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

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),
Pictures courtesy of Ricardo Miranda,L.Ac
cupping (suction cups on trigger points),
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),
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;Pictures 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; Pictures 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;Pictures 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

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

Two high quality RCTs (Rorsman & Johansson, 2006; Chen 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

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

Two high quality RCTs (Johansson et al., 2001; Park 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

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

Ten high quality RCTs (Gosman-Hedstrom et al., 1998; Johansson et al., 2001; Sze et al., 2002; Park et al., 2005; Hsieh et al., 2007; Hopwood et al., 2008; Zhu et al., 2013; Li et al., 2014; Liu et al., 2016; Xia et al., 2016) and six fair quality RCTs (Hu et al., 1993; Johansson et al., 1993; Wong et al., 1999; Pei et al., 2001; Min et al., 2008; Wang 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

Five high quality RCTs (Gosman-Hedstrom et al., 1998; Johansson et al., 2001; Park et al., 2005; Hopwood et al., 2008; Li 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

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

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

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

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

Five high quality RCTs (Sze et al., 2002; Hsieh et al., 2007; Tan et al., 2013; Li et al., 2014; Liu et al., 2016) and three fair quality RCTs (Johansson et al., 1993; Pei et al., 2001; Min 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

Three high quality RCTs (Hsieh et al., 2007; Zhu et al., 2013; Chen et al., 2016) and two fair quality RCTs (Wong et al., 1999; Min 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

Three high quality RCTs (Hsieh et al., 2007; Zhu et al., 2013; Chen et al., 2016) and two fair quality RCTs (Wong et al., 1999; Min 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

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

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

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

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

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

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

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

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

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.

Subacute phase

Range of motion

Not effective

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

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

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.

Gait parameters

Not effective

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

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.

Health-related quality of life (HRQoL)

Not effective

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.

Impression of improvement

Not effective

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

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.

Motor function

Not effective

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.

Pain

Not effective

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.

Range of motion - upper extremity

Not effective

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.

Spasticity - lower extermity

Not effective

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

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

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.

Phase not specific to one period

Balance

Not effective

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.

Cognitive function

Effective

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

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

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

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

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.

Mobility

Effective

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

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

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

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.

Range of motion

Not effective

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

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.

Stroke outcomes

Not effective

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

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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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 Medicine, 28(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.
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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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Xia, W., Zheng, C., Zhu, S., & Tang, Z. (2016). Does the addition of specific acupuncture to standard swallowing training improve outcomes in patients with dysphagia after stroke? a randomized controlled trial. Clinical Rehabilitation, 30(3), 237-246.
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Depression

Evidence Reviewed as of before: 04-01-2018

Author(s)*: Tatiana Ogourtsova PhD OT; Annabel McDermott OT; Chelsea Hellings BA; Katherine Salter BA; Sanjit Bhogal MSc; Robert Teasell MD; Norine Foley BASc; Mark Speechley PhD; Elissa Sitcoff BSC, BA; Anita Menon, MSc

Patient/Family Information

Introduction

A variety of emotional and behavioural disorders may develop following stroke. Depression, the most common emotional disorder, may affect up to 40% of all patients with stroke. Depression affects every aspect of a person’s life, such as their body, emotions, thoughts and mood. It is much more complex than simply “feeling blue” and is characterized by a persistent and pervasive feeling of sadness or hopelessness. Depression can also be associated with a combination of the following symptoms: poor appetite and weight loss (or conversely weight gain), sleep disturbances (insomnia or hypersomnia), constipation, psychomotor retardation (or conversely agitation), difficulties with concentration and thinking, withdrawal from interpersonal contact, feelings of guilt or self-blame, diminished interest or pleasure in most or all activities, and recurrent thoughts of death or suicidal ideation. Depression can occur early after stroke or in the years following. Detection of post-stroke depression is often overlooked so it is important to use reliable measures when evaluating the patient after stroke.

Various interventions exist for post-stroke depression and are reviewed in this module. These include psychosocial support programs (individual, group or community), cognitive-behavioral therapy, multimodal interventions (exercise + psychoeducation), neuro-linguistic programming therapy, speech therapy, patient-centered counselling, art therapy and wellness therapies (e.g. relaxation therapy, forest therapy, Yoga, Tai Chi, meditation, enriched environments therapy).

Note: Extensive research has investigated the benefits of various drugs such as heterocyclic antidepressants, psychostimulants, and selective serotonin reuptake inhibitors (SSRIs) to treat post-stroke depression. Drug studies are not covered in this module.

Patient/Family Information

Authors: Ying Ying Kan, BSc OT; Chantal Barakat, BSc OT; Martine Sourdif, BSc OT

Since my stroke, I feel sad and depressed. Am I normal?

Mood swings and depression are very common in patients with stroke. In fact, at least 1 person out of 4 will feel depressed or moody after a stroke. Some studies have shown that the rate of depression is even higher, as high as 1 person out of 2.

What is depression after a stroke (post-stroke depression)?

Anyone who has experienced a stroke would agree that it is a big life change. Suddenly daily activities like washing and dressing become a challenge. It is a very difficult experience that can affect your emotions.

What are mood swings?

After a stroke, you may experience rapid changes in mood. For example, you may feel happy, and then suddenly very sad. You may feel that your emotions are like a roller coaster. Some people might cry and laugh at inappropriate times.

Just like depression, these mood swings can appear when there is an injury to a specific area of your brain.

When would depression appear after a stroke?

The time after stroke that depression can appear varies. Some people become depressed shortly after the stroke, in the hours or days later. Others will experience depression much later after stroke, after as long as 3 years.

Are my mood swings/depression caused by my stroke?

It is possible that your mood swings or depression are effects of your stroke. There are two possible explanations of depression post-stroke.

Injury to your brain
Indeed, some areas of your brain control your mood and emotions. If one of these areas is affected by the stroke, it can lead to mood swings or depression.There are debates on whether the site of the lesion is related to depression. Some research indicates that individuals who have a stroke in a specific lobe (frontal) are more likely to experience depression. Other research argues that it is the side of the brain (left or right) where the stroke happened that matters.
Changes in your life skills and abilities
Changes in your physical abilities after a stroke can be very difficult to accept. You may find rehabilitation overwhelming. Everyday tasks now require extra efforts. These feelings of sadness can lead to depression.The real cause of depression is probably a combination of these two theories. That is, depression is due in part to the damages in the brain area and also due to the changes in your life skills and abilities caused by the stroke.

How do I know if I am depressed? What are the common signs of depression after a stroke?

People who are depressed share some common traits such as:

getting angry easily or crying easily.
sleeping too much or too little.
feeling down.
being slow mentally.
feeling guilty.
feeling less hopeful about the future.
not wanting to see friends.
thinking about ending one’s life.

Is it easy to detect depression after a stroke?

It is often difficult to detect depression in a person that has had a stroke. After a stroke, most people will have physical and cognitive problems. Often the treatment will focus more on those two aspects and will forget to include the person’s feelings. Sometimes, people who had a stroke have problems speaking or understanding words; this makes sharing feelings very hard. Thus, it is hard to detect depression as well. Family and close friends are often the first ones to detect signs of depression in their loved one. This is because they know the person better than any health care workers.

How is the diagnosis of depression after a stroke made?

Your clinician may ask you a series of questions or have you fill out a questionnaire. This will help to identify any signs of depression.

Are there different kinds of therapies for depression?

There are many different therapies available for depression after stroke. Those include:

Art therapy – activities to stimulate cognition, physical state, emotion, communication, social relation and spiritual dimensions (e.g. meditation with music, singing activity, group-healing circle, positive thinking, story sharing).
Coordinated discharge care – regular follow-up with a stroke nurse following discharge.
Counselling / stroke counselling and education support program –recommendations, education, and advice.
Enriched environment inpatient program – equipment and organization of a stimulating environment as well as activities in the medical ward: computers with internet connection, Skype access, Gaming Therapy, library with reading material, music station, life-size mirrors, simulated shopping corner with groceries, electronic payment machine, automatic back teller machine, board games, puzzles, chess, painting, and wood workshop.
Exercise – physical exercises (e.g. walking, stationary bicycle, weight lifting).
Forest therapy – taking long walks in the forest/nature, meditate in the forest.
Multimodal interventions –physical exercises and education together.
Neurolinguistic programming therapy – techniques aimed at shifting negative thoughts or beliefs/bad moods, increasing mental energy, releasing pressure and relaxation
Psychotherapy/Cognitive Behavioral Therapy – teaches people how to change their thinking in order to change their behavior.
Relaxation – listening to soothing music and practice meditation.
Speech therapy – training to help people with speech/language problems and depression to speak more clearly or express themselves in different ways that are more comprehensible.
Supportive home rehabilitation programs – home exercises and education.
Tai Chi – slow movement exercises and meditation.
Yoga – breath control, simple meditation, and adoption of specific bodily postures.

What depression therapies work for stroke?

Depression therapies have been examined using high quality research studies and were shown to improve depression (and other important domains such as cognitive function, anxiety, quality of life) in some patients after stroke.

In particular, for patients with acute stroke (up to 1 month after stroke): counselling, , multimodal interventions (exercises + education), neurolinguistic programming therapy and supportive home rehabilitation programs have been shown to be useful to improve depression, and other abilities/domains.

For patients with subacute stroke (from 1 to 6 months after stroke), exercise has been shown to be useful to improve depression.

For patients with chronic stroke (more than 6 months after stroke), forest therapy and relaxation have been shown to be useful to improve anxiety and depression.

For patients with stroke across the recovery continuum (acute, subacute and/or chronic), art therapy, cognitive behavioral therapy, and enriched environment inpatient program have been shown to be useful to improve depression/mood/anxiety.

What can I expect?

Your therapist will discuss with you what depression 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 depression therapies: neuropsychologist, nurse, occupational therapists, physical therapists, psychologist and speech language pathologist.

Are there any side effects or risks?

Depression therapies are usually administered by a trained health professional at a rehabilitation clinic or at home (in cases of home programs). Your therapist will monitor your reactions to the therapy closely. It is important to report to your therapist any changes in your feelings or thoughts. Your therapist will adjust the nature, intensity and the duration of therapy according to your ability, endurance and progress.

Can sleeping and eating well help?

Sure! Having proper meals and good sleep will give you more energy during your recovery. You may feel you are not hungry or you have difficulty sleeping. This is common with people who are depressed.

Should I exercise?

Yes. It is important, however, to know your own abilities and limitations when you are exercising.

If your doctor agrees, you may start an exercise class. Exercising releases an hormone (endorphin) that will make you feel good.

For information about exercise after a stroke, see Aerobic Exercise Late After Stroke or Aerobic Exercise Early After Stroke.

Should I continue my rehabilitation program if I do not feel like doing it?

Yes. It is possible that you may not feel motivated to go to your rehabilitation sessions. It is hard and demands a lot of energy. However, rehabilitation sessions will teach you many things that will help you feel independent (dressing, walking). You will be proud of yourself and feel more motivated.

Why should I bother seeing people?

Having a social life has been shown to have a positive impact on helping depression. It is very important that you continue having hobbies, such as playing cards, doing cross-words, or going outside. Your occupational therapist can show you possible ways to adapt your hobby, since certain activities may need to be modified after a stroke.

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:

Canada: Heart and Stroke Foundation

How does my depression impact on my recovery?

Indeed, being depressed may slow down your recovery. Depression may make you feel less motivated and more tired, and also may cause you to have trouble concentrating. All these symptoms of depression will slow down your recovery capacities. Many studies have shown that people with depression after a stroke do not get better as quickly as people who are not depressed. The extent to which depression can affect recovery is not really known. It seems that both physical loss and depression can act on recovery.

Will depression ever get better?

Some studies show that people who are depressed can get better. On average, the duration of major depression in people who have had a stroke is under a year. However, sometimes depression can return, so it is important to watch for the signs.

How long does it take to recover from depression after a stroke?

Recovery from depression after a stroke takes time. It can vary a lot from one person to another. For example, medication can take a few weeks to work. With treatment, people who are depressed usually get better. As mentioned above, the average duration of major depression for people who have had a stroke is a year.

Does depression lead to stroke?

Not everybody who is depressed will experience a stroke. However, some studies have shown that being depressed may increase the chances of having a stroke. When heart disease, hypertension, diabetes, and tobacco use are all ruled out, depressed people are 2.6 times more likely to report a stroke.

If I was depressed before my stroke, am I more likely to be depressed after my stroke?

Yes, if you were depressed before your stroke, you have more chances to be depressed after. This is one of the risk factors linked with depression after the stroke.

As a care provider, what can I do to avoid being depressed too?

The care provider is the one who takes care of the person who has had a stroke. Usually this person is a family member, a spouse, or a close friend. Often, the care provider will be so devoted to their loved one that they will forget to take care of their own needs.

When your loved one is depressed after a stroke, it is more difficult for both of you to stay positive, so it is especially important that you both receive support. Thus, it is very important that you, as a care provider, take time for yourself everyday. Find a moment during the day to do an activity you like such as reading or shopping. Moreover, you should continue to see your friends to share your feelings and refresh your mind.

I would like to know more about depression and stroke

Understanding how depression and stroke happen can reassure you. There are many resources online. Your health care provider can help answer your specific questions.

Clinician Information

The present module reviews 28 RCTs including 22 high quality and six fair quality studies. Studies were included in the module only if depression and/or mood/affect were the primary outcomes. Secondary outcomes have also been included in this module.

Other StrokEngine modules also include depression as an outcome of the intervention: Acupuncture, Aerobic Exercise, Music-based Interventions, Transcranial Magnetic Stimulation and Virtual Reality-Upper Extremity. Please refer to those modules for more details.

Extensive research has investigated the benefits of various drugs such as heterocyclic antidepressants, psychostimulants, and selective serotonin reuptake inhibitors (SSRIs) to treat post-stroke depression. Drug studies are not covered in this module; other types of rehabilitative interventions to treat post-stroke depression will be explored.

Results Table

View results table

Outcomes

Acute phase - Counseling

Depression

Effective

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on depression in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Depression was measured by the Yale Single Question at follow-up (3 months and 12 months post-stroke). Significant between-group difference was found at 3 months post-stroke, favoring counseling vs. no treatment. This difference did not remain significant at 12 months.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is more effective than no treatment in improving depression in patients with acute stroke, in the short term.

Functional independence

Not effective

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Functional independence was measured by the Barthel Index at follow-up (3 months and 12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving functional independence in patients with acute stroke.

Instrumental activities of daily living

Not effective

One high quality RCT (Watkins et al., 2011) investigated the effect of counseling on instrumental activities of daily living (IADLs) in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. IADLs were measured by the Nottingham Extended Activities of Daily Living at follow-up (12 months post-stroke). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving instrumental activities of daily living in patients with acute stroke.

Mood and affect

Effective

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on mood and affect in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Mood and affect was measured by the General Health Questionnaire-28 at follow-up (3 months and 12 months post-stroke). Significant between-group difference was found at both follow-up points, favoring counseling vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is more effective than no treatment in improving mood and affect in patients with acute stroke.

Recovery beliefs and expectations

Not effective

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on recovery beliefs and expectations in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual strokecare. Recovery beliefs and expectations were measured by the Stroke Expectations Questionnaire (Beliefs, Expectations, Differences between beliefs and expectations) at follow-up (3 months and 12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving recovery beliefs and expectations in patients with acute stroke.

Acute phase – Individual multimodal home intervention

Cognitve function

Not effective

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on cognitive function in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Cognitive function was measured by the Thai Mental State Examination at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital). 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 follow-up report that an individual multimodal home intervention is not more effective than a comparison intervention (standard care) in improving cognitive function in patients with acute stroke.

Depression

Effective

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on depression in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Depression was measured by the Hospital Anxiety and Depression Scale (HADS: depression) at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital). Significant between-group difference was found at both time points, favoring individual multimodal home rehabilitation vs. standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one follow-up report that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving depression in patients with acute stroke.

