Bilateral Arm Training

Evidence Reviewed as of before: 11-06-2018
Author(s)*: Annabel McDermott (OT); Nicol Korner-Bitensky (PhD OT); Tatiana Ogourtsova (PhD OT)
Patient/Family Information Table of contents

Introduction

Bilateral Arm Training (BAT) comprises repetitive practice of bilateral arm movements in symmetrical or alternating patterns. Traditionally, bilateral arm training was performed by linking both hands together so that the less-affected limb facilitated passive movement of the affected limb. Variations of bilateral arm training include bilateral isokinematic training (spatiotemporally identical active movements performed during functional tasks), use of mechanical devices to drive passive or active movement of the affected limb, or bilateral arm training with rhythmic auditory cueing or electromyography (EMG) stimulation.

The use of bilateral arm training in stroke rehabilitation is based on the assumption that symmetrical bilateral movements activate similar neural networks in both hemispheres, promoting neural plasticity and cortical repair that result in improved motor control in the affected limb. Bilateral arm training is suitable for use as an adjunct to other upper limb interventions and should involve repetitive movement during performance of novel, functional tasks.

Patient/Family Information

Author: Tatiana Ogourtsova PhD OT

What is bilateral arm training (BAT)?

Bilateral Arm Training is a type of rehabilitation that uses symmetrical (same) or alternating (opposite) movements of both arms. A stroke can disrupt the messages that are sent from your brain to your muscles; this can affect strength and movement in your arm/hand. Moving your arms during Bilateral Arm Training might send feedback to both sides of the brain (the affected and the non-affected hemispheres), which might increase brain activity. This in turn might help rebuild the side of the brain affected by the stroke, and the pathways in the brain that cause movement in the affected arm.

What is Bilateral Arm Training used for in people with stroke?

The goal of Bilateral Arm Training is to improve strength and use of the arm that was affected by the stroke.

Are there different kinds of bilateral arm therapies?

Traditionally, Bilateral Arm Training was done by linking both hands together so that the less-affected arm helped to move the affected arm.

Variations of BAT include:

  • Isokinematic BAT – identical active movements of both arms
  • BAT with robotic or mechanical devices – the device drives the movement of the affected arm
  • BAT with rhythmic auditory cueing – music or a metronome are used to guide arm movements
  • BAT with electromyography (EMG) stimulation – an electrical stimulation is applied to the muscles of the affected arm during arm movements.

Does Bilateral Arm Training work for stroke?

The use of Bilateral Arm Training has been examined using high quality research studies. It was shown to improve arm function in some patients after stroke. In particular, BAT and BAT with rhythmic auditory cueing were useful for patients with chronic stroke (more than 6 months after stroke) to improve movement, strength and function of the affected arm. It is important to note that results can vary from person to person.

What can I expect?

During traditional Bilateral Arm Training, you will practice repetitive and intensive exercises of both arms for 1-2 hours per day, 2-5 times per week for 2 weeks or more. In addition, your occupational therapist or physical therapist might choose other types of BAT (see above) to assist in moving and strengthening the affected arm. Your therapist will discuss with you the regime and type of BAT that is most suitable for you.

Who provides the treatment?

Bilateral Arm Training is usually administered by a physical therapist or an occupational therapist at a rehabilitation centre or at an out-patient clinic.

How long is the treatment period?

Bilateral Arm Training treatment regimens vary. Sessions may range from 45 minutes to 2 hours, from 2 to 5 times per week, and for 1 to 6 weeks. On average, it is delivered for 1 hour, 3 times per week for 4 weeks.

Are there any side effects or risks?

Bilateral Arm Training is usually administered by a trained health professional at a rehabilitation clinic. Your therapist will monitor your reactions to this therapy closely. It is important to report any feelings of discomfort or pain (such as pain at the shoulder of the affected arm). Your therapist will adjust the intensity and the duration of therapy according to your ability, endurance and progress.

Is Bilateral Arm Training for me?

Information on this web site is provided for informational purposes only and is not a substitute for professional medical advice. If you have or suspect you have a medical problem, promptly contact your professional healthcare provider.

Clinician Information

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

A total of 40 studies (20 high quality RCTs, ten fair quality RCTs, three poor quality RCTs and seven non-randomized studies) that investigate the use of bilateral arm therapy in post-stroke upper limb rehabilitation were reviewed. Effects of bilateral arm training among patients in the acute (two studies), subacute (three studies) or chronic (30 studies) phase of stroke recovery, or where the phase of stroke recovery is not specific to one period (three studies) are reported. Types of bilateral arm training have been differentiated according to the following categories: generic bilateral arm training; device-driven bilateral arm training (passive/active movements using mechanical devices); bilateral arm training with rhythmic auditory cueing (BATRAC); and bilateral arm training with electromyography (EMG).

Overall, results indicate that bilateral arm training is not more effective than comparison therapies and is typically less effective than constraint induced movement therapies. Recent systematic reviews by Coupar et al., (2010) and van Delden et al (2012) drew similar conclusions. The first (Coupar et al., 2010), a Cochrane review that comprised 14 RCTs (ten of which were considered suitable for inclusion in this Stroke Engine module), reported no statistically significant differences in performance of ADL, functional movement of the arm/hand or motor impairment between bilateral upper limb training vs. other specific upper limb (UL) interventions, usual care or no intervention, across all stages of stroke rehabilitation. The more recent systematic review (van Delden et al., 2012) included nine RCTs (all of which are reviewed in this Stroke Engine module; four of which were also reviewed by Coupar et al., 2010) and reported a marginally significant difference in UL motor function in favour of unilateral arm training vs. bilateral arm training among patients with acute or chronic stroke and mild UL paresis, and a marginally significant difference in UL motor activity in favour of unilateral arm training vs. bilateral arm training among patients with chronic stroke and mild UL paresis. Other measures of upper limb impairment did not show significant differences between unilateral and bilateral arm therapy.

Different methods of bilateral arm training are more effective than others: a systematic review and meta-analysis of bilateral arm training (Cauraugh et al., 2010) that included 16 comparison studies and eight pre-post design studies (15 of which were considered suitable for inclusion in this Stroke Engine module), reported a significant effect of bilateral arm training combined with EMG-triggered neuromuscular stimulation, a weak trend for active and/or passive movements (i.e. using mechanical devices), and a small, non-significant effect size for pure bilateral therapy. While similar conclusions are drawn in the Stroke Engine module, the systematic review also found a significant effect from BATRAC; discord with findings in the Stroke Engine review may relate to the exclusion of several BATRAC studies from this module (see Excluded Studies for further information).

Results are organized according to stage of stroke of participants and type of bilateral arm training used.

Results Table

View results table

Outcomes

Acute Phase

Dexterity
Conflicting
4

Two high quality RCTs (Morris et al., 2008; Morris & Van Wijck, 2012) investigated the effect of bilateral arm training on dexterity in patients with acute stroke.

The first high quality RCT (Morris et al., 2008) randomized patients to receive bilateral or unilateral arm training. Dexterity was measured by the Nine Hole Peg Test (9HPT) at post-treatment (6 weeks) and follow-up (18 weeks). A significant between-group difference was found at follow-up only, favoring unilateral vs. bilateral arm training.

The second high quality RCT (Morris & Van Wijck, 2012) randomized patients to receive bilateral or unilateral arm training. Dexterity was measured by the 9HPT at post-treatment (6 weeks) and follow-up (18 weeks). A significant between-group difference was found at post-treatment, favoring bilateral vs. unilateral arm training. This difference did not remain significant at follow-up.

Conclusion: There is conflicting evidence (Level 4) from two high quality RCTs regarding the effect of bilateral arm training on dexterity in patients with acute stroke. While a first high quality RCT found that bilateral arm training was not more effective, in the long term, than unilateral arm training; a second high quality RCT found that bilateral arm training is more effective, in the short term, than unilateral arm training in improving dexterity of patients with acute stroke recovery.

Functional independence
Not effective
1b

One high quality RCT (Morris et al., 2008) investigated the effect of bilateral arm training on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Functional independence was measured by the modified Barthel Index at post-treatment (6 weeks) and follow-up (18 weeks). No significant between-group difference was found at either time point.

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

Health-related quality of life
Not effective
1B

One high quality RCT (Morris et al., 2008) investigated the effect of bilateral arm training on health-related quality of life (HRQoL) in patients with acute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. HRQoL was measured by the Nottingham Health Profile at post-treatment (6 weeks) and follow-up (18 weeks). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) in improving health-related quality of life in patients with acute stroke.

Mood / affect
Not effective
1B

One high quality RCT (Morris et al., 2008) investigated the effect of bilateral arm training on mood/affect in patients with acute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Mood/affect were measured by the Hospital Anxiety and Depression Scale at post-treatment (6 weeks) and follow up (18 weeks). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) in improving mood/affect in patients with acute stroke.

Motor function - upper extremity
Not effective
1a

Two high quality RCTs (Morris et al., 2008; Morris & Van Wijck, 2012) investigated the effect of bilateral arm training on motor function in patients with acute stroke.

The first high quality RCT (Morris et al., 2008) randomized patients to receive bilateral or unilateral arm training. Upper extremity motor function was measured by the Action Research Arm Test (ARAT – total, gross, grip, grasp, pinch scores) and the Rivermead Motor Assessment at post-treatment (6 weeks) and follow-up (18 weeks). A significant between-group difference was found for one measure of upper extremity motor function (ARAT – pinch score) at follow-up, favoring unilateral vs. bilateral arm training.

The second high quality RCT (Morris & Van Wijck, 2012) randomized patients to receive bilateral or unilateral arm training. Upper extremity motor function was measured by the ARAT at post-treatment (6 weeks) and follow-up (18 weeks). No significant between-group difference was found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) in improving upper extremity motor function in patients with acute stroke.

Subacute Phase

Dexterity
Not effective
1B

One high quality RCT (Desrosiers et al., 2005) investigated the effect of bilateral arm training on dexterity in patients with subacute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Dexterity was measured by the Box and Block Test and the Purdue Pegboard Test at post-treatment (5 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving dexterity in patients with subacute stroke.

Functional independence
Not effective
1B

One high quality RCT (Desrosiers et al., 2005) investigated the effect of bilateral arm training on functional independence in patients with subacute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Functional independence was measured by the Functional Independence Measure and the Assessment of Motor and Process Skills at post-treatment (5 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving functional independence in patients with subacute stroke.

Grip strength
Not effective
1B

One high quality RCT (Desrosiers et al., 2005) investigated the effect of bilateral arm training on grip strength in patients with subacute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Grip strength was measured by vigorimeter at post-treatment (5 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving grip strength in patients with subacute stroke.

Kinematics
Not effective
2B

One poor quality RCT (Platz et al., 2001) investigated the effect of bilateral arm training on upper limb kinematics in patients with subacute stroke. This poor quality RCT randomized patients to receive bilateral or unilateral arm training. Movement kinematics during aiming tasks (movement time, spatial accuracy, variation of movement) were measured at post-treatment (1 week). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2b) from one poor quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving upper limb movement kinematics in patients with subacute stroke.

Motor coordination - upper extremity
Not effective
1B

One high quality RCT (Desrosiers et al., 2005) investigated the effect of bilateral arm training on upper extremity motor coordination in patients with subacute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Upper extremity motor coordination was measured by the Finger-to-Nose Test at post-treatment (5 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving upper extremity motor coordination in patients with subacute stroke.

Motor function - upper extremity
Not effective
1B

One high quality RCT (Desrosiers et al., 2005) investigated the effect of bilateral arm training on upper extremity motor function in patients with subacute stroke. This high quality RCT randomized patients to receive bilateral or unilateral arm training. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity subtest (FMA-UE) and the Upper Extremity Performance Test for the Elderly (TEMPA – Unilateral, Bilateral, Total scores) at post-treatment (5 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training) for improving upper extremity motor function in patients with subacute stroke.

Subacute Phase - Device-driven bilateral arm training

Dexterity
Not effective
1B

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on dexterity in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Dexterity was measured by the Box and Block 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 robot-assisted bilateral arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in improving dexterity in patients with subacute stroke.

Fatigue
Not effective
1B

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on fatigue in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Fatigue was measured by an 11-point self-report fatigue scale at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that robot-assisted bilateral arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in reducing fatigue in patients with subacute stroke.

Functional independence
Not effective
1B

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on functional independence in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Functional independence was measured by the Functional Independence Measure and the modified Rankin Scale at post-treatment (4 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that robot-assisted bilateral arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in improving functional independence in patients with subacute stroke.

Grip strength
Not effective
1b

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on grip strength in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Grip strength was measured by the Jamar Plus Digital Hand Dynamometer 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 robot-assisted bilateral arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in improving grip strength in patients with subacute stroke.

Motor function - upper extremity
Conflicting
4

Two high quality RCTs (Hesse et al., 2005, Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on upper extremity motor function in patients with subacute stroke.

The first high quality RCT (Hesse et al., 2005) randomized patients to receive computerized bilateral arm training or electromyography-initiated (EMG) electrical stimulation of paretic wrist extensors. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity subscale (FMA-UE) at post-treatment (6 weeks) and follow-up (3 months). Significant between-group difference was found at both time points, favoring computerized bilateral arm training vs. EMG electrical stimulation of paretic wrist extensors.

The second high quality RCT (Hsieh et al., 2017) randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Upper extremity motor function was measured by the FMA-UE at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) between two high quality RCTs regarding the effect of device-driven bilateral arm training on upper extremity motor function in patients with subacute stroke. Results indicate that computerized bilateral arm training is more effective than EMG-driven electrical stimulation of paretic wrist extensors, whereas robot-assisted bilateral arm training is not more effective than task-oriented training.

Spasticity
Not effective
1B

One high quality RCT (Hesse et al., 2005) investigated the effect of device-driven bilateral arm training on spasticity in patients with subacute stroke. This high quality RCT randomized patients to receive computerized bilateral arm training or electromyography-initiated electrical (EMG) electrical stimulation of paretic wrist extensors. Spasticity was measured by the Modified Ashworth Scale (total score) at post-treatment (6 weeks) and follow-up (3 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that computerized bilateral arm training is not more effective than a comparison intervention (EMG electrical stimulation of paretic wrist extensors) for reducing spasticity in patients with subacute stroke.

Stroke outcomes
Not effective
1B

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on stroke outcomes in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Strength, Hand function, ADL/IADL, Mobility domains) at post-treatment (4 weeks). A significant between-group difference was found for only one domain (SIS – Strength), favoring robot-assisted bilateral arm training vs. time-matched task-oriented training. No other significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that robot-assisted bilateral arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in improving stroke outcomes in patients with subacute stroke.

Wrist activity / rest cycles
Not effective
1B

One high quality RCT (Hsieh et al., 2017) investigated the effect of device-driven bilateral arm training on the activity/rest cycles of the wrist in patients with subacute stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training + task-oriented training or time-matched task-oriented training alone. Wrist activity/rest cycles were measured by a Mini-Motionlogger Actigraph 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 bilateral robot-assisted arm training + task-oriented training is not more effective than a comparison intervention (time-matched task-oriented training alone) in improving wrist activity/rest cycles in patients with subacute stroke.

Wrist strength
Effective
1B

One high quality RCT (Hesse et al., 2005) investigated the effect of device-driven bilateral arm training on wrist strength in patients with subacute stroke. This high quality RCT randomized patients to receive computerized bilateral arm training or electromyography-initiated (EMG) electrical stimulation of paretic wrist extensors. Wrist strength was measured by the Medical Research Council Scale (total score) at post-treatment (6 weeks) and follow-up (3 months). A significant between-group difference was found at both time points, favoring computerized bilateral arm training vs. EMG electrical stimulation of paretic wrist extensors.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that computerized bilateral arm training is more effective than a comparison intervention (EMG electrical stimulation of paretic wrist extensors) for improving wrist strength in patients with subacute stroke.

Chronic Phase

Dexterity
Effective
1b

One high quality RCT (Lee et al., 2017) investigated the effect of bilateral arm training on dexterity in patients with chronic stroke. This high quality RCT randomized patients to receive bilateral arm training using daily activities or time-matched occupational therapy using the Bobath approach; both groups received conventional occupational therapy. Dexterity was measured by the Box and Block Test at baseline and at post-treatment (8 weeks). A significant between-group difference was found in change scores from baseline to post-treatment, favouring bilateral arm training vs. time-matched occupational therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is more effective than a comparison intervention (time-matched occupational therapy using the Bobath approach) in improving dexterity in patients with chronic stroke.

Functional independence
Not effective
1A

Four high quality RCTs (van der Lee et al., 1999; Lin et al., 2009; Lin et al., 2010;Lee et al., 2017) and one fair quality RCT (Shim & Jung, 2015) investigated the effect of bilateral arm training on functional independence in patients with chronic stroke.

The first high quality RCT (van der Lee et al., 1999) randomized patients to receive bilateral arm training based on neurodevelopmental techniques or forced use therapy. Functional independence was measured by the Rehabilitation Activities Profile (Personal care, Occupation scores) at post-treatment (3 weeks) and follow-up (6 weeks, 6 months, 12 months). No significant between-group difference was found at any time point.

The second high quality RCT (Lin et al., 2009) randomized patients to receive bilateral arm training, modified constraint induced movement therapy (mCIMT) or dose-matched conventional rehabilitation comprising neurodevelopmental therapy and compensatory practice of functional tasks. Functional independence was measured by the Functional Independence Measure (FIM – Total, Self-care, Sphincter control, Transfers, Locomotion, Communication, Social cognition scores) at post-treatment (3 weeks). Significant between-group differences were found for one component (FIM – Locomotion), favouring mCIMT vs. bilateral arm training and conventional rehabilitation. No significant difference was found between bilateral arm training and conventional rehabilitation were found.

The third high quality RCT (Lin et al., 2010) randomized patients to receive bilateral arm training using functional tasks or occupational therapy upper limb training using neurodevelopmental techniques. Functional independence was measured by the FIM at post-treatment (3 weeks). No significant between-group difference was found.

The fourth high quality RCT (Lee et al., 2017) randomized patients to receive bilateral arm training using daily activities or time-matched conventional occupational therapy using the Bobath approach; both groups received conventional occupational therapy. Functional independence was measured by the modified Barthel Index at baseline and at post-treatment (8 weeks). A significant between-group difference was found in change scores from baseline to post-treatment, favouring bilateral arm training vs. time-matched occupational therapy.

The fair quality RCT (Shim & Jung, 2015) randomized patients to receive bilateral or unilateral arm training using functional tasks. Functional independence was measured by the FIM (Motor, Cognitive, Total scores) at post-treatment (6 weeks). Significant between-group differences (FIM – Motor, Total scores) were found, favouring bilateral vs. unilateral arm training.

Conclusion: There is strong evidence (Level 1a) from 3 high quality RCTs that bilateral arm training is not more effective than comparison interventions (forced use therapy, mCIMT, conventional rehabilitation, occupational therapy upper limb training using neurodevelopmental techniques) for improving functional independence in patients with chronic stroke. In fact, one of these high quality RCTs found a significant between-group differences on a subscale of a measure of functional independence in favor of a TCIMm compared to bilateral arm training.
Note: However, one high quality RCT and one fair quality RCT found that bilateral arm training is more effective than comparison interventions (time-matched conventional occupational therapy using the Bobath approach, unilateral arm training) in improving functional independence in patients with chronic stroke. The difference in measurement tools used and treatment duration across studies could potentially account for the discrepancies in findings.

