences in both measures of mobility were found, favoring videotape-based locomotor imagery training vs. sham imagery training.

The forth high quality RCT (Cho et al., 2012) randomized patients to receive mental imagery + gait training or gait training alone. Mobility was measured by the TUGT at post-treatment (6 weeks). Significant between-group differences were found, favoring mental imagery + gait training vs. gait training alone.

The fifth high quality RCT (Hosseini et al., 2012) randomized patients to receive mental imagery + occupational therapy or occupational therapy alone. Mobility was measured by the TUGT at post-treatment (5 weeks) and at follow-up (7 weeks). Significant between-group differences were found at post-treatment, favoring mental imagery + occupational therapy vs. occupational therapy alone. Significant between-group differences were not maintained at follow-up.

The sixth high quality RCT (Dickstein et al., 2013) randomized patients to receive mental imagery training or physical therapy. Mobility was measured by step activity monitor (community ambulation) and number of steps/minute at post-treatment (4 weeks) and at follow-up (6 weeks). There were no significant between-group differences in both measures of mobility at either time point.

The seventh high quality RCT (Kim & Lee, 2013) randomized patients to receive mental imagery + physical therapy, action observation training + physical therapy or physical therapy alone. Mobility was measured by the TUGT, Walking Ability Questionnaire, and Functional Ambulation Category at post-treatment (4 weeks). A significant between-group difference in one measure of mobility (TUGT) was found at post-treatment, favoring action observation training + physical therapy vs. physical therapy alone.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of mental imagery on mobility in patients with chronic stroke. While four high quality RCTs found that mental imagery training is more effective than comparison interventions (cognitive training + physical practice, no training, sham imagery training, gait training alone, occupational therapy alone) in improving mobility in patients with chronic stroke; three other high quality RCTs found that mental imagery is not more effective than comparison interventions (conventional rehabilitation alone, physical therapy, action observation training + physical therapy) in improving mobility in patients with chronic stroke.

Motor activity - upper extremity
Not effective
1b

One high quality RCT (Hong et al., 2012) and one fair quality RCT (Page et al., 2005) investigated the effect of mental imagery on upper extremity motor activity among patients with chronic stroke.

The high quality RCT (Hong et al., 2012) randomized patients to receive mental imagery + electromyogram-triggered electric stimulation or functional electric stimulation to the affected forearm. Upper extremity motor activity was measured by the Motor Activity Log – Amount of Use and Quality of Movement (MAL-AOU, MAL-QOM) at post-treatment (4 weeks). No significant between-group differences were found.

The fair quality RCT (Page et al., 2005) randomized patients to receive mental imagery training or relaxation training. Upper extremity motor activity was measured by the MAL at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that mental imagery training is not more effective than comparison interventions (functional electrical stimulation to the affected forearm, relaxation training) in improving upper extremity motor activity in patients with chronic stroke.

Motor function - lower extremity
Effective
1b

One high quality RCT (Cho et al., 2012) investigated the effect of mental imagery on lower extremity motor function in patients with chronic stroke. This high quality RCT randomized patients to receive mental imagery + gait training or gait training alone. Lower extremity motor function was measured by the Fugl-Meyer Assessment – Lower Extremity at post-treatment (6 weeks). Significant between-group differences were found, favoring mental imagery + gait training vs. gait training alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + gait training is more effective than a comparison intervention (gait training alone) in improving lower extremity motor function in patients with chronic stroke.

Motor function - upper extremity
Conflicting
4

Four high quality RCTs (Bovend’Eerdt et al., 2010Page et al., 2011;Hong et al., 2012Nilsen et al., 2012) and five fair quality RCTs (Page, 2000Page et al., 2005Ertelt et al., 2007Page et al., 2007Page et al., 2009) investigated the effect of mental imagery on upper extremity motor function in patients with chronic stroke.

The first high quality RCT (Bovend’Eerdt et al., 2010) randomized patients to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Upper extremity motor function was measured by the Action Research Arm Test (ARAT) at post-treatment (6 weeks). No significant between-group differences were found.

The second high quality RCT (Page et al., 2011) randomized patients to receive mental imagery or sham audio therapy. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE) and the ARAT at post-treatment (10 weeks). No significant between-group differences were found on any of the measures.

The third high quality RCT (Hong et al., 2012) randomized patients to receive mental imagery + electromyogram-triggered electric stimulation or functional electric stimulation to the affected forearm. Upper extremity motor function was measured by the FMA-UE at post-treatment (4 weeks). Significant between-group differences in upper extremity motor function were found at post-treatment, favoring mental imagery + electromyogram-triggered electric stimulation vs. functional electric stimulation to the affected forearm.

The forth high quality RCT (Nilsen et al., 2012) randomized patients to receive mental imagery training using an internal perspective (internal group), mental imagery training using an external perspective (external group), or relaxation imagery; all groups received occupational therapy. Upper extremity motor function was measured by the FMA-UE and the Jebsen-Taylor Test of Hand Function at post-treatment (6 weeks). Significant between-group differences were found on both measures, favoring both styles of mental imagery training (internal group, external group) vs. relaxation imagery.

The first fair quality RCT (Page, 2000) randomized patients to receive mental imagery training + occupational therapy or occupational therapy alone. Upper extremity motor function was measured by the FMA-UE at post-treatment (4 weeks). Significant between-group differences were found at post-treatment, favoring mental imagery training + occupational therapy vs. occupational therapy alone.

The second fair quality RCT (Page et al., 2005) randomized patients to receive mental imagery training or relaxation training. Upper extremity motor function was measured by the ARAT at post-treatment (6 weeks). Significant between-group differences were found, favoring mental imagery training vs. relaxation training.

The third fair quality RCT (Ertelt et al., 2007) randomized patients to receive action observation therapy or conventional rehabilitation. Upper extremity motor function was measured by the Frenchay Arm Test and the Wolf Motor Function Test at post-treatment (18 days); participants in the action observation group were reassessed 8 weeks later (follow-up). Significant between-group differences were found on both measures of upper extremity motor function at post-treatment, favoring action observation therapy vs. conventional rehabilitation. Significant within-group gains were maintained at follow-up.

The forth fair quality RCT (Page et al., 2007) randomized patients to receive mental imagery training or relaxation training. Upper extremity motor function was measured by the ARAT and the FMA-UE at post-treatment (1 week following a 6-week treatment). Significant between-group differences were found on both measures of upper extremity motor function at post-treatment, favoring mental imagery training vs. relaxation training.

The fifth fair quality RCT (Page et al., 2009) randomized patients to receive mental imagery + modified-constraint induced therapy (mCIMT) or mCIMT alone. Upper extremity motor function was measured by the ARAT and the FMA-UE at post-treatment (10 weeks) and follow-up (3 months). Significant between-group differences were found on both measures of upper extremity motor function at post-treatment and at follow-up, favoring mental imagery training + mCIMT vs. mCIMT alone.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of mental imagery on upper extremity motor function. While two high quality RCTs found that mental imagery was not more effective than comparison interventions (conventional rehabilitation alone, sham audio therapy) in improving upper extremity motor function in patients with chronic stroke; two other high quality RCTs found that mental imagery was more effective than comparison interventions (functional electric stimulation to the affected forearm, relaxation imagery) in improving upper extremity motor function in patients with chronic stroke.
Note:
Five fair quality RCTs found that mental imagery training is more effective than comparison interventions (occupational therapy alone, relaxation training, conventional rehabilitation, mCIMT alone) in improving upper extremity motor function in patients with chronic stroke.

Occupational performance
Not effective
1b

One high quality RCT (Nilsen et al., 2012) investigated the effect of mental imagery on occupational performance in patients with chronic stroke. This high quality RCT randomized patients to receive mental imagery training using an internal perspective (internal group), mental imagery training using an external perspective (external group), or relaxation imagery; all groups received occupational therapy. Occupational performance was measure by the Canadian Occupational Performance Measure at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery training using an internal or external perspective is not more effective than a comparison intervention (relaxation imagery) in improving occupational performance in patients with chronic stroke.

Pain
Not effective
2b

One poor quality RCT (Cacchio et al., 2009) investigated the effect of mental imagery on pain in patients with chronic stroke. This poor quality RCT randomized patients with Complex Regional Pain Syndrome (CRPS) to receive mental imagery, mirror therapy or covered mirror practice. Pain was measured by Visual Analogue Scale at post-treatment (4 weeks). Significant between-group differences were found, favoring mirror therapy vs. mental imagery and favouring mirror therapy vs. covered mirror practice.
Note: Following 4 weeks, some participants crossed-over to the mirror therapy group. A significant reduction in pain was reported among participants who crossed-over from the mental imagery and covered mirror practice groups to the mirror therapy group.

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that mental imagery is not more effective than comparison interventions (mirror therapy, covered mirror practice) in improving pain in patients with chronic stroke and CRPS. In fact, mirror therapy was more effective than mental imagery in reducing pain.

Spasticity
Not effective
1b

One high quality RCT (Hong et al., 2012) investigated the effect of mental imagery training on spasticity in patients with chronic stroke. This high quality RCT randomized patients to receive mental imagery + electromyogram-triggered electric stimulation or functional electric stimulation to the affected forearm. Spasticity was measured by the Modified Ashworth Scale at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + electromyogram-triggered electric stimulation is not more effective than a comparison intervention (functional electric stimulation to the affected forearm) in improving spasticity in patients with chronic stroke.

Stroke outcomes
Effective
2a

One fair quality RCT (Ertelt et al., 2007) investigated the effect of mental imagery on stroke outcomes in patients with chronic stroke. This high quality RCT randomized patients to receive action observation therapy or conventional rehabilitation. Stroke outcomes were measured by the Stroke Impact Scale at post-treatment (18 days); participants in the action observation group were reassessed 8 weeks later (follow-up). Significant between-group differences were found at post-treatment, favoring action observation therapy vs. conventional rehabilitation. Significant within-group gains were maintained at follow-up.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that action observation training is more effective than a comparison intervention (conventional rehabilitation) in improving stroke outcomes in patients with chronic stroke.

Phase not specific to one period

Balance
Not effective
1a

Two high quality RCTs (Braun et al., 2012; Schuster et al., 2012) investigated the effect of mental imagery on balance in patients with stroke.

The first high quality RCT (Braun et al., 2012) randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Balance was measured by the Berg Balance Scale (BBS) at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point. 

The second high quality RCT (Schuster et al., 2012) randomized patients with subacute/chronic stroke to receive embedded mental imagery training, added mental imagery training or time-matched stroke education tapes; all groups received physical therapy. Balance was measured by the BBS at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that mental imagery is not more effective than comparison interventions (conventional rehabilitation alone, time-matched stroke education tapes) in improving balance in patients with stroke.

Balance confidence
Not effective
1b

One high quality RCT (Schuster et al., 2012) investigated the effect of mental imagery training on balance confidence in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive embedded mental imagery training or added mental imagery training or time-matched stroke education tapes; all groups received physical therapy. Balance confidence was measured by the Activities-Specific Balance Confidence Scale at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that embedded or added mental imagery is not more effective than a comparison intervention (time-matched stroke education tapes) in improving balance confidence in patients with subacute/chronic stroke.

Dexterity
Not effective
1b

One high quality RCT (Braun et al., 2012) investigated the effect of mental imagery on dexterity in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Dexterity was measured by the Nine Hole Peg Test at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery is not more effective than a comparison intervention (conventional rehabilitation alone) in improving dexterity in patients with acute/subacute stroke.

Functional independence
Not effective
1a

Three high quality RCTs (Braun et al., 2012Schuster et al., 2012Timmermans et al., 2013), one fair quality RCT (Ferreira et al., 2011) and one poor quality RCT (Park et al., 2015) investigated the effect of mental imagery on functional independence in patients with stroke.