Functional independence

Effective

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Functional independence was measured by the Barthel Index (BI) and the Modified Rankin Scale (MRS) at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital, BI only). Significant between-group differences were found at post-treatment (BI, MRS) and at follow-up (BI), favoring individual multimodal home intervention vs. standard care.
Note: The Modified Rankin Scale measure was not used at the time of the follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one follow-up repot that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving functional independence in patients with acute stroke.

Health related quality of life

Effective

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) investigated the effect of an individual multimodal home intervention on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Health-related quality of life was measured by the EQ-5D at post-treatment (3 months). Significant between-group difference was found, favoring individual multimodal home intervention vs. standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving health-related quality of life in patients with acute stroke.

Acute phase - Multimodal intervention

Anxiety

Not effective

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) investigated the effect of a multimodal intervention on anxiety in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety subscale) at 1-year post-stroke (follow-up). No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Anxiety was measured by the HADS (Anxiety subscale) at post-treatment (8 weeks) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that multimodal interventions are not more effective than a comparison intervention (standard care) in reducing anxiety in patients with acute stroke.

Depression

Not effective

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) investigated the effect of a multimodal intervention on depression in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression subscale) at 1-year post-stroke follow-up. No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Depression was measured by the HADS (Depression subscale) and the Profile of Mood States (PMS – Depression subscale) at post-treatment (8 weeks) and follow-up (12 months). There were no significant between-group difference at either time point.

Functional independence

Effective

One fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on functional independence in patients with acute stroke. This fair quality RCT randomized patients to receive psychology + physical rehabilitation or no treatment. Functional independence was measured by the Barthel Index at 90 days (follow-up). Significant between-group difference was found, favoring multimodal intervention vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that multimodal intervention is more effective than no treatment in improving functional independence in patients with acute stroke.

Health related quality of life

Effective

One high quality RCT (Faulkner et al., 2015) investigated the effect of a multimodal intervention on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Change in health-related quality of life was measured by the Short-Form 36 (SF-36 – Physical component, Mental component, Mental health, Social functioning, Global health, Role physical, Role emotional, Vitality, Bodily pain, Physical functioning subscales) from baseline to post-treatment (8 weeks) and to follow-up (12 months). Significant between-group difference was found on some aspects of health-related quality of life from baseline to post-treatment (SF-36 – Physical component, Global health, Role physical, Vitality, Physical functioning) favoring multimodal intervention vs. standard care. This difference was not maintained at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention is more effective than a comparison intervention (standard care) in improving some aspects of health-related quality of life in patients with acute stroke, in the short term.

Impairments

Effective

One fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on impairments in patients with acute stroke. This fair quality RCT randomized patients to receive psychology + physical rehabilitation or no treatment. Impairments were measured by the European Stroke Scale at day 3 and day 21 of treatment. While there were no significant difference between groups at day 3 of treatment, significant between-group difference was found at day 21, favoring multimodal intervention vs. no treatment.

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

Mood and affect

Not effective

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) and one fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on mood and affect in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Overall mood was measured by the Hospital Anxiety and Depression Scale (HADS) Total score at 1-year post-stroke follow-up. No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Mood and affect were measured by the Profile of Mood States (PMS – Vigor, Confusion, Tension, Anger, Fatigue, Depression) at post-treatment (8 weeks) and follow-up (12 months). A significant between-group difference in change scores from post-treatment to follow-up of one measure of mood and affect (PMS – Fatigue) was found, favoring multimodal intervention vs. standard care.

The fair quality RCT (Wu et al., 2012) randomized patients to receive psychology + physical rehabilitation or no treatment. Mood and affect were measured by the Taita Symptom Checklist (TSCL-90 – Somatization, Obsession, Interpersonal sensitivity, Depression, Anxiety, Hostility, Fear, Paranoia, Mental disease subscores) at day 3 and day 21 of treatment. While there were no significant between-group difference at day 3 of treatment, significant between-group difference was found for most measures of mood and affect (TSCL-90 – Somatization, Obsession, Depression, Anxiety, Hostility, Fear, Mental disease) at day 21, favouring multimodal intervention vs. no treatment.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a multimodal intervention is not more effective than a comparison intervention (standard care) in improving mood and affect in patients with acute stroke. However, one fair quality RCT found that a multimodal intervention in the form of psychological + comprehensive rehabilitation training is more effective than no treatment in improving some measures of mood and affect in patients with acute stroke.

Physical activity/inactivity

Not effective

One high quality RCT (Faulkner et al., 2015) investigate the effect of a multimodal intervention on physical activity and inactivity in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Physical activity/inactivity was measured by the International Physical Activity Questionnaire at post-treatment (8 weeks) and at follow-up (12 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 is not more effective than a comparison intervention (standard care) in improving physical activity/inactivity in patients with acute stroke.

Stroke awareness

Effective

One high quality RCT (Faulkner et al., 2015) investigated the effect of a multimodal intervention on stroke awareness in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Stroke awareness was measured by the Stroke Awareness Questionnaire at baseline, post-treatment (8 weeks) and at follow-up (12 months). Significant between-group difference in stroke awareness scores was found from baseline to post-treatment, favoring multimodal intervention vs. usual care. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention is more effective than a comparison intervention (standard care) in improving stroke awareness in patients with acute stroke, in the short term.

Acute phase - Neuro-linguistic programming therapy and education

Anxiety

Effective

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on anxiety in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Anxiety was measured by the Hamilton Anxiety Scale at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at post-treatment, favoring NLP therapy + health education vs. no treatment. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in reducing anxiety in patients with acute stroke, in the short term.

Depression

Effective

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on depression in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Depression was measured by the Hamilton-17 Depression Scale at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at post-treatment, favoring NLP therapy + health education vs. no treatment. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving depression in patients with acute stroke, in the short term.

Functional independence

Effective

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Functional independence was measured by the Barthel Index at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at both time points, favoring NLP therapy + health education vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving functional independence in patients with acute stroke.

Health related quality of life

Effective

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Health-related quality of life was measured by the Quality of Life Index at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at both time points, favoring NLP therapy + health education vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving health-related quality of life in patients with acute stroke.

Stroke awareness

Effective

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on stroke awareness in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Stroke awareness was measured by the Stroke Knowledge Questionnaire at post-treatment (2 weeks). Significant between-group difference was found favoring NLP therapy + health education vs. no treatment.
Note: The Stroke Knowledge Questionnaire was not used at the time of the follow-up.

Conclusion: There is moderate evidence (Level 1b) from one fair quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving stroke awareness in patients with acute stroke.

Subacute phase - Exercise training

Depression

Conflicting

Two high quality RCTs (Lai et al., 2006; Holmgren et al., 2010) investigated the effect of exercise training on depression in patients with subacute stroke.

The first high quality RCT (Lai et al., 2006) randomized patients to receive exercise training or standard care. Depression was measured by the Geriatric Depression Scale 15 (GDS-15 – mean score, score ≥ 6) at post-treatment (3 months) and at follow-up (9 months). Significant between-group difference was found at post-treatment (GDS-15 mean score, score ≥ 6), and at follow-up (GDS-15 score ≥ 6), favoring exercises training vs. standard care.

The second high quality RCT (Holmgren et al., 2010) randomized patients to receive high-intensity functional exercises + group discussions or group discussions alone. Depression was measured by the GDS-15 at post-treatment (5 weeks) and follow-up (3, 6 months). No significant between-group difference was found at any time point.

Conclusion: There is conflicting evidence regarding the effect of exercise training on depression in patients with subacute stroke. While one high quality RCT found that exercise training is more effective than standard care, another high quality RCT found that high-intensity functional exercises + group discussions is not more effective than group discussions alone in improving depression in patients with subacute stroke.
Note: The differences in the treatment duration (3 months vs. 5 weeks) might justify the differences in findings across these two studies.

Mood and affect

Effective

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on mood and affect in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Mood and affect were measured by the Stroke Impact Scale (SIS – Emotion score) and the Short-Form-36 (SF-36 – Emotion score) at post-treatment (3 months) and at follow-up (9 months). Significant between-group differences in both measures were found at post-treatment, favoring exercises training vs. standard care. Between-group differences were not maintained at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exercise training is more effective than a comparison intervention (standard care) in improving mood and affect in patients with subacute stroke, in the short term.

Physical comorbidity

Not effective

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on physical comorbidity in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Physical comorbidity was measured by the Duke Comorbidity Scale at post-treatment (3 months) and at follow-up (9 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 exercise training is not more effective than a comparison intervention (standard care) in reducing physical comorbidity in patients with subacute stroke.

Quality of life

Not effective

One high quality RCT (Holmgren et al., 2010) investigated the effects of exercise training on quality of life in patients with subacute stroke. This high quality RCT randomized patients to receive high-intensity functional exercises + group discussions or group discussion alone. Quality of life was measured by the Short-Form-36 (SF-36 – Physical Component Scale, Mental Component Scale, Physical functioning, Role functioning physical/emotional, Bodily pain, General health, Vitality, Social functioning, Mental health subscores) at post-treatment (5 weeks) and follow-up (3, 6 months). There were no significant difference at post-treatment. Significant between-group difference was found in two measures of quality of life at 3-month follow-up (SF-36 – Mental Component Scale, Mental health subscore), favoring group discussion alone vs. high-intensity functional exercises + group discussions. Difference did not remain significant at 6-month follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that high-intensity functional exercises + group discussions is not more effective than a comparison intervention (group discussions alone) in improving quality of life in patients with subacute stroke. In fact, high-intensity functional exercises + group discussions was found to be less effective than group discussion alone in improving 2 components of quality of life in patients with subacute stroke.

Social support

Not effective

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on social support in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Social support was measured by the Pearlin Expressive Social Support Scale at post-treatment (3 months) and at follow-up (9 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 exercise training is not more effective than a comparison intervention (standard care) in improving social support in patients with subacute stroke.

Subacute phase - Speech therapy

Mood and affect

Not effective

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on mood and affect in patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Mood and affect were measured by the Mood Rating Scale (Angry-calm, Sad-happy, Afraid-secure, Anxious-relaxed, Depressed-cheerful, Frustrated-contented items) and the Multiple Adjective Checklist (Anxiety, Depression, Hostility subscores) at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group differences were found on both outcome measures at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving mood and affect in patients with subacute stroke.

Spousal depression

Not effective

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on depression among spouses of patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Spousal depression was measured by the Wakefield Depression Inventory at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving depression among spouses of patients with subacute stroke.

Spousal mental health

Not effective

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on mental health of spouses of patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Spousal mental health was measured by the Goldberg General Health Questionnaire at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving mental health of spouses of patients with subacute stroke.

Chronic phase - Autogenic relaxation

Anxiety

Effective

One high quality RCT (Golding et al., 2016) and a follow-up report (Golding et al., 2017a) investigated the effect of an autogenic relaxation program on anxiety in patients with chronic stroke. This high quality RCT randomized patients to receive an autogenic relaxation program or no treatment (waiting list). Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety subscale) at baseline, at post-treatment (1 month), and follow-up (2 and 3 months, and 12 months). Significant between-group difference was found at post-treatment and follow-up (2 and 3 months), favoring the autogenic relaxation program vs. no treatment. Between-group analyses were not conducted at 12-month follow-up. However, both groups demonstrated significantly reduced anxiety from baseline to 12-month follow-up, at which timepoint all participants had received the intervention.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an autogenic relaxation program is more effective than no treatment in reducing anxiety in patients with chronic stroke.

Depression

Not effective

One high quality RCT (Golding et al., 2017b) investigated the effect of an autogenic relaxation program on anxiety in patients with chronic stroke. This high quality RCT randomized patients to receive an autogenic relaxation program or no treatment (waiting list). Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression subscale) at post-treatment (1 month) and follow-up (2 and 3 months, and 12 months). No significant between-group difference was found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an autogenic relaxation program is not more effective than no treatment in improving depression in patients with chronic stroke.

Chronic phase - Forest therapy

Anxiety

Effective

One fair quality RCT (Chun et al., 2017) investigated the effect of forest therapy on anxiety in patients with chronic stroke. This fair quality RCT randomized patients to receive forest therapy or urban therapy in group format. Anxiety was measured by the Spielberger State-Trait Anxiety Inventory at post-treatment (4 days). Significant between-group difference was found favoring forest therapy vs. urban therapy.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that forest therapy is more effective than a comparison intervention (urban therapy) in reducing anxiety in patients with chronic stroke.

Depression

Effective

One fair quality RCT (Chun et al., 2017) investigated the effect of forest therapy on depression in patients with chronic stroke. This fair quality RCT randomized patients to receive forest therapy or urban therapy in group format. Depression was measured by the Beck Depression Inventory and the Hamilton Depression Rating Scale at post-treatment (4 days). Significant between-group differences were found at post-treatment on both outcome measures of depression, favoring forest therapy vs. urban therapy.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that forest therapy is more effective than a comparison intervention (urban therapy) in improving depression in patients with chronic stroke.

Chronic phase - Yoga

Anxiety

Not effective

Two high quality RCTs (Chan, Immink & Hillier, 2012; Immink et al., 2014) investigated the effect of yoga on anxiety in patients with chronic stroke.

The first high quality RCT (Chan, Immink & Hillier, 2012) randomized patients to receive yoga + exercises or exercises alone. Anxiety was measured by the State-Trait Anxiety Inventory (STAI – State anxiety, Trait anxiety scores) at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Immink et al., 2014) randomized patients to receive yoga or no treatment (waiting list). Anxiety was measured by the STAI (State anxiety, Trait anxiety scores) at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that yoga is not more effective than comparison intervention (exercises alone, no treatment) in reducing anxiety in patients with chronic stroke.

Balance

Not effective

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on balance in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Balance was measured by the Berg Balance 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 that yoga is not more effective than no treatment in improving balance in patients with chronic stroke.

Depression

Not effective

Two high quality RCTs (Chan, Immink & Hillier, 2012; Immink et al., 2014) investigated the effect of yoga on depression in patients with chronic stroke.

The first high quality RCT (Chan, Immink & Hillier, 2012) randomized patients to receive yoga + exercises or exercises alone. Depression was measured by the Geriatric Depression Scale – Short Form 15 (GDS-15) at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Immink et al., 2014) randomized patients to receive yoga or no treatment (waiting list). Depression was measured by the GDS-15 at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that yoga is not more effective than comparison interventions (exercises alone, no treatment) in improving depression in patients with chronic stroke.

Mobility

Not effective

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on mobility in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Mobility was measured by the 2-Minute Walking Distance test at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving mobility in patients with chronic stroke.

Motor function

Not effective

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on motor function in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Motor function was measured by the Motor 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 that yoga is not more effective than no treatment in improving motor function in patients with chronic stroke.

Stroke outcomes

Not effective

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on stroke outcomes in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Stroke outcomes were measured by the Stroke Impact Scale (SIS – Physical, Emotion, Memory, Communication, Social participation, Stroke recovery subscores) at post-treatment (10 weeks). Significant between-group difference was found for only one stroke outcome (SIS – Memory), favoring yoga vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving stroke outcomes in patients with chronic stroke.

Walking speed

Not effective

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on walking speed in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Walking speed was measured by the Comfortable Gait Speed test at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving walking speed in patients with chronic stroke.

Phase not specific to one period - Art therapy

Anxiety

Not effective

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on anxiety in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety 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 art therapy is not more effective than no art therapy (physical therapy alone) in reducing anxiety in patients with stroke.

Cognition

Not effective

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on cognition in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Cognition was measured by the Abbreviated Mental Test 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 art therapy is not more effective than no art therapy (physical therapy alone) in improving cognition in patients with stroke.

Depression

Effective

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on depression in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression score) at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is more effective than no art therapy (physical therapy alone) in improving depression in patients with stroke.