Grip strength
Not effective
1B

One high quality RCT (Suputtitada et al., 2004) and one fair quality RCT (Stoykov et al., 2009) investigated the effect of bilateral arm training on grip strength in patients with chronic stroke.

The high quality RCT (Suputtitada et al., 2004) randomized patients to receive bilateral arm training based on neurodevelopmental techniques or constraint induced movement therapy (CIMT). Grip strength was measured by dynamometer at post-treatment (2 weeks). No significant between-group difference was found.

The fair quality RCT (Stoykov et al., 2009) randomized patients to receive functional bilateral or unilateral arm training. Grip strength was measured by dynamometer at post-treatment (8 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that bilateral arm training is not more effective than comparison interventions (CIMT, unilateral arm training) for improving grip strength in patients with chronic stroke.

Kinematics - upper extremity
Effective
1a

Four high quality RCTs (Summers et al., 2007; Lin et al., 2010; Wu et al., 2011; Wu et al., 2012) investigated the effect of bilateral arm training on upper extremity movement kinematics in patients with chronic stroke.

The first high quality RCT (Summers et al., 2007) randomized patients to receive bilateral movement training or unilateral movement training. Upper extremity movement kinematics (movement time, velocity, curvature of arm trajectories and elbow angle) were measured at each training session (6 sessions). No significant between-group differences were found.

The second high quality RCT (Lin et al., 2010) randomized patients to receive bilateral arm training using functional tasks or occupational therapy upper limb training using neurodevelopmental techniques. Upper extremity movement kinematics (NMT, NTD, PPV) were measured during unilateral and bilateral reach movements at post-treatment (3 weeks). Significant between-group differences were found during unilateral (NMT, NTD) and bilateral (NMT, NTD, PPV) reach movements, favouring bilateral arm training vs. neurodevelopmental techniques.

The third high quality RCT (Wu et al., 2011) randomized patients to receive bilateral arm training, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Upper extremity movement kinematics (NMT, NMU, PV, PPV) during unilateral and bilateral reach movements were measured at post-treatment (3 weeks). Comparison of bilateral arm training vs. conventional rehabilitation revealed significant between-group differences (unilateral/bilateral NMU, unilateral/bilateral PV), favouring bilateral arm training. Comparison of bilateral arm training vs. mCIMT revealed a significant between-group difference (unilateral NMU), favouring mCIMT.
Note: Significant between-group differences (unilateral/bilateral NMU) were found favouring mCIMT vs. conventional rehabilitation.

The fourth high quality RCT (Wu et al., 2012) randomized patients to receive therapist-based bilateral arm training, robot-assisted bilateral arm training, or conventional rehabilitation. Upper extremity movement kinematics (NMT, NMU, NTrD, trunk contribution slope for the middle part during unilateral and bilateral movements, angular changes of shoulder flexion during unilateral and bilateral movements) were measured at post-treatment (4 weeks). Comparison of therapist-led bilateral arm training vs. conventional rehabilitation revealed significant between-group differences in unilateral kinematics (NMT, NMU, NTrD, trunk contribution slope for the middle part during unilateral movement) and bilateral kinematics (trunk contribution slope for the middle part during bilateral movement), favouring therapist-led bilateral arm training. Comparison of therapist-led bilateral arm training vs. robot-assisted bilateral arm training revealed significant differences in unilateral kinematics (trunk contribution slope for the middle part during unilateral movements), in favour of therapist-led bilateral arm training.
Note: Robot-assisted bilateral arm training results are reported in the device-drive bilateral arm training section.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that bilateral arm training is more effective than comparison interventions (neurodevelopmental techniques, conventional rehabilitation) in improving upper extremity kinematics in patients with chronic stroke.
Note: However, one high quality RCT found that bilateral arm training was not more effective than unilateral arm training.

NMT: Normalized movement time
NMU: Normalized movement unit
NTrD: Normalized trunk displacement
NTD: Normalized trajectory distance
PV: Peak velocity
PPV: Percentage peak velocity

Motor activity - upper extremity
Not effective
1A

Five high quality RCTs (van der Lee et al., 1999; Lin et al., 2009; Lin et al., 2010; Wu et al., 2011; Wu et al., 2012), two fair quality RCTs (Shim & Jung, 2015; Sethy et al., 2016) and one poor quality RCT (Wu et al., 2010) investigated the effect of bilateral arm training on upper extremity motor activity in patients with chronic stroke.

The first high quality RCT (van der Lee et al., 1999) randomized patients to receive bilateral arm training based on neurodevelopmental techniques or forced use therapy. Upper extremity motor activity was measured by the Motor Activity Log – Amount of Use (MAL-AOU), Quality of Movement (MAL-QOM) and Problem (MAL-Problem) scores at post-treatment (3 weeks) and follow-up (6 weeks, 6 months, 12 months). No significant between-group differences were found at any time points.

The second high quality RCT (Lin et al., 2009) randomized patients to receive bilateral arm training, modified constraint induced movement therapy (mCIMT) or dose-matched conventional rehabilitation comprising neurodevelopmental therapy and compensatory practice of functional tasks. Upper extremity motor activity was measured by MAL-AOU and MAL-QOM scores at post-treatment (3 weeks). Significant between-group differences on both upper extremity motor activity measures were found, favouring mCIMT vs. bilateral arm training. There were no significant differences between bilateral arm training and conventional rehabilitation.
Note: There were significant differences on both upper extremity motor activity measures, favouring mCIMT vs. conventional rehabilitation.

The third high quality RCT (Lin et al., 2010) randomized patients to receive bilateral arm training using functional tasks or occupational therapy upper limb training using neurodevelopmental techniques. Upper extremity motor activity was measured by the MAL-AOU and MAL-QOM at post-treatment (3 weeks). No significant between-group differences were found.

The fourth high quality RCT (Wu et al., 2011) randomized patients to receive bilateral arm training, mCIMT or conventional rehabilitation. Upper extremity motor activity was measured by the MAL-AOU and MAL-QOM at post-treatment (3 weeks). Significant between-group differences on both measures of upper extremity motor activity were found, favouring mCIMT vs. bilateral arm training. No significant differences were found between bilateral arm training and conventional rehabilitation.
Note: Comparison of mCIMT and conventional rehabilitation revealed significant between-group differences on both measures of upper extremity motor activity, favouring mCIMT.

The fifth high quality RCT (Wu et al., 20122) randomized patients to receive therapist-led bilateral arm training, robot-assisted bilateral arm training or conventional rehabilitation. Upper extremity motor activity was measured by the MAL-AOU and MAL-QOM at post-treatment (4 weeks). No significant between-group differences were found between therapist-led bilateral arm training vs. conventional rehabilitation, or between therapist-led vs. robot-assisted bilateral arm training.
Note: Robot-assisted bilateral arm training results are reported in the device-drive bilateral arm training section.

The first fair quality RCT (Shim & Jung, 2015) randomized patients to receive bilateral or unilateral arm training using functional tasks. Upper extremity motor activity (paretic/non-paretic side: amount, intensity) was measured by Actisleep accelerometry at post-treatment (6 weeks). Significant between-group differences were found on both measures of upper extremity motor activity of the paretic limb (amount; intensity: reduced sedentary activity, increased moderate activity), favouring bilateral vs. unilateral arm training.

The second fair quality RCT (Sethy et al., 2016) randomized patients to receive bilateral arm training, mCIMT, or conventional occupational therapy. Upper extremity motor activity was measured by the MAL-AOU and MAL-QOM at baseline and at post-treatment (8 weeks). The bilateral arm training group demonstrated significant gains on both measures of motor activity from pre- to post-treatment.
Note: Between-group differences were not clearly reported, results are not used to determine level of evidence in the conclusion below.

The poor quality RCT (Wu et al., 2010) randomized patients to receive bilateral arm training or mCIMT. Upper extremity motor activity was measured by the MAL- AOU and MAL-QOM at post-treatment (3 weeks). Between-group differences were not reported and no within-group statistical analysis is available.
Note: Results are not used to determine level of evidence in the conclusion below.

Conclusion: There is strong evidence (Level 1a) from five high quality RCTs that bilateral arm training is not more effective than comparison interventions (forced use therapy, modified constraint induced movement therapy, conventional rehabilitation, neurodevelopmental techniques) for improving upper extremity motor activity in patients with chronic stroke. In fact, two high quality RCTs found that mCIMT was more effective than bilateral arm training.
Note: However, one fair quality RCT found that bilateral arm training is more effective than a comparison intervention (unilateral arm training using functional tasks) in improving upper extremity motor activity.

Motor function - upper extremity
Conflicting
4

Eight high quality RCTs (van der Lee et al., 1999; Suputtitada et al., 2004; Summers et al., 2007; Lin et al., 2009; Lin et al., 2010; Wu et al., 2011; Wu et al., 2012; Lee et al., 2017), four fair quality RCTs (Stoykov et al., 2009; Hayner et al., 2010; Singer et al., 2013; Sethy et al., 2016), and one poor quality RCT (Wu et al., 2010) investigated the effect of bilateral arm training on upper extremity motor function in patients with chronic stroke.

The first high quality RCT (van der Lee et al., 1999) randomized patients to receive bilateral arm training based on neurodevelopmental techniques or forced use therapy. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT) at post-treatment (3 weeks) and follow-up (6 weeks, 6 months, 12 months). No significant between-group differences were found in any of the measurements, at any time points.

The second high quality RCT (Suputtitada et al., 2004) randomized patients to receive bilateral arm training based on neurodevelopmental techniques or constraint induced movement therapy (CIMT). Upper extremity motor function was measured by the ARAT (Total, Grasp, Grip, Pinch, Gross scores) at post-treatment (2 weeks). Significant between-group differences were found on all upper extremity motor function measures at post-treatment, favouring CIMT vs. bilateral arm training.

The third high quality RCT (Summers et al., 2007) randomized patients to receive bilateral or unilateral movement training. Upper extremity motor function was measured by the modified Motor Assessment Scale (Upper arm function, Hand movements, Advanced hand movements) at post-treatment (6 days). Significant between-group differences were found on all upper extremity motor function measures at post-treatment, favouring bilateral vs. unilateral movement training.

The fourth high quality RCT (Lin et al., 2009) randomized patients to receive bilateral arm training, modified CIMT (mCIMT) or dose-matched conventional rehabilitation comprising neurodevelopmental therapy and compensatory practice of functional tasks. Upper extremity motor function was measured by the FMA-UE (Overall, Proximal, Distal scores) at post-treatment (3 weeks). Significant between-group differences were found on all measures of upper extremity motor function, favouring bilateral arm training vs. conventional rehabilitation. There were no significant differences between bilateral arm training and mCIMT.
Note: Significant between-group differences on two measures of upper extremity motor function (FMA-UE Overall, Distal scores) were found, favouring mCIMT vs. conventional rehabilitation.

The fifth high quality RCT (Lin et al., 2010) randomized patients to receive bilateral arm training using functional tasks or occupational therapy upper limb training using neurodevelopmental techniques. Upper extremity motor function was measured by the FMA-UE at post-treatment (3 weeks). A significant between-group difference was found at post-treatment, favouring bilateral arm training vs. occupational therapy using neurodevelopmental techniques.

The sixth high quality RCT (Wu et al., 2011) randomized patients to receive bilateral arm training, mCIMT or conventional rehabilitation. Upper extremity motor function was measured by the Wolf-Motor Function Test (WMFT – Performance time, Functional ability, Strength) at post-treatment (3 weeks). No significant differences were found between bilateral arm training and mCIMT, or between bilateral arm training and conventional rehabilitation.
Note: Significant between-group differences on two measures of upper extremity motor function (WMFT – Performance time, Functional ability) were found at post-treatment, favouring mCIMT vs. conventional rehabilitation.

The seventh high quality RCT (Wu et al., 2012) randomized patients to receive therapist-led bilateral arm training, robot-assisted bilateral arm training, or conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE (Total, Proximal, Distal scores) at post-treatment (4 weeks). Comparison of therapist-led bilateral arm training vs. conventional rehabilitation revealed a significant between-group difference (FMA-UE Distal score), favouring therapist-led bilateral arm training. There were no differences between therapist-led and robot-assisted bilateral arm training.
Note: Robot-assisted bilateral arm training results are reported in the device-drive bilateral arm training section.

The eighth high quality RCT (Lee et al., 2017) randomized patients to receive bilateral arm training using daily activities or time-matched conventional occupational therapy using the Bobath approach; both groups received conventional occupational therapy. Upper extremity motor function was measured by the FMA-UE at post-treatment (8 weeks). A significant between-group differences was found for change scores from baseline to post-treatment, favouring bilateral arm training vs. time-matched occupational therapy.

The first fair quality RCT (Stoykov et al., 2009) randomized patients to receive functional bilateral or unilateral arm training. Upper extremity motor function was measured by the Motor Status Scale (MSS – Shoulder/elbow, Wrist/hand) and the Motor Assessment Scale (MAS – Upper arm function, Hand movements, Advanced hand activities, Total score) at post-treatment (8 weeks). A significant between-group difference was found for only one measure of upper extremity motor function (MAS – Upper arm function), favouring bilateral vs. unilateral arm training.

The second fair quality RCT (Hayner et al., 2010) randomized patients to receive bilateral arm training or mCIMT. Upper extremity motor function was measured by the WMFT at post-treatment (10 days) and follow-up (6 months). No significant between-group difference was found at either time point.

The third fair quality RCT (Singer et al., 2013) randomized patients to receive bilateral or unilateral task-specific arm training. Upper extremity motor function was measured by the FMA-UE and the Arm Motor Ability Test at post-treatment (6 weeks) and follow-up (1 month, 3 months). No significant between-group differences were found at any time point.

The fourth fair quality RCT (Sethy et al., 2016) randomized patients to receive bilateral arm training, mCIMT, or conventional occupational therapy. Upper extremity motor function was measured by the FMA-UE (Proximal, Distal scores) and the ARAT at baseline and at post-treatment (8 weeks). The bilateral arm training group demonstrated significant improvements in some measures of motor function (FMA-UE – Proximal scores, ARAT) from pre- to post-treatment.
Note: Between-group differences were not clearly stated, results are not used to determine level of evidence in the conclusion below.

The poor quality RCT (Wu et al., 2010) randomized patients to receive bilateral arm training or mCIMT. Upper extremity motor function was measured by the FMA-UE and the ARAT at post-treatment (3 weeks). Between-group differences were not reported and no within-group statistical analysis is available.
Note: Results are not used to determine level of evidence in the conclusion below.

Conclusion: There is conflicting evidence (Level 4) regarding the use of bilateral arm training to improve upper extremity motor function in patients with chronic stroke. While five high quality RCTs found bilateral arm training was more effective than comparison interventions (unilateral movement training, dose-matched conventional rehabilitation comprising neurodevelopmental therapy and compensatory practice of functional tasks, occupational therapy upper limb training using neurodevelopmental techniques and Bobath approach), three high quality RCTs and two fair quality RCTs found it was not more effective than similar interventions (forced use therapy, mCIMT, conventional rehabilitation, unilateral task-specific arm training). In fact, one high quality RCT and one fair quality RCT found that mCIMT was more effective than bilateral arm training.

Pinch strength
Not effective
1B

One high quality RCT (Suputtitada et al., 2004) investigated the effect of bilateral arm training on pinch strength in patients with chronic stroke. This high quality RCT randomized patients to receive bilateral arm training based on neurodevelopmental techniques or constraint induced movement therapy (CIMT). Pinch strength was measured by dynamometer at post-treatment (2 weeks). A significant between-group difference was found, favouring CIMT vs. bilateral arm training.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that bilateral arm training is not more effective than a comparison intervention (CIMT) for improving pinch strength in patients with chronic stroke. In fact, the high quality RCT found that CIMT was more effective than bilateral arm training.

Strength - upper extremity
Conflicting
4

Two fair quality RCTs (Stoykov et al., 2009; Shim & Jung, 2015) investigated the effect of bilateral arm training on upper extremity strength in patients with chronic stroke.

The first fair quality RCT (Stoykov et al., 2009) randomized patients to receive functional bilateral or unilateral arm training. Upper extremity strength (shoulder flexion/extension, internal/external rotation; elbow flexion/extension; wrist flexion/extension) was measured by dynamometer at post-treatment (8 weeks). No significant between-group differences were found.

The second fair quality RCT (Shim & Jung, 2015) randomized patients to receive bilateral or unilateral arm training using functional tasks. Arm strength (paretic side) was measured by the Manual Function Test at post-treatment (6 weeks). A significant between-group difference was found, favouring bilateral vs. unilateral arm training.

Conclusion: There is conflicting evidence (Level 4) between two fair quality RCTs regarding the effectiveness of bilateral arm training vs. unilateral arm training on upper extremity strength in patients with chronic stroke. While a first fair quality RCT found that bilateral arm training was not more effective than unilateral arm training; a second fair quality RCT found that bilateral arm training is more effective than unilateral arm training in improving upper extremity strength in patients with chronic stroke.

Stroke outcomes
Not effective
1A

Two high quality RCTs (Lin et al., 2009; Wu et al., 2012) investigated the effects of bilateral arm training on stroke outcomes in patients with chronic stroke.

The first high quality RCT (Lin et al., 2009) randomized patients to receive bilateral arm training, modified constraint induced therapy (mCIMT) or dose-matched conventional rehabilitation comprising neurodevelopmental therapy and compensatory practice of functional tasks. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Total score, Strength, Memory, Emotion, Communication, ADL/IADL, Mobility, Hand function, Social participation) at post-treatment (3 weeks). Significant between-group differences were found on three domains (SIS – Total score, ADL/IADL, Social participation), favouring mCIMT vs. bilateral arm training. No significant differences between bilateral arm training and conventional rehabilitation were found.
Note: Significant between-group differences in three domains (SIS – Total score, ADL/IADL, Hand function) were found favouring mCIMT vs. conventional rehabilitation.

The second high quality RCT (Wu et al., 2012) randomized patients to receive therapist-led bilateral arm training, robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, or conventional rehabilitation. Stroke outcomes were measured by the SIS at post-treatment (4 weeks). No significant between-group differences were found between therapist-led bilateral arm training vs. conventional rehabilitation, or between therapist-led vs. robot-assisted bilateral arm training.
Note: Robot-assisted bilateral arm training results are reported in the device-drive bilateral arm training section.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that bilateral arm training is not more effective than comparison interventions (mCIMT, conventional rehabilitation) for improving stroke outcomes in patients with chronic stroke. In fact, one of the high quality RCTs found that mCIMT was more effective than bilateral arm training for improving stroke outcomes.