The first high quality RCT (Braun et al., 2012) randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Functional independence was measured by the Barthel Index (BI); patients’ and therapists’ perception of performance of daily activities (e.g. drinking, walking) was measured by a 10-point numeric rating scale at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found on either measure at either time point.

The second high quality RCT (Schuster et al., 2012) randomized patients with subacute/chronic stroke to receive embedded mental imagery training, added mental imagery training, or time-matched stroke education tapes; all groups received physical therapy. Functional independence was measured by the BI at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found at either time point.

The third high quality RCT (Timmermans et al., 2013) randomized patients with acute/subacute stroke to receive mental imagery or neurodevelopmental therapy; both groups received conventional rehabilitation. Functional independence was measured by the BI at post-treatment (6 weeks) and at follow-up (6 and 12 months). No significant between-group differences were found at any time point.

The fair quality RCT (Ferreira et al., 2011) randomized patients with subacute/chronic stroke to receive mental imagery + conventional rehabilitation, visual scanning training + conventional rehabilitation, or conventional rehabilitation alone. Functional independence was measured by the Functional Independence Measure (FIM) at post-treatment (5 weeks) and at follow-up (3 months). There were no significant differences between mental imagery + conventional rehabilitation and other treatment groups at either time point.
Note: Significant between-group differences in functional independence (FIM – self-care items only) were found at post-treatment, favoring visual scanning + conventional rehabilitation vs. conventional rehabilitation alone. Differences did not remain significant at follow-up.

The poor quality RCT (Park et al., 2015) randomized patients with subacute/chronic stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Functional independence was measured by the modified BI at post-treatment (2 weeks). Significant between-group differences were found, favoring mental imagery + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs and one fair quality RCT that mental imagery is not more effective than comparison interventions (conventional rehabilitation alone, time-matched stroke education tapes, neurodevelopmental therapy, visual scanning training + conventional rehabilitation) in improving functional independence in patients with stroke.
Note
: One poor quality RCT found that mental imagery training + conventional rehabilitation is more effective than a comparison intervention (conventional rehabilitation alone) in improving functional independence in patients with subacute/chronic stroke.

Gait speed
Not effective
1b

One high quality RCT (Braun et al., 2012) investigated the effect of mental imagery on gait speed in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Gait speed was measured by the 10 Meter Walk Test at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + conventional rehabilitation is not more effective than a comparison intervention (conventional rehabilitation alone) in improving gait speed in patients with acute/subacute stroke.

Grip strength
Effective
2a

One fair quality RCT (Muller et al., 2007) investigated the effect of mental imagery on grip strength in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive mental imagery training, motor practice training or conventional physical therapy. Grip strength was measured by a force transducer at post-treatment (4 weeks). Significant between-group differences were found, favoring mental imagery vs. physical therapy l rehabilitation and favoring motor practice vs. physical therapy rehabilitation.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that mental imagery training is more effective than a comparison intervention (conventional physical therapy) in improving grip strength in patients with acute/subacute stroke.

Instrumental activities of daily living (IADLs)
Not effective
1b

One high quality RCT (Timmermans et al., 2013) investigated the effect of mental imagery on instrumental activities of daily living (IADLs) in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive mental imagery or neurodevelopmental therapy; both groups received conventional rehabilitation. IADLs were measured by the Frenchay Activity Index at post-treatment (6 weeks) and at follow-up (6 and 12 months). No significant between-group differences were found at any time point. 

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery is not more effective than a comparison intervention (neurodevelopmental therapy) in improving IADLs in patients with acute/subacute stroke.

Mobility
Not effective
1b

One high quality RCT (Braun et al., 2012) investigated the effect of mental imagery on mobility in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Mobility was measured by the Rivermead Mobility Index at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point. 

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery + conventional rehabilitation is not more effective than a comparison intervention (conventional rehabilitation alone) in improving mobility in patients with acute/subacute stroke.

Motor activity
Not effective
1b

One high quality RCT (Schuster et al., 2012) investigated the effect of mental imagery on motor activity in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive embedded mental imagery training, added mental imagery training, or time-matched stroke education tapes; all groups received physical therapy. Motor activity was measured by (i) time taken to complete a motor task; (ii) the Chedoke McMaster Stroke Assessment (activity scale); and (iii) stage of motor task as per Adams & Tyson classification, at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found on any measure at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that embedded or added mental imagery training is not more effective than a comparison (time-matched stroke education tapes) in improving motor activity in patients with subacute/chronic stroke.

Motor activity - upper extremity
Not effective
1b

One high quality RCT (Timmermans et al., 2013) and one quasi-experimental design study (Rajesh, 2015) investigated the effect of motor imagery on upper extremity motor activity among patients with stroke.

The high quality RCT (Timmermans et al., 2013) randomized patients with acute/subacute stroke to receive mental imagery or neurodevelopmental therapy; both groups received conventional rehabilitation. Upper extremity motor activity was measured by accelerometry (total activity, activity/hour, activity ratio of affected/unaffected arm) at post-treatment (6 weeks) and at follow-up (6 and 12 months). No significant between-group differences were found at either time point.

The quasi-experimental design study (Rajesh, 2015) assigned patients with stroke (stage of recovery not specified) to receive mental imagery + occupational therapy or occupational therapy alone. Upper extremity motor activity was measured by the Motor Activity Log at post-treatment (3 weeks). Significant between-group differences were found, favoring mental imagery + conventional occupational therapy vs. conventional occupational therapy alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery is not more effective than a comparison intervention (neurodevelopmental therapy) in improving upper extremity motor activity in patients with acute/subacute stroke.
Note:
However, one quasi-experimental study found that mental imagery was more effective than a comparison intervention (conventional occupational therapy alone) in improving upper extremity motor activity in patients with stroke. Discrepancies could result from differences in employed measurement scales and treatment duration (6 vs. 3 weeks).

Motor function - upper extremity
Not effective
1a

Two high quality RCTs (Welfringer et al., 2011Timmermans et al., 2013), two fair quality RCTs (Page et al., 2001Muller et al., 2007), and one poor quality RCT (Park et al., 2015) investigated the effect of mental imagery on upper extremity motor function in patients with stroke.

The first high quality RCT (Welfringer et al., 2011) randomized patients with acute/subacute stroke to receive visuomotor imagery + conventional rehabilitation or conventional rehabilitation alone. Upper extremity motor function was measured by the Action Research Arm Test (ARAT) at post-treatment (3 weeks). No significant between-group differences were found.

The second high quality RCT (Timmermans et al., 2013) randomized patients with acute/subacute stroke to receive mental imagery or neurodevelopmental therapy; both groups received conventional rehabilitation. Upper extremity motor function was measured by the Wolf Motor Function Test, Frenchay Arm Test and Fugl-Meyer Assessment – Upper Extremity (FMA-UE) at post-treatment (6 weeks) and at follow-up (6 and 12 months). No significant between-group differences were found on any measure at any time point. 

The first fair quality RCT (Page et al., 2001) randomized patients with acute/subacute/chronic stroke to receive mental imagery training or stroke education; both groups received time-matched occupational therapy. Upper extremity motor function was measured by the FMA-UE and the ARAT at post-treatment (6 weeks). Differences in both measures of upper extremity motor function were found at post-treatment, favoring mental imagery training vs. stroke education.

The second fair quality RCT (Muller et al., 2007) randomized patients with acute/subacute stroke to receive mental imagery training, motor practice or conventional physical therapy. Upper extremity motor function was measured by the Jebsen Hand Function Test (JHFT – writing, turning over card, picking up small objects, simulated feeding, stacking checkers, picking up large light cans, picking up large heavy cans) at post-treatment (4 weeks). Significant between-group differences were found in some aspect of upper extremity motor function (JHFT – writing, simulated feeding), favoring mental imagery training vs. conventional physical therapy and favoring motor practice vs. conventional physical therapy.

The poor quality RCT (Park et al., 2015) randomized patients with subacute/chronic stroke to receive mental imagery training + conventional rehabilitation or conventional rehabilitation alone. Upper extremity motor function was measured by the ARAT and the FMA-UE at post-treatment (2 weeks). Significant between-group differences were found on both measures of upper extremity motor function at post-treatment, favoring mental imagery training + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that mental imagery is not more effective than comparison interventions (conventional rehabilitation alone, neurodevelopmental therapy) in improving upper extremity motor function in patients with stroke.
Note: 
However, two fair quality RCTs and one poor quality RCT found that mental imagery is more effective than comparison interventions (stroke education, conventional physical therapy, conventional rehabilitation alone) in improving upper extremity motor function in patients with stroke.

Motor imagery ability
Not effective
1b

One high quality RCT (Schuster et al., 2012) investigated the effect of mental imagery on motor imagery ability in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive embedded mental imagery training, added mental imagery training, or time-matched stroke education tapes; all groups received physical therapy. Motor imagery ability was measured by the Imaprax Questionnaire and the Kinesthetic and Visual Imagery Questionnaire at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found on either measure at either time point.

Conclusion: There is moderate evidence (Level 1a) from one high quality RCT that embedded or added mental imagery is not more effective than a comparison intervention (time-matched stroke education tapes) in improving motor imagery ability in patients with stroke.

Unilateral spatial neglect
Not effective
1b

One high quality RCT (Welfringer et al., 2011) and one fair quality RCT (Ferreira et al., 2011) investigated the effect of mental imagery on unilateral spatial neglect (USN) in patients with stroke.

The high quality RCT (Welfringer et al., 2011) randomized patients with acute/subacute stroke to receive visuomotor imagery + conventional rehabilitation or conventional rehabilitation alone. USN was measured by the Bells Cancellation Test, Reading Test, Flower Copying Test, Clock Drawing Test and Representation Test (body touching, visual arm imagery, kinesthetic arm imagery) at post-treatment (3 weeks). No significant between-group differences were found on any measure.

The fair quality RCT (Ferreira et al., 2011) randomized patients with subacute/chronic stroke to receive mental imagery + conventional rehabilitation, visual scanning training + conventional rehabilitation, or conventional rehabilitation alone. USN was measured by the Behavioral Inattention Test at post-treatment (5 weeks) and at follow-up (3 months). There were no significant differences between mental imagery + conventional rehabilitation and other groups at either time point.
Note: Significant between-group differences favoring visual scanning + conventional rehabilitation vs. conventional rehabilitation alone were found at post-treatment and at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that mental imagery + conventional rehabilitation is not more effective than comparison interventions (conventional rehabilitation alone, visual scanning training + conventional rehabilitation) in improving USN in patients with stroke.

Quality of life
Not effective
1b

One high quality RCT (Schuster et al., 2012) and one quasi-experimental design study (Rajesh, 2015) investigated the effect of mental imagery on quality of life in patients with stroke.

The high quality RCT (Schuster et al., 2012) randomized patients with subacute/chronic stroke to receive embedded mental imagery training, added mental imagery training, or time-matched stroke education tapes; all groups received physical therapy. Quality of life was measured by Visual Analogue Scale at post-treatment (2 weeks) and follow-up (1 month). No significant between-group differences were found at either time point.

The quasi-experimental design study (Rajesh, 2015) assigned patients with stroke (stage of recovery not specified) to receive mental imagery + conventional occupational therapy or conventional occupational therapy alone. Quality of life was measured by the Stroke-Specific Quality of Life scale at post-treatment (3 weeks). Significant between-group differences were found, favoring mental imagery practice + conventional occupational therapy vs. conventional occupational therapy alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that embedded or added mental imagery training is not more effective than a comparison intervention (time-matched stroke education tapes) in improving quality of life in patients with subacute/chronic stroke.
Note
: One quasi-experimental study found that mental imagery training + conventional occupational therapy is more effective than a comparison intervention (conventional occupational therapy alone) in improving quality of life in patients with stroke. Discrepancies could result from differences in employed measurement scales and treatment duration (2 vs. 3 weeks).