Functional independence

Effective

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on functional independence in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Functional independence was measured by the Modified Barthel Index at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

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

Health related quality of life

Effective

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. HRQoL was measured by the Pictorial Thai Quality of Life Questionnaire at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is more effective than no art therapy (physical therapy alone) in improving health-related quality of life in patients with stroke.

Phase not specific to one period - Cognitive behavioral therapy

Anger

Effective

One fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on anger in patients with stroke. This fair quality RCT randomized patients with acute / subacute / chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional therapy. Anger was measured by the State-Trait Anger Expression Inventory (STAXI – State anger, Hostility, Anger-in, Anger-out, Anger control items) at baseline and at post-treatment (1 month). Significant between-group difference in anger (STAXI – State anger, Anger-out, Anger control) change scores from baseline to post-treatment was found in favor of CBT vs. no CBT. In contrast, significant between-group difference in anger (STAXI – Anger-in) change scores from baseline to post-treatment was found in favor of no CBT vs. CBT.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that cognitive behavioral therapy is more effective than no CBT in improving some aspects of anger in patients with stroke.

Anxiety

Not effective

Two high quality RCTs (Hoffmann et al., 2015; Kootker et al., 2017) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on anxiety in patients with stroke.

The first high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety score) and the State-Trait Anxiety Inventory (STAI – Trait anxiety, State anxiety scores) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found on both outcome measures at either time point.

The second high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Anxiety was measured by the HADS (Anxiety score) at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at any time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Anxiety was measured by the Hamilton Anxiety Rating Scale at post-treatment (1 month). 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 cognitive behavioral therapy is not more effective than a comparison intervention (self-management intervention, computerized cognitive therapy, no treatment) in reducing anxiety in patients with stroke.

Caregiver burden

Not effective

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on burden among caregivers of patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Caregivers’ burden was measured by the Caregiver Strain Index at follow-up (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving caregiver burden following stroke.

Coping

Not effective

One high quality RCT (Kootker et al., 2017) investigated the effect of cognitive behavioral therapy (CBT) on coping in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation / communication strategies) or computerized cognitive therapy. Coping was measured by the Utrecht Proactive Coping Competence Life Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than a comparison intervention (computerized cognitive training) in improving coping in patients with stroke.

Depression

Not effective

Four high quality RCTs (Lincoln & Flannaghan, 2003; Thomas et al., 2012; Hoffmann et al., 2015; Kootker et al., 2017) and two fair quality RCTs (Chang et al., 2011; Alexopoulos et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on depression in patients with stroke.

The first high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. Depression was measured by the Beck Depression Inventory and the Wakefield Self-Assessment of Depression Inventory at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found on both outcome measures at either time point.

The second high quality RCT (Thomas et al., 2012) randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Depression was measured by the Stroke Aphasia Depression Questionnaire 21-item hospital version at post-treatment (3 months) and follow-up (6 months). No significant between-group difference was found at post-treatment, however a significant between-group difference in depression was found at follow-up, favoring CBT vs. no CBT.

The third high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression score) and the Montgomery and Asberg Depression Rating Scale at post-treatment (8 sessions) and follow-up (3 months). A significant between-group difference in one measure of depression (HADS – Depression) was found at post-treatment, favoring CBT vs. no treatment. Differences did not remain significant at follow-up. No other between-group differences were found.

The fourth high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Depression was measured by the HADS (Depression score) and the Post-Stroke Depression Rating Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group differences were found on both outcome measures at any time point.

The first fair quality RCT (Chang et al., 2011) randomized patients with acute / subacute / chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Depression was measured by the Hamilton Depression Rating Scale (HDRS) at baseline and at post-treatment (1 month). Significant between-group difference in depression change scores from baseline to post-treatment was found, favoring CBT vs. no CBT.

The second fair quality RCT (Alexopoulos et al., 2012) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (Ecosystem Focused Therapy: education and behavioral training, goal setting) or education on stroke and depression. Depression was measured by the HDRS at post-treatment (3 months). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs and one fair quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, no treatment, self-management intervention, computerized cognitive therapy, education on stroke and depression) in improving depression in patients with stroke.
Note: However, one high quality RCT saw significant between-group differences in one measure of depression immediately following CBT versus no treatment; a fair quality RCT also found differences in depression in favour of CBT vs. no CBT. In addition, one of the high quality RCTs that saw no difference between CBT and no CBT immediately post-treatment found CBT to be more effective than no CBT at 6-month follow-up.

Disability

Not effective

One high quality RCT (Lincoln & Flannaghan, 2003) and one fair quality RCT (Alexopoulos et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on disability in patients with stroke.

The high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. Disability was measured by the London Handicap Scale at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at any time point.

The fair quality RCT (Alexopoulos et al., 2012) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (Ecosystem Focused Therapy: education and behavioral training, goal setting) or education on stroke and depression. Disability was measured by the World Health Organization Disability Assessment Schedule II at post-treatment (3 months). Significant between-group difference was found favoring CBT vs. education.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, no treatment) in improving disability in patients with stroke.
Note: However, one fair quality RCT found that CBT was more effective than a comparison intervention (education on stroke and depression) in improving disability in patients with stroke.

Functional independence

Not effective

One high quality RCT (Hoffmann et al., 2015) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on functional independence in patients with stroke.

The high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Functional independence was measured by the modified Barthel Index (mBI) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Functional independence was measured by the BI at baseline and at post-treatment (1 month). Significant between-group difference in functional independence change scores from baseline to post-treatment was found, favoring CBT vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (self-management intervention, no treatment) in improving functional independence in patients with stroke.
Note: However, one fair quality RCT found that CBT is more effective than no CBT in improving functional independence in patients with stroke.

Health related quality of life

Not effective

Two high quality RCTs (Hoffmann et al., 2015; Kootker et al., 2017) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on health-related quality of life (HRQoL) in patients with stroke.

The first high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. HRQoL was measured by the Stroke and Aphasia Quality of Life Scale (SAQoL – General, Psychosocial, Physical, Communication subscores) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

The second high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. HRQoL was measured by the Life Satisfaction Questionnaire and the Stroke Specific Quality of Life (SSQoL) Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group differences were found on both outcome measures at any time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. HRQoL was measured by the SSQoL at baseline and post-treatment (1 month). Significant between-group difference in SSQoL change scores from baseline to post-treatment was found, favoring CBT vs. no treatment.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that cognitive behavioral therapy is not more effective than comparison interventions (self-management intervention, no treatment, computerized cognitive therapy) in improving health-related quality of life in patients with stroke.
Note: However, one fair quality RCT found that CBT was more effective than no CBT in improving health-related quality of life in patients with stroke.

Instrumental activities of daily living

Not effective

Two high quality RCTs (Lincoln & Flannaghan, 2003; Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on instrumental activities of daily living (IADLs) in patients with stroke.

The first high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. IADLs were measured by the Extended Activities of Daily Living Scale at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at either time point.

The second high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. IADLs were measured by the Nottingham Extended Activities of Daily Living Scale at post-treatment (8 sessions) and follow-up (3 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 cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, self-management intervention, no treatment) in improving instrumental activities of daily living in patients with stroke.

Leisure

Not effective

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on leisure in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Leisure was measured by the Nottingham Leisure Questionnaire at post-treatment (3 months) and follow-up (6 months). While no significant between-group difference was found at post-treatment, a significant between-group difference in leisure was found at follow-up, favoring CBT vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving leisure in patients with stroke.

Mood and affect

Effective

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on mood and affect in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Mood and affect was measured by the Visual Analogue Mood Scale (Sad item) at post-treatment (3 months) and follow-up (6 months). A significant between-group difference was found at both time points, favoring CBT vs. no CBT.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no CBT in improving mood and affect in patients with stroke.

Satisfaction with care

Not effective

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on satisfaction with care in patients with stroke and their caregivers. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Patients’ and carers’ satisfaction with care was measured by the Visual Analogue Satisfaction with Care Rating at follow-up (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving satisfaction with care in patients with stroke.

Self-efficacy

Not effective

One high quality RCT (Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on self-efficacy in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Self-efficacy was measured by the Stroke Self-Efficacy Questionnaire at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

Self-esteem

Effective

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on self-esteem in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Self-esteem was measured by the Visual Analogue Self-Esteem Scale at post-treatment (3 months) and follow-up (6 months). A significant between-group difference in self-esteem was found at both time points, favoring CBT vs. no CBT.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no CBT in improving self-esteem in patients with stroke.

Social participation

Not effective

One high quality RCT (Kootker et al., 2017) investigated the effect of cognitive behavioral therapy (CBT) on social participation in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Social participation was measured by the Utrecht Scale for Evaluation of Rehabilitation (Participation subscale) at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at either time point.

Stroke knowledge

Effective

One high quality RCT (Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on stroke knowledge in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Stroke knowledge was measured by the Stroke Knowledge Questionnaire at post-treatment (8 sessions) and follow-up (3 months). Significant between-group differences were found for stroke knowledge at post-treatment, favoring CBT vs. no treatment. These differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no treatment in improving self-efficacy in patients with stroke.
Note: CBT was not more effective than a comparison intervention (self-management intervention) in improving stroke knowledge.

Phase not specific to one period - Discharge care coordination

Adherence to self-management practices

Effective

One fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on adherence to self-management practices in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. Adherence to self-management practices was measured by the number of incidences in which patients did not follow through with self-management practices (medication regimen, medical appointments, dietary requirements, home exercise program, stress reduction, and other individualized recommendations) at follow-up (3 months post-discharge). Significant between-group difference was found favoring care coordination vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that discharge care coordination is more effective than no treatment in improving adherence to self-management practices in patients with stroke.

Caregiver burden

Effective

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on burden among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Caregivers’ burden was measured by the Caregiver Strain Index at baseline, at post-treatment (3 months post-stroke), and at follow-up (12 months post-stroke). Significant between-group difference was found at post-treatment, favoring discharge education and support vs. usual care. In addition, there were significant between-group difference in caregiver burden change scores from baseline to follow-up, favoring discharge education and support vs. usual care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that discharge support and education from a stroke nurse is more effective than a comparison intervention (usual discharge care) in improving caregiver’s burden among caregivers of patient with stroke.

Depression

Conflicting

Two high quality RCTs (Burton & Gibbon, 2005; Graven et al., 2016) and one fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on depression among patients with stroke.

The first high quality RCT (Burton & Gibbon, 2005) randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Depression was measured by the Beck Depression Inventory at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). No significant between-group difference was found at either time point.

The high quality RCT (Graven et al., 2016) randomized patients with acute/subacute stroke to receive multimodal discharge management (liaison with services, education, follow-up) or standard discharge care. Depression was measured by the Geriatric Depression Scale (GDS-15) at follow-up (1 year post-stroke). Significant between-group difference was found favoring multimodal discharge management vs. standard discharge care.

The fair quality RCT (Clairborne, 2006) randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. Depression was measured by the GDS-15 at follow-up (3 months post-discharge). Significant between-group difference was found at follow-up, favoring care coordination vs. no treatment.

Conclusion: There is conflicting evidence (Level 4) on the effect of discharge care coordination in improving depression in patients with stroke. While one high quality RCT found that discharge support and education from a stroke nurse is not more effective than usual discharge care; another high quality RCT and a fair quality RCT found that discharge care coordination is more effective than usual discharge care in improving depression in patients with stroke.
Note: Differences in outcomes measures used could explain the differences in found treatment effects across these studies.

Functional independence

Effective

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on functional independence in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Functional independence was measured by the Barthel Index at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). While no significant between-group difference was found at post-treatment, there was a significant between-group difference in change scores from 3 to 12 months, favoring discharge support vs. usual discharge care.

Health related quality of life

Effective

One high quality RCT (Burton & Gibbon, 2005) and one fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on health-related quality of life (HRQoL) in patients with stroke.

The high quality RCT (Burton & Gibbon, 2005) randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. HRQoL was measured by the Nottingham Health Profile (NHP – Total score, Energy, Emotional reaction, Physical mobility, Pain, Social isolation, Sleep subscores) at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). Significant between-group difference was found at post-treatment (NHP – Emotional reaction, Pain, Social isolation), and at follow-up (NHP – Emotional reaction, Social isolation, Total score), favoring discharge support and education vs. usual care.

The fair quality RCT (Clairborne, 2006) randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. HRQoL was measured by the Short-Form 36 (SF-36 – Physical Component Summary; SF-36 – Mental Component Summary) at follow-up (3 months post-discharge). Significant between-group difference was found (SF-36 – Mental Component Summary) favoring care coordination vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that discharge care coordination is more effective than comparison interventions (usual discharge care, no treatment) in improving aspects of health-related quality of life in patients with stroke.

Instrumental activities of daily living

Not effective

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on instrumental activities of daily living (IADLs) in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. IADLs were measured by the Frenchay Activities Index at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that continued discharge support from a stroke nurse is not more effective than a comparison intervention (usual discharge care) in improving instrumental activities of daily living in patients with stroke.

Phase not specific to one period - Environmental enrichment inpatient program

Cognition

Not effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on cognition in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Cognition was measured by the Montreal Cognitive Assessment at post-treatment (discharge from the inpatient ward, range of duration: 9-12 days). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is not more effective than a comparison intervention (usual ward activity) in improving cognition in patients with stroke.

Emotional state

Effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on emotional state of patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Emotional state was measured by the Depression Anxiety Stress Scale (DASS – Total, Depression, Anxiety, Stress subscores) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). Significant between-group difference was seen for all measures of negative emotional state (DASS – Total, Depression, Anxiety, Stress subscores) at post-treatment, favoring EE inpatient program vs. usual ward activity. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is more effective than a comparison intervention (usual ward activity) in improving negative emotional state of patients with stroke, in the short term.

Functional independence

Effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on functional independence in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Functional independence was measured by the Functional Independence Measure (FIM – Motor total, Self-care, Sphincter, Mobility, Locomotion, Cognition total, Communication, Psychosocial, Social cognition subscores) at post-treatment (discharge from the inpatient ward, range of duration: 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). Significant between-group difference was found for three measures of functional independence (FIM – Motor total, Self-care, Mobility subscores) at post-treatment, favoring EE inpatient program vs. usual ward activity. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is more effective than a comparison intervention (usual ward activity) in improving some aspects of functional independence in patients with stroke, in the short term.

Health related beliefs

Not effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on health-related beliefs in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Health-related beliefs were measured by the Multidimensional Health Locus of Control Scale (MHLC – Internal, Chance, Doctors, Other people items) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). A significant between-group difference in one item (MHLC – Internal) was found at post-treatment, favoring EE inpatient program vs. usual ward activity. Differences did not remain significant at follow-up.

Health related quality of life

Not effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. HRQoL was measured by the EQ-5D (Mobility, Self-care, Daily activity, Pain/discomfort, Anxiety/depression, Index value, Overall health scores) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). A significant between-group difference in one measure (EQ-5D – Index value) was seen at post-treatment, favoring EE inpatient program vs. usual ward activity. At follow-up there was a significant between-group difference in overall health-related quality of life (EQ-5D – Overall health), favoring EE inpatient program vs. usual ward activity.

Self-esteem

Not effective

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on self-esteem in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Self-esteem was measured by the Rosenberg Self-Esteem Scale at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). No significant between-group difference was found at either time point.

Phase not specific to one period - Relaxation

Anxiety

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on anxiety in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety) at post-treatment (3 months) and follow-up (7 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 relaxation is not more effective than a comparison intervention (exercise training) in reducing anxiety in patients with stroke.