Chronic Phase - Bilateral Arm Training with electromyography (EMG) stimulation

Dexterity
Effective
2B

One fair quality RCT (Cauraugh & Kim, 2002) investigated the use of bilateral arm training with EMG stimulation on dexterity in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral arm training + EMG-triggered neuromuscular stimulation of wrist and finger extensors, unilateral arm training + EMG-triggered neuromuscular stimulation of wrist and finger extensors, or active wrist and finger extension exercises. Dexterity was measured by the Box and Block Test at baseline and at post-treatment (2 weeks). A significant within-group difference was reported for bilateral arm training + EMG stimulation and unilateral arm training + EMG stimulation, but not for active wrist and finger extension exercises.
Note: Between-group differences were not clearly reported.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that bilateral arm training with EMG stimulation is effective in improving dexterity in patients with chronic stroke.

Kinematics - upper extremity
Effective
2B

Two fair quality RCTs (Cauraugh & Kim, 2002; Cauraugh, Kim & Duley, 2005) investigated the effect of bilateral arm training with EMG stimulation on movement kinematics in patients with chronic stroke.

The first fair quality RCT (Cauraugh & Kim, 2002) randomized patients to receive bilateral arm training + EMG-triggered neuromuscular stimulation of wrist and finger extensors, unilateral arm training and EMG-triggered neuromuscular stimulation of wrist and finger extensors, or active wrist and finger extension exercises. Movement kinematics (motor reaction time) were measured at baseline and at post-treatment (2 weeks). A significant within-group difference was reported for bilateral arm training + EMG stimulation and unilateral arm training + EMG stimulation, but not for active wrist and finger extension exercises.
Note: Between-group differences were not clearly reported.

The second fair quality RCT (Cauraugh, Kim & Duley, 2005) randomized patients to receive bilateral or unilateral arm training with active EMG-neuromuscular stimulation. Movement kinematics (peak velocity, variability in peak velocity, percentage of total movement time in acceleration/deceleration phase, median reaction time, movement time) were measured at post-treatment (2 weeks). The bilateral arm training group demonstrated significant improvements in several movement kinematics measures (higher peak velocity when moving both arms together, less variability in peak velocity when moving the paretic limb alone, less percentage of total movement time in the deceleration phase when moving both arms together, movement time). The unilateral arm training group demonstrated high peak velocity when moving the paretic arm only.
Note: Between-group differences were not reported.

Conclusion: There is limited evidence (Level 2b) from two fair quality RCTs that bilateral arm training with EMG stimulation is effective in improving upper extremity movement kinematics in patients with chronic stroke.

Wrist strength
Effective
2B

One fair quality RCT (Cauraugh & Kim, 2002) investigated the effect of bilateral arm training with EMG stimulation on wrist strength in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral arm training + EMG-triggered neuromuscular stimulation of wrist and finger extensors, unilateral arm training and EMG-triggered neuromuscular stimulation of wrist and finger extensors, or active wrist and finger extension exercises. Wrist strength was measured at baseline and at post-treatment (2 weeks). A significant within-group difference was reported for bilateral arm training + EMG stimulation and unilateral arm training + EMG stimulation, but not for active wrist and finger extension exercises.
Note: Between-group differences were not clearly reported.

Conclusion: There is limited evidence (Level 2b) from one fair quality RCT that bilateral arm training with EMG stimulation is effective in improving wrist strength in patients with chronic stroke.

Chronic Phase - Bilateral Arm Training with Rhythmic Auditory Cueing (BATRAC)

Dexterity
Not effective
1a

Two high quality RCTs (Dispa et al., 2013; Waller et al., 2014) and one poor quality RCT (Rosa et al., 2010) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on dexterity in patients with chronic stroke.

The first high quality cross-over RCT (Dispa et al., 2013) randomized patients to receive bilateral movement therapy with rhythmic auditory cueing or unilateral movement therapy with rhythmic auditory cueing. Dexterity was measured by the Purdue Pegboard Test at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found at either time point.

The second high quality RCT (Waller et al., 2014) randomized patients to receive BATRAC or unilateral task-oriented training for 6 weeks (phase 1), followed by unilateral task-oriented training for 6 weeks (phase 2). Dexterity was measured by the Box and Block Test at post-phase 1 (6 weeks), post-phase 2 (12 weeks) and follow-up (18 weeks). No significant between-group difference was found at any time points.

The poor quality RCT (Rosa et al., 2010) randomized patients to receive BATRAC or unilateral training. Dexterity was measured by the Purdue Pegboard Test at baseline and at post-treatment (6 weeks). Between-group difference was not reported. An improvement in dexterity was found in 3 of 3 unilateral training participants vs. 2 of 3 BATRAC participants. One participant from each group was not able to complete the assessment.
Note: This study is not used to determine level of evidence in the conclusion below.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that BATRAC is not more effective than comparison interventions (unilateral movement therapy with rhythmic auditory cueing, unilateral task-oriented training) in improving dexterity in patients with chronic stroke.

Fine motor coordination
Not effective
2b

One non-randomized study (McCombe Waller & Whitall, 2004) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on fine motor coordination in patients with chronic stroke. This non-randomized study assigned patients to receive BATRAC. Fine motor coordination was measured by a finger tapping task (paretic/non-paretic hand consistency & rate) at baseline and at post-treatment (6 weeks). There was no significant improvement in fine motor coordination of the paretic hand. The non-paretic hand showed a significant improvement in finger tapping consistency but a significant decline in tapping rate post-treatment.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that receive BATRAC is not effective in improving fine motor coordination of the affected hand in patients with chronic stroke.

Functional use - upper extremity
Not effective
1b

One high quality RCT (Luft et al., 2004) and two non-randomized studies (Whitall et al., 2000; McCombe Waller & Whitall, 2004) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on functional use of the upper extremity in patients with chronic stroke.

The high quality RCT (Luft et al., 2004) randomized patients to receive BATRAC or dose-matched unilateral upper limb exercises based on neurodevelopmental techniques. Functional use of the upper extremity was measured by the University of Maryland Arm Questionnaire for Stroke (UMAQS) at post-treatment (6 weeks). No significant between-group difference was found.

The first non-randomized study (Whitall et al., 2000) assigned patients to receive BATRAC. Functional use of the upper extremity was measured by the UMAQS at baseline, at post-treatment (6 weeks) and follow-up (2 months). There were significant improvements in daily use of the hemiparetic arm at both post-intervention measurement times compared to the baseline.

The second non-randomized study (McCombe Waller & Whitall, 2004) assigned patients to receive BATRAC. Functional use of the upper extremity was measured by the UMAQS at post-treatment (6 weeks). Significant improvement was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than a comparison intervention (unilateral upper limb exercises based on neurodevelopmental techniques) in improving functional use of the upper extremity in patients with chronic stroke.
Note: However, two non-randomized studies reported significant improvements in functional use of the upper limb following BATRAC.

Grip strength
Not effective
1b

One high quality RCT (Dispa et al., 2013) and one non-randomized study (Whitall et al., 2000) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on grip strength in patients with chronic stroke.

The high quality cross-over RCT (Dispa et al., 2013) randomized patients to receive bilateral movement therapy with rhythmic auditory cueing or unilateral movement therapy with rhythmic auditory cueing. Grip-lift force coordination (preloading phase, loading phase, grip force max, hold ratio, cross-correlation coefficient, time shift) was measured by manipulandum sensors at post-treatment (4 weeks, 8 weeks). No significant between-group differences were found at either time point.

The non-randomized study (Whitall et al., 2000) assigned patients to receive BATRAC. Grip strength was measured by dynamometer at baseline, at post-treatment (6 weeks) and follow-up (2 months). No significant improvement was found at the two post-intervention measurement times compared to the baseline.

Conclusion: There is moderate evidence (Level 1b) from one high-quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral movement therapy with rhythmic auditory cueing) in improving grip-lift force coordination in patients with chronic stroke. Furthermore, one non-RCT design study also reported no significant gains in grip strength following BATRAC.

Kinematics - upper extremity
Not effective
2a

One fair quality RCT (McCombe Waller, Liu & Whitall, 2008) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity movement kinematics in patients with chronic stroke. This fair quality RCT randomized patients to receive BATRAC or unilateral upper limb training based on neurodevelopmental techniques. Upper extremity movement kinematics (distance moved, movement time, peak acceleration, peak velocity, movement units of the paretic hand on bilateral reach, and hand path accuracy of paretic/non-paretic hand on bilateral reach) were measured at post-treatment (6 weeks). Significant between-group differences in two measures of upper extremity kinematics (movement units of the paretic hand on bilateral reach; hand path accuracy of paretic and non-paretic hands on bilateral reach task) were found, favouring BATRAC vs. unilateral neurodevelopmental techniques.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that BATRAC is not more effective than a comparison intervention (unilateral neurodevelopmental techniques) for improving unilateral measures of upper extremity movement kinematics in patients with chronic stroke. However, results showed that BATRAC was more effective than unilateral neurodevelopmental techniques in improving some kinematic measures during bilateral reach tasks.

Motor function - upper extremity
Not effective
1A

Five high quality RCTs (Luft et al., 2004; Whitall et al., 2011; Dispa et al., 2013; Shahine & Shafshak, 2014; Waller et al., 2014), one fair quality RCT (McCombe Waller, Liu & Whitall, 2008), one poor quality RCT(Rosa et al., 2010) and two non-randomized studies (Whitall et al., 2000; McCombe Waller & Whitall, 2004) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity motor function in patients with chronic stroke.

The first high quality RCT (Luft et al., 2004) randomized patients to receive BATRAC or dose-matched upper limb exercises based on neurodevelopmental techniques. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE) and the Wolf Motor Function Test (WMFT – Time, Strength scores) at post-treatment (6 weeks). No significant between-group differences were found.

The second high quality RCT (Whitall et al., 2011) randomized patients to receive BATRAC or dose-matched unilateral therapeutic exercises based on neurodevelopmental techniques. Upper extremity motor function was measured by the FMA-UE and the WMFT (Time, Strength, Function scores) at post-treatment (6 weeks) and follow-up (4 months). No significant between-group differences were found at either time point.

The third high quality cross-over RCT (Dispa et al., 2013) randomized patients to receive BATRAC or unilateral arm training with rhythmic auditory cueing. Upper extremity motor activity was measured by the ABILHAND Questionnaire at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found at either time point.

The fourth high quality RCT (Shahine & Shafshak, 2014) randomized patients to receive BATRAC or unilateral upper extremity rehabilitation. Upper extremity motor function was measured by the FMA-UE at post-treatment (8 weeks). No significant between-group difference was found.

The fifth high quality RCT (Waller et al., 2014) randomized patients to receive BATRAC or unilateral task-oriented training for 6 weeks (phase 1), followed by unilateral task-oriented training for 6 weeks (phase 2). Upper extremity motor function was measured by the FMA-UE, modified WMFT (mWMFT), and the University of Maryland Arm Questionnaire for Stroke (UMAQS) at baseline, at post-phase 1 (6 weeks), post-phase 2 (12 weeks) and follow-up (18 weeks). There were no significant differences between groups post-phase 1 (6 weeks). However, significant between-group differences were found for two measures of upper extremity motor function (mWMFT, UMAQS) change scores from baseline to post-phase 2 and from baseline to follow-up, favouring BATRAC vs. unilateral task-oriented training.

The fair quality RCT (McCombe Waller, Liu & Whitall, 2008) randomized patients to receive BATRAC or unilateral upper limb training based on neurodevelopmental techniques. Upper extremity motor function was measured by the FMA-UE and mWMFT (Time, Strength scores) at post-treatment (6 weeks). Between-group differences were not reported. The BATRAC group demonstrated significant improvements on all measures of upper extremity motor function; the unilateral upper limb training group demonstrated significant improvements on two measures (FMA-UE; mWMFT – Strength).
Note: This study is not used to determine level of evidence in the conclusion below.

The poor quality RCT (Rosa et al., 2010) randomized patients to receive BATRAC or unilateral training. Upper extremity motor function was measured by the FMA-UE at baseline and at post-treatment (6 weeks). No between-group difference was reported. An improvement was found in 3 of 4 unilateral training group participants, vs. 1 of 4 BATRAC participants; 2 of 4 BATRAC participants demonstrated poorer upper extremity motor function at post-treatment.
Note: This study is not used to determine level of evidence in the conclusion below.

The first non-randomized study (Whitall et al., 2000) assigned patients to receive BATRAC. Upper extremity motor function was measured by the FMA-UE (Motor performance section) and the WMFT (Time, Strength, Function scores) at post-treatment (6 weeks) and follow-up (2 months). Significant improvements in two measures of upper extremity motor function (FMA-UE; WMFT – Time) were found at both time points.

The second non-randomized study (McCombe Waller & Whitall, 2004) assigned patients to receive BATRAC. Upper extremity motor function was measured by the FMA-UE and WMFT at post-treatment (6 weeks). Significant improvements in both measures of upper extremity motor function were found.

Conclusion: There is strong evidence (Level 1a) from five high quality RCTs that BATRAC is not more effective than comparison interventions (upper extremity exercises based on neurodevelopmental techniques, unilateral therapeutic exercises based on neurodevelopmental techniques, unilateral arm training with rhythmic auditory cueing, unilateral upper extremity rehabilitation, unilateral task-oriented training) for improving upper extremity motor function in patients with chronic stroke. A poor quality RCT reported poorer outcomes following BATRAC vs. unilateral training.
Note: However, one high quality RCT reported long-term benefits of BATRAC vs. unilateral task-oriented training. Furthermore, one fair quality RCT and two non-randomized studies reported significant improvements in upper extremity motor function following BATRAC.

Motor recovery - upper extremity
Effective
1B

One high quality RCT (Shahine & Shafshak, 2014) investigated the effect of BATRAC on upper extremity motor recovery in patients with chronic stroke. This high quality RCT randomized patients to receive BATRAC or unilateral upper extremity rehabilitation. Upper extremity motor recovery was measured by Motor Evoked Potentials (transcranial magnetic stimulation threshold, motor condition time, amplitude ratio) of the paretic abductor pollicis brevis at post-treatment (8 weeks). Significant between-group differences were found on all measures of upper extremity motor recovery, favouring BATRAC vs. unilateral upper extremity rehabilitation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is more effective than a comparison intervention (unilateral upper extremity rehabilitation) in improving upper extremity motor recovery in patients with chronic stroke.

Range of motion - upper extremity
Not effective
2B

One non-randomized study (Whitall et al., 2000) investigated the use of bilateral arm training with rhythmic auditory cueing (BATRAC) on range of motion in the upper extremity in patients with chronic stroke. This non-randomized study assigned patients to receive BATRAC. Active and passive range of motion (aROM, pROM) at the shoulder (flexion, extension, abduction, adduction), elbow (flexion, extension), wrist (flexion, extension) and thumb (opposition) was measured at post-treatment (6 weeks) and follow-up (2 months). At post-treatment significant improvements in shoulder aROM (extension only), wrist aROM/pROM (flexion only), and thumb aROM (opposition) were found. At follow-up, improvements in wrist pROM (flexion only) and thumb aROM (opposition) were maintained.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that BATRAC is not effective for improving upper extremity range of motion in patients with chronic stroke.
Note: However, the study found significant and sustained improvements in wrist flexion and thumb opposition.

Satisfaction with activities and participation
Not effective
1B

One high quality RCT (Dispa et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on satisfaction with activities and participation in patients with chronic stroke. This high quality cross-over RCT randomized patients to receive BATRAC or unilateral arm training with rhythmic auditory cueing. Satisfaction with activities and participation was measured by the SATIS-Stroke Questionnaire at post-treatment (4 weeks, 8 weeks). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high-quality RCT that bilateral arm training is not more effective than a comparison intervention (unilateral arm training with rhythmic auditory cueing) in improving satisfaction with activities and participation in patients with chronic stroke.

Spasticity
Not effective
1B

One high quality RCT (Waller et al., 2014) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on spasticity in patients with chronic stroke. This high quality RCT randomized patients to receive BATRAC or unilateral task-oriented training for 6 weeks (phase 1), followed by unilateral task-oriented training for 6 weeks (phase 2). Spasticity was measured by the Modified Ashworth Scale at post-phase 1 (6 weeks), post-phase 2 (12 weeks) and follow-up (18 weeks). No significant between-group difference was found at any time points.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than a comparison intervention (unilateral task-oriented training) in reducing spasticity in patients with chronic stroke.

Strength - upper extremity
Not effective
1A

Two high quality RCTs (Luft et al., 2004; Whitall et al., 2011) and one non-randomized study (Whitall et al., 2000) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity strength in patients with chronic stroke.

The first high quality RCT (Luft et al., 2004) randomized patients to receive BATRAC or dose-matched upper limb exercises based on neurodevelopmental techniques. Strength of the paretic shoulder and elbow was measured by a dynamometer at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Whitall et al., 2011) randomized patients to receive BATRAC or dose-matched unilateral therapeutic exercises based on neurodevelopmental techniques. Isometric shoulder strength (flexion/extension) and isokinetic elbow (flexion/extension) and wrist (flexion/extension) strength of the paretic/non-paretic limbs were measured by dynamometer at post-treatment (6 weeks) and at follow-up (4 months). No significant between-group differences in shoulder strength were found at either time point. Significant between-group differences in strength of the non-paretic elbow (flexion only) and non-paretic wrist (flexion only) were found at post-treatment, favouring BATRAC vs. neurodevelopmental techniques. Conversely, a significant between-group difference in strength of the paretic wrist (extension only) was found, favouring the neurodevelopmental approach vs. BATRAC. Differences remained significant at follow-up.

One non-randomized study (Whitall et al., 2000) assigned patients to receive BATRAC. Isometric strength of the paretic/non-paretic shoulder, elbow and wrist (flexion/extension) was measured at post-treatment (6 weeks) and follow-up (2 months). At post-treatment there were no significant changes in shoulder or elbow strength, but there was a significant improvement in paretic wrist strength (flexion only). At follow-up there was a significant improvement in non-paretic elbow strength (flexion only) and non-paretic wrist strength(extension).

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that BATRAC is not more effective than a comparison intervention (neurodevelopmental techniques) in improving paretic upper extremity strength (shoulder, elbow, wrist).
Note: BATRAC was more effective than neurodevelopmental techniques in improving non-paretic wrist and elbow strength, whereas the neurodevelopmental approach was more effective than BATRAC for improving paretic wrist strength. Furthermore, a non-randomized study found significant short-term improvements in paretic wrist strength (flexion only), and significant long-term improvements in non-paretic elbow strength (flexion only) and non-paretic wrist strength (extension), following a BATRAC.

Stroke outcomes
Not effective
1B

One high quality RCT (Whitall et al., 2011) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on stroke outcomes in patients with chronic stroke. This high quality RCT randomized patients to receive BATRAC or dose-matched unilateral therapeutic exercises based on neurodevelopmental techniques. Stroke outcomes were measured with the Stroke Impact Scale (SIS – Total, Emotion, Hand function, Strength domains) at post-treatment (6 weeks) and at follow-up (4 months). A significant between-group difference was found for one score (SIS – Total score) at follow-up only, favouring BATRAC vs. unilateral neurodevelopmental techniques.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than a comparison intervention (unilateral neurodevelopmental techniques) in improving stroke outcomes in patients with chronic stroke.