Sensation
Not effective
1b

One high quality RCT (Welfringer et al., 2011) investigated the effect of visual imagery on sensation in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive visuomotor imagery with conventional rehabilitation or conventional rehabilitation alone. Upper extremity sensation was measured by the Arm Function Test – Sensation score at post-treatment (3 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that visual imagery + conventional rehabilitation is not more effective than a comparison intervention (conventional rehabilitation alone) for improving sensation in patients with acute/subacute stroke.

Strength
Not effective
1b

One high quality RCT (Braun et al., 2012) investigated the effect of mental imagery training on strength in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive mental imagery + conventional rehabilitation or conventional rehabilitation alone. Strength was measured by the Motricity Index at post-treatment (6 weeks) and at follow-up (6 months). No significant between-group differences were found at either time point. 

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that mental imagery training + conventional rehabilitation is not more effective than a comparison intervention (conventional rehabilitation alone) in improving strength in patients with acute/subacute stroke.

References

Bovend’Eerdt, T.J., Dawes, H., Sackley, C., Hooshang, I., & Wade, D.T. (2010). An Integrated Motor Imagery Program to Improve Functional Task Performance in Neurorehabilitation: A Single-Blind Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation, 91, 939-946.
https://www.ncbi.nlm.nih.gov/pubmed/20510987

Braun, S.M., Beurskens, A.J., Kleynen, M., Oudelaar, B., Schols, J.M., & Wade, D.T. (2012). A multicenter randomized controlled trial to compare subacute “treatment as usual” with and without mental practice among persons with stroke in Dutch Nursing Homes. JAMDA, 13, 1-7.
https://www.ncbi.nlm.nih.gov/pubmed/21450196

Cacchio, A., De Blasis, E., Necozione, S., di Orio, F., & Santilli, V. (2009). Mirror therapy for Chronic Complex Regional Pain Syndrome type 1 and stroke. New England Journal of Medicine, 361(6), 634-636.
http://www.nejm.org/doi/full/10.1056/nejmc0902799#t=article

Cho, H. Y., Kim, J. S., & Lee, G. C. (2012). Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clinical rehabilitation27(8), 675-680.
http://journals.sagepub.com/doi/abs/10.1177/0269215512464702

Dickstein, R., Deutsch, J.E., Yoeli, Y., Kafri, M., Falash, F., Dunsky, A., Eshet, A., & Alexander, N. (2013). Effects of integrated motor imagery practice on gait of individuals with chronic stroke: a half-crossover randomized study. Archives of Physical Medicine and Rehabilitation, 94, 2119-25.
https://www.ncbi.nlm.nih.gov/pubmed/23872048

Ertelt, D., Small, S., Solodkin, A., Dettmers, C., McNamara, A., Binkofsk,i F.,&  Buccino G. (2007). Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage, 36,164-173.
https://www.ncbi.nlm.nih.gov/pubmed/17499164

Ferreira, H.P., Lopes, M.A.L., Luiz, R.R., Cardoso, L., & Andre, S. (2011). Is visual scanning better than mental practice in hemispatial neglect? Results from a pilot study. Topics in Stroke Rehabilitation, 18(2), 155-61.
https://www.ncbi.nlm.nih.gov/pubmed/21447465

Hong, I.K., Choi, J.B., & Lee, J.H. (2012). Cortical changes after mental imagery training combined with electromyography-triggered electrical stimulation in patients with chronic stroke. Stroke, 43, 2506-09.
https://www.ncbi.nlm.nih.gov/pubmed/22798329

Hosseini, S.A., Fallahpour, M., Sayadi, M., Gharib, M., & Haghgoo, H. (2012). The impact of mental practice on stroke patients’ postural balance. Journal of Neurological Sciences, 322 (1-2), 263-7.
https://www.ncbi.nlm.nih.gov/pubmed/22857987

Hwang, S, Jeon, H, Yi, C, Kwon, O, et al. (2010). Locomotor imagery training improves gait performance in people with chronic hemiparetic stroke: a controlled clinical trial. Clinical Rehabilitation, 24, 514-522.
https://www.ncbi.nlm.nih.gov/pubmed/20392784

Ietswaart, M., Johnston, M., Kijkerman, C., Joice, S., Scott, C. L., MacWalter, R. S., & Hamilton, S. J. C. (2011). Mental practice with motor imagery in stroke recovery: Randomized controlled trial of efficacy. Brain, 134, 1373-1386.
https://www.ncbi.nlm.nih.gov/pubmed/21515905

Kim, J. H., & Lee, B. H. (2013). Action observation training for functional activities after stroke: a pilot randomized controlled trial. NeuroRehabilitation33(4), 565-574.
http://content.iospress.com/articles/neurorehabilitation/nre991

Lee, G.C., Song, C.H., Lee, Y.W., Cho, H.Y., & Lee, S.W. (2011). Effects of motor imagery training on gait ability of patients with chronic stroke. Journal of Physical Therapy Science, 23, 197-200.
https://www.jstage.jst.go.jp/article/jpts/23/2/23_2_197/_pdf

Liu, K.P., Chan, C.C., Lee, T.M., Hui-Chan, C.W. et al. (2004). Mental imagery for promoting relearning for people after stroke: A Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation, 85(9), 1403-1408.
https://www.ncbi.nlm.nih.gov/pubmed/15375808

Liu, K.P., Chan, C.C., Wong, R.S., Kwan, I.W., Yau, C.S., Li, L.S., Lee, T.M. (2009). A randomized controlled trial of mental imagery augment generalization of learning in acute poststroke patients. Stroke, 40(6), 2222-5.
https://www.ncbi.nlm.nih.gov/pubmed/19390069

Malouin, F., Richards, C. L., Durand, A., & Doyon, J. (2009). Added value of mental practice combined with a small amount of physical practice on the relearning of rising and sitting post-stroke: A pilot study. Journal of Neurologic Physical Therapy, 33, 195-202.
https://www.ncbi.nlm.nih.gov/pubmed/20208464

Müller, K., Bütefisch, C. M., Seitz, R., J. & Hömberg, V. (2007). Mental practice improves hand function after hemiparetic stroke. Restorative Neurology and Neuroscience, 25, 501-11.
https://www.ncbi.nlm.nih.gov/pubmed/18334768

Nilsen, D.M., Gillen, G., DiRusso, T., & Gordon, A.M. (2012). Effect of imagery perspective on occupational performance after stroke: a randomized controlled trial. The American Journal of Occupational Therapy, 66(3), 320-9.
https://www.ncbi.nlm.nih.gov/pubmed/22549597

Oostra, K.M., Oomen, A., Vanderstraeten, G., & Vingerhoets, G. (2015). Influence of motor imagery training on gait rehabilitation in sub-acute stroke: a randomized controlled trial. Journal of Rehabilitation Medicine, 47, 204-9.
https://www.ncbi.nlm.nih.gov/pubmed/25403275

Page, S.J. (2000). Imagery improves upper extremity motor function in chronic stroke patients: A pilot study. The Occupational Therapy Journal of Research, 20(3), 200-213.
http://psycnet.apa.org/psycinfo/2000-00370-003

Page, J.S., Levine, P., Sisto, S., & Johnston, M.V. (2001). A randomized efficacy and feasibility study of imagery in acute stroke. Clinical Rehabilitation, 15, 233-240.
https://www.ncbi.nlm.nih.gov/pubmed/11386392

Page, S. J., Levine, D., & Leonard, A.C. (2005). Effects of mental practice on affected limb use and function in chronic stroke. Archives of Physical Medicine & Rehabilitation, 86(3), 399-402.
https://www.ncbi.nlm.nih.gov/pubmed/15759218

Page, J.S., Laine, D., & Leonard, A.C. (2007). Mental practice in chronic stroke: results of a randomized, placebo-controlled trial. Stroke, 38(4), 1293-7.
https://www.ncbi.nlm.nih.gov/pubmed/17332444

Page, S., Levine, P., & Khoury, J. (2009). Modified Constraint-Induced Therapy Combined With Mental Practice: Thinking Through Better Motor Outcomes. Stroke, 40(2), 551-554.
https://www.ncbi.nlm.nih.gov/pubmed/19109542

Page, S.J., Dunning, K., Hermann, V., Leonard, A., & Levine, P. (2011). Longer versus shorter mental practice sessions for affected upper extremity movement after stroke: a randomized controlled trial. Clinical Rehabilitation, 25(7), 627-637.
https://www.ncbi.nlm.nih.gov/pubmed/21427151

Park, J., Lee, N., Cho, M., Kim, D., & Yang, Y. (2015). Effects of mental practice on stroke patients’ upper extremity function and daily activity performance. Journal of physical therapy science27(4), 1075-1077.
https://www.jstage.jst.go.jp/article/jpts/27/4/27_jpts-2014-664/_article

Rajesh, T. (2015). Effects of Motor Imagery on Upper Extremity Functional Task Performance and Quality of Life among Stroke Survivors. Disability, CBR & Inclusive Development26(1), 109-124.
http://dcidj.org/article/view/225

Riccio, I., Iolascon, G., Barillari, M.R., Gimigliano, R., Gimigliano, F. (2010) Mental Practice is effective in upper limb recovery after stroke: a randomized single-blind cross-over study. European Journal of Physical Rehabilitation Medicine,46 (1): 19-25.
https://www.ncbi.nlm.nih.gov/pubmed/20332722

Schuster, C., Butler, J., Andrews, B., Kischka, U., & Ettlin, T. (2012). Comparison of embedded and added motor imagery training in patients after stroke: results of a randomised controlled pilot trial. Trials13(1), 11.
https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-11

Timmermans, A.A.A., Verbunt, J.A., van Woerden, R., Moennekens, M., Pernot, D.H., & Seelen, H.A.M. (2013). Effect of mental practice on the improvement of function and daily activity performance of the upper extremity in patients with subacute stroke: a randomized clinical trial. JAMDA, 14, 204-12.
https://www.ncbi.nlm.nih.gov/pubmed/23273853

Welfringer, A., Leifert-Fiebach, G., Babinsky, R., & Brant, T. (2011). Visuomotor imagery as a new tool in the rehabilitation of neglect: a randomized controlled study of feasibility and efficacy. Disability and Rehabilitation, 33 (21-22), 2033-43.
https://www.ncbi.nlm.nih.gov/pubmed/21348577

Excluded studies

Arulmozhe, A. & Sivakumar, V.P.R. (2016). Comparison of embedded versus added motor imagery training for improving balance and gait in individuals with strokeInternational Journal of Pharmaceutical and Clinical Research, 8(9), 1331-8.
Reason for exclusion: Both groups received a type of motor imagery training (added vs. embedded).

Barclay-Goddard, R. E., Stevenson, T. J., Poluha, W. & Thalman, L. (2011). Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke. Cochrane Database of Systematic Reviews 2011, Issue 5. Art. No.: CD005950. DOI: 10.1002/14651858.CD005950.pub4.
Reason for exclusionSystematic review.

Braun, S. M., Beurskens, A. J., Borm, P. J., Schack, T., & Wade, D. T. (2006). The effects of mental practice in stroke rehabilitation: A systematic reviewArchives of Physical Medicine and Rehabilitation87, 842-852.
Reason for exclusionSystematic review.

Butler A.J., & Page S.J. (2006). Mental practice with motor imagery: evidence for motor recovery and cortical reorganization after strokeArchives of Physical Medicine & Rehabilitation87(12 Suppl 2), S2-11.
Reason for exclusion: Not RCT.

Chan, K.Y. & Cameron, L.D. (2012). Promoting physical activity with goal-oriented mental imagery: a randomized controlled trial. Journal of Behavioral Medicine35, 347-63.
Reason for exclusion: No stroke population studied.