Balance

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on balance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Balance was measured by the Functional Reach Test at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Depression

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on depression in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression) at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Functional independence

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on functional independence in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Functional independence was measured by the Functional Independence Measure at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Instrumental activities of daily living

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on instrumental activities of daily living (IADLs) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. IADLs were measured by the Nottingham Extended Activities of Daily Living Scale at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Health related quality of life

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. HRQoL was measured by the Short-Form 36 (SF-36 – Physical functioning, Role physical, General health, Vitality, Mental health scores) at post-treatment (3 months) and follow-up (7 months). A significant between-group difference in one measure of HRQoL (SF-36 – Role physical) was found at both time points, favoring exercise vs. relaxation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving health-related quality of life in patients with stroke.
Note: In fact, exercise training was found to be more effective than relaxation in improving quality of life relating to physical role function.

Mobility

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on mobility in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Mobility was measured by the Rivermead Mobility Index and the Timed Up and Go Test (TUG) at post-treatment (3 months) and follow-up (7 months). A significant between-group difference in one measure of mobility (TUG) was found at post-treatment, favoring exercise vs. relaxation. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving mobility in patients with stroke.
Note: In fact, exercise training was found to be more effective than relaxation in improving one measure of mobility.

Power/strength (lower extremity)

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on lower extremity power/strength in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Lower extremity power was measured by the Nottingham Power Rig (NPR – Affected extensors, Non-affected extensors, W/kg) and lower extremity strength was measured by the Sit-to-Stand timed test at post-treatment (3 months) and follow-up (7 months). No significant between-group differences were found at either time point for either measure.

Walking economy

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on walking economy in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Walking economy (oxygen uptake, ml/kg per meter) was measured by a portable breath-by-breath metabolic measurement system at post-treatment (3 months) and follow-up (7 months). A significant between-group difference was found at post-treatment, favoring exercise training vs. relaxation. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving walking economy in patients with stroke.
Note: In fact, exercise training was found to be more effective than relaxation in improving walking economy.

Walking speed

Not effective

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on walking speed in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke to receive relaxation or exercise training. Walking speed (m/s) was measured by walking a 17-m circuit at comfortable speed at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Phase not specific to one period - Stroke psychosocial education programs

Caregivers' burden

Not effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on burden among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ burden was measured by the Zarit Burden Inventory at post-treatment (6 months) and at follow-up (12 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 home-based psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving caregivers’ burden among caregivers of patients with stroke.

Caregiver's coping

Not effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on coping among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ coping was measured by the Family Crisis Oriented Personal Evaluation Scales (F-COPES – Mobilising family support, Acquiring social support, Reframing, Seeking spiritual support, Passive appraisal subscores) at post-treatment (6 months) and follow-up (12 months). Significant between-group difference in two measures of coping (F-COPES – Mobilising family support, Acquiring social support) was found at follow-up only, favoring home-based psychosocial education + mailed information vs. mailed information alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving coping among caregivers of individuals who have had a stroke.

Caregivers' preparedness

Not effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on preparedness among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ preparedness was measured by the 4-Item Caregiver Preparedness Scale at post-treatment (6 months) and at follow-up (12 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 psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving preparedness among caregivers of individuals who have had a stroke.

Caregivers' social support

Not effective

Two high quality RCTs (Smith et al., 2012; Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on social support among caregivers of individuals with stroke.

The first high quality RCT (Smith et al., 2012) randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Caregiver’s social support was measured by the 11-item Medical Outcome Study (MOS) Social Support Survey at post-treatment (9 weeks) and follow-up (1 month). No significant between-group difference was found at either time point.

The second high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ social support was measured by the MOS Social Support Survey at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a stroke psychosocial education program is not more effective than comparison interventions (no treatment, mailed information alone) in improving social support among caregivers of individuals who have had a stroke.

Depression

Not effective

Three high quality RCTs (Smith et al., 2012; Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on depression in patients with stroke.

The first high quality RCT (Smith et al., 2012) randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Depression among patients and caregivers was measured by the Patient Health Questionnaire – 9 (PHQ) and the 20-item Center for Epidemiological Studies Depression (CESD) at post-treatment (9 weeks) and follow-up (1 month). There were no significant differences in depression among patients at either time point. Significant between-group differences in caregivers’ depression (CESD) were found at both time points, favoring the web-based psychoeducation program vs. no program.

The second high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Depression among patients and caregivers was measured by the Brief Geriatric Depression Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point for patients or caregivers.

The third high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home visits, mailed information, educational sessions) or mailed information alone (2 brochures). Depression was measured by the Geriatric Depression Scale at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that a stroke psychosocial education program is not more effective than comparison interventions (no treatment, mailed information alone) in improving depression in patients with stroke.
Note: Results regarding depression among caregivers was conflicting (level 4). One high quality RCT reported significant differences on one measure of depression (CESD) among caregivers in favour of web-based psychoeducational intervention vs. no treatment, whereas a second high quality RCT found no difference in caregivers’ depression following home-based psychosocial education + mailed information vs. mailed information alone.

Functional independence

Effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on functional independence in patients with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Functional independence was measured by the Functional Independence Measure (FIM – Motor, Cognitive subtotals) at post-treatment (6 months) and at follow-up (12 months). Significant between-group difference was found at post-treatment (FIM – Cognitive), favoring psychosocial education + mailed information vs. mailed information alone. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that home-based psychosocial education + mailed information is more effective than comparison interventions (mailed information alone) in improving functional independence in patients with stroke.

Health related quality of life

Conflicting

Two high quality RCTs (Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on health-related quality of life (HRQoL) in patients with stroke.

The first high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. HRQoL of patients and caregivers was measured by the Medical Outcomes Study Short-Form Survey (SF-36) at post-treatment (6 months) and at follow-up (12 months). Significant between-group difference in HRQoL of patients and caregivers was found at post-treatment, favoring psychosocial education + mailed information vs. mailed intervention alone. Difference did not remain significant at follow-up.

The second high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). HRQoL was measured by the World Health Organization Quality of Life Short Version at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of psychosocial education programs on health-related quality of life following stroke. One high quality RCT reported that psychosocial education + mailed information was more effective than mailed information alone in improving health-related quality of life of patients and carers, whereas a second high quality RCT found no significant difference between stroke education + support vs. mailed information in improving health-related quality of life of patients following stroke. Differences in content, administration and duration of services, and/or outcome measures used to assess health-related quality of life may account for differences in findings.

Health services usage

Not effective

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on health services usage in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Health services usage (use frequency of health services) was measured at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a stroke education + support is not more effective than a comparison intervention (mailed information alone) in improving patients’ use of health services after stroke.

Mastery

Not effective

One high quality RCTs (Smith et al., 2012) investigated the effect of a stroke psychosocial education program on mastery among patients with stroke and their caregivers. This high quality RCT randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Mastery among patients and caregivers was measured by the Pearlin & Schooler Mastery Scale at post-treatment (9 weeks) and follow-up (1 month). 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 web-based psychoeducation intervention is not more effective than a comparison intervention (no treatment) in improving mastery in patients with stroke or their caregivers.

Perceived stress

Not effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on perceived stress among patients with stroke and their caregivers. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Perceived stress among patients and caregivers was measured by the 10-item Perceived Stress Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found for patients or caregivers at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in reducing perceived stress among patients with stroke and their caregivers.

Psychological symptoms

Not effective

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on psychological symptoms in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Psychological symptoms were measured by the Symptom Checklist 90 Revised (Somatization subscale) at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that stroke education and support is not more effective than a comparison intervention (mailed information) in improving psychological symptoms in patients with stroke.

Quality of caregiving relationship

Not effective

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on the quality of caregiving relationships between patients with stroke and their caregivers. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Quality of caregiving relationships between patients and caregivers was measured by the Mutuality Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point among patients or caregivers.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving the quality of caregiving relationship in patients with stroke and their caregivers.

Self-esteem

Not effective

One high quality RCTs (Smith et al., 2012) investigated the effect of a stroke psychosocial education program on self-esteem among patients with stroke and their caregivers. This high quality RCT randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Patients’ and caregivers’ self-esteem was measured by the Rosenberg Self-Esteem Scale at post-treatment (9 weeks) and follow-up (1 month). 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 web-based psychoeducational intervention is not more effective than no treatment in improving self-esteem in patients with stroke and their caregivers.

Stroke outcomes

Not effective

Two high quality RCTs (Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on stroke outcomes in patients with stroke.

The first high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Physical, Emotion, Memory, Communication, Social participation, Stroke recovery subscores) at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

The second high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Stroke outcomes were measured by the SIS (Physical domain score) at post-treatment (1 year). Significant between-group difference was found favoring mailed information alone vs. stroke education and support intervention.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a stroke psychosocial education program is not more effective than a comparison intervention (mailed information alone) in improving stroke outcomes in patients with stroke.
Note: In fact, one high quality RCT found that stroke education + support was LESS effective than mailed information alone.

Stroke recurrence

Not effective

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on the incidence of recurrent stroke(s) in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). The incidence of recurrent stroke(s) was measured at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that stroke education and support is not more effective than a comparison intervention (mailed information alone) in reducing the incidence of recurrent stroke(s) in patients with stroke.

Phase not specific to one period - Tai Chi

Depression

Not effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on depression in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Depression was measured by the Center for Epidemiologic Studies Depression Scale 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 Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving depression in patients with stroke.

Endurance

Effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on endurance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Endurance was measured by the 2-Minute Step Test at post-treatment (12 weeks). Significant between-group differences were found, favoring Tai Chi vs. standard care; and favoring the time-matched fitness program vs. standard care. There were no significant differences between Tai Chi and the time-matched fitness program.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is more effective than a comparison intervention (standard care) in improving endurance in patients with stroke. It is not more effective than a time-matched fitness program.

Falls

Effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on falls rate in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Falls rate was measured at post-treatment (12 weeks). Significant between-group differences were found, favoring Tai Chi vs. standard care. There were no significant differences between Tai Chi and the time-matched fitness program, or between the time-matched fitness program and standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is more effective than a comparison intervention (standard care) in reducing the rate of falls in patients with stroke. It is not more effective than a time-matched fitness program.

Health related quality of life

Not effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. HRQoL was measured by the 36-Item Short-Form Survey (SF-36 – Physical Component Score, Mental Component Score) 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 Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving health-related quality of life in patients with stroke.

Mobility

Not effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on mobility in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Mobility was measured by the Short-Form Performance Battery (SFPB – Total, Balance, Strength, Gait subscores) at post-treatment (12 weeks). There were no significant differences in any measure of mobility between Tai Chi and the time-matched fitness program, or Tai Chi and standard care.
Note: A significant between-group difference in one mobility score (SFPB – Strength) was found, favoring the time-matched fitness program vs. standard care.

Sleep quality

Not effective

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on sleep quality in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Sleep quality was measured by the Pittsburgh Sleep Quality Index at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) that Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving sleep quality in patients with stroke.

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Watkins, C. L., Auton, M. F., Deans, C. F., Dickinson, H. A., Jack, C. I., Lightbody, C. E., … & Leathley, M. J. (2007). Motivational interviewing early after acute stroke: a randomized, controlled trial. Stroke, 38(3), 1004-1009.
http://stroke.ahajournals.org/content/38/3/1004.short

Watkins, C. L., Wathan, J. V., Leathley, M. J., Auton, M. F., Deans, C. F., Dickinson, H. A., … & Lightbody, C. E. (2011). The 12-month effects of early motivational interviewing after acute stroke: a randomized controlled trial. Stroke, 42(7), 1956-1961.
http://stroke.ahajournals.org/content/42/7/1956.short

Wu, D. Y., Guo, M., Gao, Y. S., Kang, Y. H., Guo, J. C., Jiang, X. L., … & Liu, T. (2012). Clinical effects of comprehensive therapy of early psychological intervention and rehabilitation training on neurological rehabilitation of patients with acute stroke. Asian Pacific Journal of Tropical Medicine, 5(11), 914-916.
https://www.sciencedirect.com/science/article/pii/S1995764512601710

Excluded Studies

Aben, L., Heijenbrok-Kal, M. H., Ponds, R. W., Busschbach, J. J., & Ribbers, G. M. (2014). Long-lasting effects of a new memory self-efficacy training for stroke patients: a randomized controlled trial. Neurorehabilitation and Neural Repair, 28(3), 199-206.
Reason for exclusion: Study part of COGNITIVE REHABILITATION module.

Aben, L., Heijenbrok-Kal, M. H., van Loon, E. M., Groet, E., Ponds, R. W., Busschbach, J. J., & Ribbers, G. M. (2013). Training memory self-efficacy in the chronic stage after stroke: a randomized controlled trial. Neurorehabilitation and Neural Repair, 27(2), 110-117.
Reason for exclusion: Study part of COGNITIVE REHABILITATION module.

Byl, N. N., Abrams, G. M., Pitsch, E., Fedulow, I., Kim, H., Simkins, M., … & Rosen, J. (2013). Chronic stroke survivors achieve comparable outcomes following virtual task specific repetitive training guided by a wearable robotic orthosis (UL-EXO7) and actual task specific repetitive training guided by a physical therapist. Journal of Hand Therapy, 26(4), 343-352.
Reason for exclusion: Study part of ROBOTICS module.

Damush, T. M., Kroenke, K., Bair, M. J., Wu, J., Tu, W., Krebs, E. E., & Poleshuck, E. (2016). Pain self‐management training increases self‐efficacy, self‐management behaviours and pain and depression outcomes. European Journal of Pain, 20(7), 1070-1078.
Reason for exclusion: No population of interest.

Fary, K. H. A. N., & FAFRM, M. (2017). Effectiveness of a structured sexual rehabilitation programme following stroke: A randomized controlled trial. Journal of Rehabilitation Medicine, 49, 333-340.
Reason for exclusion: Study part of SEXUALITY module.

Hackett, M. L., Carter, G., Crimmins, D., Clarke, T., Arblaster, L., Billot, L., … & Sturm, J. (2013). ImProving Outcomes after STroke (POST): results from the randomized clinical pilot trial. International Journal of Stroke, 8(8), 707-710.
Reason for exclusion: Intervention consisted of sending a post-card to patients with stroke and not provided directly by rehabilitation professionals (OT/PT/SLP, etc.).

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.
Reason for exclusion: Intervention not performed within a rehabilitation context; not specified whether a rehabilitation professional delivered the intervention.

Joubert, J., Reid, C., Joubert, L., Barton, D., Ruth, D., Jackson, D., & Davis, S. M. (2006). Risk factor management and depression post-stroke: the value of an integrated model of care. Journal of Clinical Neuroscience, 13(1), 84-90.
Reason for exclusion: Intervention provided by MDs, not rehabilitation professionals (OT/PT/SLP, etc.).

Jun, E. M., Roh, Y. H., & Kim, M. J. (2013). The effect of music‐movement therapy on physical and psychological states of stroke patients. Journal of Clinical Nursing, 22(1-2), 22-31.
Reason for exclusion: Study part of MUSIC-BASED INTERVENTIONS module.

Khedr, E. M., Abo El-Fetoh, N., Ali, A. M., El-Hammady, D. H., Khalifa, H., Atta, H., & Karim, A. A. (2014). Dual-hemisphere repetitive transcranial magnetic stimulation for rehabilitation of poststroke aphasia: a randomized, double-blind clinical trial. Neurorehabilitation and Neural Repair, 28(8), 740-750.
Reason for exclusion: Study part of rTMS module.

Kim, D. S., Park, Y. G., Choi, J. H., Im, S. H., Jung, K. J., Cha, Y. A., … & Yoon, Y. H. (2011). Effects of music therapy on mood in stroke patients. Yonsei Medical Journal, 52(6), 977-981.
Reason for exclusion: Study part of MUSIC-BASED INTERVENTIONS module.

Kirk, H., Kersten, P., Crawford, P., Keens, A., Ashburn, A., & Conway, J. (2014). The cardiac model of rehabilitation for reducing cardiovascular risk factors post transient ischaemic attack and stroke: a randomized controlled trial. Clinical Rehabilitation, 28(4), 339-349.
Reason for exclusion: Depression as secondary outcome.