Chronic Phase - Bilateral video game training

Motor function - upper extremity
Effective
2B

One non-randomized study (Hijmans et al., 2011) investigated the effect of bilateral video game training on upper extremity motor function in patients with chronic stroke. This non-randomized design study assigned patients to receive unilateral mouse-based computer game training using the less-affected hand (phase 1), then a washout period of no training (phase 2), then bilateral video game training using the CyWee Z game controller (phase 3). Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE), the Wolf-Motor Function Test (WMFT), and the Disabilities of Arm Shoulder and Hand (DASH) at baseline and following phase 1 (unilateral training, 2.5 weeks), phase 2 (washout period, approx. week 5) and phase 3 (bilateral training, 7.5 weeks). A significant improvement was found in one measure of upper extremity motor function (FMA-UE) from baseline to phase 3.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that bilateral video game training is effective for improving upper extremity motor function in patients with chronic stroke.
Note: However, results were only significant for 1 of 3 measures of upper extremity motor function used.

Chronic Phase - Device-driven bilateral arm training

Cognitive function
Not effective
2a

One fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on cognitive function in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Cognitive function was measured by the Saint Louis University Mental Status Examination at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in improving cognitive function in patients with chronic stroke.

Depression
Not effective
2A

One fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on depression in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Depression was measured by the Beck Depression Inventory at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in improving depression in patients with chronic stroke.

Dexterity
Not effective
2A

One fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on dexterity in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Dexterity was measured by the Motor Skill Performance Score (Box and Block Test + Tapper Test combined scores) at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in improving dexterity in patients with chronic stroke.

Functional independence
Not effective
1b

One high quality RCT (Lum et al., 2002) and one fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on functional independence in patients with chronic stroke.

The high quality RCT (Lum et al., 2002) randomized patients to receive bilateral robot-assisted movement training using the MIT-MANUS robot manipulator or conventional upper limb rehabilitation using neurodevelopmental techniques. Functional independence was measured by the Functional Independence Measure (FIM) and the Barthel Index at mid-treatment (1 month), post-treatment (2 months) and follow-up (6 months). A significant between-group difference was found for one measure of functional independence (FIM) at follow-up (6 months) only, favouring bilateral robot-assisted movement training vs. neurodevelopmental techniques.

The fair quality RCT (Byl et al., 2013) randomized patients to receive to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Functional independence was measured by the CAFÉ 40 + Stroke Impact Scale (Self-care domain) combined score at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (neurodevelopmental techniques, unilateral robotic training, unilateral therapist-led training) for improving functional independence in patients with chronic stroke.
Note: The high quality RCT found long-term gains in functional independence in favour of bilateral device-driven bilateral arm training vs. neurodevelopmental techniques.

Grip strength
Not effective
2A

One fair quality RCT (Stinear et al., 2008) and one non-RCT design study (Chang et al., 2007) investigated the effect of device-driven bilateral arm training on grip strength in patients with chronic stroke.

The fair quality RCT (Stinear et al., 2008) randomized patients to receive active-passive bilateral therapy using a mechanical device + motor practice or motor practice alone. Grip strength was measured by a dynamometer at post-treatment (4 weeks) and follow-up (8 weeks). No significant between-group difference was found at either time point.

The non-randomized study (Chang et al., 2007) assigned patients to receive robot-aided bilateral training using a bilateral force-induced isokinetic arm movement trainer (BFIAMT) and conventional rehabilitation. Grip strength was measured by a Jamar dynamometer at post-treatment (8 weeks) and follow-up (16 weeks). A significant improvement was found at both time points.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than a comparison intervention (motor practice alone) for improving grip strength in patients with chronic stroke.
Note: However, a non-randomized study reported a significant improvement in grip strength following robot-aided bilateral training.

Kinematics
Effective
1a

Thee high quality RCTs (Lum et al., 2002; Wu et al., 2012; Wu et al., 2013) and one non-RCT design study (Chang et al., 2007) investigated the effect of device-driven bilateral arm training on movement kinematics in patients with chronic stroke.

The first high quality RCT (Lum et al., 2002) randomized patients to receive robot-assisted bilateral movement training using the MIT-MANUS robot manipulator or conventional upper limb rehabilitation using neurodevelopmental techniques. Movement kinematics during reaching at tabletop and shoulder heights (forward-lateral, lateral, forward-medial, forward) were measured at post-treatment (2 months). Significant between-group differences were found for reach kinematics at tabletop height (forward-lateral, lateral) and shoulder height (forward-lateral, lateral, forward-medial, forward), favouring robot-assisted bilateral movement training vs. neurodevelopmental techniques.

The second high quality RCT (Wu et al., 2012) randomized patients to receive robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, therapist-led bilateral arm training, or conventional rehabilitation. Movement kinematics (NMT, NMU, NTD, trunk contribution slope for the middle part during unilateral and bilateral movement, angular changes of shoulder flexion during unilateral and bilateral movements) were measured at post-treatment (4 weeks). Comparison of robot-assisted bilateral arm training vs. conventional rehabilitation revealed significant differences (angular changes of normalized shoulder flexion during unilateral and bilateral movements), favouring robot-assisted bilateral arm training. Comparison of robot-assisted bilateral arm training vs. therapist-led bilateral arm training revealed a significant difference in one variable (angular changes of normalized shoulder flexion during unilateral movements), favouring robot-assisted bilateral arm training.
Note: There was a significant difference in one variable (unilateral trunk contribution slop for the middle part), in favour of therapist-led bilateral arm training vs. robot-assisted bilateral arm training; further therapist-led bilateral arm training results are reported in the bilateral arm training section above.

The third high quality RCT (Wu et al., 2013) randomized patients to receive robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, robot-assisted unilateral arm training or conventional rehabilitation. Movement kinematics (NMT, NMU, trunk contribution, slope start/mid during unilateral and bilateral movements) were measured at post-treatment (4 weeks). Comparison of bilateral vs. unilateral robot-assisted arm training revealed a significant between-group difference for one variable (slope start during bilateral movement), favouring robot-assisted bilateral arm training. There were no significant differences between robot-assisted bilateral arm training and conventional rehabilitation.
Note: Comparison of robot-assisted unilateral arm training vs. conventional rehabilitation revealed a significant between-group difference for one measure (slope mid during bilateral movement), favouring conventional rehabilitation.

The non-randomized study (Chang et al., 2007) assigned patients to receive robot-aided bilateral training using a bilateral force-induced isokinetic arm movement trainer (BFIAMT) and conventional rehabilitation. Reaching movement kinematics (movement time, peak velocity, percentage of time to peak velocity, normalized jerk score) were measured at post-treatment (8 weeks) and follow-up (16 weeks). Significant improvements in all reaching movement kinematics were found at post-treatment, but these did not remain significant at follow-up.

Conclusion: There is strong evidence (level 1a) from three high quality RCTs that device-driven bilateral arm training is more effective than comparison interventions (conventional upper limb rehabilitation using neurodevelopmental techniques, conventional rehabilitation,therapist-led bilateral arm training, or robot-assisted unilateral arm training) for improving kinematics in patients with chronic stroke. Further, a non-randomized study found significant short-term improvement in reach kinematics following robot-aided bilateral training.

NMT: Normalized movement time
NMU: Normalized movement unit
NTD: Normalized trunk displacement

Motor activity - upper extremity
Not effective
1A

Two high quality RCTs (Wu et al., 2012; Wu et al., 2013) investigated the effect of device-driven bilateral arm training on upper extremity motor activity in patients with chronic stroke.

The first high quality RCT (Wu et al., 2012) randomized patients with chronic stroke to receive robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, therapist-led bilateral arm training, or conventional rehabilitation. Upper extremity motor activity was measured by the Motor Activity Log – Amount of Use (MAL-AOU) and – Quality of Movement (MAL-QOM) at post-treatment (4 weeks). There were no significant differences between robot-assisted bilateral arm training and therapist-led bilateral arm training, or between robot-assisted bilateral arm training and conventional rehabilitation.
Note: Therapist-led bilateral arm training results are reported in the bilateral arm training section.

The second high quality RCT (Wu et al., 2013) randomized patients to receive bilateral robot-assisted arm training using the Bi-Manu-Track arm trainer, unilateral robot-assisted arm training or conventional rehabilitation. Upper extremity motor activity was measured by the MAL-AOU, MAL-QOM and the ABILHAND Questionnaire at post-treatment (4 weeks). No significant between-group differences were found in any of the measurements.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that device-driven bilateral arm training is not more effective than comparison interventions (therapist-led bilateral arm training, conventional rehabilitation, unilateral robot-assisted arm training) for improving upper extremity motor activity in patients with chronic stroke.

Motor function - upper extremity
Not effective
1A

Three high quality RCTs (Lum et al., 2002; Wu et al., 2012; Wu et al., 2013), two fair quality RCTs (Stinear et al., 2008; Byl et al., 2013), and two non-RCT design studies (Hesse et al., 2003; Chang et al., 2007) investigated the effect of device-driven bilateral arm training on the upper extremity motor function in patients with chronic stroke.

The first high quality RCT (Lum et al., 2002) randomized patients to receive bilateral robot-assisted movement training using the MIT-MANUS robot manipulator or conventional upper limb rehabilitation using neurodevelopmental techniques. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE – Proximal, Distal scores) at mid-treatment (1 month), post-treatment (2 months) and follow-up (6 months). A significant between-group difference (FMA-UE Proximal score only) was found at mid-treatment and at post-treatment, favouring bilateral robot-assisted movement training vs. neurodevelopmental techniques. This difference was not maintained at 6-month follow-up.

The second high quality RCT (Wu et al., 2012) randomized patients to receive robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, therapist-led bilateral arm training, or conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE (Proximal, Distal, Total scores) at post-treatment (4 weeks). There were no significant differences between robot-assisted bilateral arm training and conventional rehabilitation, or between robot-assisted bilateral arm training and therapist-led bilateral arm training.
Note: Therapist-led bilateral arm training results are reported in the bilateral arm training section above.

The third high quality RCT (Wu et al., 2013) randomized patients to receive bilateral robot-assisted arm training using the Bi-Manu-Track arm trainer, unilateral robot-assisted arm training or conventional rehabilitation. Upper extremity motor function was measured by the Wolf-Motor Function Test (WMFT – Time, Functional ability scores) at post-treatment (4 weeks). Comparison of bilateral and unilateral robot-assisted arm training revealed a significant between-group difference on one measure (WMFT – Time), favouring unilateral vs. bilateral robot-assisted arm training. No other between-group differences were found.

The first fair quality RCT (Stinear et al., 2008) randomized patients to receive bilateral therapy using a mechanical device + motor practice or motor practice alone. Upper extremity motor function was measured by the FMA-UE at post-treatment (4 weeks) and follow-up (8 weeks). A significant between-group difference was found at follow-up, favouring bilateral therapy + motor practice vs. motor practice alone.

The second fair quality RCT (Byl et al., 2013) randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Upper extremity motor function was measured by the FMA-UE and the Motor Proficiency Speed Score (Wolf-Motor Function Test + Digital Reaction Time Test combined scores) at post-treatment (6 weeks). No significant between-group differences were found.

The first non-randomized study (Hesse et al., 2003) assigned patients to receive bilateral arm training using a robotic arm trainer and conventional rehabilitation. Upper extremity motor function was measured by the Rivermead Motor Assessment at baseline, at post-treatment (3 weeks) and follow-up (3 months). No significant change was found at either time point.

The second non-randomized study (Chang et al., 2007) assigned patients to receive robot-aided bilateral training using a bilateral force-induced isokinetic arm movement trainer (BFIAMT) and conventional rehabilitation. Upper extremity motor function was measured by the FMA-UE and the Frenchay Arm Test at baseline, at post-treatment (8 weeks) and follow-up (16 weeks). A significant improvement was found for one measure of upper extremity motor function (FMA-UE) at both time points post-treatment.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that device-driven bilateral arm training is not more effective than comparison interventions (therapist-led bilateral arm training, conventional rehabilitation or unilateral robot-assisted arm training ) in improving upper extremity motor function in patients with chronic stroke. In fact, one high quality RCT found that device-driven bilateral arm training was less effective than device-driven unilateral arm training on one measure of motor function. Further, one fair quality RCT found that device-driven bilateral arm training is not more effective than comparison intervention (therapist-led unilateral arm training) in improving upper extremity motor function.
Note: One high quality RCT found significant differences in one measure of upper extremity motor function, in favour of device-driven bilateral arm training vs. neurodevelopmental techniques. Similarly, one fair quality RCT found that bilateral arm training using a mechanical device was more effective in the long term than no arm training with no device for improving motor function. A non-randomized study also reported improved upper limb motor function following device-driven bilateral arm training.

Neurological recovery
Not effective
2a

One fair quality RCT (Stinear et al., 2008) investigated the effect of device-driven bilateral arm training on neurological recovery in patients with chronic stroke. This fair quality RCT randomized patients to receive active-passive bilateral arm therapy using a mechanical device and motor practice or motor practice alone. Neurological recovery was measured by the National Institutes of Health Stroke Scale at post-treatment (4 weeks) and follow-up (8 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 bilateral arm therapy using a mechanical device is not more effective than a comparison intervention (motor practice alone) for improving neurological recovery in patients with chronic stroke.

Pain
Not effective
2A

One fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on pain in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Pain was measured by a self-rated 0-10 ordinal scale at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in reducing pain in patients with chronic stroke.

Range of motion
Not effective
2A

One fair quality RCT (Byl et al., 2013) investigated the effect of device-driven bilateral arm training on range of motion in patients with chronic stroke. This fair quality RCT randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Active range of motion of the upper extremity (shoulder flexion/extension, abduction/adduction, internal/external rotation; elbow flexion/extension; wrist flexion/extension) was measured by goniometer at post-treatment (6 weeks). No significant between-group differences were found.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in improving range of motion in patients with chronic stroke.

Spasticity - upper extremity
Not effective
2A

One fair quality RCT (Byl et al., 2013) and two non-randomized studies (Hesse et al., 2003; Chang et al., 2007) investigated the effect of device-driven bilateral arm training on upper extremity spasticity in patients with chronic stroke.

The fair quality RCT (Byl et al., 2013) randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Upper extremity spasticity was measured by the Modified Ashworth Scale (MAS) at post-treatment (6 weeks). No significant between-group differences were found.

The first non-randomized study (Hesse et al., 2003) assigned patients to receive bilateral arm training using a robotic arm trainer and conventional rehabilitation. Elbow spasticity was measured by the MAS at baseline, at post-treatment (3 weeks) and follow-up (3 months). No significant change was found at either time point.

The second non-randomized study (Chang et al., 2007) provided patients with robot-aided bilateral training using a bilateral force-induced isokinetic arm movement trainer (BFIAMT) and conventional rehabilitation. Upper extremity spasticity was measured by the MAS at post-treatment (8 weeks) and follow-up (16 weeks). No significant change was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that device-driven bilateral arm training is not more effective than comparison interventions (unilateral robotic training, unilateral therapist-led training) in reducing upper extremity spasticity in patients with chronic stroke. Further, two non-randomized studies found no improvements in upper extremity spasticity following device-driven bilateral arm training.

Spasticity (wrist/finger)
Effective
2b

One non-randomized study (Hesse et al., 2003) investigated the effect of device-driven bilateral arm training on wrist/finger spasticity in patients with chronic stroke. This non-randomized study assigned patients to receive bilateral arm training using a robotic arm trainer and conventional rehabilitation. Wrist/finger spasticity was measured by the Modified Ashworth Scale at baseline, at post-treatment (3 weeks) and follow-up (3 months). A significant improvement was found at post-treatment but did not remain significant at follow-up.

Conclusion: There is limited evidence (Level 2b) from one non-RCT design study that device-driven bilateral arm training is effective in improving wrist/finger spasticity in patients with chronic stroke in the short term.

Strength - upper extremity
Effective
1B

One high quality RCT (Lum et al., 2002), one fair quality RCT (Byl et al., 2013) and one non-RCT design study (Chang et al., 2007) investigated the effect of device-driven bilateral arm training on upper extremity strength in patients with chronic stroke.

The high quality RCT (Lum et al., 2002) randomized patients to receive bilateral robot-assisted movement training using the MIT-MANUS robot manipulator or conventional upper limb rehabilitation using neurodevelopmental techniques. Shoulder strength (flexion/extension, abduction/adduction, internal/external rotation) and elbow strength (flexion/extension) was measured by torque at post-treatment (2 months). Significant between-group differences in some components of upper extremity strength (shoulder: flexion, abduction, adduction; elbow: flexion only) were found only at post-treatment, favouring bilateral robot-assisted movement training vs. neurodevelopmental techniques.

The fair quality RCT (Byl et al., 2013) randomized patients to receive bilateral robotic task specific repetitive training (TSRT) using the UL-EXO7 robotic orthosis, or unilateral robotic TSRT, or unilateral physical therapist-led TSRT. Arm strength was measured by the Manual Muscle Test (total upper extremity score) at post-treatment (6 weeks). No significant between-group differences were found.

The non-randomized study (Chang et al., 2007) assigned patients to receive robot-aided bilateral training using a bilateral force-induced isokinetic arm movement trainer (BFIAMT) and conventional rehabilitation. Elbow strength (push/pull) was measured by the BFIAMT at post-treatment (8 weeks) and follow-up (16 weeks). A significant improvement was found at both time points.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that device-driven bilateral arm training is more effective than a comparison intervention (neurodevelopmental techniques) for improving upper extremity strength in patients with chronic stroke. One non-randomized study also found improvements in elbow strength following robot-aided bilateral training.
Note: However, a fair quality RCT found that bilateral robotic training was not more effective than unilateral robotic training or unilateral therapist-led training in improving upper extremity strength.

Stroke outcomes
Effective
1B

One high quality RCT (Wu et al., 2012) investigated the effect of device-driven bilateral arm training on stroke outcomes in patients with stroke. This high quality RCT randomized patients to receive robot-assisted bilateral arm training using the Bi-Manu-Track arm trainer, therapist-led bilateral arm training, or conventional rehabilitation. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Total, Strength, Memory, Emotion, Communication, ADL/IADL, Mobility, Hand function, Social participation, Physical function domain) at post-treatment (4 weeks). Comparison of robot-assisted bilateral arm training and conventional rehabilitation revealed significant between-group differences for some stroke outcomes (SIS – Total score, Strength, Physical function domain), favouring robot-assisted bilateral arm training. There were no significant differences between robot-assisted bilateral arm training and therapist-led bilateral arm training.
Note: Therapist-led bilateral arm training results are reported in the bilateral arm training section above.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that device-drive bilateral arm training is more effective than a comparison intervention (conventional rehabilitation) for improving some stroke outcomes in patients with chronic stroke. Device-driven bilateral arm training was not more effective than therapist-led bilateral arm training.

Phase not specific to one period – Bilateral Arm Training with Rhythmic Auditory Cueing (BATRAC)

Dexterity
Not Effective
1B

One high quality RCT (Van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on dexterity in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Dexterity was measured by the Nine Hole Peg Test at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving dexterity in patients with stroke.

Motor activity - upper extremity
Not Effective
1B

One high quality RCT (van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity motor activity in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Upper extremity motor activity was measured by the Motor Activity Log (Amount of Use, Quality of Movement) at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving upper extremity motor activity in patients with stroke.