Dickstein, R., Dunsky, A., & Marcovitz, E. (2005). Motor imagery for gait rehabilitation in post-stroke hemiparesis. Physical Therapy, 84(12), 1167-1175.
Reason for exclusion: Not RCT.

Dijkerman H.C. (2004). Does motor imagery training improve hand function in chronic stroke patients? A pilot study. Clinical Rehabilitation18(5), 538-49.
Reason for exclusion: Not RCT.

Dunsky, A., Dickstein, R., Ariav, C., Deutsch, J., & Marcovitz E. (2006) Motor imagery practice in gait rehabilitation of chronic post-stroke hemiparesis: four case studies. International Journal of Rehabilitation Studies29, 351-356.
Reason for exclusion: Not RCT.

Grabherr, L., Jola, C., Berra, G., Theiler, R., & Mast, F.W. (2015). Motor imagery training improves precision of an upper limb movement in patients with hemiparesis. Neurorehabilitation, 36, 157-66.
Reason for exclusion: Not RCT; outcomes available in RCTs.

Guttman, A., Burstin, A., Brown, R., Bril, S., & Dickstein, R. (2012). Motor imagery practice for improving sit to stand and reaching to grasp in individuals with poststroke hemiparesis. Topics in Stroke Rehabilitation19(4), 306-19.
Reason for exclusion: Not RCT.

Harris, J.E. & Hebert, A. (2015). Utilization of motor imagery in upper limb rehabilitation: a systematic scoping review. Clinical Rehabilitation, 29(11), 1092-1107.
Reason for exclusionSystematic review.

Hewett, T.E., Ford, K.R., Levine, P., & Page, S.J. (2007). Reaching kinematics to measure motor changes after mental practice in strokeTopics in Stroke Rehabilitation14(4), 23-9.
Reason for exclusion: Not RCT.

Jackson, P.L., Doyon, J., Richards, C.L., & Malouin F. (2004). The efficacy of combined physical and mental practice in the learning of a foot-sequence task after stroke: A case report. NeuroRehabilitation and Neural Repair18(2), 106-111.
Reason for exclusion: Not RCT.

Kim, J.S., Oh, D.W., Kim, S.Y. & Choi, J.D. (2011). Visual and kinesthetic locomotor imagery training integrated with auditory step rhythm for walking performance of patients with chronic strokeClinical Rehabilitation, 25(2): 134-45.
Reason for exclusion: Mental imagery provided to all groups with varying intensities.

Leifert-Fierbach, G., Welfringer., Babinsky, R., & Brandt, T. (2013). Motor imagery training in patietns with chronic neglect: a pilot study. NeuroRehabilitation, 32, 43-58.
Reason for exclusion: Not RCT.

Liu, K.P., Chan, C.C., Lee, T.M., & Hui-Chan, C.W. (2004b). Mental imagery for relearning of people after brain injury. Brain Injury18(11), 1163-72.
Reason for exclusion: Not RCT.

Liu, H., Song, L., & Zhang, T. (2014). Mental practice combined with physical practice to enhance hand recovery in stroke patients. Behavioral Neurology, 1-9.
Reason for exclusion: Not RCT.

Malouin, F., Belleville, S., Richards, C.L., Desrosiers, J., & Doyon J. (2004). Working memory and mental practice outcomes after strokeArchives of Physical Medicine and Rehabilitation5, 177-83.
Reason for exclusion: Not RCT.

Page, J.S., Levine, P., Sisto, S., & Johnston, M.V. (2001b). Mental practice combined with physical practice for upper-limb motor deficit in sub-acute strokePhysical Therapy81(8), 1455-1462.
Reason for exclusion: Not RCT.

Page, S.J., Levine, P., & Hill, V. (2007b). Mental practice as a gateway to modified Constraint-Induced Movement Therapy: A promising combination to improve function. American Journal of Occupational Therapy61, 321-327.
Reason for exclusion: Not RCT.

Stevens, J.A. & Stoykov, P.M.E. (2003). Using motor imagery in the rehabilitation of hemiparesis.Archives of Physical Medicine and Rehabilitation, 84(7), 1090-2.
Reason for exclusion: Not RCT.

Yoo, E., Park E., & Chung B. (2001). Mental practice effect on line-tracing accuracy in persons with hemiparetic stroke: A preliminary study. Archives of Physical Medicine and Rehabilitation, 82, 1213-8.
Reason for exclusion: Not RCT.

Music Therapy

Evidence Reviewed as of before: 19-07-2017
Author(s)*: Tatiana Ogourtsova, PhD Candidate MSc BSc OT; Elissa Sitcoff, BA BSc; Sandy Landry, BSc OT; Virginie Bissonnette, BSc OT; Anne-Julie Laforest, BSc OT; Jolyann Lavoi, BSc OT; Valérie Parenteau, BSc OT; Annabel McDermott, OT; Nicol Korner-Bitensky, PhD OT
Patient/Family Information Table of contents

Introduction

Music interventions are used to optimize an individual’s emotional well-being, physical health, social functioning, communication abilities, and cognitive skills. This module reviews studies that incorporate music as the primary type of intervention.

Patient/Family Information

Authors*: Erica Kader; Elissa Sitcoff, BA BSc; Sandy Landry, BSc OT; Virginie Bissonnette, BSc OT; Anne-Julie Laforest, BSc OT; Jolyann Lavoi, BSc OT; Valérie Parenteau, BSc OT; Nicol Korner-Bitensky, PhD OT

What is music therapy?

Music therapy is a specific form of rehabilitation that is typically facilitated by an accredited music therapist and uses music in a variety of ways to help achieve therapeutic goals. Music therapy has been found to be helpful for people who have had a stroke. Since music is emotionally and intellectually stimulating, this form of therapy can help to maintain or improve one’s physical and mental health, quality of life, and well-being.

Are there different kinds of music therapy?

Music therapy can be provided in different forms, depending on your needs and preferences. Various ways of conducting music therapy and its benefits include:

  • Active listening – develops attention, memory, and awareness to your environment.
  • Composing/songwriting – can be a way of sharing your feelings and being able to express yourself.
  • Improvising movements to music – a creative, non-verbal way of expressing feelings. Since improvisation does not require any previous musical training anyone can participate.
  • Rhythmic movements and dancing – improves movement, speed, balance, breathing, stamina, relaxation of muscles, and walking.
  • Playing instruments – increases coordination, balance, and strength. As an example, hitting a tambourine with a stick is a good exercise to improve your hand-eye coordination and develop strength in your arms and hands. This is a great activity whether or not you have previous experience playing instruments.
  • Singing – improves communication, speech, language skills, articulation, and breathing control. Singing is particularly useful after a stroke for those who are unable to speak, because sometimes even though speech is affected, the individual is still able to sing. This happens because the speech center located in the brain is in a different location than the brain area used for singing. So, someone may have damage to the brain area responsible for speech, but no damage to the area responsible for singing.
With permission of the Music Therapy Association of British Columbia

Is music therapy offered individually or in a group?

Music therapy can be offered either way, so it is your choice. You and your music therapist can plan your music therapy sessions together. Benefits to participating in a group includes improving communication and social skills, making new friends, and the opportunity to share feelings and experiences. Playing instruments in a group can help develop cooperation and attention, as well as improve self-esteem and well-being. Composing and songwriting is another activity that works well in a group, as it allows you to communicate and work along with others. If you are not comfortable working in a group, music therapy sessions can also be offered on an individual basis. Individual sessions may lead to group sessions later on in the rehabilitation process, or the treatment plan may involve a combination of both. For people who are restricted to bed, music therapy can even be offered at their bedside with portable instruments.

Why use music therapy after a stroke?

Music therapy has the ability to help in the rehabilitation of individuals who have had a stroke. The research on the effects of this intervention is still quite new. There is some limited evidence suggesting that music therapy can help improve the movement of the arms, walking, pain perception, mood, and behaviour after stroke.

Courtesy of the Institute for Music and Neurologic Function

Do music-based treatments work in post-stroke rehabilitation?

Researchers have studied how different music-based treatments can help patients with stroke:

In individuals with ACUTE stroke (up to 1 month after stroke), studies found that:

  • Listening to music is MORE helpful than comparison treatment(s) in improving attention, memory, mood and affect. It is AS helpful as comparison treatment(s) in improving executive functions (cognitive processes that assist in managing oneself and one’s resources in order to achieve a goal), language, music cognition, quality of life, and the ability to identify visual and spatial relationships among objects.
  • Music-movement therapy is MORE helpful than comparison treatment(s) in improving mood and affect, and range of motion. It is AS helpful as comparison treatment(s) in improving functional independence in self-care activities (e.g. dressing, feeding), and muscle strength.
  • Rhythmic music interventions are MORE helpful than comparison treatment(s) in improving walking ability.

In individuals with SUBACUTE stroke (1 month to 6 months after stroke), studies found that:

  • Music training is MORE helpful than a comparison treatment in improving hand and arm function.

In individuals with CHRONIC stroke (more than 6 months after stroke), studies found that:

  • Music therapy + occupational therapy is MORE helpful than comparison treatment(s) in improving functional independence in self-care activities (e.g. dressing, feeding), quality of life, sensation, and arm function. It is AS helpful as comparison treatment(s) in improving consequences of stroke, and arm movement quality.
  • Melodic intonation therapy is AS helpful as a comparison treatment in improving language.
  • Rhythmic music interventions are MORE helpful than comparison treatment(s) in improving balance, behavior, walking ability, grip strength, interpersonal relationships, quality of life, legs range of movement, consequences of stroke, and mood and affect. They are AS helpful as comparison treatment(s) in improving cognitive functions (e.g. attention), dexterity, language, musical behavior, occupational performance, arm function, memory, and walking endurance.

In individuals with stroke (acute, subacute and/or chronic), studies found that:

  • Melodic intonation therapy is MORE helpful than a comparison treatment in improving language.
  • Music performance is AS helpful as comparison treatment(s) in improving dexterity and arm range of motion and function.
  • Rhythmic music interventions are MORE helpful than comparison treatment(s) in improving balance, and walking ability. They are AS helpful as comparison treatment(s) in improving dexterity, sensation, strength, stroke consequences, arm function and activity.

Who provides the treatment?

Many hospitals and rehabilitation centers have music therapy programs that are conducted by accredited music therapists. The music therapist will meet with you to assess your needs and discuss preferences, so that he or she can design a program specific to your needs. In some centers it may be a recreational therapist or leisure therapist who provides music therapy. Ask your health professional or family members to help you find out more about the music therapy services offered in your hospital, rehabilitation center or community.

Are there any side effects or risks?

You do not face any risks when participating in music therapy after a stroke, as long as activities are practiced in a manner that fits your abilities. Consult your physician or rehabilitation healthcare professional for the best advice on how to participate safely. This is especially important if you are going to incorporate dancing or rhythmic movements into your music sessions and have some balance difficulties. *Family members/friends: it is important to help the person who has had a stroke seek out new activities such as music therapy that may be both pleasant and therapeutic.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

This module reviews 24 studies that use music as a primary means of rehabilitation; of these, 12 are high quality RCTs, seven are fair quality RCTs, one is a poor quality RCT and four are non-randomized studies.

This module reviews the following types of music-based interventions:

Listening to music: Participants listening to music.

Music therapy + occupational therapy: Participants playing instruments (e.g. drums, bells, shakers, mallets, chimes, piano, harp) with the affected upper limb to encourage proximal and distal upper limb movements, with attention to positioning and movement quality.

Melodic intonation therapy: Participants singing phrases and tap to the rhythm of the phrases; this intervention has been shown to improve outcomes related to language/aphasia.

Music-movement therapy: Participants performing movements of lower and upper extremities while listening to music.

Music performance: Participants playing acoustic musical instruments and/or iPads with touchscreen musical instruments as part of fine/distal exercise.

Music training: Participants are taught to play a musical instrument.