Lempka, S. F., Malone, D. A., Hu, B., Baker, K. B., Wyant, A., Ozinga, J. G., … & Machado, A. G. (2017). Randomized clinical trial of deep brain stimulation for poststroke pain. Annals of Neurology, 81(5), 653-663.
Reason for exclusion: Study part of rTMS/BRAIN STIMULATION module.

Linder, S. M., Rosenfeldt, A. B., Bay, R. C., Sahu, K., Wolf, S. L., & Alberts, J. L. (2015). Improving quality of life and depression after stroke through telerehabilitation. American Journal of Occupational Therapy, 69(2), 6902290020p1-6902290020p10.
Reason for exclusion: Study part of ROBOTICS module.

Man, S. C., Hung, B. H., Ng, R. M., Yu, X. C., Cheung, H., Fung, M. P., … & Ziea, E. (2014). A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complementary and Alternative Medicine, 14(1), 255.
Reason for exclusion: Study part of ACUPUNCTURE module.

Mayo, N. E., Anderson, S., Barclay, R., Cameron, J. I., Desrosiers, J., Eng, J. J., … & Richards, C. L. (2015). Getting on with the rest of your life following stroke: a randomized trial of a complex intervention aimed at enhancing life participation post stroke. Clinical Rehabilitation, 29(12), 1198-1211.
Reason for exclusion: Study part of LEISURE/PARTICIPATION module.

Qian, X., Zhou, X., You, Y., Shu, S., Fang, F., Huang, S., & Zhou, S. (2015). Traditional chinese acupuncture for poststroke depression: A single-blind double-simulated randomized controlled trial. The Journal of Alternative and Complementary Medicine, 21(12), 748-753.
Reason for exclusion: Study part of ACUPUNCTURE module (excluded as both groups received a form of acupuncture treatment).

Renner, C. I., Outermans, J., Ludwig, R., Brendel, C., Kwakkel, G., & Hummelsheim, H. (2016). Group therapy task training versus individual task training during inpatient stroke rehabilitation: A randomised controlled trial. Clinical Rehabilitation, 30(7), 637-648.
Reason for exclusion: Study part of LOWER EXTREMITIES TASK-ORIENTED module.

Rochette, A., Korner-Bitensky, N., Bishop, D., Teasell, R., White, C. L., Bravo, G., … & Kapral, M. (2013). The YOU CALL–WE CALL Randomized Clinical Trial: Impact of a Multimodal Support Intervention After a Mild Stroke. Circulation: Cardiovascular Quality and Outcomes, 6(6), 674-679.
Reason for exclusion: Depression as a secondary outcome.

Sackley, C. M., Walker, M. F., Burton, C. R., Watkins, C. L., Mant, J., Roalfe, A. K., … & Fletcher-Smith, J. (2015). An occupational therapy intervention for residents with stroke related disabilities in UK care homes (OTCH): cluster randomised controlled trial. BMJ, 350, h468.
Reason for exclusion: Depression as secondary outcome.

Taricco, M., Dallolio, L., Calugi, S., Rucci, P., Fugazzaro, S., Stuart, M., … & EFG [Esercizio Fisico di Gruppo]/2009 Investigators. (2014). Impact of adapted physical activity and therapeutic patient education on functioning and quality of life in patients with postacute strokes. Neurorehabilitation and Neural Repair, 28(8), 719-728.
Reason for exclusion: Depression as a secondary outcome; not a RCT.

Thanakiatpinyo, T., Suwannatrai, S., Suwannatrai, U., Khumkaew, P., Wiwattamongkol, D., Vannabhum, M., … & Kuptniratsaikul, V. (2014). The efficacy of traditional Thai massage in decreasing spasticity in elderly stroke patients. Clinical Interventions in Aging, 9, 1311.
Reason for exclusion: Depression as a secondary outcome.

Visser, M. M., Heijenbrok-Kal, M. H., van‘t Spijker, A., Lannoo, E., Busschbach, J. J., & Ribbers, G. M. (2016). Problem-solving therapy during outpatient stroke rehabilitation improves coping and health-related quality of life: randomized controlled trial. Stroke, 47(1), 135-142.
Reason for exclusion: Depression as a secondary outcome.

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

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

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

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

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

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.

Language

Not effective

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.

Memory

Effective

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

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.

Music cognition

Not effective

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.

Quality of life

Not effective

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

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.

Acute phase - Music-movement therapy

Behavioral outcomes

Effective

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

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

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

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

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

Upper extremity motor function

Effective

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.

Chronic phase - Melodic intonation therapy

Language

Not effective

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

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

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.

Sensation

Effective

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.

Stroke outcomes

Not effective

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

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.

Upper extremity motor function

Effective

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

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

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

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

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

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.

Grip strength

Effective

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

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

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

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

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.

Occupational performance

Not effective

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

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

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

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

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

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

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

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.

Working memory

Not effective

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

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

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

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

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

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

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.

Gait ability

Effective

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

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

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.

Strength

Not effective

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.

Stroke outcomes

Not effective

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

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.

Upper extremity motor function

Conflicting

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

Bunketorp-Käll, L., Lundgren-Nilsson, Å., Samuelsson, H., Pekny, T., Blomvé, K., Pekna, M., … & Nilsson, M. (2017). Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke. Stroke, STROKEAHA-116.
http://stroke.ahajournals.org/content/early/2017/06/15/STROKEAHA.116.016433.short

Cha, Y., Kim, Y., Hwang, S., & Chung, Y. (2014). Intensive gait training with rhythmic auditory stimulation in individuals with chronic hemiparetic stroke: A pilot randomized controlled study. NeuroRehabilitation, 35(4), 681-688.
http://content.iospress.com/articles/neurorehabilitation/nre1182

Chouhan, S., & Kumar, S. (2012). Comparing the effects of rhythmic auditory cueing and visual cueing in acute hemiparetic stroke. International Journal of Therapy & Rehabilitation, 19(6).
http://www.magonlinelibrary.com/doi/abs/10.12968/ijtr.2012.19.6.344

Conklyn, D., Novak, E., Boissy, A., Bethoux, F., & Chemali, K. (2012). The effects of modified melodic intonation therapy on nonfluent aphasia: A pilot study. Journal of Speech, Language, and Hearing Research, 55(5), 1463-1471.
http://jslhr.pubs.asha.org/article.aspx?articleid=1782681

Hill, V., Dunn, L., Dunning, K., & Page, S. J. (2011). A pilot study of rhythm and timing training as a supplement to occupational therapy in stroke rehabilitation. Topics in Stroke Rehabilitation, 18(6), 728-737.
http://www.tandfonline.com/doi/abs/10.1310/tsr1806-728

Jeong, S., & Kim, M. T. (2007). Effects of a theory-driven music and movement program for stroke survivors in a community setting. Applied Nursing Research, 20(3), 125-131.
http://www.sciencedirect.com/science/article/pii/S0897189707000572

Kim J., Park, S., Lim, H., Park, G., Kim, M., & Lee, B. (2012). Effects of the combination of rhythmic auditory stimulation and task-oriented training on functional recovery of subacute stroke patients. Journal of Physical Therapy Science, 24(12), 1307-1313.
http://ci.nii.ac.jp/naid/10031148292/

Paul, S., & Ramsey, D. (1998). The effects of electronic music‐making as a therapeutic activity for improving upper extremity active range of motion. Occupational Therapy International, 5(3), 223-237.
http://onlinelibrary.wiley.com/doi/10.1002/oti.77/full

Purdie, H., Hamilton, S., & Baldwin, S. (1997). Music therapy: facilitating behavioural and psychological change in people with stroke-a pilot study. International Journal of Rehabilitation Research, 20(3), 325-328.
http://journals.lww.com/intjrehabilres/citation/1997/09000/music_therapy__facilitating_behavioural_and.9.aspx

Raghavan, P., Geller, D., Guerrero, N., Aluru, V., Eimicke, J. P., Teresi, J. A., Ogedegbe, G., Palumbo, A. & Turry, A. (2016). Music Upper Limb Therapy—Integrated: An Enriched Collaborative Approach for Stroke Rehabilitation. Frontiers in Human Neuroscience, 10.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5053999/

Raglio, A., Oasi, O., Gianotti, M., Rossi, A., Goulene, K., & Stramba-Badiale, M. (2016). Improvement of spontaneous language in stroke patients with chronic aphasia treated with music therapy: a randomized controlled trial. International Journal of Neuroscience, 126(3), 235-242.
http://www.tandfonline.com/doi/abs/10.3109/00207454.2015.1010647

Särkämö, T., Pihko, E., Laitinen, S., Forsblom, A., Soinila, S., Mikkonen, M., Autti, T., Silvennoinen, H.M., Erkkilä, J., Laine, M., & Peretz, I. (2010). Music and speech listening enhance the recovery of early sensory processing after stroke. Journal of Cognitive Neuroscience, 22(12), 2716-2727.
http://www.mitpressjournals.org/doi/abs/10.1162/jocn.2009.21376#.WPTkq9Lytzo

Särkämö, T., Tervaniemi, M., Laitinen, S., Forsblom, A., Soinila, S., Mikkonen, M., Autti, T., Silvennoinen, H.M., Erkkilä, J., Laine, M., Peretz, I., & HIetanen, M. (2008). Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain, 131(3), 866-876.
https://academic.oup.com/brain/article/131/3/866/318687/Music-listening-enhances-cognitive-recovery-and

Schauer, M., & Mauritz, K. H. (2003). Musical motor feedback (MMF) in walking hemiparetic stroke patients: randomized trials of gait improvement. Clinical Rehabilitation, 17(7), 713-722.
http://journals.sagepub.com/doi/abs/10.1191/0269215503cr668oa

Schneider, S., Schönle, P. W., Altenmüller, E., & Münte, T. F. (2007). Using musical instruments to improve motor skill recovery following a stroke. Journal of Neurology, 254(10), 1339-1346.
https://link.springer.com/article/10.1007%2Fs00415-006-0523-2?LI=true

Street, A. J., Magee, W. L., Bateman, A., Parker, M., Odell-Miller, H., & Fachner, J. (2017). Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial. Clinical Rehabilitation, 0269215517717060.
http://journals.sagepub.com/doi/abs/10.1177/0269215517717060

Suh, J. H., Han, S. J., Jeon, S. Y., Kim, H. J., Lee, J. E., Yoon, T. S., & Chong, H. J. (2014). Effect of rhythmic auditory stimulation on gait and balance in hemiplegic stroke patients. NeuroRehabilitation, 34(1), 193-199.
http://content.iospress.com/articles/neurorehabilitation/nre1008

Thaut, M. H., McIntosh, G. C., & Rice, R. R. (1997). Rhythmic facilitation of gait training in hemiparetic stroke rehabilitation. Journal of the Neurological Sciences, 151(2), 207-212.
http://www.jns-journal.com/article/S0022-510X(97)00146-9/abstract

Thaut, M. H., Leins, A. K., Rice, R. R., Argstatter, H., Kenyon, G. P., McIntosh, G. C., Bolay, H.V. & Fetter, M. (2007). Rhythmic auditor y stimulation improves gait more than NDT/Bobath training in near-ambulatory patients early poststroke: a single-blind, randomized trial. Neurorehabilitation and Neural Repair, 21(5), 455-459.
http://journals.sagepub.com/doi/abs/10.1177/1545968307300523

Tong, Y., Forreider, B., Sun, X., Geng, X., Zhang, W., Du, H., Zhang, T. & Ding, Y. (2015). Music-supported therapy (MST) in improving post-stroke patients’ upper-limb motor function: a randomised controlled pilot study. Neurological research, 37(5), 434-440.
http://www.tandfonline.com/doi/abs/10.1179/1743132815Y.0000000034

van Delden, A. L. E., Peper, C. L. E., Nienhuys, K. N., Zijp, N. I., Beek, P. J., & Kwakkel, G. (2013). Unilateral versus bilateral upper limb training after stroke. Stroke, STROKEAHA-113.
http://stroke.ahajournals.org/content/strokeaha/early/2013/07/18/STROKEAHA.113.001969.full.pdf

Van Der Meulen, I., Van De Sandt-Koenderman, M. W., Heijenbrok, M. H., Visch-Brink, E., & Ribbers, G. M. (2016). Melodic intonation therapy in Chronic Aphasia: Evidence from a pilot randomized controlled trial. Frontiers in human neuroscience, 10.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5088197/

Villeneuve, M., Penhune, V., & Lamontagne, A. (2014). A piano training program to improve manual dexterity and upper extremity function in chronic stroke survivors. Frontiers in human neuroscience, 8.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4141215/

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 stroke. International 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 Therapy, 22 (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 dysphagia. Journal 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 RCT; quasi-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 exclusion: Stroke 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 Neuroscience, 34(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.

Repetitive Transcranial Magnetic Stimulation (rTMS)

Evidence Reviewed as of before: 01-04-2012

Author(s)*: Adam Kagan, B.Sc.; Sarah Bouchard-Cyr; Mylène Boudreau; Amélie Brais; Valérie Hotte; Jo-Annie Paré; Anne-Marie Préville; Mylène Proulx

Patient/Family Information

Introduction

Transcranial magnetic stimulation is a pain-free, non-invasive technique used to stimulate the central nervous system. The electric currents necessary to stimulate the brain are produced by rapidly changing magnetic fields that are initiated by a brief high-intensity electric current that passes through a wire coil held over the scalp. The subsequent magnetic field is projected perpendicular to the electric current and is able to passes through the layers of human tissue (skin, bone, cortex) with very little impedence. TMS can be delivered via single-pulse, double-pulse, paired-pulse and repetitive pulse (rTMS). rTMS is the method currently under investigation for use as a treatment for stroke mainly due to its ability to modulate excitability in the cerebral cortex over longer time periods (compared to other types of TMS). It can also enhance some cognitive processes, regulate activity in specific brain regions and provide causal information about the roles of different cortical regions in behavioural performance. The use of rTMS can also enhance neuroplasticity during motor training. Theta burst stimulation is a type of rTMS that has been found to effectively induce synaptic long-term potentiation and depression and is also currently under investigation for use as a treatment therapy for stroke. According to some experimental studies, a stroke would cause a relative hyperactivity of the unaffected hemisphere due to the release from reciprocal inhibition by the opposite hemisphere which would explain some of the dysfunctions observed in this population (Brighina et al, 2003). This phenomenon is called “interhemispheric inhibitory interactions”. Thus inhibitory stimulation (low frequency rTMS) to the unaffected hemisphere could work to curb this problem. In addition, other researchers like Talelli et al. (2007) suggest that excitation of the affected hemisphere (with high frequency rTMS) enhances corticospinal output and leads to promising therapeutic results. Nevertheless, there is still a clear lack of knowledge on the exact mechanisms of TMS.

Note: Only the studies that looked at rTMS as a rehabilitation intervention were considered in this module.

Patient/Family Information

Author: Shreya Prasanna, PhD student

What is Repetitive Transcranial Magnetic Stimulation?

After a stroke, changes in the electrical activity of the cells within your brain take place. These changes may explain why you are experiencing functional problems after the stroke (e.g. difficulty moving your arm or leg). Repetitive Transcranial Magnetic Stimulation (rTMS) is a pain-free, non-invasive technique used to stimulate the cells in your brain. This stimulation alters the electrical activity of cells in targeted areas of the brain. Specifically, pulsed magnetic fields are generated by passing current pulses through a conducting coil. The coil is held close to your scalp so that the pulsed magnetic field passes through the skull and stimulates your brain cells. When this stimulation is delivered at regular intervals, it is termed as rTMS. This therapy has been studied by high quality research studies and has been found beneficial for arm function in patients.

Are there different kinds of rTMS?

rTMS can be applied at low, medium and high frequencies depending on which side of your brain is being treated. A low frequency rTMS is often used to stimulate the part of the brain on the same side as your weaker arm/leg. A medium or high frequency rTMS is used to stimulate the part of the brain on the opposite side of your weaker arm/leg.