Motor function - upper extremity
Not Effective
1B

One high quality RCT (van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity motor function in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Upper extremity motor function was measured by the Action Research Arm Test (Grasp, Grip, Pinch, Gross movement scores) and the Fugl-Meyer Assessment – Upper Extremity at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving upper extremity motor function in patients with stroke.

Sensation
Not Effective
1B

One high quality RCT (van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on sensation in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Sensation was measured by the Erasmus modification of the Nottingham Sensory Assessment at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving sensation in patients with stroke.

Strength - upper extremity
Not Effective
1B

One high quality RCT (van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on upper extremity strength in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Upper extremity strength was measured by the Motricity Index (upper extremity score) at post-treatment (6 weeks) and follow-up (12 weeks). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving upper extremity strength in patients with stroke.

Stroke outcomes
Not Effective
1B

One high quality RCT (van Delden et al., 2013) investigated the effect of bilateral arm training with rhythmic auditory cueing (BATRAC) on stroke outcomes in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive BATRAC, modified constraint induced movement therapy (mCIMT) or conventional rehabilitation. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Strength, Memory, Emotion, Communication, ADL/IADL, Mobility, Hand function, Social participation domains) at post-treatment (6 weeks) and follow-up (12 weeks). Significant between-group differences were found for two components (SIS – Strength, Emotion domains) at follow-up, favoring conventional rehabilitation vs. BATRAC.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that BATRAC is not more effective than comparison interventions (mCIMT, conventional rehabilitation) in improving stroke outcomes in patients with stroke.
Note: In fact, BATRAC was found to be less effective than conventional rehabilitation in improving two stroke outcomes.

Phase not specific to one period - Device-driven bilateral arm training

Grip strength
Not effective
2B

One non-randomized study (Stinear & Byblow, 2004) investigated the effect of device-driven bilateral arm training on grip strength in patients with stroke. This non-randomized study assigned patients with subacute/chronic stroke to receive active-passive bimanual movement therapy using a Manipulada machine. Grip strength was measured at baseline and at post-treatment (4 weeks). No significant improvement was found.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that device-driven bilateral arm training is not effective in improving grip strength in patients with stroke.

Motor function - upper extremity
Effective
2B

Two non-randomized studies (Stinear & Byblow, 2004; Sampson et al., 2012) investigated the effect of device-driven bilateral arm training on upper extremity motor function in patients with stroke.

The first non-randomized study (Stinear & Byblow, 2004) assigned patients with subacute/chronic stroke to receive active-passive bimanual movement therapy using the Manipulada machine. Upper extremity motor function was measured by the Fugl-Meyer Assessment – Upper Extremity (FMA-UE) at baseline and at post-treatment (4 weeks). A significant improvement was found at post-treatment.

The second non-randomized study (Sampson et al., 2012) assigned patients with subacute/chronic stroke to receive bilateral arm training using the BUiLT bilateral arm trainer. Upper extremity motor function was measured by the FMA-UE at baseline and at post-treatment (6 weeks). An improvement was found, however statistical data was not provided.
Note: This study is not used to determine level of evidence in the conclusion below.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that device-driven bilateral arm training is effective in improving upper extremity motor function in patients with stroke. A second study also reported improvements following bilateral training using a device.

Strength - upper extremity
Not effective
2B

Two non-randomized studies (Stinear & Byblow, 2004; Sampson et al., 2012) investigated the effect of device-driven bilateral arm training on upper extremity strength in patients with stroke.

The first non-randomized study (Stinear & Byblow, 2004) assigned patients with subacute/chronic stroke to receive active-passive bimanual movement therapy using the Manipulada machine. Wrist strength (flexion/extension) was measured at baseline and at post-treatment (4 weeks). No significant improvement was reported from baseline to post-treatment.

The second non-randomized study (Sampson et al., 2012) assigned patients with subacute/chronic stroke to receive bilateral arm training using the BUiLT bilateral arm trainer. Isometric strength at the shoulder (flexion, extension, abduction, external/internal rotation) and elbow (flexion/extension) was measured by dynamometer at post-treatment (6 weeks). Improved strength at the shoulder and elbow were reported, however statistical data was not provided.
Note: This study is not used to determine level of evidence in the conclusion below.

Conclusion: There is limited evidence (Level 2b) from one non-randomized study that device-driven bilateral arm training is not effective in improving upper extremity strength in patients with stroke.

References

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.
http://www.sciencedirect.com/science/article/pii/S0894113013000720

Cauraugh, J.H. & Kim, S. (2002). Two coupled motor recovery protocols are better than one – electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke, 33, 1589-94.
http://stroke.ahajournals.org/content/33/6/1589.short

Cauraugh, J.H., Kim, S.B., & Duley, A. (2005). Coupled bilateral movements and active neuromuscular stimulation: intralimb transfer evidence during bimanual aiming. Neuroscience Letters, 382, 39-44.
https://www.ncbi.nlm.nih.gov/pubmed/15911118

Cauraugh, J.H., Lodha, N., Naik, S.K., & Summers, J.J. (2010). Bilateral movement training and stroke motor recovery progress: A structured review and meta-analysis. Human Movement Science, 29, 853-70.
https://www.ncbi.nlm.nih.gov/pubmed/19926154

Chang, J.J., Tung, W.L., Wu, W.L., Huang, M.H., & Su, F.C. (2007). Effects of robot-aided bilateral force-induced isokinetic arm training combined with conventional rehabilitation on arm motor function in patients with chronic stroke. Archives of Physical Medicine and Rehabilitation, 88, 1332-8.
https://www.ncbi.nlm.nih.gov/pubmed/17908578

Coupar, F., Pollock, A., van Wijck, F., Morris, J., & Langhorne, P. (2010). Simultaneous bilateral training for improving arm function after stroke. Cochrane Database of Systematic Reviews, 4. Art.No.: CD006432. DOI: 10.1002/14651858.CD006432.pub.2
https://www.ncbi.nlm.nih.gov/pubmed/20393947

Desrosiers, J., Bourbonnais, D., Corriveau, H., Gosselin, S., & Bravo, G. (2005). Effectiveness of unilateral and symmetrical bilateral task training for arm during the subacute phase after stroke: a randomized controlled trial. Clinical Rehabilitation, 19, 581-93.
https://www.ncbi.nlm.nih.gov/pubmed/16180593

Dispa, D., Lejeune, T., & Thonnard, J. L. (2013). The effect of repetitive rhythmic precision grip task-oriented rehabilitation in chronic stroke patients: a pilot study. International Journal of Rehabilitation Research, 36(1), 81-87.
http://journals.lww.com/intjrehabilres/Abstract/2013/03000/The_effect_of_repetitive_rhythmic_precision_grip.11.aspx

Hayner, K., Gibson, G., & Giles, G.M. (2010). Comparison of constraint-induced movement therapy and bilateral treatment of equal intensity in people with chronic upper-extremity dysfunction after cerebrovascular accident. American Journal of Occupational Therapy, 64, 528-39.
https://www.ncbi.nlm.nih.gov/pubmed/20825123

Hesse, S., Schulte-Tigges, G., Konrad, M., Bardeleben, A., & Werner, C. (2003). Robot-assisted arm trainer for the passive and active practice of bilateral forearm and wrist movements in hemiparetic subjects. Archives of Physical Medicine and Rehabilitation, 84, 915-20.
https://www.ncbi.nlm.nih.gov/pubmed/12808550

Hesse, S., Werner, C., Pohl, M., Rueckriem, S., Mehrholz, J., & Lingnau, M.L. (2005). Computerized arm training improves the motor control of the severely affected arm after stroke – a single-blinded randomized trial in two centers. Stroke, 36, 1960-6.
https://www.ncbi.nlm.nih.gov/pubmed/16109908

Hijmans, J.M., Hale, L.A., Satherley, J.A., McMillan, N.J., & King, M.J., (2011). Bilateral upper-limb rehabilitation after stroke using a movement-based game controller. Journal of Rehabilitative Research & Development, 48(8), 1005-1014.
https://www.ncbi.nlm.nih.gov/pubmed/22068375

Hsieh, Y. W., Wu, C. Y., Wang, W. E., Lin, K. C., Chang, K. C., Chen, C. C., & Liu, C. T. (2017). Bilateral robotic priming before task-oriented approach in subacute stroke rehabilitation: A pilot randomized controlled trial. Clinical Rehabilitation, 31(2), 225-233.
http://journals.sagepub.com/doi/abs/10.1177/0269215516633275

Lee, M. J., Lee, J. H., Koo, H. M., & Lee, S. M. (2017). Effectiveness of Bilateral Arm Training for Improving Extremity Function and Activities of Daily Living Performance in Hemiplegic Patients. Journal of Stroke and Cerebrovascular Diseases, 26(5), 1020-1025.
http://www.sciencedirect.com/science/article/pii/S105230571630605X

Lin, K-C., Chang, Y-F., Wu, C-Y., & Chen, Y-A. (2009). Effects of constraint-induced therapy versus bilateral arm training on motor performance, daily functions, and quality of life in stroke survivors. Neurorehabilitation and Neural Repair, 23(5), 441-448.
https://www.ncbi.nlm.nih.gov/pubmed/19118130

Lin, K-C., Chen, Y-A., Chen, C-L., Wu, C-Y., & Chang, Y-F. (2010). The effects of bilateral arm training on motor control and functional performance in chronic stroke: a randomized controlled study. Neurorehabilitation and Neural Repair, 24(1), 42-51.
https://www.ncbi.nlm.nih.gov/pubmed/19729583

Luft, A.R., McCombe-Waller, S., Whitall, J., Forrester, L.W., Macko, R., Sorkin, J.D., Schulz, J.B., Goldberg, A.P., & Hanley, D.F. (2004). Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. The Journal of the American Medical Association, 292, 1853-61.
https://www.ncbi.nlm.nih.gov/pubmed/15494583

Lum, P.S., Burgar, C.G., Shor, P.C., Magmundar, M., & Van der Loos, M. (2002). Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Archives of Physical Medicine and Rehabilitation, 83, 952-9.
https://www.ncbi.nlm.nih.gov/pubmed/12098155

McCombe Waller, S., Liu, W. & Whitall, J. (2008). Temporal and spatial control following bilateral versus unilateral training. Human Movement Science, 27, 749-58.
https://www.ncbi.nlm.nih.gov/pubmed/18639360

McCombe Waller, S. & Whitall, J. (2004). Fine motor control in adults with and without chronic hemiparesis: baseline comparison to nondisabled adults and effects of bilateral arm training. Archives of Physical Medicine and Rehabilitation, 85, 1076-83.
https://www.ncbi.nlm.nih.gov/pubmed/15241753

Morris, J.H. & Van Wijck, F. (2012). Responses of the less affected arm to bilateral upper limb task training in early rehabilitation after stroke: a randomized controlled trial. Physical Medicine and Rehabilitation, 93, 1129-37.
https://www.ncbi.nlm.nih.gov/pubmed/22421627

Morris, J.H., van Wijke, F., Joice, S., Ogston, S.A., Cole, I., & MacWalter, R.S. (2008). A comparison of bilateral and unilateral upper-limb task training in early poststroke rehabilitation: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 89, 1237-45.
https://www.ncbi.nlm.nih.gov/pubmed/18586126

Platz, T., Bock, S., & Prass, K. (2001). Reduced skillfulness of arm motor behaviour among motor stroke patients with good clinical recovery: does it indicate reduced automaticity? Can it be improved by unilateral or bilateral training? A kinematic motion analysis study. Neuropsychologia, 39, 687-98.
https://www.ncbi.nlm.nih.gov/pubmed/11311299

Rosa, M., Vasconcelos, O., & Marques, A. (2010). The influence of two rehabilitation protocols in upper-limb function of stroke patients. International Journal of Therapy and Rehabilitation, 17(9), 464-70.
https://www.magonlinelibrary.com/doi/abs/10.12968/ijtr.2010.17.9.78036

Sampson, M., Shau, Y.W., & King, M.J. (2012). Bilateral upper limb trainer with virtual reality for post-stroke rehabilitation: case series report. Disability and Rehabilitation: Assistive Technology, 7(1), 55-62.
https://www.ncbi.nlm.nih.gov/pubmed/21446826

Sethy, D., Bajpai, P., Kujur, E. S., Mohakud, K., & Sahoo, S. (2016). Effectiveness of modified constraint induced movement therapy and bilateral arm training on upper extremity function after chronic stroke: A comparative study. Open Journal of Therapy and Rehabilitation, 4(01), 1.
http://file.scirp.org/pdf/OJTR_2016021515264295.pdf

Shahine, E. M., & Shafshak, T. S. (2014). The effect of repetitive bilateral arm training with rhythmic auditory cueing on motor performance and central motor changes in patients with chronic stroke. Egyptian Rheumatology and Rehabilitation, 41(1), 8.
http://err.eg.net/article.asp?issn=1110-161X;year=2014;volume=41;issue=1;spage=8;epage=13;aulast=Shahine

Shim, S., & Jung, J. (2015). Effects of bilateral training on motor function, amount of activity and activity intensity measured with an accelerometer of patients with stroke. Journal of Physical Therapy Science, 27(3), 751-754.
https://www.jstage.jst.go.jp/article/jpts/27/3/27_jpts-2014-585/_article/-char/ja/

Singer, B.J., Vallence, A., Cleary, S., Cooper, I., & Loftus, A.M. (2013). The effect of EMG triggered electrical stimulation plus task practice on arm function in chronic stroke patients with moderate-severe arm deficits. Restorative Neurology and Neuroscience, 31, 681-691.
https://www.ncbi.nlm.nih.gov/pubmed/23963340

Stinear, C.M., Barber, P.A., Coxon, J.P., Fleming, M.K., & Byblow, W.D. (2008). Priming the motor system enhances the effects of upper limb therapy in chronic stroke. Brain, 131, 1381-90.
https://www.ncbi.nlm.nih.gov/pubmed/18356189

Stinear, J.W. & Byblow, W.D. (2004). Rhythmic bilateral movement training modulates corticomotor excitability and enhances upper limb motricity poststroke: a pilot study. Journal of Clinical Neurophysiology, 21(2), 124-31.
https://www.ncbi.nlm.nih.gov/pubmed/15284604

Stoykov, M.E., Lewis, G.N., & Corcos, D.M. (2009). Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabilitation and Neural Repair, 23(9), 945-53.
https://www.ncbi.nlm.nih.gov/pubmed/19531608

Summers, J.J., Kagerer, F.A., Garry, M.I., Hiraga, C.Y., Loftus, A., & Cauraugh, J.H. (2007). Bilateral and unilateral movement training on upper limb function in chronic stroke patients: a TMS study. Journal of the Neurological Sciences, 252, 76-82.
https://www.ncbi.nlm.nih.gov/pubmed/17134723

Suputtitada, a., Suwanwela, N.C., & Tumvitee, S. (2004). Effectiveness of constraint-induced movement therapy in chronic stroke patients. Journal of the Medical Association of Thailand, 87(12), 1482-90.
https://www.ncbi.nlm.nih.gov/pubmed/15822545

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 Delden, A. L. E., Beek, P. J., Roerdink, M., Kwakkel, G., & Peper, C. L. E. (2015). Unilateral and bilateral upper-limb training interventions after stroke have similar effects on bimanual coupling strength. Neurorehabilitation and Neural Repair, 29(3), 255-267.
http://journals.sagepub.com/doi/abs/10.1177/1545968314543498

van Delden, A.E.Q., Peper, C.E., Beek, P.J., & Kwakkel, G. (2012). Unilateral versus bilateral upper limb exercise therapy after stroke: a systematic review. Journal of Rehabilitation Medicine, 44, 106-17.
https://www.ncbi.nlm.nih.gov/pubmed/22266762

van der Lee, J.H., Wagenaar, R.C., Lankhorst, G.J., Vogelaar, T.W., Deville, W.L., & Bouter, L.M. (1999). Forced use of the upper extremity in chronic stroke patients – results from a single-blind randomized clinical trial. Stroke, 30, 2369-75.
https://www.ncbi.nlm.nih.gov/pubmed/10548673

Waller, S. M., Whitall, J., Jenkins, T., Magder, L. S., Hanley, D. F., Goldberg, A., & Luft, A. R. (2014). Sequencing bilateral and unilateral task-oriented training versus task oriented training alone to improve arm function in individuals with chronic stroke. BMC Neurology, 14(1), 236.
https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-014-0236-6

Whitall, J., McCombe Waller, S., Silver, K.H.C., & Macko, R.F. (2000). Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke, 31, 2390-5.
https://www.ncbi.nlm.nih.gov/pubmed/11022069

Whitall, J., McCombe Waller, S., Sorkin, J.D., Forrester, L.W., Macko, R.F., Hanley, D.F. Goldberg, A.P., & Luft, A. (2011). Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial. Neurorehabilitation and Neural Repair, 25(2), 118-29.
https://www.ncbi.nlm.nih.gov/pubmed/20930212

Wu, C.Y., Chuang, L.L., Lin, K.C., Chen, H.C., & Tsay, P.K. (2011). Randomized trial of distributed constraint- induced therapy versus bilateral arm training for the rehabilitation of upper-limb motor control and function after stroke. Neurorehabilitation and Neural Repair, 25(2), 130-9.
https://www.ncbi.nlm.nih.gov/pubmed/20947493

Wu, C.Y., Hsieh, Y.W., Lin, K.C., Chuang, L.L., Chang, Y.F., Liu, H.L., Chen, C.L., Lin, K.H., & Wai, Y.Y. (2010). Brain reorganization after bilateral arm training and distributed constraint-induced therapy in stroke patients: a preliminary functional magnetic resonance imaging study. Chang Gung Medical Journal, 33, 628-38.
https://www.ncbi.nlm.nih.gov/pubmed/21199608

Wu, C.Y., Yang, C.L., Chen, M.D., Lin, K.C., & Wu, L.L. (2013). Unilateral versus bilateral robot-assisted rehabilitation on arm-trunk control and functions post stroke: a randomized controlled trial. Journal of Neuroengineering and Rehabilitation, 10, 35.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3640972/

Wu, C.Y., Yang, C.L., Chuang, L.L., Lin, K.C., Chen, H.C., Chen, M.D., & Huang, W.C. (2012). Effect of therapist-based versus robot-assisted bilateral arm training on motor control, functional performance, and quality of life after chronic stroke: a clinical trial. Physical Therapy, 92(8), 1006-16.
https://www.ncbi.nlm.nih.gov/pubmed/22517782

Excluded Studies

Chuang, L. L., Chen, Y. L., Chen, C. C., Li, Y. C., Wong, A. M. K., Hsu, A. L., & Chang, Y. J. (2017). Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. Journal of Neuroengineering and Rehabilitation, 14(1), 122.

Reason for exclusion: Both group received bilateral upper extremity training following their respective treatment of neuromuscular electrical stimulation or transcutaneous electrical nerve stimulation.

Hsieh, Y. W., Liing, R. J., Lin, K. C., Wu, C. Y., Liou, T. H., Lin, J. C., & Hung, J. W. (2016). Sequencing bilateral robot-assisted arm therapy and constraint-induced therapy improves reach to press and trunk kinematics in patients with stroke. Journal of Neuroengineering and Rehabilitation, 13(1), 31.