Rhythmic music interventions: Participants performing matching upper and/or lower extremity movements or gait patters to musical rhythm.

Results Table

View results table

Outcomes

Acute phase - Listening to music

Attention
Effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on attention in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Measures of attention were taken at 3 and 6 months post-stroke, and outcomes included: (1) attention, measured by the CogniSpeed reaction time software; (2) focused attention, measured by the mental subtraction and Stroop subtests (number correct and reaction time); and (3) sustained attention, measured by the vigilance (number correct, reaction time) and simple reaction time subtests. Significant between-group differences in focused attention were found at 3 months post-stroke, favoring the music group vs. the control group. Significant between-group differences in focused attention were found at 6 months post-stroke, favoring the music group vs. the audio book group, and favoring the music group vs. the control group. There were no significant between-group differences in other measures of attention at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is more effective than comparison interventions (listening to audio books, no training) in improving focused attention in patients with acute stroke. However, no between-group differences were found on measures of attention or sustained attention.

Auditory sensory memory
Not effective
1b

One high quality RCT (Sarkamo et al., 2010) investigated the effect of music interventions on auditory sensory memory in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Auditory sensory memory was evaluated by the magnetically-measured mismatch negativity (MMNm) responses to change in sound frequency and duration from baseline to 3 and 6 months post-stroke. There were no significant differences between groups at 3 months post-stroke. At 6 months post-stroke, there were significant between-group differences in auditory sensory memory (frequency MMNm only), favoring the music group vs. the control group.
Note: Comparison of the audio book group vs. the control group revealed significant differences favoring the audio book group in frequency MMNm (left and right lesions) and duration MMNm (right lesions only) at 6 months post-stroke.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (listening to audio books, no training) in improving auditory sensory memory among patients with acute stroke in the short term.
Note:
However, this high quality RCT showed that patients who listened to music demonstrated significantly better auditory sensory memory several months following treatment than patients who received conventional rehabilitation alone.

Executive function
Not effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on executive function in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Executive function was measured by the Frontal Assessment Battery at 3 and 6 months post-stroke. No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (listening to audio books, no training) in improving executive function in patients with acute stroke.

Language
Not effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on language in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Language was measured by the Finnish version of the Boston Diagnostic Aphasia Examination (word repetition, sentencing repetition, reading subtests), the CERAD battery (verbal fluency, naming subtests) and the Token Test at 3 and 6 months post-stroke. No significant between-group differences were found at either time point on any of the measures.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (listening to audio books, no training) in improving language in patients with acute stroke.

Memory
Effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on memory in patients with acute stroke. This high quality RCT randomized patients to a music group that listened to music for a minimum 1 hour/day, a language group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Measures of memory were taken at 3 and 6 months post-stroke and outcomes included: (1) verbal memory, measured by the Rivermead Behavioral Memory Test (story recall subtests) and an auditory list learning task; and (2) short-term working memory, measured by the Wechsler Memory Scale – Revised (digit span subtest) and a memory interference task. Significant between-group differences in verbal memory were found at 3 months post-stroke, favoring the music group vs. the audio book group, and favoring the music group vs. the control group. Similarly, significant between-group differences in verbal memory were found at 6 months post-stroke, favoring the music group vs. the audio book group. There were no significant between-group differences in short-term working memory at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is more effective than comparison interventions (listening to audio books, no training) in improving verbal memory in patients with acute stroke. However, no between-group differences were found on measures of short-term working memory.

Mood
Effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on mood in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Mood was measured by a shortened Finnish Version of the Profile of Mood States at 3 and 6 months post-stroke. Significant between-group differences in mood (depression score only) were found at 3 months post-stroke favoring the music group vs. the control group.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is more effective than comparison interventions (listening to audio books, no training) in improving mood in patients with acute stroke.

Music cognition
Not effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on music cognition in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Music cognition was measured by the Montreal Battery of Evaluation of Amusia (scale and rhythm subtests) at 3 months post-stroke. No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (listening to audio books, no training) in improving music cognition in patients with acute stroke.

Quality of life
Not effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on quality of life in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Quality of life was measured by the Stroke and Aphasia Quality of Life Scale – 39 (self-rated, proxy rated) at 3 and 6 months post-stroke. No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (audio therapy, no training) in improving quality of life in patients with acute stroke.

Visuospatial skills
Not effective
1b

One high quality RCT (Sarkamo et al., 2008) investigated the effect of music interventions on visuospatial skills in patients with acute stroke. This high quality RCT randomized patients to a group that listened to music for a minimum 1 hour/day, a group that listened to audio books for a minimum 1 hour/day, or a control group that received no training; all groups received conventional rehabilitation for the duration of the 2-month study. Visuospatial skills were measured by the Clock Drawing Test, Figure Copying Test, Benton Visual Retention Test (short version), and Balloons Test (subtest B) at 3 and 6 months post-stroke. No significant between-group differences were found at either time point on any of the measures.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that listening to music is not more effective than comparison interventions (listening to audio books, no training) in improving visuospatial skills in patients with acute stroke.

Acute phase - Music-movement therapy

Behavioral outcomes
Effective
2b

One poor quality RCT (Jun et al., 2012) investigated the effect of music interventions on mood and affect in patients with acute stroke. This poor quality RCT randomized patients to receive music-movement therapy or no training; both groups received standard care. Behavioral outcomes were assessed according to: 1) mood measured by the Korean version of the Profile of Mood States Brief Instrument; and 2) depression, measured by the Center for Epidemiologic Studies Depression Scale at post-treatment (8 weeks). Significant between-group differences were found for mood favoring music-movement therapy vs. no training.  

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that music-movement therapy is more effective than no training in improving behavioral outcomes (mood) in patients with acute stroke.

Functional independence
Not effective
2b

One poor quality RCT (Jun et al., 2012) investigated the effect of music interventions on functional independence in patients with acute stroke. This poor quality RCT randomized patients to receive music-movement therapy or no training; both groups received standard care. Functional independence was measured by the Korean modified Barthel Index at post-treatment (8 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that music-movement therapy is not more effective than no training in improving functional independence in patients with acute stroke.

Muscle strength
Not effective
2b

One poor quality RCT (Jun et al., 2012) investigated the effect of music interventions on muscle strength in patients with acute stroke. This poor quality RCT randomized patients to receive music-movement therapy or no training; both groups received standard care. Muscle strength of the affected upper and lower extremities was measured by the Medical Research Council Scale at post-treatment (8 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that music-movement therapy is not more effective than no training in improving muscle strength in patients with acute stroke.

Range of motion
Effective
2b

One poor quality RCT (Jun et al., 2012) investigated the effect of music interventions on range of motion (ROM) in patients with acute stroke. This poor quality RCT randomized patients to receive music-movement therapy or no training; both groups received standard care. ROM of the affected side (shoulder/elbow/wrist flexion, hip/knee flexion) was measured by goniometer at post-treatment (8 weeks). Significant between-group differences in ROM were found (shoulder/elbow flexion, hip flexion), favoring music-movement therapy vs. no training.

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that music-movement therapy is more effective than no training in improving range of motion of the proximal joints of patients with acute stroke.

Acute phase - Rhythmic music interventions

Gait parameters
Effective
2a

One fair quality RCT (Schneider et al., 2007) investigated the effect of music interventions on dexterity in patients with subacute stroke. This fair quality RCT randomized patients to receive music training (drum and/or piano) + conventional rehabilitation or conventional rehabilitation alone. Dexterity was measured by the Box and Block Test and the Nine Hole Peg Test at post-treatment (3 weeks). Significant between-group differences were found on both measures of dexterity, favoring music training + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that music training + conventional rehabilitation is more effective than conventional rehabilitation alone in improving dexterity in patients with subacute stroke.

Subacute phase - Music training

Dexterity
Effective
2a

One fair quality RCT (Schneider et al., 2007) investigated the effect of music interventions on dexterity in patients with subacute stroke. This fair quality RCT randomized patients to receive music training (drum and/or piano) + conventional rehabilitation or conventional rehabilitation alone. Dexterity was measured by the Box and Block Test and the Nine Hole Peg Test at post-treatment (3 weeks). Significant between-group differences were found on both measures of dexterity, favoring music training + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that music training + conventional rehabilitation is more effective than conventional rehabilitation alone in improving dexterity in patients with subacute stroke.

Upper extremity motor function
Effective
2a

One fair quality RCT (Schneider et al., 2007) investigated the effect of music interventions on upper extremity motor function in patients with subacute stroke. This fair quality RCT randomized patients to receive music training (drum and/or piano) + conventional rehabilitation or conventional rehabilitation alone.  Upper extremity motor function was measured by the Action Research Arm Test, Arm Paresis Score, and computerized hand/fingers movement analysis (velocity and frequency profile) at post-treatment (3 weeks). Significant between-group differences were found on all measures of upper extremity motor function, favoring music training + conventional rehabilitation vs. conventional rehabilitation alone.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that music training + conventional rehabilitation is more effective than conventional rehabilitation alone in improving upper extremity motor function in patients with subacute stroke.

Chronic phase - Melodic intonation therapy

Language
Not effective
1b

One high quality RCT (van Der Meulen et al., 2016), investigated the effect of music interventions on language in patients with chronic stroke. This high quality cross-over design RCT randomized patients to receive melodic intonation therapy (MIT) or no treatment. Language was measured by the Sabadel story retell task, Amsterdam-Nijmegen Everyday Language Test, Aachen Aphasia Test (naming, repetition, auditory comprehension), and MIT task (trained/untrained items) at post-treatment (6 weeks) and at follow-up (12 weeks). Significant between-group differences were found on only one measure of language (MIT task – trained items) at post-treatment favoring MIT vs. no treatment. These differences were not maintained at follow-up.
Note: When the control group crossed-over to receive the MIT treatment, no significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that melodic intonation therapy is not more effective than no treatment in improving language in patients with chronic stroke.

Chronic phase - Music therapy and occupational therapy

Functional independence
Effective
2b

One quasi-experimental design study (Raghavan et al., 2016) investigated the effect of music interventions on functional independence in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper limb training. Functional independence was measured by the Modified Rankin Scale at baseline, post-treatment (6 weeks) and follow-up (1 year). Significant improvements were found at both time points.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is effective in improving functional independence in patients with chronic stroke.

Quality of life
Effective
2b

One quasi-experimental design study (Raghavan et al., 2016) investigated the effect of music interventions on quality of life in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper limb training. Quality of life was measured by the World Health Organization Well-Being Index at baseline, post-treatment (6 weeks) and follow-up (1 year). Significant improvements were found at both time points.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is effective in improving quality of life in patients with chronic stroke.

Sensation
Effective
2b

One quasi-experimental design study (Raghavan et al., 2016) investigated the effect of music interventions on sensation in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper limb training. Sensation was measured by the Two-Point Discrimination Test at baseline, post-treatment (6 weeks) and follow-up (1 year). Significant improvements were found at both time points.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is effective in improving sensation in patients with chronic stroke.

Stroke outcomes
Not effective
2b

One quasi-experimental design study (Raghavan et al., 2016) investigated the effect of music interventions on stroke outcomes in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper limb training. Stroke outcomes were measured by the Stroke Impact Scale (SIS activities of daily living, participation subscales) at baseline, post-treatment (6 weeks) and follow-up (1 year). There were no significant changes in stroke outcomes from baseline to post-treatment. There was a significant improvement on one measure (SIS – activities of daily living) from post-treatment to follow-up.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is not effective in improving stroke outcomes in patients with chronic stroke in the short term.
Note
: However, the quasi-experimental design study showed significant improvements in one measure of stroke outcomes (activities of daily living) in the long term.

Upper extremity kinematics
Not effective
2b

One quasi-experimental design studies (Raghavan et al., 2016) investigated the effect of music interventions on upper extremity kinematics in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper-limb training. Kinematic analysis of wrist flexion/extension was performed at baseline and at post-treatment (6 weeks). No significant changes were found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is not effective in improving upper extremity kinematics in patients with chronic stroke.