Does it work for stroke?

Although the exact mechanisms of rTMS are still being studied, there is evidence that the use of rTMS as an adjunct can help improve hand function for some people after stroke, especially those who already have some use of their hand and arm. For example, research studies have reported that patients who receive rTMS have better control of their affected hand and have better ability to try and manipulate fine objects.

What can I expect?

Typically a session of rTMS is non-invasive and painless. A small, plastic-covered coil is placed against your head to deliver the rTMS. The rTMS is provided for several minutes. You will be required to wear earplugs during this session. It is often followed by a session of physical and/or occupational therapy, which involves exercises to promote the use of your weaker arm and hand.

Side effects/risks?

Common side-effects after a session of rTMS can include a minor headache which often resolves after a few hours or with a dose of acetaminophen (i.e. Tylenol®). A very rare side-effect is the risk of seizures. However, your doctor will examine you thoroughly before beginning this treatment in order to examine the possibility for this risk. Some people should not be treated with rTMS. These include people with: a history of seizures, cardiac pacemakers, and metal implants anywhere in the head or mouth.

Who provides the treatment?

A trained medical technician provides the rTMS. The exercise session following that is provided by a physical or occupational therapist. You can speak to your therapist or physician about whether you are a suitable candidate for rTMS and where you can obtain this treatment.

How many treatments?

The exact number of treatment sessions can vary based on your goals, your needs and your tolerance to the intervention. While there is some variability in regards to the frequency/duration of rTMS treatments as reported in research studies, rTMS is often provided for approximately 5-10 sessions, with each session lasting from 10-25 mins. As such, the frequency/duration of your rTMS treatment sessions will be suggested by your therapist or physician.

Is rTMS for me?

rTMS can be beneficial to those individuals who have difficulty in their arm and hand function after stroke. Studies have shown that rTMS may be useful for individuals who have had a stroke very recently, over the past couple of months and those who have experienced a stroke six or more months ago.

Clinician Information

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of stimulating the central nervous system and is currently being considered as a possible treatment for stroke. rTMS is usually delivered via an electronic device that is placed over the scalp and transmits rapidly changing magnetic fields down through a specific section of the brain. While the exact mechanisms of how rTMS works are still under investigation, it is believed that the changing magnetic fields act to modulate the cortical excitability. Low frequency rTMS appears to lower cortical excitability and is thus usually delivered to the unaffected hemisphere (which can become over active post stroke), while high frequency rTMS raises cortical excitability and is often delivered to the affected hemisphere.

To date, 26 studies are included and reviewed in this module. More specifically: 13 high quality RCTs, two fair quality crossover studies, two quasi-experimental studies, two repeated measures studies, one randomly controlled feasibility study, six pre-post studies.

Note: Low-frequency rTMS implies 1-4Hz, high-frequency rTMS implies 5-10Hz. As well, the term ‘affected’ refers to the brain hemisphere affected by stroke (for example ‘affected motor cortex’ refers to the motor cortex on the affected side of the brain).

Note: Please see the Authors results table and publication abstracts for further details of rTMS (e.g. intensity, motor threshold, location).

Results Table

View results table

Outcomes

Acute phase: Low-frequency rTMS over the affected motor cortex vs. control conditions

Activities of daily living

Effective

One high quality RCTs (Khedr et al., 2005) studied the effect of rTMS on activities of daily living (ADLs) in patients with acute stroke. This high quality RCT found a significant difference on the Barthel Index immediately post-intervention and at a 10-day follow up, following 10 sessions of low-frequency rTMS over the motor cortex of the affected hemisphere compared to sham rTMS. Both groups also received usual care. As well, a significantly higher percentage of patients who received low-frequency rTMS compared to sham rTMS scored in the ‘independent’ range (Barthel Index greater or equal to 75) at the 10-day follow-up only.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the motor cortex of the affected hemisphere is more effective than sham rTMS in improving activities of daily living in patients with acute stroke.

Elbow torque

Insufficient evidence

One randomized controlled feasibility study (Pomeroy et al., 2007) investigated the effect of rTMS combined with muscle contraction on elbow torque as measured by an isokinetic dynamometer. No significant effect was found for low-frequency rTMS over the motor cortex of the affected hemisphere, combined with either real or placebo muscle contraction when compared to sham rTMS combined with either real or placebo muscle contraction exercises. However, because it was a feasibility study, it was not powered to find significant differences between groups – nor was it a hypothesis testing study.
Note: This study involved some patients with subacute stroke, however the average time after stroke was 27 days, and the majority of patients were in the acute stage.

Conclusion: There is insufficient scientific evidence (level 5) describing the effect of low-frequency rTMS over the motor cortex of the affected hemisphere on elbow torque of the paretic arm in patients with acute stroke, however it should be noted that one randomized controlled feasibility study found no effect.

Purposeful movement

Insufficient evidence

One randomized controlled feasibility study (Pomeroy et al., 2007) investigated the effect of rTMS combined with muscle contraction on purposeful movement measured by the Action Research Arm Test. No significant effect was found for a single session of low-frequency rTMS over the motor cortex of the affected hemisphere, combined with either real or placebo muscle contraction, when compared to sham rTMS combined with either real or placebo muscle contraction exercises. However, because it was a feasibility study, it was not powered to find significant differences between groups – nor was it a hypothesis testing study.
Note: This study involved some patients with subacute stroke, however the average time after stroke was 27 days, and the majority of patients were in the acute stage.

Conclusion: There is insufficient scientific evidence (level 5) describing the effect of low-frequency rTMS over the motor cortex of the affected hemisphere on purposeful movement of the paretic arm in patients with acute stroke, however it should be noted that 1 randomized controlled feasibility study found no effect.

Acute phase: Low-frequency rTMS over the oesophageal motor cortex of both hemispheres simultaneously vs. control conditions

Activities of daily living

Effective

The high quality RCT (Khedr et al., 2010) involved patients with lateral medullary infarction (LMI) or other brainstem infarctions. At post-treatment and at 2-month follow-up the study found a significant difference in ADLs (measured by the Barthel Index) for the LMI patients only, in favour of low-frequency rTMS over the oesophageal motor cortex of both hemispheres, compared to sham rTMS.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the oesophageal motor cortex of both hemispheres is more effective than sham rTMS in improving activities of daily living in patients with acute stroke resulting from lateral medullary infarction.

Dysphagia

Effective

One high quality RCT (Khedr et al., 2010) studied the effect of rTMS on dysphagia in patients with acute stroke. This high quality RCT found a significant difference in dysphagia (measured by a standardized swallowing questionnaire) in favour of a group of patients who received 5 sessions of low-frequency rTMS over the oesophageal motor cortex of both hemispheres (simultaneously), compared to a group who received sham rTMS.

Conclusion: There is moderate (level 1b) evidence from 1 high quality RCT that low-frequency rTMS over the oesophageal motor cortex of both hemispheres is more effective than sham rTMS for improving dysphagia in patients with acute stroke.

Grip strength

Not effective

One high quality RCT (Khedr et al., 2010) studied the effect of rTMS on grip strength in patients with acute stroke. This high quality RCT found no significant difference in grip strength at post-treatment between a group of patients who received 5 sessions of low-frequency rTMS over the oesophageal motor cortex of both hemispheres (simultaneously), and a group who received sham rTMS.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that low- frequency rTMS over the motor cortex of both hemispheres is not more effective than sham rTMS in improving grip strength in patients with acute stroke.

Neurological outcomes and recovery

Not effective

One high quality RCTs (Khedr et al., 2010) studied the effect of rTMS on neurological outcomes and recovery in patients with acute stroke. This high quality RCT found no significant difference in neurological outcomes and recovery (measured by the National Institute of Health Stroke Scale) between a group of patients who received 5 sessions of low-frequency rTMS over the oesophageal motor cortex of both hemispheres, compared to a group who received sham rTMS.

Conclusion: There is moderate (level 1b) evidence from 1 high quality RCT that low-frequency rTMS over the oesophageal motor cortex of both hemispheres is not more effective than sham rTMS in improving neurological outcomes and recovery in patients with acute stroke.

Acute phase: Low-frequency rTMS over the unaffected motor cortex vs. control conditions

Grip strength

Not effective

One high quality crossover RCT (Lieperta et al., 2007) studied the effect of rTMS on grip strength in patients with acute stroke. This high quality crossover RCT reported no significant change in grip strength following a single session of low-frequency rTMS over the motor cortex of the unaffected hemisphere compared to sham rTMS.

Conclusion : There is moderate evidence (level 1b) from one high quality crossover RCT that low- frequency rTMS over the motor cortex of the unaffected hemisphere is not more effective than sham rTMS in improving grip strength in patients with acute stroke.

Manual dexterity

Effective

One high quality crossover study (Lieperta et al., 2007) studied the effect of rTMS on manual dexterity in patients with acute stroke. The study reported a significant improvement in the Nine Holes Peg Test (NHPT) following a single session of low-frequency rTMS over the motor cortex of the unaffected hemisphere compared to sham rTMS (control).

Conclusion: There is moderate evidence (level 1b) from one high quality crossover RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving manual dexterity in patients with acute stroke.

Subacute phase: Low-frequency rTMS over the unaffected motor cortex vs. control conditions

Activities of daily living

Effective

One high quality RCT (Emara et al., 2010) investigated the effect of rTMS on activities of daily living in patients with subacute stroke. This high quality RCT randomized patients into 3 groups: 1) low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS), 2) high-frequency rTMS over the motor cortex of the affected hemisphere (high-rTMS), or 3) sham rTMS. All 3 groups also received standard rehabilitation. At 10 days, the study found a significant between-group difference in activities of daily living (measured by the Activity Index) in favour of both low-rTMS and high-rTMS compared to sham rTMS. These differences were maintained over 12 weeks of follow-up.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving activities of daily living in patients with subacute stroke.

Cognitive impairment

Not effective

One high quality RCT (Emara et al., 2010) investigated the effect of rTMS on cognitive impairment in patients with subacute stroke. This high quality RCT randomized patients into 3 groups: 1) low-frequency rTMS over the unaffected hemisphere (low-rTMS), 2) high-frequency rTMS over the affected hemisphere (high-rTMS), or 3) sham rTMS. In addition, all 3 groups received standard rehabilitation. At 10 days, the study found no significant between-group difference in cognitive impairment (measured by the Mini-Mental State Examination).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is not more effective than sham rTMS for improving cognitive impairment in patients with subacute stroke.

Grip strength

Effective

One repeated measures study (Dafotakis et al., 2008) examined the effect of rTMS on grip strength in patients with subacute stroke. This repeated measures study found that low-frequency rTMS over the primary motor cortex of the unaffected hemisphere improved the efficiency of grip force scaling and spatio-temporal scaling coupling between grip and lift forces significantly more than sham rTMS (control).

Conclusion: There is limited evidence (level 2b) from 1 repeated measures study that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective in improving some aspects of grip strength related to object lifting.

Manual dexterity

Effective

One high quality crossover study (Mansur et al., 2005) investigated the effects of rTMS on manual dexterity in patients with subacute stroke. This high quality crossover study randomised patients to receive the following 3 treatments scenarios in random order: (1) low-frequency rTMS over the primary motor cortex of the unaffected hemisphere (2) low-frequency rTMS over the premotor cortex of the unaffected hemisphere, or (3) sham rTMS (control). The study found a significant improvement in the Purdue Pegboard test following ‘scenario 1’ compared to the sham condition, whereas the improvement was not significant for ‘scenario 2’ compared to the sham condition.

Conclusion1: There is moderate evidence (level 1b) from 1 high quality crossover study that low-frequency rTMS over the primary motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving manual dexterity in patients with subacute stroke.

Quality of life

Effective

One high quality RCT (Emara et al., 2010) investigated the effect of rTMS on quality of life in patients with subacute stroke. This high quality RCT randomized patients to 3 groups: 1) low-frequency rTMS over the unaffected hemisphere (low-rTMS), 2) high-frequency rTMS over the affected hemisphere (high-rTMS), or 3) sham rTMS. All 3 groups also received standard rehabilitation. At 10 days, the study found a significant between-group difference in quality of life (measured by the Modified Rankin Scale) in favour of both low-rTMS and high-rTMS compared to sham rTMS. These differences were maintained over 12 weeks of follow-up.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than sham rTMS in improving quality of life in patients with subacute stroke.

Reaction time of the hand

Effective

One high quality crossover study (Mansur et al., 2005) investigated the effects of rTMS on reaction time of the hand in patients with subacute stroke. In the study, patients received the following 3 treatments scenarios in random order: (1) low-frequency rTMS over the primary motor cortex of the unaffected hemisphere (2) low-frequency rTMS over the premotor cortex of the unaffected hemisphere, or (3) sham rTMS (control). A significant improvement in simple reaction time, and 4-choice reaction time was found following ‘scenario 1’ compared to the sham condition, however there was no significant improvement reported for the finger tapping test. None of these three tests showed any improvement following ‘scenario 2’ compared to the sham condition.

Conclusion: There is moderate evidence (level 1b) from 1 high quality crossover study that low-frequency rTMS to the primary motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving some aspects of reaction time of the hand in patients with subacute stroke.

Subacute phase: Low-frequency rTMS over the right inferior frontal gyrus vs. control conditions

Aphasia

Effective

One high quality RCT (Weiduschat et al., 2010) investigated the effect of rTMS on aphasia in patients with subacute stroke. This high quality RCT randomized patients with subacute stroke to receive low-frequency rTMS over the right triangular part of the inferior frontal gyrus or sham rTMS. At 2 weeks (following 10 sessions) a significant between-group difference in aphasia (measured by the Aachen Aphasia Test) was found in favour of rTMS compared to sham rTMS. It should be noted that both groups also received speech and language therapy.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the right triangular part of the inferior frontal gyrus is more effective than sham rTMS for improving aphasia in patients with subacute stroke.

Subacute Phase: Low-frequency rTMS over the parietal lobe of the unaffected hemisphere vs. control conditions

Unilateral spatial neglect

Effective

One quasi-experimental study (Lim et al. 2010) and 1 pre-post study (Brighina et al, 2003) investigated the effect of rTMS on unilateral spatial neglect in patients with subacute stroke.

The quasi-experimental study (Lim et al. 2010) found a significant between-group difference at 2 weeks (immediately post-treatment) in contra-lesional neglect, measured by the Line bisection test (p=.053), with less neglect found for a group that received low-frequency rTMS group over the parietal area of the unaffected hemisphere combined with behavioural therapy, compared to a group that received behavioural therapy alone.

The pre-post study (Brighina et al, 2003) found a significant improvement in the Length judgment of prebisected lines, the Line bisection task and the Clock drawing task following 2 weeks of low-frequency rTMS over the parietal cortex of the unaffected hemisphere in 3 patients with contralateral visuospatial neglect and right brain ischemic stroke.

Conclusion: There is limited evidence (level 2b) from 1 quasi-experimental study that low-frequency rTMS over the parietal lobe of the unaffected hemisphere + behavioral therapy is more effective than behavioural therapy alone for improving certain aspects of unilateral spatial neglect in patients with subacute stroke. In addition 1 pre-post study found improvements in unilateral spatial neglect in patients with subacute stroke following low-frequency rTMS over the parietal cortex of the unaffected hemisphere.

Subacute phase: High-frequency rTMS over the affected motor cortex vs. control conditions

Activities of daily living

Conflicting

Two high quality RCTs (Chang et al., 2010, Emara et al., 2010) investigated the effect of rTMS on activities of daily living in patients with subacute stroke.

The first high quality RCT (Chang et al., 2010) found no significant difference at 2 weeks (post-treatment) or at 3 months (follow-up) in activities of daily living (measured by the Barthel Index) between high-frequency rTMS over the motor cortex of the affected hemisphere combined with motor training, compared to sham rTMS combined with motor training.