Reason for exclusion: Both group received bilateral upper extremity training using the Bi-Manu-Track exoskeleton.

Jung, N. H., Kim, K. M., Oh, J. S., & Chang, M. (2013). The effects of bilateral arm training on reaching performance and activities of daily living of stroke patients. Journal of Physical Therapy Science, 25(4), 449-452.

Reason for exclusion: Not RCT; outcomes of interest available in RCTs for the population studied (i.e. patients with chronic stroke).

Lee, S., Kim, Y., & Lee, B. H. (2016). Effect of Virtual Reality‐based Bilateral Upper Extremity Training on Upper Extremity Function after Stroke: A Randomized Controlled Clinical Trial. Occupational Therapy International, 23(4), 357-368.

Reason for exclusion: Both group received bilateral upper extremity training; the intervention group received bilateral upper extremity training within a virtual reality context.

Mudie, M.H. & Matyas, T.A. (1996). Upper extremity retraining following stroke: effects of bilateral practice. Journal of NeuroEngineering and Rehabilitation, 10, 167-84.

Reason for exclusion: Not RCT; results for similar outcomes and similar treatment available in RCTs.

Mudie, M.H. & Matyas, T.A. (2000). Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disability and Rehabilitation, 22(1/2), 23-7.

Reason for exclusion: Not RCT; results for similar outcomes and similar treatment available in RCTs.

Rodrigues, L. C., Farias, N. C., Gomes, R. P., & Michaelsen, S. M. (2016). Feasibility and effectiveness of adding object-related bilateral symmetrical training to mirror therapy in chronic stroke: A randomized controlled pilot study. Physiotherapy Theory and Practice, 32(2), 83-91.

Reason for exclusion: Both group received bilateral upper extremity training; the intervention group received bilateral upper extremity training with the mirror, whereas in the control group the mirror was covered.

Song, G. B. (2015). The effects of task-oriented versus repetitive bilateral arm training on upper limb function and activities of daily living in stroke patients. Journal of Physical Therapy Science, 27(5), 1353-1355.

Reason for exclusion: Both group received a form of bilateral upper extremity training.

Yu, G. H., Lee, J. S., Kim, S. K., & Cha, T. H. (2017). Effects of interactive metronome training on upper extremity function, ADL and QOL in stroke patients. NeuroRehabilitation, (Preprint), 1-8.

Reason for exclusion: Both group received a form of bilateral upper extremity training.

Constraint-Induced Movement Therapy – Upper Extremity

Evidence Reviewed as of before: 22-09-2016
Author(s)*: Annabel McDermott, OT
Editor(s): Annie Rochette OT, PhD
Expert Reviewer: Johanne Higgins OT PhD
Patient/Family Information Table of contents

Introduction

Constraint-Induced Movement Therapy (CIMT) consists of a set of rehabilitation techniques designed to reduce functional problems in the most affected upper extremity of clients with stroke. This therapy involves constraining movements of the less-affected arm, usually with a sling or mitt for 90% of waking hours, while intensively inducing the use of the more-affected arm. Concentrated, repetitive training of the more-affected limb is usually performed for six hours a day for a two to three week period. Compliance of the patient for the rigorous restraint and training schedule, as well as the required intensity of therapy provided by therapists in a clinical setting, are important issues to consider.

Modified CIMT (mCIMT) is a less intense treatment that involves the same principles as CIMT (i.e. restraint of the less-affected upper extremity and practice of functional activities of the more-affected extremity), but with less intensity than traditional CIMT (i.e. less time). The common therapeutic factor in all CIMT techniques includes concentrated, repetitive tasks with the more-affected arm.

Functional benefits appear to be largely confined to those individuals with some active wrist and hand movement. Studies have explored the efficacy of this intervention for improving functional outcomes post-stroke.

A number of neuro-imaging and transcranial magnetic stimulation studies have shown that CIMT can produce a massive use-dependent cortical reorganization that increases the area of cortex involved in the innervation of movement of the more-affected limb (Taub et al., 1999). In terms of studies examining the effectiveness of this treatment intervention, high quality randomized controlled trials (RCTs) have reported a positive impact for patients with stroke. However, functional benefits appear to be largely confined to those individuals with some active wrist and hand movement.

Patient/Family Information

Authors: Anita Menon, MSc.

What is constraint-induced movement therapy (CIMT)?

After a stroke, regaining strength and function in your weaker arm (the side weakened by the stroke) can be challenging. Constraint-Induced Movement Therapy (CIMT) involves intensive training of the weaker arm while restricting the use of the stronger arm. Specifically, the use of the stronger arm is restricted by the use of a mitten or a sling for much of each day. The idea is to encourage you to use your weaker hand to do daily activities. This therapy has been studied by high quality research studies and has been found beneficial for arm function in some patients- especially those who already have some use of their arm and hand.

The use of an arm sling during walking training. The sling makes it impossible to use stronger arm. The man must use his weaker arm to hold

Use of a mitten while writing. The mitten makes it impossible to use the good arm. The woman is forced to use her weaker hand to write

Are there different kinds of constraint-induced therapies?

The term “CIMT” is used to describe a newer technique based on older existing techniques that force the patients to use their weaker arm. These older techniques are called “forced-use” therapy. The goal is to intensively train the weaker arm by using it to perform daily tasks such as preparing meals, engage in fun activities such as throwing a ball or fine motor activities such as writing.

More recently, research has looked at the benefit of modified CIMT (mCIMT), which is based on the same principles as CIMT but with less time wearing the restraint and fewer hours of exercise each day.

What is it used for in people with stroke?

The goal of CIMT is to help regain strength and function on the weaker side of the body, typically the side affected by the stroke. CIMT is used for a variety of purposes. Here we describe its use for arm and hand therapy.

Does it work for stroke?

As already mentioned, this therapy has been examined using high quality research studies and has been found beneficial for arm function in some patients after a stroke – especially those who already have some use of their arm and hand.

Although researchers are not exactly sure of how it works, some experts suggest that CIMT affects the brain by enlarging the brain area controlling the weaker arm. Research studies have reported that patients who receive CIMT have better control of their weaker arm and better ability to perform daily activities such as cooking and dressing when compared to people with stroke who received other forms of arm and hand therapy.

What can I expect?

Your therapist will decide with you what regime is most suitable for you. However, CIMT typically requires you to wear either a large mitten or an arm sling on your stronger arm, many hours a day, seven days a week, for about two weeks or more. The mitten or the sling is worn to encourage you to use your weaker arm and hand to do everyday tasks. In addition, the occupational therapist or physical therapist providing the treatment will do exercises with you and may also give you exercises to do on your own or with a family member or friend. While results can vary from person to person, there is scientific evidence that many people who receive this therapy can have improved use of their weaker arm.

Are there any side effects or risks?

CIMT is usually done by a physical therapist or an occupational therapist at a rehabilitation centre or out-patient clinic. However, many of the exercises must be done outside of treatment time. Family members and friends can be very important in helping you do these exercises. Ask your therapist to give you and your friends/family specific information on exercises.

How long is the treatment period?

Intense, repetitive training of the weaker arm is usually given for 90 percent of waking hours (about 13 hours/day) for a 2-week period. This can be done in the clinic, at home, and wherever else it is safe to do so.

An alternative form of CIMT – modified CIMT – is done for fewer hours and possibly, for more weeks. Consult with your therapist or physician who will help you decide which is right for you – CIMT or mCIMT.

This treatment program requires a good deal of self-discipline and commitment. Individuals with stroke tell us it is hard work! Improvement has been shown to be best for those who spend lots of time using the mitten or the sling.

Who provides the treatment?

CIMT is usually provided by a physical therapist or an occupational therapist at a rehabilitation centre or out-patient clinic. However, many of the exercises must be done outside of treatment time. Family members and friends can be very important in helping you do these exercises. Ask your therapist to give you and your friends/family specific information on exercises.

Is constraint-induced movement therapy for me?

CIMT can be of benefit to those who have lost some of the use of their upper limb following stroke. Studies have looked at the benefit 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. There is some positive research that suggests that CIMT may be beneficial for certain patients at all of these times.

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 effectiveness of Constraint-Induced Movement Therapy (CIMT) has been explored as an approach to reducing motor impairment and improving motor activity during functional tasks post-stroke. Fifty-one RCTs, 35 of high quality, 12 of fair quality and four of poor quality have examined the effectiveness of CIMT (restraint for 90% of waking hours and 6 hours of upper limb therapy per day for 2 weeks) or modified CIMT (mCIMT – whereby restraint and/or therapy is provided at a lesser intensity than CIMT) in comparison to traditional upper extremity (UE) therapy OR other forms of UE treatment. Studies have explored the use of CIMT or mCIMT at varying phases of stroke recovery: seven RCTs in the acute phase, 16 RCTs in the subacute phase, and 16 RCTs in the chronic phase of stroke recovery. An additional 12 RCTs examined the use of CIMT or mCIMT with populations of patients where the time since stroke was not specific to one period of recovery.

There is evidence to support CIMT and mCIMT as an effective therapy for patients with upper extremity deficits following a stroke. A systematic review and meta-analysis by Corbetta et al. (2010) updated an earlier Cochrane review by Sirtori et al. (2009) of the efficacy of CIMT, mCIMT and forced use techniques for upper extremity rehabilitation in patients with hemiparesis following stroke. A more recent systematic review and meta-analysis by Shi et al. (2011) compared only mCIMT with conventional rehabilitation (e.g. physiotherapy, occupational therapy, neurodevelopmental therapy, neuromuscular facilitation and daily living retraining).

The results from all reviews indicate a significant effect of CIMT, mCIMT or forced use therapy on arm motor function and impairment. The effect on disability is less conclusive, with Sirtori et al. (2009) reporting a moderate effect of CIMT, mCIMT or forced use therapy immediately post-intervention (but not 3 to 6 months post-intervention), Corbetta et al. (2010) reporting no significant effect of CIMT, mCIMT or forced use therapy on disability, and Shi et al. (2011) reporting a significant effect of mCIMT when disability is measured using the Functional Independence Measure, but not the Barthel Index. While all but two studies included in these three reviews are also reviewed on this website, differentiation of the studies according to the particular type of intervention (CIMT or mCIMT) and stage of stroke, as well as the inclusion of other non-randomized studies, has contributed to variation on StrokEngine in reported outcomes at different stroke stages.

The Cochrane review by Sirtori et al. (2009) concluded that restriction of the hand only, and a treatment protocol of no more than 30 hours indicate a significant effect size. Other studies suggest that functional benefits appear to be confined to a subset of stroke patients with existing active wrist and arm movements.

We have reviewed all of the CIMT and mCIMT studies to identify outcomes according to stage of post-stroke recovery (acute, subacute, chronic). Patients less than one month post-stroke were identified as acute, those between 1 and 6 months post-stroke as subacute, and those greater than 6 months post-stroke as chronic. Intensity and duration of treatment were also important factors in influencing outcome, and these details are included in the review of each study.

Results Table

View results table

Outcomes

Acute phase: mCIMT vs. control or alternative interventions

Depression
Not effective
1b

One high quality RCT (Dromerick et al., 2009) examined the effect of mCIMT on depression among patients with acute stroke. This high quality RCT randomized patients with acute stroke to receive ‘standard’ mCIMT (shaping therapy for 2 hours/day and restraint 6 hours/day), ‘intensive’ mCIMT (shaping therapy for 3 hours/day and restraint 90% of waking hours) or conventional UE therapy. There were no significant between-group differences in depression (Geriatric Depression-15 Scale) at post-treatment (14 days) or follow-up (90 days).

Note: The terms ‘standard’ and ‘intensive’ mCIMT were defined by the authors of this study.

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

Note: The high quality RCT also found no difference in depression between different intensities of mCIMT.

Dexterity
Conflicting
4

Two high quality RCTs (Boake et al., 2007; Thrane et al., 2015) have investigated the effect of mCIMT on dexterity in patients with acute stroke.

The first high quality RCT (Boake et al., 2007) randomized patients with acute stroke to receive mCIMT or to receive intensive traditional upper extremity therapy (control group). The mCIMT group received 3 hours of therapy a day and wore a constraint 90% of waking hours. Dexterity was measured with the Grooved Pegboard Test at baseline, at 14-15 days (post-treatment) and at 3 to 4 months post-stroke (follow-up). No significant between-group difference in dexterity was found at either time point.

The second high quality RCT (Thrane et al., 2015) randomized patients with acute stroke to receive mCIMT or usual care. The mCIMT group received rehabilitation for 3 hours/day over 10 consecutive weekdays and wore a mitt on the nonaffected hand for 90% of waking hours. Dexterity was measured with the Nine Hole Peg Test at baseline, 2 weeks (post-treatment) and six months (follow-up). A significant between-group difference in dexterity was found at post-treatment in favour of the mCIMT group compared to the control group. This difference did not remain significant at 6-month follow-up.

Conclusion: There is conflicting evidence (level 4) from 2 high quality RCTs regarding the effect of mCIMT on dexterity. While one high quality RCT found that mCIMT is not more effective than intensive traditional therapy, a second high quality RCT found that mCIMT was more effective than usual care in improving dexterity among patients with acute stroke.

TNote: The significant difference found post-treatment did not remain significant at 6-month follow up.

Functional independence and activities of daily living
Not effective
1a

Three high quality RCTs (Dromerick et al., 2000; Dromerick et al., 2009; Liu et al., 2016) examined the effects of mCIMT on functional independence in patients with acute stroke.

The first high quality RCT (Dromerick et al., 2000) randomized patients with acute stroke to receive mCIMT plus conventional UE therapy or conventional UE therapy alone. The mCIMT group wore a padded mitt 6 hours a day for 14 days and received traditional therapy 2 hours a day. Functional independence in ADL was measured with the Barthel Index and 5 subscales of the Functional Independence Measure (FIM) at discharge from inpatient rehabilitation. A significant between-group difference in upper extremity dressing (FIM), was found in favour of mCIMT compared to conventional UE. There were no other significant between-group differences found in functional independence in ADL (Barthel Index; FIM eating, bathing, grooming and lower body dressing subscales) on discharge.

The second high quality RCT (Dromerick et al., 2009) randomized patients with acute stroke to receive ‘standard’ mCIMT (shaping therapy for 2 hours/day and restraint 6 hours/day), ‘intensive’ mCIMT (shaping therapy for 3 hours/day and restraint 90% of waking hours) or conventional UE therapy. Functional independence was measured with the FIM upper extremity score (sum of the 5 FIM items requiring significant hand and arm use) at baseline, at 14-15 days (post-treatment) and at 3 to 4 months post-stroke (follow-up). No significant between-group differences were found in functional independence at either time point.

Note: The terms ‘standard’ and ‘intensive’ CIMT were defined by the authors of this study.

The third high quality RCT (Liu et al., 2016) randomized patients with acute stroke to receive self-regulated mCIMT (SR-mCIMT), mCIMT or conventional rehabilitation. Participants in the mCIMT groups wore a restraint for 4 hours/day and all participants received individual training for 1 hour/day for 10 days. Functional ability was measured at baseline, 2 weeks (post-treatment) and 4 weeks post-treatment (follow-up) using the Lawton Instrumental Activities of Daily Living Scale (Lawton IADL). There was no signficiant difference in functional ability beween mCIMT and conventional rehabilitation at post-treatment or at follow-up.

Note: There were significant between-group differences in functional ability at post-treatment in favour of SR-mCIMT compared to conventional rehabilitation and in favour of SR-mCIMT compared to mCIMT, but differences did not remain significant at follow-up.

Conclusion: There is strong evidence (level 1a) from 3 high quality RCTs that mCIMT is not more effective than conventional rehabilitation for improving functional independence in patients with acute stroke.

Note: One of the high quality RCTs found a significant difference in the FIM upper extremity dressing score only, in favour of mCIMT compared to conventional rehabilitation.

Note: One high quality RCT found no difference in functional independence between different intensities of mCIMT.

Note: One high quality RCT found that self-regulated mCIMT was more effective than both mCIMT and conventional rehabilitation, although differences did not remain significant at 4 weeks post-treatment.

Motor activity (Upper extremity)
Conflicting
4

Three high quality RCTs (Boake et al., 2007; Thrane et al., 2015; Liu et al., 2016) and 1 fair quality RCT (Page et al., 2005) examined the effects of mCIMT on UE motor activity in patients with acute stroke.

The first high quality RCT (Boake et al., 2007) randomized patients with acute stroke to receive mCIMT or conventional UE therapy. The mCIMT group received therapy 3 hours/day and wore a constraint 90% of waking hours. Upper extremity motor activity was measured with the Motor Activity Log – Amount of Use (MAL-AOU) and – Quality of Movement (MAL-QOM) subscales at baseline, at 14-15 days (post-treatment) and at 3 to 4 months post-stroke (follow-up). There were no significant between-group differences in motor activity at post-treatment or follow up.

The second high quality RCT (Thrane et al., 2015) randomized patients with acute stroke to receive mCIMT or usual care. Participants in the mCIMT group received rehabilitation for 3 hours/day over 10 consecutive weekdays and wore a mitt on the non-affected hand for 90% of waking hours. Upper extremity motor activity was measured according to arm use during functional tasks (arm use ratio) at baseline, 2 weeks (post-treatment) and six months (follow-up). No significant between-group difference were found in functional arm use at either time post.

The third high quality RCT (Liu et al., 2016) randomized patients with acute stroke to receive self-regulated mCIMT (SR-mCIMT), mCIMT or conventional rehabilitation. Participants in the mCIMT groups wore a restraint for 4 hours/day and all participants received individual training for 1 hour/day for 10 days. Upper extremity motor activity was measured at baseline, 2 weeks (post-treatment) and 4 weeks post-treatment (follow-up), using the MAL-AOU and MAL-QOM. At post-treatment there were significant differences in MAL-AOU and MAL-QOM scores in favour of mCIMT compared to conventional rehabilitation; differences did not remain significant at follow-up.

Note: Comparison of SR-mCIMT with conventional rehabilitation showed significant differences in MAL-AOU and MAL-QOM scores at post-treatment and follow-up. Comparison of SR-mCIMT with mCIMT showed significant differences in MAL-AOU scores in favour of SR-mCIMT at post-treatment, but differences did not remain significant at follow-up.

The fair quality RCT (Page et al., 2005) randomized patients with acute stroke to receive mCIMT or conventional rehabilitation. The mCIMT group wore a restraint for 5 hours/day and received 30 minutes of individual therapy 3 days/week for 10 weeks. Motor activity was measured using the Motor Activity Log (MAL) at baseline and 10 weeks (post-treatmeant). At post-treatment the mCIMT group demonstrated a significant improvement in motor activity (MAL).

Note: As this study did not report significant between-group differences these results are not used to determine level of evidence below.

Conclusion: There is conflicting evidence (level 4) among 3 high quality RCTs. While 2 high quality RCTs reported that mCIMT (training 3 hours/day and restraint 90% of waking hours for 2 weeks) is not more effective than conventional rehabilitation, 1 high quality RCT found that mCIMT of less intensity (training 1 hour/day and restraint for 4-5 hours/day for 2 weeks) to be more effective than conventional rehabilitation.

Note: One fair quality RCT also reported significant improvement in motor activity following mCIMT, but did not report between-group differences.