Upper extremity motor function
Effective
2b

One quasi-experimental design studies (Raghavan et al., 2016) investigated the effect of music interventions on upper extremity motor function in patients with chronic stroke. This quasi-experimental design study assigned patients to receive music therapy + occupational therapy integrated upper-limb training. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity subscale at baseline, post-treatment (6 weeks) and 1-year follow-up. Significant improvements were found at both time points.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that music therapy + occupational therapy integrated upper limb training is effective in improving upper extremity motor function in patients with chronic stroke.

Chronic phase - Rhythmic music interventions

Balance
Effective
1a

Two high quality RCTs (Cha et al., 2014; Bunketorp-Kall et al., 2017) investigated the effect of music interventions on balance in patients with chronic stroke.

The first high quality RCT (Cha et al., 2014) randomized patients to receive rhythmic auditory stimulation (RAS) gait training or time-matched standard gait training. Balance was measured by the Berg Balance Scale (BBS) at post-treatment (6 weeks). Significant between-group differences were found, favoring RAS gait training vs. time-matched standard gait training.

The second high quality RCTs (Bunketorp-Kall et al., 2017) randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Balance was measured by the BBS and the Backstrand, Dahlberg and Liljenas Balance Scale (BDL-BS) at post-treatment (12 weeks) and follow-up (6 months). Significant between-group differences (BDL-BS only) were found at post-treatment and follow-up, favoring rhythm-and-music therapy vs. no treatment. There were no significant differences between rhythm-and-music therapy and horse-riding therapy at either time point on any of the measures.
Note: There was also a significant between-group difference (BBS, BDL-BS) at post-treatment, favoring horse-riding therapy vs. no treatment. These differences did not remain significant at follow-up.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that rhythmic music interventions are more effective than comparison interventions (time-matched standard gait training, no treatment) in improving balance in patients with chronic stroke.

Behavior
Effective
2b

One fair quality RCT (Raglio et al., 2016) and one quasi-experimental design study (Purdie et al., 1997) investigated the effect of music interventions on behavior in patients with chronic stroke.

The fair quality RCT (Raglio et al., 2016) randomized patients to receive music therapy (using rhythmic melodic instruments and singing) + speech language therapy or speech language therapy alone. Behavior was measured by the Big Five Observer (energy/extroversion, friendship, diligence, emotional stability, open mindedness) at post-treatment (15 weeks). Neither group demonstrated significant changes in behaviour at post-treatment.
Note: This study did not report between-group analyses so is not used to determine the level of evidence in the conclusion below.

The quasi-experimental design study (Purdie et al., 1997) randomized patients to receive music therapy (using percussion/synthesizers and singing) or no music therapy. Behavior was measured by the Behavior Rating Scale (BRS) at post-treatment (12 weeks). Significant between-group differences were found (BRS emotional stability, spontaneous interaction subscales), favoring music therapy vs. no music therapy.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that rhythmic music intervention is more effective than no music therapy in improving some aspects of behavior in patients with chronic stroke.
Note
: However, one fair quality RCT reported no significant change in behavior following rhythmic music therapy + speech language therapy.

Cognitive function
Not effective
1b

One high quality RCT (Bunketorp-Kall et al., 2017) investigated the effect of music interventions on cognitive function in patients with chronic stroke. This high quality RCT randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Cognitive function was measured by the Barrow Neurological Institute Screen for Higher Cerebral Functions at post-treatment (12 weeks) and follow-up (6 months). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythmic music intervention is not more effective than comparison interventions (horse-riding therapy, no treatment) in improving cognitive function in patients with chronic stroke.

Dexterity
Not effective
2b

Two quasi-experimental design studies (Hill et al., 2011; Villeneuve et al., 2014) investigated the effect of music interventions on dexterity in patients with chronic stroke.

The first quasi-experimental design study (Hill et al., 2011) assigned patients to receive rhythm and timing training (interactive metronome training) + occupational therapy or occupational therapy alone. Dexterity was measured by the Box and Block Test at post-treatment (10 weeks). No significant between-group differences were found

The second quasi-experimental AABA design study (Villeneuve et al., 2014) assigned patients to receive music-supported therapy (using piano training). Dexterity was measured by the Box and Block Test and the Nine Hole Peg Test at post-treatment (3 weeks) and follow-up (6 weeks). Significant improvements in both measures of dexterity were found at post-treatment. No significant changes in scores were observed from post-treatment to follow-up.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that rhythmic music intervention is not more effective than a comparison intervention (occupational therapy alone) in improving dexterity in patients with chronic stroke.
Note
: One quasi-experimental design study found improvements in dexterity immediately following music-supported therapy using piano training.

Gait parameters
Effective
1b

One high quality RCT (Cha et al., 2014) investigated the effect of music interventions on gait parameters in patients with chronic stroke. This high quality RCT randomized patients to receive rhythmic auditory stimulation (RAS) gait training or time-matched standard gait training. Gait parameters (gait velocity, cadence, stride length of the affected/less-affected legs, double stance period of the affected/less-affected legs) were measured by the GAITRite system at post-treatment (6 weeks). Significant between-group differences were found for all gait parameters of the affected leg and most gait parameters of the less affected leg (excluding stride length, double stance period), favoring RAS gait training vs. time-matched standard gait training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythmic auditory stimulation gait training is more effective than a comparison intervention (time-matched standard gait training) in improving gait parameters in patients with chronic stroke.

Grip strength
Effective
1b

One high quality RCT (Bunketorp-Kall et al., 2017) investigated the effect of music interventions on grip strength in patients with chronic stroke. This high quality RCT randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Grip strength was measured by the GRIPPIT (right/left hands – max, mean and final scores) at post-treatment (12 weeks) and follow-up (6 months). Significant between-group differences were found at post-treatment (right hand max score, left hand final score), and at follow-up (left hand final score only), favoring rhythm-and-music therapy vs. no treatment. There were no significant differences between rhythm-and-music therapy and horse-riding therapy at either time point on any of the measures.
Note: There were no significant differences between horse-riding therapy and no treatment at either time point on any of the measures.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythm-and-music therapy is more effective than no treatment in improving grip strength in patients with chronic stroke.

Interpersonal relationships
Effective
2a

One fair quality RCT (Jeong et al., 2007) investigated the effect of music interventions on interpersonal relationships of patients with chronic stroke. This fair quality RCT randomized patients to receive rhythmic auditory stimulation (RAS) music-movement training (using dynamic rhythmic movement and rhythm tools) or no treatment. Perception of interpersonal relationships was measured by the Relationship Change Scale at post-treatment (8 weeks). Significant between-group differences were found, favoring RAS music-movement training vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that rhythmic music interventions are more effective than no treatment in improving interpersonal relationships in patients with chronic stroke.

Language
Not effective
2b

One fair quality RCT (Raglio et al., 2016) and one quasi-experimental design study (Purdie et al., 1997) investigated the effect of music interventions on language in patients with chronic stroke.

The fair quality RCT (Raglio et al., 2016) randomized patients to receive music therapy (using rhythmic melodic instruments and singing) + speech language therapy or speech language therapy alone. Language was measured by the Token Test, Boston Naming Test and Aachener Aphasie Test (picture description, spontaneous speech) at post-treatment (15 weeks). Neither group demonstrated a significant change on any measure of language at post-treatment.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

The quasi-experimental design study (Purdie et al., 1997) randomized patients to receive music therapy training (using percussion/synthesizers and singing) or no music therapy. Language was measured by the Frenchay Aphasia Screening Test at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that rhythmic music intervention is not more effective than no music therapy in improving language in patients with chronic stroke.
Note
: Further, one fair quality RCT reported no significant improvement in language following music therapy + speech language therapy.

Mood and affect
Effective
2a

Two fair quality RCTs (Jeong et al., 2007; Raglio et al., 2016) and one quasi-experimental design study (Purdie et al., 1997) investigated the effect of music interventions on mood and affect in patients with chronic stroke.

The first fair quality RCT (Jeong et al., 2007) randomized patients to receive rhythmic auditory stimulation (RAS) music-movement training (using dynamic rhythmic movement and rhythm tools) or no treatment. Mood and affect were measured by the Profile of Mood States at post-treatment (8 weeks). Significant between-group differences were found, favoring RAS music-movement training vs. no treatment.

The second fair quality RCT (Raglio et al., 2016) randomized patients to receive music therapy (using rhythmic melodic instruments and singing) + speech language therapy or speech language therapy alone. Mood and affect were measured by the Beck Depression Inventory at post-treatment (15 weeks). Neither group demonstrated a significant change in mood.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

The quasi-experimental design study (Purdie et al., 1997) randomized patients to receive music therapy (using percussion/synthesizers and singing) or no music therapy. Mood and affect were measured by the Hospital Anxiety and Depression Scale at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fai quality RCT that rhythmic music intervention is more effective than no treatment for improving mood and affect in patients with stroke.
Note
: However, a quasi-experimental design study found that rhythmic music therapy was not more effective than no treatment for improving mood and affect; a second fair quality RCT also reported no significant improvements in mood and affect following music therapy + speech language therapy. Differences in the type and duration of music interventions and outcome measures used could account for discrepancies in findings among studies.

Music behavior
Not effective
2b

One quasi-experimental design study (Purdie et al., 1997) investigated the effect of music interventions on musical behavior in patients with chronic stroke. This quasi-experimental design study randomized patients to receive music therapy (using percussion/synthesizers and singing) or no music therapy. Musical behavior was measured by the Musical Behavior Rating Scale at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that rhythmic music intervention is not more effective than no music therapy in improving musical behavior in patients with chronic stroke.

Occupational performance
Not effective
2b

One quasi-experimental design study (Hill et al., 2011) investigated the effect of music interventions on occupational performance in patients with chronic stroke. This quasi-experimental design study assigned patients to receive rhythm and timing training (interactive metronome training) + occupational therapy or occupational therapy alone. Occupational performance was measured by the Canadian Occupational Performance Measure (COPM – satisfaction, performance) at post-treatment (10 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental design study that rhythm and timing training + occupational therapy is not more effective than a comparison intervention (occupational therapy alone) in improving occupational performance in patients with chronic stroke.

Quality of life
Effective
1b

One high quality RCT (Cha et al., 2014) and two fair quality RCTs (Jeong et al., 2007; Raglio et al., 2016) investigated the effect of music interventions on quality of life in patients with chronic stroke.

The high quality RCT (Cha et al., 2014) randomized patients to receive rhythmic auditory stimulation (RAS) gait training or time-matched standard gait training. Quality of life was measured by the Stroke Specific Quality of Life Scale (SS-QoL) at post-treatment (6 weeks). Significant between-group differences were found, favoring RAS gait training vs. time-matched standard gait training.

The first fair quality RCT (Jeong et al., 2007) randomized patients to receive RAS music-movement training (using dynamic rhythmic movement and rhythm tools) or no treatment. Quality of life was measured by the SS-QoL at post-treatment (8 weeks). No significant between-group differences were found.

The second fair quality RCT (Raglio et al., 2016) randomized patients to receive music therapy (using rhythmic melodic instruments and singing) + speech language therapy or speech language therapy alone. Quality of life was measured by the Short-Form 36 at post-treatment (15 weeks). Neither group demonstrated a significant change.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythmic auditory stimulation gait training is more effective than a comparison intervention (standard gait training) in improving quality of life in patients with chronic stroke.
Note
: However, one fair quality RCT found no significant difference between rhythmic auditory stimulation music-movement training and no treatment. Similarly, a second fair quality RCT found no significant improvement in quality of life following music therapy + speech language therapy. Differences in the type and duration of music interventions and outcome measures used could account for discrepancies in findings among studies.