The second high quality RCT (Emara et al., 2010) randomized patients into 3 groups: 1) low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS), 2) high-frequency rTMS over the motor cortex of the affected hemisphere (high-rTMS), or 3) sham rTMS. All 3 groups also received standard rehabilitation. At 10 days, the study found a significant between-group difference in activities of daily living (measured by the Activity Index) in favour of both low-rTMS and high-rTMS compared to sham rTMS. These differences were maintained over 12 weeks of follow-up.

Conclusion: There is conflicting evidence (level 4) between 2 high quality RCTs regarding the effect of high-frequency rTMS over the motor cortex of the affected hemisphere on activities of daily living in patients with subacute stroke.

Cognitive impairment

Not effective

Grip strength

Not effective

One high quality RCT (Chang et al., 2010) examined the effect of rTMS on grip strength in patients with subacute stroke. This high quality RCT found no significant difference at 2 weeks (immediately post-treatment) or at 3 months post-stroke in grip strength between a group of patients who received high-frequency rTMS over the motor cortex of the affected hemisphere combined with motor training, compared to sham rTMS combined with motor training. However it should be noted that this study may not have been adequately powered (n=28) and that a within-group pre-post improvement in grip strength was found for the real rTMS group, but not the sham rTMS group at 3 months post-stroke.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that high-frequency rTMS over the motor cortex of the affected hemisphere is not more effective than sham rTMS for improving grip strength in patients with subacute stroke. However it should be noted that this study may not have been adequately powered (n=28) and that a within-group pre-post improvement in grip strength was found for real rTMS group, but not sham rTMS group at 3 months post-stroke.

Manual dexterity

Not effective

One high quality RCT (Chang et al., 2010) investigated the effects of rTMS on manual dexterity in patients with subacute stroke. This high quality RCT found no significant difference at 2 weeks (post-treatment) or at 3 months post-stroke in manual dexterity, as measured by the Box and Block Test, between high-frequency rTMS over the motor cortex of the affected hemisphere combined with motor training, compared to sham rTMS combined with motor training.

Mobility

Not effective

One high quality RCT (Chang et al., 2010) investigated the effect of rTMS on lower extremity motor function in patients with subacute stroke. There were no significant differences found at either post-treatment (2 weeks), or at follow-up (3 months post stroke) on the Functional Ambulation Category between a group of patients who received high-frequency rTMS over the motor cortex of the affected hemisphere combined with motor training, compared to sham rTMS combined with motor training.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT, that high-frequency rTMS over the motor cortex of the affected hemisphere is not more effective than sham rTMS for improving mobility in patients with subacute stroke.

Motor function (lower extremity)

Not effective

One high quality RCT (Chang et al., 2010) investigated the effect of rTMS on lower extremity motor function in patients with subacute stroke. There were no significant differences found at either post-treatment (2 weeks), or at follow-up (3 months post stroke) on the leg score of the Motricity Index (MI-A) or the Fugl-Meyer Assessment –lower limb score between a group of patients who received high-frequency rTMS over the primary motor cortex of the affected hemisphere combined with motor training, compared to sham rTMS combined with motor training.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT, that high-frequency rTMS over the motor cortex of the affected hemisphere is not more effective than sham rTMS for improving lower extremity motor function in patients with subacute stroke.

Motor function (upper extremity)

Effective

One high quality RCT (Chang et al., 2010) investigated the effects of rTMS on upper extremity motor function in patients with subacute stroke. This high quality RCT found a significant difference at 2 weeks (post-treatment) in motor function (measured by the arm section of the Motricity Index) in favour of high-frequency rTMS over the motor cortex of the affected hemisphere combined with motor training (hi-rTMS), compared to sham rTMS combined with motor training. Additionally a significant group X time interaction was found at 3-months post-stroke suggesting that hi-rTMS may have resulted in additional improvements that lasted at 3 months after onset of stroke.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT, that high-frequency rTMS over the motor cortex of the affected hemisphere is more effective than sham rTMS for improving upper extremity motor function in the short-term in patients with subacute stroke. While a significant group by time interaction indicated that real rTMS may have resulted in additional improvements that lasted 3 months after onset of stroke, the between-group difference at 3 months was not significant.

Quality of life

Effective

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that high-frequency rTMS over the motor cortex of the affected hemisphere is more effective than sham rTMS in improving quality of life in patients with subacute stroke.

Chronic phase: Bilateral rTMS (Low-frequency rTMS over the unaffected motor cortex combined with high frequency rTMS over the affected motor cortex) vs. control conditions

Pinch acceleration

Effective

One high quality RCT (Takeuchi et al., 2009) investigated the effect of rTMS on pinch acceleration in patients with chronic stroke. This high quality RCT randomized patients into 3 groups: 1) low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS) 2) high-frequency rTMS over the motor cortex of the affected hemisphere (high-rTMS), or 3) bilateral rTMS (bi-rTMS), which consisted of low-rTMS combined with hi-rTMS. All 3 groups also received motor training. At post-treatment (1 session) a significant between-group difference in pinch acceleration (measured by a monoaxial accelerometer) was found in favour of both bi-rTMS and low-rTMS compared to high-rTMS and these differences were maintained at 7-day follow-up.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that bilateral rTMS, involving low-frequency rTMS over the unaffected motor cortex (low-rTMS) combined with high-frequency rTMS over the affected motor cortex (high-rTMS) is more effective than high-rTMS alone for improving pinch acceleration in patients with chronic stroke.

Pinch force

Effective

One high quality RCT (Takeuchi et al., 2009) investigated the effect of rTMS on pinch force in patients with chronic stroke. This high quality RCT randomized patients into 3 groups: 1) low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS) 2) high-frequency rTMS over the motor cortex (high-rTMS) of the affected hemisphere, or 3) bilateral rTMS (bi-rTMS), which consisted of low-rTMS combined with hi-rTMS. All 3 groups also received motor training. At post-treatment (1 session) and 7-day follow-up, a significant between-group difference was found in pinch force (measured by a pinch gauge), in favour of bi-rTMS compared to both high- and low-rTMS.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that bilateral rTMS, involving low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS) combined with high-frequency rTMS over the motor cortex of the affected hemisphere (high-rTMS) is more effective for improving pinch force compared to either low-rTMS or high-rTMS alone, in patients with chronic stroke.

Chronic phase: Excitatory theta burst stimulation over the motor cortex of the affected hemisphere and Inhibitory theta burst stimulation over the motor cortex of the unaffected hemisphere vs. control conditions

Grip strength

Not effective

One fair quality cross-over study (Talelli et al., 2007) investigated the impact of rTMS on grip strength in patients with chronic stroke. The study reported no significant effects on grip strength following either excitatory theta burst stimulation (iTBS) over the motor cortex of the affected hemisphere, inhibitory theta burst stimulation (cTBS) over the motor cortex of the unaffected hemisphere or sham stimulation.
Note: iTBS involved 20 trains of 10 theta bursts with 8-sec intervals (600 bursts) whereas cTBS involved 100 continuous trains of theta burst stimulation.
Note: This study involved only 6 patients and thus may not have been adequately powered to provide significant results.

Conclusion: There is limited evidence (level 2a) from 1 fair quality crossover study that excitatory theta burst stimulation over the motor cortex of the affected hemisphere or inhibitory theta burst stimulation over the motor cortex of the affected hemisphere is not more effective than sham rTMS for improving grip strength in patients with chronic stroke.

Reaction time of the hand

Effective

One fair quality crossover study (Talelli et al., 2007) investigated the impact of rTMS on reaction time and speed of the paretic hand of 6 patients with chronic stroke. This fair quality cross-over study found significant improvement in simple reaction time with the application of excitatory stimulation (iTBS) over the affected cortex compared to inhibitory stimulation (cTBS) over the unaffected hemisphere immediately after stimulation, and compared to sham stimulation up to 30 minutes after stimulation. No significant improvement was found for choice reaction time for any of the 3 conditions.
Note: iTBS involved 20 trains of 10 the same theta bursts with 8-sec intervals (600 bursts) whereas cTBS involved 100 continuous trains of theta burst stimulation.

Conclusion: There is limited evidence (level 2a) from one fair quality crossover study, that excitatory theta burst stimulation over the motor cortex affected hemisphere is more effective than inhibitory theta burst stimulation over the primary cortex of the unaffected hemisphere (immediately after stimulation only) or sham rTMS (up to 30 minutes after stimulation) for improving simple reaction time in patients with chronic stroke.

Chronic phase: Low-frequency rTMS over the both sides of the brain vs. control conditions

Activities of daily living

Insufficient evidence

One pre-post study (Mally & Dinya, 2008) investigated the effect of rTMS on activities of daily living (ADLs) in patients with chronic stroke. This pre-post study divided participants into 4 groups. Group A consisted of patients who had movement in the paretic arm that could be evoked by a TMS pulse to either hemisphere of the brain. Group B consisted of patients who had no paretic arm movement evoked from either side of the brain; the pathway to the healthy arm was stimulated from where visible movement could be evoked. Patients in Group C had paretic arm movement that could only be evoked from the contralateral side of the brain, while patients in group D had paretic arm movement that could only be evoked from the ipsilateral side of the brain. Only patients in group B improved in functional activities (dressing, catching and walking as measured by a 4 point scale) following 1-week of low-frequency rTMS (where the region of the brain stimulated during treatment corresponded with the group to which the patient belonged).

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of low-frequency rTMS over the both sides of the brain on activities of daily living in patients with chronic stroke. However it should be noted that one pre-post study found a significant improvement in ADLs following low-frequency rTMS over the both sides of the brain in patients who had no initial paretic arm movement evoked from either side of the brain.

Lower extremity movement (either hemisphere)

Insufficient evidence

One pre-post study (Mally & Dinya, 2008) investigated the effect of rTMS on lower extremity movement in patients with chronic stroke. Participants were divided into 4 groups. Group A consisted of patients who had a movement in the paretic arm that could be evoked by a TMS pulse (low-frequency) to either hemisphere of the brain. Group B consisted of patients who had no paretic arm movement evoked from either side of the brain; the pathway to the healthy arm was stimulated from where visible movement could be evoked. Patients in Group C had paretic arm movement that could only be evoked from the contralateral side of the brain, while patients in group D had paretic arm movement that could only be evoked from the ipsilateral side of the brain. Patients in group B and C improved significantly in lower extremity movement (as measured by several 4 point scales) following a 1-week program of low-frequency rTMS (the region of the brain stimulated during treatment corresponded with the group to which the patient belonged).

Conclusion: While there is insufficient scientific evidence (level 5) that rTMS improves lower extremity movement in patients with chronic stroke, 1 pre-post study found that patients who received low-frequency rTMS to the motor cortex of either the unaffected or the affected hemisphere showed some improvements.

Spasticity of the hand

Insufficient evidence

One pre-post study (Mally & Dinya, 2008) investigated the effect of rTMS on hand spasticity in patients with chronic stroke. This pre-post study divided patients with chronic stroke into 4 groups. Group A consisted of patients who had a movement in the paretic arm that could be evoked by a TMS pulse (low-frequency) to either hemisphere of the brain. Group B consisted of patients who had no paretic arm movement evoked from either side of the brain; the pathway to the healthy arm was stimulated from where visible movement could be evoked. Patients in Group C had paretic arm movement that could only be evoked from the contralateral side of the brain, while patients in group D had paretic arm movement that could only be evoked from the ipsilateral side of the brain. Patients in group A, B and C improved significantly in finger spasticity (as measured by a 4-point scale), with group B improving the most, following a 1-week program of low-frequency rTMS where the region of the brain stimulated during treatment corresponded with the group to which the patient belonged.

Conclusion: There is insufficient scientific evidence (level 5) showing an effect of low-frequency rTMS over the both sides of the brain on spasticity in patients with chronic stroke, however 1 pre-post study found significant within-group improvements in spasticity when rTMS was applies to either the affected or unaffected hemisphere, especially when applied to the affected hemisphere of patients with no movement evoked potential of the paretic arm from TMS to the affected hemisphere.

Upper extremity movement (either hemisphere)

Insufficient evidence

One pre-post study (Mally & Dinya, 2008) investigated the effect of rTMS on overall upper extremity movement in patients with chronic stroke. Participants were divided into 4 groups. Group A consisted of patients who had a movement in the paretic arm that could be evoked by a TMS pulse (low-frequency) to either hemisphere of the brain. Group B consisted of patients who had no paretic arm movement evoked from either side of the brain; the pathway to the healthy arm was stimulated from where visible movement could be evoked. Patients in Group C had paretic arm movement that could only be evoked from the contralateral side of the brain, while patients in group D had paretic arm movement that could only be evoked from the ipsilateral side of the brain. Patients in group B and C improved significantly in upper extremity movement (as measured by several 4 point scales) following a 1-week program of low-frequency rTMS (the region of the brain stimulated during treatment corresponded with the group to which the patient belonged).

Conclusion: While there is insufficient scientific evidence (level 5) that rTMS improves overall upper extremity movement in patients with chronic stroke, 1 pre-post study found that patients who received low-frequency rTMS to the unaffected hemisphere, especially those who had no evoked movement from either hemisphere before treatment, showed some improvements.

Chronic phase: Low-frequency rTMS over the left prefrontal cortex vs. control conditions

Activities of daily

Not effective

One high quality RCT (Kim et al., 2010) investigated the effect of rTMS on activities of daily living (ADLs) in patients with chronic stroke. This high quality RCT found no significant difference in ADLs (measured by the Barthel Index) at 2 weeks (immediately post-treatment) between low-frequency rTMS over the left prefrontal cortex, high-frequency rTMS over the left prefrontal cortex and sham rTMS.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the left prefrontal cortex is not more effective than sham rTMS in improving activities of living in patients with chronic stroke.

Cognitive impairment

Not effective

One high quality RCT (Kim et al., 2010) investigated the effects of rTMS on cognitive impairment in patients with chronic stroke. This high quality RCT found no significant difference in cognitive impairment (measured by the Mini-Mental State Examination) at 2 weeks (immediately post-treatment) between low-frequency rTMS over the left prefrontal cortex, high-frequency rTMS over the left prefrontal cortex and sham rTMS.

Conclusion: There is moderate evidence (level 1b) that low-frequency rTMS over the left prefrontal cortex, is not more effective than sham rTMS in improving cognitive impairment in patients with chronic stroke.

Mood

Not effective

One high quality RCT (Kim et al., 2010) investigated the effect of rTMS on mood in patients with chronic stroke. This high quality RCT found a significant difference in mood (measured by the Beck Depression Scale) at post-treatment (2 weeks) in favour of high-frequency rTMS over the left prefrontal cortex compared to low-frequency rTMS over the left prefrontal cortex or sham rTMS.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that low-frequency rTMS over the left prefrontal cortex or sham rTMS is less effective than high-frequency rTMS over the left prefrontal cortex in improving mood in patients with chronic stroke.

Chronic phase: Low-frequency rTMS over the right Broca's area

Aphasia

Insufficient evidence

One pre-post study (Naeser et al., 2005) investigated the effect of rTMS on patients with chronic stroke and chronic aphasia. The study found some short-term improvements in naming (as measured by the Snodgrass and Vanderwart) as well as some longer lasting improvement in naming (as measured by the Boston Naming test and the Boston Diagnostic Aphasia Exam) following 2 weeks of low-frequency rTMS over the anterior portion of the right Broca’s area.

Conclusion: While there is insufficient scientific evidence (level 5) that rTMS has an effect on aphasia in patients with chronic stroke, one pre-post study showed some improvements in naming ability following low-frequency rTMS to the right Broca’s area.

Chronic phase: Low-frequency rTMS over the unaffected motor cortex vs. control conditions

Manual dexterity

Effective

One high quality RCT (Fregni et al., 2006) investigated the effect of rTMS on manual dexterity in patients with chronic stroke. This high quality RCT reported significant improvement on the Purdue Pegboard test and Jebsen-Taylor Hand Function Test for subjects who received 5 sessions over 5 days of low-frequency rTMS over the motor cortex of the unaffected hemisphere, compared to those who received sham rTMS.