Note: One high quality RCT also found that self-regulated mCIMT was more effective than both mCIMT and conventional rehabilitation, although differences did not remain significant at 1-month follow-up.

Motor function (Upper extremity)
Conflicting
4

Six high quality RCTs (Dromerick et al., 2000; Boake et al., 2007; Dromerick et al., 2009; Thrane et al., 2015; El-Helow et al., 2015; Liu et al., 2016) and 1 fair quality RCT (Page et al., 2005) examined the effectiveness of mCIMT on upper extremity motor function in patients with acute stroke.

The first high quality RCT (Dromerick et al., 2000) randomized patients with acute stroke to receive mCIMT and conventional UE therapy or conventional upper extremity therapy alone. The mCIMT group wore a padded mitt 6 hours/day and received traditional therapy 2 hours/day. Motor function was measured with the Action Research Arm Test (ARAT) at baseline and at post-treatment (14 days). A significant between-group differences in motor function ARAT total score and pinch subscale was found at post-treatment in favour of mCIMT compared to conventional UE therapy alone. No significant between-group differences were found in other ARAT subscales (grasp, grip, gross movement).

The second high quality RCT (Boake et al., 2007) randomized patients with acute stroke to receive mCIMT or conventional UE therapy. The mCIMT group received 3 hours of therapy/day and wore a restraint 90% of waking hours. Motor function was measured with the Fugl Meyer Assessment of Motor Recovery (FMA) and with movements of the affected hand evoked by transcranial magnetic stimulation (TMS) at baseline, at 14-15 days (post-treatment) and at 3 to 4 months post-stroke (follow-up). There was no significant between-group difference in upper extremity motor function at post-treatment or at follow-up.

The third high quality RCT (Dromerick et al., 2009) randomized patients with acute stroke to receive ‘standard’ mCIMT (shaping therapy for 2 hours/day and restraint 6 hours/day), ‘intensive’ mCIMT (shaping therapy for 3 hours/day and restraint 90% of waking hours) or conventional UE therapy. Motor function was measured with the ARAT at baseline, 14 days (post-treatment) and 90 days (follow-up). There were no significant between-group differences in motor function between standard mCIMT and conventional UE therapy at post-treatment or at follow-up. There were significant between-group differences in motor function at post-treatment and follow-up, in favour of standard mCIMT and conventional UE therapy compared to intensive mCIMT.

Note: The terms ‘standard’ and ‘intensive’ CIMT were defined by the authors of this study.

The fourth high quality RCT (Thrane et al., 2015) randomly assigned patients with acute stroke to receive mCIMT or usual care. Participants in the mCIMT group received rehabilitation for 3 hours/day over 10 consecutive weekdays and wore a mitt on the non-affected hand for 90% of waking hours. Motor function was measured with the Wolf Motor Function Test (WMFT) and the FMA-Upper Extremity (FMA-UE) at baseline, 2 weeks (post-treatment) and six months (follow-up). A significant between-group difference was found post-treatment in one subscale of WMFT (performance time) in favour of the mCIMT group compared to the control group. This difference did not remain significant at 6-month follow-up. No significant differences were found in other subscales of the WMFT (functional ability, arm strength and grip strength) or for the FMA-UE at either time point.

The fifth high quality RCT (El-Helow et al., 2015) randomized patients with acute stroke to receive mCIMT or conventional rehabilitation. The mCIMT group wore a restraint for up to 6 hours/day and received shaping intervention for 2 hours/day. Upper extremity motor function was measured with the FMA and ARAT at baseline and 2 weeks (post-treatment). There were significant between-group differences in FMA and ARAT scores at post-treatment, in favour of mCIMT compared to the control group.

The sixth high quality RCT (Liu et al., 2016) randomized patients with acute stroke to receive self-regulated mCIMT (SR-mCIMT), mCIMT or conventional rehabilitation. Participants in the mCIMT groups wore a restraint for 4 hours/day and all participants received individual training for 1 hour/day for 10 days. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 4 weeks post-treatment (follow-up) using the ARAT (total score, grasp, grip, pinch and gross movement subscales) and the FMA-UE (total score, upper arm, wrist, hand and coordination subscales). At post-treatment there were significant between-group differences in upper extremity motor function (ARAT total, grip, pinch; FMA-UE total score only) in favour of mCIMT compared with conventional rehabilitation; at follow-up there was a significant between-group difference on only one measure of upper extremity motor function (FMA-UE hand), in favour of mCIMT.

Note: Comparison of SR-mCIMT with conventional rehabilitation showed significant between-group differences at post-treatment (ARAT total, pinch; FMA-UE total, upper arm, wrist, hand, coordination) and follow-up (ARAT grip, gross movement; FMA-UE wrist, coordination), in favour of SR-mCIMT. Comparison of SR-mCIMT with mCIMT showed significant differences in only 2 measures of upper extremity motor function at post-treatment (FMA-UE total, coordination), and 3 measures at follow-up (ARAT pinch; FMA-UE hand, coordination), in favour of SR-mCIMT.

The fair quality RCT (Page et al., 2005) randomized patients with acute stroke to receive mCIMT or conventional rehabilitation. The mCIMT group wore a restraint for 5 hours, 5 days/week and received 30 minutes of individual therapy 3 days/week. Motor function was measured with the FMA and the ARAT at baseline and 10 weeks (post-treatment). At post-treatment the mCIMT group demonstrated greater improvement in motor function compared to conventional rehabilitation.

Note: As this study did not report significant between-group differences, these results are not used to determine level of evidence below.

Conclusion: There is conflicting evidence (level 4) among 6 high quality RCTs regarding the effectiveness of mCIMT compared to other interventions. Four of the six high quality RCTs reported significant differences on some measures of upper extremity motor function at post-treatment, in favour of mCIMT compared to conventional rehabilitation. Meanwhile, five of the six high quality RCTs also reported no significant differences on other measures of upper extremity motor function between mCIMT and comparison interventions at post-treatment or follow-up time points.

Note: One high quality RCT found that a mCIMT program of higher intensity (restraint for 90% of waking hours and therapy for 3 hours/day) is less effective than a mCIMT program at a lower intensity (restraint for 6 hours/day and therapy for 2 hours/day) or conventional rehabilitation.

Note: One high quality RCT found that self-regulated mCIMT was more effective than both mCIMT and conventional rehabilitation.

Note: One fair quality RCT also reported significant improvement in motor function following mCIMT, but did not report between-group differences.

Pain
Not effective
1b

One high quality RCT (Dromerick et al., 2009) examined the effects of mCIMT on perception of pain among patients with acute stroke. This high quality RCT randomized patients with acute stroke to receive ‘standard’ mCIMT (shaping therapy for 2 hours/day and restraint 6 hours/day), ‘intensive’ mCIMT (shaping therapy for 3 hours/day and restraint 90% of waking hours) or conventional UE therapy. Pain was measured with the Wong-Baker Faces Scale at baseline, 14 days (post-treatment) and 90 days (follow-up). No significant between-group differences were found in pain for any group at post-treatment or follow-up.

Note: The terms ‘standard’ and ‘intensive’ CIMT were defined by the authors of this study.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is not more effective than conventional rehabilitation for alleviating pain among patients with acute stroke.

Note: The high quality RCT also found no difference in pain between different intensities of mCIMT.

Stroke outcomes
Not effective
1A

Two high quality RCTs (Dromerick et al., 2009; Thrane et al., 2015) examined the effects of mCIMT on stroke outcomes in patients with acute stroke.

The high quality RCT (Dromerick et al., 2009) randomized patients with acute stroke to receive ‘standard’ mCIMT (shaping therapy for 2 hours/day and restraint 6 hours/day), ‘intensive’ mCIMT (shaping therapy for 3 hours/day and restraint 90% of waking hours) or conventional UE therapy. Stroke outcomes were measured at baseline, post-treatment (14 days) and follow-up (90 days), using the Stroke Impact Scale (SIS) hand function subtest. There were no significant differences in self-perception of hand function (SIS hand function subscale) at post-treatment (14 days) or follow-up (90 days) between standard mCIMT and conventional UE therapy. However, there were significant between-group differences in SIS hand function scores at follow-up (90 days), in favour of both standard CIMT and conventional UE therapy when compared with high-intensity CIMT.

Note: The terms ‘standard’ and ‘intensive’ CIMT were defined by the authors of this study.

The second high quality RCT (Thrane et al., 2015) randomly assigned patients with acute stroke to receive modified CIMT or usual care. Participants in the mCIMT group received rehabilitation for 3 hours/day over 10 consecutive weekdays and wore a mitt on the nonaffected hand for 90% of waking hours. Stroke outcomes were measured with the SIS hand function, ADL/IADL, participation/role function and global perception of recovery subtests at baseline, 2 weeks (post-treatment) and six months (follow-up). There were no significant between-group differences in stroke outcomes at post-treatment (2 weeks) or at 6-month follow-up.

Conclusion: There is strong evidence (level 1a) from 2 high quality RCTs that mCIMT is not more effective than conventional rehabilitation for improving stroke outcomes in patients with acute stroke.

Note: One quality RCT found that high-intensity mCIMT (restraint for 90% of waking hours and therapy for 3 hours/day) is less effective than low-intensity mCIMT (restraint for 6 hours/day and therapy for 2 hours/day) or conventional rehabilitation for improving self-perception of hand function.

Subacute phase: CIMT vs. control or alternative interventions

Finger dexterity
Not effective
2A

A fair quality RCT (Yoon et al., 2014) has examined the effect of CIMT on dexterity among patients with subacute stroke. This fair quality RCT randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Finger dexterity was measured at baseline and 2 weeks (post-treatment) using the Nine Hole Peg Test (NHPT). There was no significant difference in finger dexterity at post-treatment between CIMT and the control group.

Note: At post-treatment the CIMT + mirror therapy group showed significantly better finger dexterity than the CIMT group and the control group.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that CIMT is not more effective than a comparison intervention (occupational therapy) for improving finger dexterity among patients with subacute stroke.

Note: This fair quality RCT found that CIMT with mirror therapy was more effective than CIMT alone for improving finger dexterity.

Functional independence
Effective
2A

One fair quality RCT (Yoon et al., 2014) has examined the effect of CIMT on functional independence among patients with subacute stroke. This fair quality RCT randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Functional independence was measured at baseline and 2 weeks (post-treatment) using the Korean version of the modified Barthel Index (K-mBI). At post-treatment there was a significant between-group difference in functional independence, in favour of CIMT compared to the control group.

Note: At post-treatment the CIMT + mirror therapy group also showed significantly better K-mBI scores than the control group. There were no significant differences between CIMT and CIMT + mirror therapy at post-treatment.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that CIMT is more effective than comparison interventions (occupational therapy) for improving functional independence among patients with subacute stroke.

Grip strength
Effective
2a

A fair quality RCT (Yoon et al., 2014) has examined the effect of CIMT on grip strength among patients with subacute stroke. This fair quality RCT randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Grip strength was measured at baseline and 2 weeks (post-treatment). There was a significant between-group difference in grip strength at post-treatment, in favour of CIMT compared to the control group.

Note: At post-treatment the CIMT + mirror therapy group showed significantly better grip strength than the CIMT group and the control group.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that CIMT is more effective than a comparison intervention (occupational therapy) for improving grip strength among patients with subacute stroke.

Note: The fair quality RCT found that CIMT with mirror therapy was more effective than CIMT alone for improving grip strength.

Manual dexterity
Effective
2A

A fair quality RCT (Yoon et al., 2014) examined the effect of CIMT on dexterity among patients with subacute stroke. This fair quality RCT randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Manual dexterity was measured at baseline and 2 weeks (post-treatment) using the Box and Block Test (BBT). There was a significant between-group difference in manual dexterity at post-treatment, in favour of CIMT compared to the control group.

Note: At post-treatment the CIMT + mirror therapy group showed significantly better manual dexterity than the CIMT group and the control group.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that CIMT is more effective than a comparison intervention (occupational therapy) for improving manual dexterity among patients with subacute stroke.

Note: The fair quality RCT found that CIMT with mirror therapy was more effective than CIMT alone for improving manual dexterity.

Motor function (Upper extremity)
Not effective
1b

One high quality RCT (Sawaki et al., 2008) and 1 fair quality RCT (Yoon et al., 2014) have examined the effect of CIMT on upper extremity (UE) motor function in patients with subacute stroke.

The high quality RCT (Sawaki et al., 2008) randomized patients with subacute stroke to receive CIMT or usual care. The CIMT group wore a padded mitt on the less-affected limb for at least 90% of waking hours and performed intensive therapy for 6 hours/day, 5 days/week for 2 weeks. Upper extremity motor function was measured using the Wolf Motor Function Test (WMFT) at baseline, 2 weeks (post-treatment) and at 4 months (follow-up). There was a significant between-group difference in only one measure of upper extremity motor function (WMFT grip strength), in favour of the CIMT group compared to the control group. There were no significant between-group differences in other measures of UE motor function (WMFT weight and time-based measures).

The fair quality RCT (Yoon et al., 2014) randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Upper extremity motor function was measured at baseline and 2 weeks (post-treatment) using the Wolf Motor Function Test (WMFT) and the Fugl-Meyer Assessment (FMA) – total score and Upper Extremity score (FMA-UE). At post-treatment there was a significant between-group difference in one measure of upper extremity motor function (WMFT), in favour of CIMT compared to the control group.

Note: At post-treatment the CIMT + mirror therapy group also showed significantly better WMFT scores than the control group.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT and 1 fair quality RCT that CIMT is not more effective than comparison interventions (usual care, CIMT with mirror therapy, occupational therapy) in improving UE motor function in patients with subacute stroke.

Note: However the high quality RCT found a difference in WMFT grip strength in favour of CIMT vs. usual care; the fair quality RCT found differences in WMFT scores in favour of CIMT vs. OT and in favour of CIMT + mirror therapy vs. OT.

Stroke recovery
Not effective
2A

One fair quality RCT (Yoon et al., 2014) has examined the effect of CIMT on stroke recovery among patients with subacute stroke. This fair quality RCT randomized patients with subacute stroke to receive CIMT, CIMT + mirror therapy, or a control group that received occupational therapy and a self-exercise program. Stroke recovery was measured at baseline and 2 weeks (post-treatment) using the Brunnstrom stages of stroke recovery. There were no significant between-group differences in stroke recovery at post-treatment.

Conclusion: There is limited evidence (level 2a) from 1 fair quality RCT that CIMT is not more effective than comparison interventions (CIMT and mirror therapy, occupational therapy) for improving stroke recovery among patients with subacute stroke.

Subacute phase: mCIMT vs. control or alternative interventions

Dexterity
Conflicting
4

Four high quality RCTs (Myint et al., 2008; Hammer & Lindmark, 2009b; Brunner, Skouen & Strand, 2012; Treger et al., 2012) have examined the effect of mCIMT on finger dexterity in patients with subacute stroke.

The first high quality RCT (Myint et al., 2008) randomized patients with subacute stroke to receive either mCIMT or conventional occupational and physical therapy. The mCIMT group wore a shoulder sling on the less-affected extremity for 90% of waking hours and received 4 hours daily therapy. Finger dexterity was measured using the Nine Hole Peg Test (NHPT) at baseline, 10 days (post-treatment) and follow-up (12 weeks). There were significant between-group differences in dexterity at post-treatment and follow-up, in favour of mCIMT compared to conventional rehabilitation.

The second high quality RCT (Hammer & Lindmark, 2009b) randomized patients with subacute stroke to a ‘forced use’ group or a control group that received conventional rehabilitation. The forced use group wore a sling to promote forced use of the paretic upper limb for up to 6 hours/day, 5 days/week. Finger dexterity was measured using the 16 Hole Peg Test at baseline, 2 weeks (post-treatment), 1 month (follow-up A) and 3 months (follow-up B). There were no significant between-group differences in dexterity at any time point.

The third high quality RCT (Brunner, Skouen & Strand, 2012) randomized patients with subacute stroke to receive mCIMT or bimanual task-related training. The mCIMT group wore a restraint for 4 hours/day in addition to therapist-directed training for 4 hours/week and self-directed training for 2-3 hours/day for 4 weeks. Finger dexterity was measured at baseline, 4 weeks (post-treatment) and 3-month follow-up using the Nine Hole Peg Test (NHPT). There were no significant between-group differences in finger dexterity at any time point.

The fourth high quality RCT (Treger et al., 2012) randomly assigned patients with subacute stroke to receive mCIMT or conventional rehabilitation. The mCIMT group restrained the non-affected hand during 1-hour rehabilitation sessions and wore a mitten for up to 4 hours each weekday for 2 weeks. Dexterity was measured by a peg task and a ball grasp, carry and release task modified from the Manual Function Test at baseline and 4 weeks. There were significant between-group differences in dexterity at 4 weeks, in favour of mCIMT compared to conventional rehabilitation.

Conclusion: There is conflicting evidence (level 4) between 2 high quality RCTs that found mCIMT to be more effective than comparison interventions (conventional rehabilitation), and a third high quality RCT that found mCIMT was not more effective than the comparison interventions (bimanual task training) for improving finger dexterity in patients with subacute stroke. A fourth high quality RCT found that forced use therapy with conventional rehabilitation was not more effective than conventional rehabilitation alone for improving finger/manual dexterity among patients with subacute stroke.

Functional independence and activities of daily living
Conflicting
4

Three high quality RCTs (Myint et al., 2008, Azab et al., 2009; Treger et al., 2012) examined the effects of mCIMT on functional independence and activities of daily living (ADLs) in patients with subacute stroke.

The first high quality RCT (Myint et al., 2008) randomized patients with subacute stroke to receive mCIMT or conventional occupational and physical therapy. The mCIMT group received 4 hours daily of therapy and wore a shoulder sling on the less-affected extremity for 90% of waking hours. Functional independence was measured using the modified Barthel Index (mBI) at baseline, 2 weeks (post-treatment) and 12 weeks (follow-up). There were no significant between-group differences in ADLs at either time point.

The second high quality RCT (Azab et al., 2009) randomized patients with subacute stroke to receive mCIMT or standard rehabilitation. The mCIMT group wore a mitt on the unaffected hand for 6-7 hours per day and both groups received physical therapy and occupational therapy for 40 mins/session, 3 times/week for the treatment period. Functional independence was measured using the Barthel Index (BI) at baseline, 4 weeks (post-treatment) and 6 months (follow-up). There was a significant between-group difference in functional independence at both time points, in favour of mCIMT compared to standard rehabilitation.

The third high quality RCT (Treger et al., 2012) randomly assigned patients with subacute stroke to receive mCIMT or conventional rehabilitation. The mCIMT group restrained the nonaffected hand during 1-hour rehabilitation sessions and wore a mitten for up to 4 hours each weekday for 2 weeks. Functional independence was measured according to spoon use over 30 seconds, at baseline and at 4 weeks. There was a significant between-group difference in spoon use at 4 weeks, in favour of mCIMT compared to conventional rehabilitation.