Range of motion - lower extremity
Effective
2a

One fair quality RCT (Jeong et al., 2007) investigated the effect of music interventions on lower extremity range of motion (ROM) in patients with chronic stroke. This fair quality RCT randomized patients to receive rhythmic auditory stimulation (RAS) music-movement training (using dynamic rhythmic movement and rhythm tools) or no treatment. Lower extremity ROM (ankle flexion/extension) was measured by goniometer at post-treatment (8 weeks). Significant between-group differences were found (ankle extension only), favoring RAS music-movement training vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that rhythmic auditory stimulation music-movement training is more effective than no treatment in improving lower extremity range of motion (ankle extension only) in patients with chronic stroke.

Range of motion - upper extremity
Not effective
2b

One fair quality RCT (Jeong et al., 2007) investigated the effect of music interventions on upper extremity range of motion (ROM) in patients with chronic stroke. This fair quality RCT randomized patients to receive rhythmic auditory stimulation (RAS) music-movement training (using dynamic rhythmic movement and rhythm tools) or no treatment. Shoulder ROM (flexion) was measured by goniometer and shoulder flexibility was measured using the Back Scratch Test (upward, downward) at post-treatment (8 weeks). Significant between-group differences were found in shoulder flexibility, favoring RAS music-movement training vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that rhythmic auditory stimulation music-movement training is not more effective than no treatment in improving shoulder range of motion in patients with chronic stroke.
Note: However, this fair quality RCT found that RAS music-movement training is more effective than no treatment for improving shoulder flexibility.

Stroke outcomes
Effective
1b

One high quality RCT (Bunketorp-Kall et al., 2017) and one quasi-experimental design study (Hill et al., 2011) investigated the effect of music interventions on stroke outcomes in patients with chronic stroke.

The high quality RCT (Bunketorp-Kall et al., 2017) randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Item 9) according to (a) the proportion of individuals reporting meaningful recovery; and (b) change scores from baseline to post-treatment (12 weeks) and follow-up (3 and 6 months). There were significant between-group differences in both measures at post-treatment and both follow-up time points, favoring rhythm-and-music therapy vs. no treatment. There were no significant differences between rhythm-and-music therapy and horse-riding therapy at any time point.
Note: Significant between-group differences were also found in favour of horse-riding therapy vs. no treatment at post-treatment and both follow-up time points.

The quasi-experimental design study (Hill et al., 2011) assigned patients to receive rhythm and timing training (interactive metronome training) + occupational therapy or occupational therapy alone. Stroke outcomes were measured by the SIS at post-treatment (10 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythm-and-music therapy is more effective than no treatment in improving stroke outcomes in patients with chronic stroke.
Note
: However, the high quality RCT found that rhythm-and-music therapy was not more effective than horse-riding therapy, and a quasi-experimental design study found that rhythm and timing training + occupational therapy was not more effective than occupational therapy alone in improving stroke outcomes in patients with chronic stroke.

Upper extremity coordination
Insufficient evidence
5

One quasi-experimental design study (Villeneuve et al., 2014) investigated the effect of music interventions on upper extremity coordination in patients with chronic stroke. This quasi-experimental AABA design study assigned patients to receive music-supported therapy (using piano training). Upper extremity coordination was measured by the Finger to Nose Test and the Finger Tapping Test at post-treatment (3 weeks) and follow-up (6 weeks). Significant improvements were found on both measures at post-treatment. No significant changes in scores were observed from post-treatment to follow-up.
Note: This study did not report between-group analyses and is not used to determine level of evidence in the conclusion below.

Conclusion: There is insufficient evidence (Level 5) regarding the effectiveness of rhythmic music interventions on upper extremity coordination among patients with chronic stroke. However, one quasi-experimental design study reported significant improvements in upper extremity coordination of patients with chronic stroke immediately following music-supported therapy.

Upper extremity motor function
Not effective
2b

Two quasi-experimental design studies (Hill et al., 2011; Villeneuve et al., 2014) investigated the effect of music interventions on upper extremity motor function in patients with chronic stroke.

The first quasi-experimental design study (Hill et al., 2011) assigned patients to receive rhythm and timing training (interactive metronome training) + occupational therapy or occupational therapy alone. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity subtest (FMA-UE) and the Arm Motor Ability Test (AMAT) at post-treatment (10 weeks). There was a significant between-group difference on one measure of upper extremity function (AMAT), favouring occupational therapy alone vs. interactive metronome training + occupational therapy.

The second quasi-experimental AABA design study (Villeneuve et al., 2014) assigned patients to receive music-supported therapy (using piano training). Upper extremity motor function was measured by the Jebsen Hand Function Test at post-treatment (3 weeks) and follow-up (6 weeks). Significant improvements were found at post-treatment. No significant changes in scores were observed from post-treatment to follow-up.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

Conclusion: There is limited evidence (Level 2b) from one quasi-experimental study that rhythmic music intervention is not more effective than a comparison intervention (occupational therapy alone) in improving upper extremity motor function in patients with chronic stroke. In fact, occupational therapy alone was found to be more effective than metronome training + occupational therapy.
Note
: However, a second quasi-experimental design study reported significant improvements in upper extremity motor function following music-supported training in patients with chronic stroke.

Walking endurance
Not effective
1b

One high quality RCT (Bunketorp-Kall et al., 2017) investigated the effect of music interventions on walking endurance in patients with chronic stroke. This high quality RCT randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Walking endurance was measured by the Timed Up and Go Test at post-treatment (12 weeks) and follow-up (6 months). There were no significant differences between rhythm-and-music therapy vs. horse-riding therapy, nor between rhythm-and-music therapy vs. no treatment at either time point.
Note: There were significant between-group differences in favour of horse-riding therapy vs. no treatment at post-treatment and at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythmic music intervention is not more effective than comparison interventions (horse-riding therapy, no treatment) in improving walking endurance in patients with chronic stroke.

Working memory
Not effective
1b

One high quality RCT (Bunketorp-Kall et al., 2017) investigated the effect of music interventions on working memory in patients with chronic stroke. This high quality RCT randomized patients to receive rhythm-and-music therapy (listening to music while performing rhythmic movements of the hands and feet), horse-riding therapy or no treatment. Working memory was measured by the Letter-Number Sequencing Test at post-treatment (12 weeks) and follow-up (6 months). Significant between-group differences were found at follow-up only, favoring rhythm-and-music therapy vs. no treatment. No other significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that rhythmic music intervention is not more effective, in the short term, than no treatment, and, in the short and the long term, than horse-riding therapy, in improving working memory in patients with chronic stroke.
Note:
However, a significant between-group difference was found, in the long term, favoring rhythmic music intervention vs. no treatment.

Phase not specific to one period - Melodic intonation therapy

Language
Effective
2a

One fair quality RCT (Conklyn et al., 2012) investigated the effect of music interventions on language in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke and Broca’s aphasia to receive 3 sessions of modified melodic intonation therapy (MMIT) or education. Language were measured by a non-standardized modified version of the Western Aphasia Battery (mWAS – repetition, responsiveness, total score) at baseline and at the end of each session. Significant between-group differences were found after session 1 (mWAS – repetition, responsiveness, total score), and after session 2 (mWAS – responsiveness), favoring MMIT vs. education. No results were provided following session 3.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that one session of modified melodic intonation therapy is more effective than a comparison intervention (education) in improving language in patients with stroke and Broca’s aphasia.

Phase not specific to one period - Music performance

Dexterity
Not effective
1b

One high quality RCT (Street et al., 2017) investigated the effect of music interventions on dexterity in patients with stroke. This high quality cross-over design RCT randomized patients with subacute/chronic stroke to receive music performance therapy (therapeutic instrumental music performance) or no treatment. Dexterity was measured by the Nine Hole Peg Test at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that music performance therapy is not more effective than no treatment in improving dexterity in patients with stroke.

Range of motion
Not effective
2a

One fair quality RCT (Paul & Ramsey, 1998) investigated the effect of music interventions on range of motion (ROM) in patients with stroke. This fair quality RCT randomized patients with subacute/chronic stroke to receive music performance therapy (group-based electronic music-making training) or recreation therapy. ROM (shoulder flexion/elbow extension) was measured by JAMAR goniometer at post-treatment (10 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that group-based music performance therapy is not more effective than a comparison intervention (recreation therapy) in improving upper extremity range of motion in patients with stroke.

Upper extremity motor function
Not effective
1b

One high quality RCT (Street et al., 2017) investigated the effect of music interventions on upper extremity (UE) motor function in patients with stroke. This high quality cross-over design RCT randomized patients with subacute/chronic stroke to receive music performance therapy (therapeutic instrumental music performance) or no treatment. UE motor function was measured by the Action Research Arm Test at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that music performance therapy is not more effective than no treatment in improving upper extremity motor function in patients with stroke.

Phase not specific to one period - Rhythmic music interventions

Balance
Effective
1a

Two high quality RCTs (Chouhan & Kumar, 2012; Suh et al., 2014) and one fair quality RCT (Kim et al., 2012) investigated the effect of music interventions on balance in patients with stroke.

The first high quality RCT (Chouhan & Kumar, 2012) randomized patients with acute/subacute stroke to receive rhythmic auditory stimulation (RAS) gait/fine/gross motor training, visual cueing gait/fine/gross motor training or no additional training. Balance was measured by the Dynamic Gait Index during treatment (1 and 2 weeks), post-treatment (3 weeks) and follow-up (4 weeks). Significant between-group differences were found at 2, 3 and 4 weeks, favoring RAS training vs. no training. Significant between-group differences were found at all time points, favoring RAS training vs. visual cueing training.
Note: Significant between-group differences in balance were found at all time points, favoring visual cueing training vs. no training.

The second high quality RCT (Suh et al., 2014) randomized patients with acute/subacute/chronic stroke to receive RAS gait training + neurodevelopmental therapy (NDT) or NDT alone. Balance was measured using the Biosway® computerized dynamic posturography system (overall stability index, anteroposterior index and mediolateral index) at post-treatment (3 weeks). Significant between-group differences in all measures of balance were found, favoring RAS gait training + NDT vs. NDT alone.

The fair quality RCT (Kim et al., 2012) randomized patients with subacute/chronic stroke to receive RAS gait training + conventional physical therapy or conventional physical therapy alone. Balance was measured by the Four-Square Step Test, Up/Down Stairs (sec), Timed Up and Go Test (TUG); and balance confidence was measured by the Activities Specific Balance Confidence Scale (ABC Scale) at post-treatment (5 weeks). Significant between-group differences were found on the TUG and ABC Scale, favoring RAS gait training + conventional physical therapy vs. conventional physical therapy alone.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and one fair quality RCT that rhythmic music interventions are more effective than comparison interventions (visual cueing training, no training, NDT alone, conventional physical therapy alone) in improving balance and balance confidence in patients with stroke.

Dexterity
Not effective
1b

One high quality RCT (van Delden et al., 2013) investigated the effect of music interventions on dexterity in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing (mBATRAC), modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Dexterity was measured by the Nine Hole Peg Test at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point. 

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that modified bilateral arm training with rhythmic auditory cueing is not more effective than comparison interventions (modified constraint induced movement therapy, conventional rehabilitation) in improving dexterity in patients with stroke.

Gait ability
Effective
2a

One fair quality RCT (Kim et al., 2012) investigated the effect of music interventions on gait ability in patients with stroke. This fair quality RCT randomized patients with subacute/chronic stroke to receive rhythmic auditory stimulation (RAS) gait training + conventional physical therapy or conventional physical therapy alone. Gait ability was measured by the Functional Ambulation Category (FAC) test and the Dynamic Gait Index (DGI) at post-treatment (5 weeks). There was a significant between-group difference on one measure of gait ability (DGI) at post-treatment, favoring RAS gait training + conventional physical therapy vs. conventional physical therapy alone.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that rhythmic auditory gait training is more effective than a comparison intervention (conventional physical therapy alone) in improving gait ability in patients with stroke.