Mood

Insufficient evidence

One repeated measures study (Boggio et al., 2006) investigated the effect of rTMS on mood in patients with chronic stroke. This repeated measures study showed no improvement in mood (measured by a visual analogue scale) following low-frequency rTMS over the motor cortex of the unaffected hemisphere.

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of low-frequency rTMS over the contralateral hemisphere on mood in patients with chronic stroke, however it should be noted that 1 repeated measures study found no improvements following treatment.

Motor function (upper extremity)

Insufficient evidence

One pre-post study (Kakuda et al., 2011) investigated the effects of rTMS on motor function in patients with chronic stroke. Patients were divided based on Brunnstrom stage of recovery for hand-fingers into 3 groups: stage III, stage IV, & stage V. At 15 days, the study found an improvement in all groups on the Fugl-Meyer Assessment – upper extremity (FMA-UE) and Wolf Motor Function Test – upper extremity following low-frequency rTMS over the motor cortex of the unaffected hemisphere combined with occupational therapy. Patients in stage IV improved significantly more than the other 2 stages on the FMA, and patients in stage III improved significantly less than the other 2 stages on the WMFT. The authors concluded that rTMS appears to improve motor function, and that outcomes are influenced by baseline severity of upper limb hemi-paresis.
Note: This study did not compare the intervention to a control group; therefore results of this study were not used to inform levels of evidence. The study was included in this review, however, to note the effect of different baseline severity on outcome.

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of rTMS on upper extremity motor function in patients with chronic stroke. However, 1 pre-post study found some improvement in motor function following low-frequency rTMS over the motor cortex of the unaffected hemisphere.

Pinch acceleration

Effective

Two high quality RCTs (Takeuchi et al., 2005, Takeuchi et al., 2009) investigated the effect of rTMS on pinch acceleration in patients with chronic stroke.

The first high quality RCT (Takeuchi et al., 2005) reported significantly greater pinch acceleration (measured by a monoaxial accelerometer) at post-treatment (single session) in favour of low-frequency rTMS over the motor cortex of the unaffected hemisphere compared to sham rTMS. However the between-group difference did not remain at 30 minutes post-intervention. Both groups also received motor training.

The second high quality RCT (Takeuchi et al., 2009) randomized patients into 3 groups: 1) low-frequency rTMS over the motor cortex of the unaffected hemisphere (low-rTMS) 2) high-frequency rTMS over the motor cortex of the affected hemisphere (high-rTMS), or 3) bilateral rTMS (bi-rTMS), which consisted of low-rTMS combined with hi-rTMS. All 3 groups also received motor training. At post-treatment (1 session) a significant between-group difference in pinch acceleration (measured by a monoaxial accelerometer) was found in favour of both bi-rTMS and low-rTMS compared to high-rTMS and these differences were maintained at 7-day follow-up.

Conclusion: There is strong evidence (level 1a) from 2 high quality RCTs that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than control conditions (sham rTMS, high-frequency rTMS) for improving pinch acceleration in patients with chronic stroke. It should be noted that one study demonstrated immediate effects only.

Pinch force

Not effective

One high quality RCT (Takeuchi et al., 2005) investigated the effect of rTMS on pinch force in patients with chronic stroke. This high quality RCT found no significant difference in pinch force (measured by a pinch gauge) at post-treatment between 1 session of low-frequency rTMS over the unaffected motor cortex compare to sham rTMS. Both groups also received motor training.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is not more effective than sham rTMS in improving pinch force in patients with chronic stroke.

Range of motion of the hand

Insufficient evidence

One repeated measures study (Boggio et al., 2006) investigated the effect of rTMS on hand range of motion in patients with chronic stroke. This repeated measures study found a marked improvement in fingers and thumb range of motion (measured by angle of extension) following a single session of low-frequency rTMS over the motor cortex of the unaffected hemisphere and these improvements were maintained at the 4-month follow-up. No changes were found following sham rTMS.
Note: This study only involved 1 patient and did not do multiple baseline assessments beforehand; therefore results of this study were not used to inform levels of evidence.

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of rTMS on hand range of motion. However, 1 repeated measures study found some improvement motion following low-frequency rTMS.
Note: This repeated measures study was deemed unqualified to inform levels of evidence.

Reaction time of the hand

Effective

One high quality RCT (Fregni et al., 2006) investigated the impact of rTMS on reaction time and speed of the paretic hand in patients with chronic stroke. This high quality RCT reported significant improvement in simple reaction time and choice reaction time for subjects who received 5 sessions over 5 days of low-frequency rTMS over the motor cortex of the unaffected hemisphere compared to those who received sham rTMS.

Conclusion: There is moderate evidence (Level 1b) from 1 high quality RCT that suggests that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving reaction time of the paretic hand in patients with chronic stroke.

Spasticity of the hand

Insufficient evidence

One repeated measures study (Boggio et al., 2006) investigated the effect of rTMS on hand spasticity in patients with chronic stroke. This repeated measures study reported no effect of low-frequency rTMS over the motor cortex of the unaffected hemisphere on spasticity (measured by the Modified Ashworth Scale) in a 74-year-old woman with chronic stroke.
Note: This study only involved 1 patient and did not to multiple baseline assessments beforehand; therefore results of this study were not used to inform levels of evidence.

Conclusion: There is insufficient scientific evidence (level 5) showing an effect of low-frequency rTMS over the motor cortex of the unaffected hemisphere on spasticity in patients with chronic stroke, however 1 low quality repeated measures study found no improvement in spasticity following low-frequency rTMS to the unaffected hemisphere.

Chronic phase: Low-frequency rTMS over the unaffected parietal lobe vs. control conditions

Cognitive impairment

Insufficient evidence

One pre-post study (Shindo et al., 2006) investigated the effects of rTMS on cognitive impairment in patients with chronic stroke. This pre-post study found no change in cognitive impairment or dementia (measure by the Mini-Mental State Examination and the Revised Hasegawa Dementia Scale) following 2 weeks of low-frequency rTMS over the parietal cortex of the unaffected hemisphere.

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of low-frequency rTMS over the parietal cortex of the unaffected hemisphere on cognitive impairment in patients with chronic stroke. However, it should be noted that one pre-post study found no effect of treatment on cognitive impairment or dementia.

Chronic phase: High-frequency rTMS over the affected motor cortex vs. control conditions

Activities of daily living

Not effective

One quasi-experimental study (Izumi et al., 2008) investigated the effect of rTMS on activities of daily living (ADLs) in patients with chronic stroke. This quasi-experimental study found no significant difference at 4 weeks (immediately post-treatment) in activities of daily living (measured by the Barthel Index) between high-frequency rTMS over the motor cortex of the affected hemisphere during maximum finger or thumb extension and sham rTMS.

Conclusion: There is limited evidence (level 2b) from one quasi-experimental study that high-frequency rTMS over motor cortex of the affective hemisphere is not more effective than sham rTMS for improving activities of daily living in patients with chronic stroke.

Hand function

Not effective

One quasi-experimental study (Izumi et al., 2008) investigated the effect of rTMS on overall hand function in patients with chronic stroke. This study found no significant difference at 4 weeks (immediately post-treatment) in overall hand function, as measured by Brunnstrom’s protocol, the Manual Function Test, and the hand items of the Stroke Impairment Assessment Set, between high-frequency rTMS over the motor cortex of the affected hemisphere during maximum finger or thumb extension compared to sham rTMS (control). However a trend towards significance was found for the Manual Function Test in favour of the real rTMS group.
Note: This study only involved 9 subjects and thus may not have been powered to find significant results.

Conclusion: There is limited evidence (level 2b) from 1 quasi-experimental study showing that high-frequency rTMS over the motor cortex of the affected hemisphere, during maximum finger or thumb extension is not more effective than sham rTMS for improving overall hand function in patients with chronic stroke. It should be noted that this study may not have been powered to find significant results.

Manual dexterity

Effective

One high quality cross-over study (Kim et al., 2006) investigated the effect of rTMS on manual dexterity in patients with chronic stroke. This high quality cross-over study showed significant improvement in movement accuracy and movement time of paretic fingers (as measured by a sequential motor task) with the application of 1 session of high-frequency rTMS over the motor cortex of the affected hemisphere compared to sham rTMS combined with the same movement tasks.
Note: The positive change in movement accuracy was related to increased cortical excitability following the real rTMS condition.

Conclusion: There is moderate evidence (level 1b), from 1 high quality crossover study that high-frequency rTMS over the motor cortex of the affected hemisphere is effective than sham rTMS for improving manual dexterity in patients with chronic stroke.

Range of motion of the hand

Insufficient evidence

One randomized cross-over study (Koganemaru et al., 2010) investigated the effect of rTMS on hand range of motion in patients with chronic stroke. This randomized crossover study randomized patients to receive, in random order: 1) high-frequency rTMS over the affected hemisphere (rTMS), 2) extensor motor training (EMT) and 3) both interventions combined (rTMS+EMT). At post-treatment (1 session), no within-group improvements were found for any of the 3 groups. However, when rTMS+EMT was continued for a further 8 weeks, a within-group improvement in hand range of motion (measurement tool not described) was found.
Note: This study did not compare rTMS to a control group; therefore results of this study were not used to inform levels of evidence.

Conclusion: There is insufficient scientific evidence (level 5) regarding the effect of rTMS on hand range of motion. However, 1 randomized crossover trial found some improvement motion following high-frequency rTMS.
Note: This randomized crossover trial was deemed unqualified to inform levels of evidence.

Spasticity of the hand

Not effective

One fair quality randomized cross-over study (Koganemaru et al., 2010) and one quasi-experimental study (Izumi et al., 2008) investigated the effect of rTMS on hand spasticity in patients with chronic stroke.

In the fair quality randomized crossover trial (Koganemaru et al., 2010), patients received (in random order) a single session of: 1) high-frequency rTMS over the motor cortex of the affected hemisphere (rTMS), 2) extensor motor training (EMT) and 3) both interventions combined (rTMS+EMT). No between-group comparisons were reported in this study*. However it should be noted that at post-treatment a significant improvement in hand spasticity (Modified Ashworth Scale) was found for the rTMS+EMT group only. In addition, patients continued receiving rTMS+EMT for 8 weeks. At the end of 8 weeks significant improvements were found for spasticity.
* Between-group comparisons were not reported; therefore results of this study were not used to inform levels of evidence.

The quasi-experimental study (Izumi et al., 2008) found no significant difference at 4 weeks (post-treatment) in paretic hand spasticity (measured by the Modified Ashworth Scale) between high-frequency rTMS over the motor cortex of the affected hemisphere during maximum finger or thumb extension vs. sham rTMS. However a tendency towards significance was found for wrist spasticity in favour of the real rTMS group.
Note: This study only involved 9 subjects and thus may not have been adequately powered to find significant results.

Conclusion: There is limited evidence (level 2b) from 1 quasi-experimental study that high-frequency rTMS over the motor cortex of the affected hemisphere, during maximum finger or thumb extension is not more effective than sham rTMS for improving spasticity in patients with chronic stroke. However, it should be noted that one randomized crossover study found a significant within-group improvement following high-rTMS over the motor cortex of the affected hemispherecombined with extensor motor training.

Stroke outcomes

Not effective

One quasi-experimental study (Izumi et al., 2008) investigated the effects of rTMS on stroke severity and overall function in patients with chronic stroke. The study found no significant difference at 4 weeks (immediately post-treatment) in overall stroke impairment (measured by the Stroke Impairment Assessment Set) between high-frequency rTMS over the motor cortex of the affected hemisphere during maximum finger or thumb extension vs. sham rTMS (control).
Note: This study only involved 9 subjects and thus may not have been powered to find significant results.

Conclusion: There is limited evidence (level 2b) from one quasi-experimental study showing that high-frequency rTMS over the motor cortex of the affected hemisphere is not more effective than sham rTMS for improving overall stroke impairment in patients with chronic stroke.

Chronic phase: High-frequency rTMS over the left prefrontal cortex vs. control conditions

Activities of daily

Not effective

One high quality RCT (Kim et al., 2010) investigated the effect of rTMS on activities of daily living (ADLs) in patients with chronic stroke. This high quality RCT found no significant difference in ADLs (measured by the Barthel Index) at 2 weeks (immediately post-treatment) between high-frequency rTMS over the left prefrontal cortex, low-frequency rTMS over the left prefrontal cortex and sham rTMS.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that both low-frequency rTMS over the left prefrontal cortex and high-frequency rTMS over the left prefrontal cortex are not more effective than sham rTMS in improving activities of daily living in patients with chronic stroke.

Cognitive impairment

Not effective

One high quality RCT (Kim et al., 2010) investigated the effects of rTMS on cognitive impairment in patients with chronic stroke. This high quality RCT found no significant difference in cognitive impairment (measure by the Mini-Mental State Examination) at 2 weeks (immediately post-treatment) between high-frequency rTMS over the left prefrontal cortex, low-frequency rTMS over the left prefrontal cortex and sham rTMS.

Conclusion: There is moderate evidence (level 1b) that both low-frequency rTMS over the left prefrontal cortex, and high-frequency rTMS over the left prefrontal cortex are not more effective than sham rTMS in improving cognitive impairment in patients with chronic stroke.

Mood

Effective

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that high-frequency rTMS over the left prefrontal cortex is more effective than low-frequency rTMS over the left prefrontal cortex or sham rTMS in improving mood in patients with chronic stroke.

Chronic phase: High-frequency rTMS over the unaffected motor cortex vs. control conditions

Safety of rTMS

Insufficient evidence

One pre-post study (Carey et al., 2007) investigated the safety of rTMS on patients with chronic stroke. The study found no significant impairment of overall function after high-frequency rTMS over the motor cortex of the unaffected hemisphere as measured by the Wechsler Adult Intelligence Scale-third edition, Beck Depression Inventory-Second edition or the NIH Stroke Scale at post treatment or follow-up. Interviews with the patients on treatment day showed some tiredness, headache, anxiety and nausea. There was a significant impairment shown by the HVLT-R (Hopkins Verbal Learning Test-Revised) for word memory at post-test, but the score returned to normal at follow-up over the next 5 days. As well, there was no significant impairment of the fingers motor control of the normal and paretic hand with the finger-tracking performance test at post-test and follow-up.

Conclusion: While there is insufficient scientific evidence (level 5) describing whether or not rTMS is safe for patient with chronic stroke, one pre-post study concluded that high-frequency rTMS over the unaffected hemisphere does not cause any profound negative impact on daily function. Although some minor impairments were found immediately post treatment in this study, the problems faded at subsequent follow-up tests.

Pediatric - chronic phase: Low-frequency rTMS over the unaffected motor cortex vs. control conditions

Grip strength

Effective

One high quality RCT (Kirton et al., 2008) studied the effects of rTMS on grip strength in children with chronic stroke. The study reported a significant between-group difference at 1-day follow-up and 7-day follow-up for grip strength (measured by a dynamometer) in favour of 8 days of low-frequency rTMS over the motor cortex of the unaffected hemisphere vs. sham rTMS.

Upper extremity motor function

Effective

One high quality RCT (Kirton et al., 2008) studied the effects of rTMS on upper extremity motor function in children with chronic stroke. The results showed a significant improvement at a 1-day follow-up in upper extremity motor function (measured by the Melbourne Assessment of Upper Extremity Function) in favour of 8 days of low-frequency rTMS over the motor cortex of the unaffected hemisphere vs. sham rTMS, however the difference was no longer significant at a 1-week follow-up.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that low-frequency rTMS over the motor cortex of the unaffected hemisphere is more effective than sham rTMS for improving upper extremity motor function at 1-day follow-up in children with chronic stroke. However, this difference was no longer significant at 1-week follow-up.

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