Gait parameters
Conflicting
4

Two high quality RCTs (Thaut et al., 2007; Suh et al., 2014) and two fair quality RCTs (Schauer & Mauritz, 2003; Kim et al., 2012) investigated the effect of music interventions on gait parameters in patients with stroke.

The first high quality RCT (Thaut et al., 2007) randomized patients with acute/subacute stroke to receive rhythmic auditory stimulation (RAS) gait training or neurodevelopmental therapy (NDT) training. Gait parameters (velocity, stride length, cadence, symmetry) were measured by computerized foot sensors at post-treatment (3 week). Significant between-group differences were found in all gait parameters, favoring RAS gait training vs. NDT gait training.

The second high quality RCT (Suh et al., 2014) randomized patients with acute / subacute / chronic stroke to receive RAS gait training + neurodevelopmental therapy (NDT) or NDT alone. Gait parameters (cadence, velocity, stride length) were measured at baseline and post-treatment (3 weeks). There were no significant differences in gait parameter scores at post-treatment.
Note: However, there was a significant between-group difference in change scores from baseline to post-treatment for one gait parameter only (velocity), favoring RAS gait training + NDT vs. NDT alone.

The first fair quality RCT (Schauer & Mauritz, 2003) randomized patients with subacute/chronic stroke to receive gait training with musical motor feedback or conventional gait training. Gait parameters (walking speed, stride length, cadence, symmetry deviation, rollover path length) were measured by computerized foot sensors at post-treatment (3 weeks). Significant within-treatment group improvements were noted for most measures.
Note: This study did not report between-group analyses so is not used to determine level of evidence in the conclusion below.

The second fair quality RCT (Kim et al., 2012) randomized patients with subacute/chronic stroke to receive RAS gait training + conventional physical therapy or conventional physical therapy alone. Gait parameters (velocity, cadence, stride length, cycle time) were measured by the GAITRite system at post-treatment (5 weeks). There were significant between-group differences in two gait parameters (velocity, cadence), favoring RAS gait training + conventional physical therapy vs. conventional physical therapy alone.

Conclusion: There is conflicting evidence (Level 4) from two high quality RCTs regarding the effectiveness of rhythmic auditory stimulation (RAS) gait training in improving gait parameters in patients with stroke. While one high quality RCT found that RAS gait training was more effective than a comparison intervention (NDT gait training), a second high quality RCT reported that RAS gait training + NDT was not more effective than a comparison intervention (NDT alone) in improving gait parameters in patients with stroke. Further, a fair quality RCT reported significant differences in 2 of 4 gait parameters following RAS gait training vs. conventional physical therapy alone. Another fair quality RCT reported improved gait parameters following gait training with music motor feedback.

Sensation
Not effective
1b

One high quality RCT (van Delden et al., 2013) investigated the effect of music interventions on sensation in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing, modified constraint induced movement therapy or conventional rehabilitation. Sensation was measured by the Eramus modification of the Nottingham Sensory Assessment at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point. 

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that modified bilateral arm training with rhythmic auditory cueing is not more effective than comparison interventions (modified constraint induced movement therapy, conventional rehabilitation) in improving sensation in patients with stroke.

Strength
Not effective
1b

One high quality RCT (van Delden et al., 2013) investigated the effect of music interventions on strength in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing, modified constraint induced movement therapy or conventional rehabilitation. Strength was measured by the Motricity Index at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that modified bilateral arm training with rhythmic auditory cueing is not more effective than comparison interventions (modified constraint induced movement therapy, conventional rehabilitation) in improving strength in patients with stroke.

Stroke outcomes
Not effective
1b

One high quality RCT (van Delden et al., 2013) investigated the effect of music interventions on stroke outcomes in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing (mBATRAC), modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Stroke outcomes were measured by the Stroke Impact Scale (SIS – strength, memory, emotion, communication, ADL, mobility, hand function, social participation subtests) at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at post-treatment. Significant between-group differences were found at follow-up (SIS strength, emotion), favoring conventional rehabilitation vs. mBATRAC.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that modified bilateral arm training with rhythmic auditory cueing is not more effective than comparison interventions (modified constraint induced movement therapy, conventional rehabilitation) in improving stroke outcomes in patients with stroke. In fact, modified bilateral arm training with rhythmic auditory cueing was found to be less effective than conventional rehabilitation in improving some stroke outcomes in patients with stroke.

Upper extremity motor activity
Not effective
1b

One high quality RCT (van Delden et al., 2013) investigated the effect of music interventions on upper extremity motor activity in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing, modified constraint induced movement therapy or conventional rehabilitation. Upper extremity motor activity was measured by the Motor Activity Log (amount of use, quality of movement) at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that modified bilateral arm training with rhythmic auditory cueing is not more effective than comparison interventions (modified constraint induced movement therapy, conventional rehabilitation) in improving upper extremity motor activity in patients with stroke.

Upper extremity motor function
Conflicting
4

Two high quality RCTs (Chouhan & Kumar, 2012; van Delden et al., 2013) and one fair quality RCT (Tong et al., 2015) investigated the effect of music interventions on upper extremity motor function in patients with stroke.

The first high quality RCT (Chouhan & Kumar, 2012) randomized patients with acute/subacute stroke to receive gait/fine/gross motor rhythmic auditory stimulation (RAS) training, gait/fine/gross motor visual cueing training, or no training; all groups received conventional rehabilitation. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity subscale (FMA-UE) during treatment (1 and 2 weeks), post-treatment (3 weeks) and follow-up (4 weeks). Significant between-group differences were found at 3 and 4 weeks, favoring RAS training vs. no training. However, significant between-group differences were found at 2, 3 and 4 weeks, favoring visual cueing training vs. RAS training.
Note: There were also significant between-group differences at 2, 3, and 4 weeks, favouring visual cueing training vs. no training.

The second high quality RCT (van Delden et al., 2013) randomized patients with acute/subacute stroke to receive modified bilateral arm training with rhythmic auditory cueing, modified constraint induced movement therapy or conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE and the Action Research Arm Test at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point on any of the measures.

The fair quality RCT (Tong et al., 2015) randomized patients with acute/subacute/chronic stroke to receive music-supported therapy (musical instrument rhythmic training using wooden percussion instruments) or muted music-supported therapy. Upper extremity motor function was measured by the FMA-UE and the Wolf Motor Function Test (WMFT quality, time) at post-treatment (4 weeks). Significant between-group differences were found (WMFT quality, time), favoring music-supported training vs. muted music-supported training.

Conclusion: There is conflicting evidence (Level 4) from two high quality RCTs regarding the effectiveness of rhythmic music interventions in improving upper extremity motor function in patients with stroke. Results from two high quality RCTs indicate that rhythmic auditory stimulation training is more effective than no training; not more effective than (i.e. comparable to) modified constraint induced movement therapy or conventional rehabilitation; and less effective than visual cueing training. Further, a fair quality RCT found that musical instrument rhythmic training is more effective than the comparison intervention (muted music-supported therapy) in improving upper extremity motor function in patients with stroke.

References

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Excluded Studies

Cha, Y., Kim, Y., & Chung, Y. (2014). Immediate effects of rhythmic auditory stimulation with tempo changes on gait in stroke patients. Journal of Physical Therapy Science, 26(4), 479-482.
Reason for exclusion: Cross-sectional observational study, not an intervention RCT.

Chouhan, S., & Kumar, S. (2012). Comparing the effects of rhythmic auditory cueing and visual cueing in acute hemiparetic strokeInternational Journal of Therapy and Rehabilitation, 19(6), 344-351.
Reason for exclusion: Same as Chouhan & Kumar 2012 publication that is already included (manuscript published twice, see references section for details).

Cofrancesco, Elaine M. (1985). The Effect of Music Therapy on Hand Grasp Strength and Functional Task Performance in Stroke Patients. Journal of Music Therapy22 (3), 129-145.
Reason for exclusion: Not RCT.

Cross P., McLellan M., Vomberg E., Monga M., & Monga, T.N. (1984). Observations on the use of music in rehabilitation of stroke patients. Physiotherapy Canada, 36(4), 197-201.
Reason for exclusion: Not RCT.

Dogan, S. K., Tur, B. S., Dilek, L., & Kucukdeveci, A. (2011). Single music therapy session reduces anxiety in patients with stroke/Tek seans muzik terapisi inmeli hastalarda anksiyeteyi azaltir. Turkish Journal of Physical Medicine and Rehabilitation, 12-16.
Reason for exclusion: Not RCT.

Friedman, N., Chan, V., Zondervan, D., Bachman, M., & Reinkensmeyer, D. J. (2011, August). MusicGlove: Motivating and quantifying hand movement rehabilitation by using functional grips to play music. In Engineering in Medicine and Biology Society, EMBC, 2011 Annual International Conference of the IEEE (pp. 2359-2363). IEEE.
Reason for exclusion: Not RCT.

Kim, S. J. (2010). Music therapy protocol development to enhance swallowing training for stroke patients with dysphagiaJournal of Music Therapy, 47(2), 102-119.
Reason for exclusion: Protocol, not RCT.

Kim S.J. & Koh, I. (2005). The Effects of Music on Pain Perception of Stroke Patients during Upper Extremities Joint Exercises. Journal of Music Therapy, 42(1), 81-92.
Reason for exclusion: Not RCT.

Kim, D.S., Park, Y. G., Choi, J.H., Im, S.H., Jung, K.J., Cha, Y.A., Jung, C.O., & Yoon, Y.H. (2011). Effects of music therapy on mood in stroke patients. Yonsei Medical Journal, 52(6), 977-81.
Reason for exclusion: Not RCTquasi-experimental study design with outcomes available in RCTs.

Magee W.L., & Davinson, J.W (2002). The effects of Music Therapy on Mood States in Neurological Patients: A Pilot Study. Journal of Music Therapy, 39(1), 20-29.
Reason for exclusion: Not RCT.

Prassas S., Thaut M., McIntosh G., & Rice, R. (1997). Effect of auditory rhythmic cueing on gait kinematic parameters of stroke patients. Gait and Posture, 6, 218-223.
Reason for exclusion: Not RCT.

Ribeiro, A. S. F., Ramos, A., Bermejo, E., Casero, M., Corrales, J. M., & Grantham, S. (2014). Effects of different musical stimuli in vital signs and facial expressions in patients with cerebral damage: a pilot study. Journal of Neuroscience Nursing, 46(2), 117-124.
Reason for exclusionStroke population less than 50% of the sample.

Trobia, J., Gaggioli, A., & Antonietti, A. (2011). Combined use of music and virtual reality to support mental practice in stroke rehabilitation. Journal of CyberTherapy and Rehabilitation, 4(1), 57-61.
Reason for exclusion: Not RCT.

van Vugt, F. T., Kafczyk, T., Kuhn, W., Rollnik, J. D., Tillmann, B., & Altenmüller, E. (2016). The role of auditory feedback in music-supported stroke rehabilitation: a single-blinded randomised controlled intervention. Restorative Neurology and Neuroscience34(2), 297-311.
Reason for exclusion: Both groups received a type of music therapy; the feedback was variable between groups.

Van Vugt, F. T., Ritter, J., Rollnik, J. D., & Altenmüller, E. (2014). Music-supported motor training after stroke reveals no superiority of synchronization in group therapy. Frontiers in human neuroscience, 8, 315.
Reason for exclusion: Both groups received a form of music therapy.

van Wijck, F., Knox, D., Dodds, C., Cassidy, G., Alexander, G., & MacDonald, R. (2012). Making music after stroke: using musical activities to enhance arm function. Annals of the New York Academy of Sciences, 1252(1), 305-311.
Reason for exclusion: Review.

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