Conclusion: There is conflicting evidence (level 4) regarding the effect of mCIMT on functional independence in patients with subacute stroke. One high quality RCT reported that a short-term (2-week) high-intensity mCIMT program was not more effective than conventional rehabiliation, whereas a second high quality RCT reported that a longer (4-week), low-intensity mCIMT program was more effective than conventional rehabilitation. A third high quality RCT also reported that low-intensity mCIMT was more effective than conventional rehabilitation, using a non-standardised measure of functional rehabilitation (spoon use).

Grip strength
Not effective
1b

One high quality RCT (Hammer & Lindmark, 2009b) investigated the effect of mCIMT on hand strength in patients with subacute stroke. This high quality RCT randomized patients with subacute stroke to a ‘forced use’ group or a control group that received conventional rehabilitation. The forced use group wore a sling to promote forced use of the paretic upper limb for up to 6 hours/day, 5 days/week for 2 weeks. Isometric grip strength was measured at baseline, 2 weeks (post-treatment), 1 month (follow-up A) and 3 months (follow-up B). There was no significant between-group difference in grip strength at any time point.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that mCIMT is not more effective than comparison interventions (conventional rehabilitation) for improving grip strength among patients with subacute stroke.

Motor activity (Upper extremity)
Not effective
1a

Five high quality RCTs (Page et al., 2002; Myint et al., 2008; Hammer & Lindmark, 2009a; Brogardh et al., 2009b; Brogardh & Lexell, 2010 – follow-up study; Brunner, Skouen & Strand, 2012) and one fair quality RCT (Page et al., 2001) examined the effects of mCIMT on UE motor activity in patients with subacute stroke.

The first high quality RCT (Page et al., 2002) randomized patients with subacute stroke to receive mCIMT, traditional therapy, or no treatment. The mCIMT group wore a restraint for 5 hours/day and received 30 minutes each of physical therapy and occupational therapy 3 times/week. Upper extremity motor activity was measured using the Motor Activity Log (MAL) at baseline and at 10 weeks (post-treatment). There were no significant between-group differences in MAL scores at post-treatment.

The second high quality RCT (Myint et al., 2008) randomized patients with subacute stroke to receive either mCIMT or conventional occupational and physical therapy. The mCIMT group received therapy for 4 hours/day and wore a shoulder sling on the less-affected extremity for 90% of waking hours during the 10-day treatment period. Upper extremity motor activity was measured using the MAL Amount of Use (MAL-AOU) and Quality of Movement (MAL-QOM) at baseline, 2 weeks (post-treatment) and 12 weeks (follow-up). There were significant between-group differences in motor activity at both time points, in favour of mCIMT compared to conventional therapy.

The third high quality RCT (Hammer & Lindmark, 2009a) randomized patients with subacute stroke to a ‘forced use’ group or a control group that received conventional rehabilitation alone. The forced use group wore a sling to promote forced use of the paretic upper limb for up to 6 hours/day, 5 days/week for 2 weeks. Upper extremity motor activity was measured using the MAL-AOU and MAL-QOM at baseline, 2 weeks (post-treatment), 1 month (follow-up A) and 3 months (follow-up B). There were no significant between-group differences in motor activity at any time point.

The fourth high quality RCT (Brogardh et al., 2009b) randomized patients with subacute stroke to a mCIMT group that wore a mitt on the less affected arm for 90% of waking hours, or a group that did not wear a mitt. Both groups received 3 hours of therapy for the affected arm for 12 days. Upper extremity motor activity was measured using the MAL at baseline, 2 weeks (post-treatment) and 3 months (follow-up). There were no significant between-group differences in motor activity at either time point.

Further to the study by Brogardh et al, 2009b (Brogardh & Lexell, 2010), no significant between-group differences in upper extremity motor activity (MAL-AOU, MAL-QOM) were seen at 12 months follow-up.

The fifth high quality RCT (Brunner, Skouen & Strand, 2012) randomized patients with subacute stroke to receive mCIMT or bimanual task-related training. The mCIMT group wore a restraint for 4 hours/day in addition to therapist-directed training for 4 hours/week and self-directed training for 2-3 hours/day for 4 weeks. Upper extremity motor activity was measured at baseline, 4 weeks (post-treatment) and 3-month follow-up using the MAL-AOU and MAL-QOM. There were no significant between-group differences in upper extremity motor activity at any time point.

The fair quality RCT (Page et al., 2001) randomized patients with subacute stroke to receive mCIMT, conventional rehabilitation or no therapy. mCIMT comprised 30 minutes each of physiotherapy and occupational therapy 5 days/week for 10 weeks and restraint of the less affected arm 5 hours/day, 5 days/week for 10 weeks. Upper extremity motor activity was measured using the MAL-AOU and MAL-QOM. The mCIMT group demonstrated improved motor activity at post-treatment, whereas the other two groups did not demonstrate substantial improvement.

Note: Statistical data and between-group differences were not reported; accordingly this study is not included in determining level of evidence in the conclusion below.

Conclusion: There is strong evidence (level 1a) from 4 high quality RCTs that mCIMT or forced-use therapy is not more effective than control therapies (e.g. no treatment, conventional rehabilitation, mCIMT training with no mitt use, bimanual task training) for improving UE motor activity in patients with subacute stroke.

Note: However, one high quality RCT did find significant between-group differences in UE motor activity in favour of mCIMT compared to conventional therapy. Also, one fair quality RCT demonstrated improved motor activity at post-treatment for the mCIMT group but as statistical data and between-group differences were not reported, this study is not included in determining level of evidence.

Motor function (Upper extremity)
Not effective
1a

Five high quality RCTs (Page et al., 2002; Myint et al., 2008; Hammer & Lindmark, 2009b; Brogardh et al., 2009b; Brogardh & Lexell, 2010 – follow-up study; Brunner, Skouen & Strand, 2012) and one fair quality RCT (Page et al., 2001) examined the effects of mCIMT on upper extremity (UE) motor function in patients with subacute stroke.

The first high quality RCT (Page et al., 2002) randomized patients with subacute stroke to receive mCIMT, traditional therapy, or no treatment. The mCIMT group wore a restraint for 5 hours/day and received 30 minutes each of physical therapy and occupational therapy 3 times/week for 10 weeks. Motor function was assessed using the Fugl-Meyer Assessment (FMA) and the Action Research Arm Test (ARAT) at baseline, 10 weeks (post-treatment). At post-treatment (10 weeks) there was a significant between-group difference in FMA scores in favour of mCIMT compared to traditional therapy and no therapy at post-treatment. There were no significant differences in ARAT scores between any groups at post-treatment.

The second high quality RCT (Myint et al., 2008) randomized patients with subacute stroke to receive either mCIMT or conventional occupational and physical therapy. The mCIMT group wore a shoulder sling on the less-affected extremity for 90% of waking hours and received 4 hours daily therapy for 10 days. Upper extremity motor function was measured using the ARAT and Functional Test of the Hemiparetic Upper Extremity (FTHUE) at baseline, 10 days (post-treatment) and 12 weeks (follow-up). There were significant between-group differences in ARAT (grasp, grip, pinch, gross movement) and FTHUE scores at post-treatment, and in ARAT (total, grip) and FTHUE scores at follow-up, in favour of mCIMT compared to conventional therapy.

The third high quality RCT (Hammer & Lindmark, 2009b) randomized patients with subacute stroke to a ‘forced use’ group or a control group that received conventional rehabilitation. The forced use group wore a sling to promote forced use of the paretic upper limb for up to 6 hours/day, 5 days/week for 2 weeks. Upper extremity motor function was measured using the FMA-UE, ARAT and Motor Assessment Scale at baseline, 2 weeks (post-treatment), 1 month (follow-up A) and 3 months (follow-up B). There were no significant between-group differences in upper extremity motor function at any time point.

The fourth high quality RCT (Brogardh et al., 2009b) randomized patients with subacute stroke to a mCIMT group that wore a mitt on the less affected arm for 90% of waking hours, or a group that did not wear a mitt. Both groups received 3 hours of therapy for the affected arm for 12 days. Upper extremity motor function was measured using the modified Motor Assessment Scale and the Sollerman Hand Function Test (SHFT) at baseline, 2 weeks (post-treatment), 3 months and 12 months (follows-up). There were no significant between-group differences in upper extremity motor function at post-treatment or at follow-up (see Brogardh & Lexell, 2010).

The fifth high quality RCT (Brunner, Skouen & Strand, 2012) randomized patients with subacute stroke to receive mCIMT or bimanual task-related training. The mCIMT group wore a restraint for 4 hours/day in addition to therapist-directed training for 4 hours/week and self-directed training for 2-3 hours/day for 4 weeks. Upper extremity motor function was measured at baseline, 4 weeks (post-treatment) and 3-month follow-up using the ARAT. There were no significant between-group differences in upper extremity motor function at any time point

The fair quality RCT (Page et al., 2001) randomized patients with subacute stroke to receive mCIMT, conventional rehabilitation or no therapy. mCIMT comprised 30 minutes each of physiotherapy and occupational therapy 5 days/week for 10 weeks and restraint of the less affected arm 5 hours/day, 5 days/week for 10 weeks. Upper extremity motor function was measured using the ARAT, FMA and Wolf Motor Function Test (WMFT) at baseline and 10 weeks (post-treatment). The mCIMT group demonstrated substantial improvements in motor function whereas the other groups did not demonstrate substantial improvements on any measure of upper extremity motor function. Statistical data and between-group differences were not reported; accordingly this study is not included in determining level of evidence in the conclusion below.

Conclusion: There is strong evidence (level 1a) from 4 high quality RCTs that mCIMT or forced use therapy is not more effective than comparison interventions (conventional rehabilitation, no treatment, mCIMT training with no mitt use or bimanual task training) for improving upper extremity motor function among patients with subacute stroke. However, 1 of these high quality RCTs found results in favour of mCIMT on one measure of upper extremity motor function (FMA) but not another (ARAT); and another highquality RCTfound that mCIMT is more effective than control therapy (e.g. conventional rehabilitation).

Note: Studies varied in constraint intensity (from 4 hours/day to 90% of waking hours), frequency of therapy (from 3 to 20 hours/week) and intervention duration (from 10 days to 10 weeks), which is likely to account for discrepancies in results among studies.

Note: One fair quality RCT demonstrated improved motor function at post-treatment for the mCIMT group but as statistical data and between-group differences were not reported, this study is not included in determining level of evidence.

Spasticity
Not effective
1B

One high quality RCT (Hammer & Lindmark, 2009b) examined the effects of mCIMT on upper extremity spasticity in patients with subacute stroke. This high quality study randomized patients with subacute stroke to a ‘forced use’ group that wore a sling on the less affected arm for up to 6 hours/day, 5 days a week for 2 weeks, or to a control group that received conventional rehabilitation alone. Upper extremity spasticity was measured using the Modified Ashworth Scale at baseline, 2 weeks (post-treatment), 1 month (follow-up A) and 3 months (follow-up B). There were no significant between-group differences in upper extremity spasticity at any time point.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that mCIMT is not more effective than conventional rehabilitation for improving upper extremity spasticityin patients with subacute stroke.

Chronic phase: CIMT vs. control or alternative interventions

Functional independence
Not effective
1B

One high quality RCT (Huseyinsinoglu, Ozdincler, & Krespi, 2012) investigated the effect of CIMT on functional independence in patients with chronic stroke. This high quality RCT randomized patients with chronic stroke to receive CIMT or Bobath Concept therapy. Functional independence was measured using the Functional Independence Measure (FIM self cares and total score) at baseline and 2 weeks (post-treatment). There were no significant between-group differences in functional independence at post-treatment.

Conclusion: There is moderate (level 1b) evidence from 1 high quality RCT that CIMT is not more effective than a comparison intervention (Bobath Concept therapy) for improving functional independence among patients with chronic stroke.

Hand strength
Effective
1b

One high quality RCT (Suputtitada et al., 2004) investigated the effect of CIMT on hand strength in patients with chronic stroke. This high quality RCT randomized patients with chronic stroke to receive CIMT and affected-UE training or bimanual-UE training without restraint. Pinch strength and grip strength were measured by dynamometer at baseline and 2 weeks (post-treatment). At post-treatment there were significant between-group differences in pinch strength only, in favour of the CIMT group compared to the control group.

Conclusion: There is moderate evidence (level 1b) from one high quality RCT that CIMT is more effective than comparison interventions (bimanual upper extremity training) for improving pinch strength – but not grip strength – among patients with chronic stroke.

Kinematics (Upper extremity)
Insufficient evidence
5

One pre-post study (Richards et al., 2008) investigated the effect of CIMT on upper extremity kinematics with 3 patients with chronic stroke and ataxia. This pre-post study assigned patients to wear a mitten restraint during 90% of waking hours. Patients 1 and 2 received therapy 6 hours a day (CIMT) while patient 3 received therapy 3 hours a day (mCIMT). All participants demonstrated improved kinematic reaching values post-intervention, with no significant between-patient differences.

Note: Patients 1 and 2 improved on all kinematic measures: maximum velocity and time to maximum velocity increased, while index of curvature, number of peaks in the velocity profile, and trunk movement decreased. Participant 3 improved on some kinematic measures (smoother velocity profile, increased time to maximum velocity and decreased number of peaks in the velocity profile) but not all (decreased maximum velocity, increased index of curvature).

Conclusion: There is an insufficient evidence (level 5) comparing CIMT and control therapies on upper extremity kinematics in patients with chronic stroke. However, 1 non-experimental study found that CIMT is effective for improving reach kinematics in patients with chronic stroke.

Motor activity (Upper extremity)
Effective
1b

One high quality RCT (Huseyinsinoglu, Ozdincler, & Krespi, 2012), two fair quality RCTs (Wittenberg et al., 2003; Brogårdh & Sjülund, 2006; Brogårdh et al., 2009a – follow-up study) and 2 non-experimental studies (Taub et al., 2006; Kunkel et al., 1999) examined the effectiveness of CIMT on motor activity in patients with chronic stroke.

The high quality RCT (Huseyinsinoglu, Ozdincler, & Krespi, 2012) randomized patients with chronic stroke to receive CIMT or Bobath Concept therapy. Upper extremity motor activity was measured using the Motor Activity Log – Amout of Use (MAL-AOU) and – Quality of Movement (MAL-QOM) at baseline and 2 weeks (post-treatment). There was a significant between-group difference in MAL-AOU and MAL-QOM scores at post-treatment, in favour of CIMT compared to Bobath Concept therapy.

The first fair quality RCT (Wittenberg et al., 2003) randomized patients with chronic stroke to receive either CIMT and task-oriented training or task-oriented training alone. Upper extremity motor activity was measured using the MAL at baseline and 10 days (post-treatment). There were significant gains in MAL scores at post-treatment, in favour of CIMT + task-oriented training compared to task-oriented training alone.

The second fair quality RCT (Brogårdh & Sjülund, 2006) provided patients with chronic stroke with a 2-week CIMT program, then randomized patients to prolonged mitt use for a further 3 months, or no further treatment. All participants demonstrated improved MAL-AOU and MAL-QOM scores after 2 weeks of CIMT, however no significant between-group differences were reported at 3 months.

Note: The authors reported that the small sample size was a limitation of this study.

A 4-year follow-up to this study (Brogårdh et al., 2009a) found a significant improvement in upper extremity motor activity from baseline to 4 years. However, comparison from post-treatment time points (2 weeks and 3 months) to 4-year follow-up revealed a significant decrease in motor activity.

A controlled clinical trial (Taub et al., 2006) assigned patients with chronic stroke to a CIMT group or a control group that received time-matched and interaction-matched physical, cognitive and relaxation exercises. Upper extremity motor activity was measured using the MAL-QOM subtest and the Upper Extremity Actual Amout of Use test (AAUT) at baseline, 2 weeks (post-treatment), 4 weeks (follow-up A) and 2 years (follow-up B). There was a significantly greater improvement in upper extremity motor activity at post-treatment, in favour of CIMT compared to the control group. No significant between-group differences were reported at follow-up time points.

A pre-post study without multiple baselines (Kunkel et al., 1999) assigned patients with chronic stroke to receive CIMT. Upper extremity motor activity was measured using the MAL and AAUT at baseline, 2 weeks (post-treatment) and 3 months (follow-up). Significant improvements in upper extremity motor activity were noted at both time points.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT, 1 fair quality RCT and 1 non-experimental study that CIMT is more effective than comparison interventions (e.g. Bobath Concept therapy, task-oriented training, time-matched physical/cognitive/relaxation exercises) for improving upper extremity motor activity in patients with chronic stroke. Further, 1 fairquality RCTand 1 non-experimental study found significant improvements in motor activity following CIMT.

Note: One fair quality RCT found no benefit to prolonged mitt use following CIMT.

Motor function (Upper extremity)
Conflicting
4

Three high quality RCTs (Suputtitada et al., 2004; Huseyinsinoglu, Ozdincler, & Krespi, 2012; Abo et al., 2014), 2 fair quality RCTs (Wittenberg et al., 2003; Brogårdh & Sjülund, 2006; Brogårdh et al., 2009a – follow-up study) and 2 non-experimental studies (Taub et al., 2006; Kunkel et al., 1999) examined the effects of CIMT on upper extremity motor function in patients with chronic stroke.

The first high quality RCT (Suputtitada et al., 2004) randomized patients with chronic stroke to receive CIMT and affected-UE training or bimanual-UE training without restraint. Upper extremity motor function was measured using the Action Research Arm Test (ARAT). At post-treatment, there were significant between-group differences in upper extremity motor function, in favour of CIMT compared to the control group.

The second high quality RCT (Huseyinsinoglu, Ozdincler, & Krespi, 2012) randomized patients with chronic stroke to receive CIMT or Bobath Concept therapy. Upper extremity motor function was measured at baseline and 2 weeks (post-treatment) using the Wolf Motor Function Test – Functional Ability and – Performance Time (WMFT-FA, WMFT-PT) subtests. There was no significant between-group difference in upper extremity motor function at post-treatment.

The third high quality RCT (Abo et al., 2014) randomized patients with chronic stroke to receive CIMT or low-frequency rTMS with intensive OT (NEURO). Upper extremity motor function was measured at baseline and 15 days (post-treatment) using the FMA and WMFT-FA and WMFT-PT. There were significant between-group differences in FMA and WMFT-FA scores at post-treatment, in favour of NEURO compared to CIMT.

The first fair quality RCT (Wittenberg et al., 2003) randomized patients with chronic stroke to receive CIMT and task-oriented training or task-oriented training alone. Upper extremity motor function was measured at baseline and at 2 weeks (post-treatment) using the WMFT and the Assessment of Motor and Process Skills (AMPS), and using Transcranial Magnetic Stimulation and Positron Emission Tomography (PET) scans. There were no significant between-group differences on any measure of upper extremity motor function at post-treatment.

The second fair quality RCT (Brogårdh & Sjülund, 2006) provided patients with chronic stroke with a 2-week CIMT program, then randomized patients to prolonged mitt use for a further 3 months, or no further treatment. Upper extremity motor function was measured at baseline and 2 weeks (post-treatment) using the modified Motor Assessment Scale (MAS) and the Sollerman Hand Function Test (SHFT). All participants demonstrated improved upper extremity motor function after 2 weeks of CIMT. After 3 months there were no significant differences in motor function between prolonged mitt use and no mitt use.

A 4-year follow-up to this study (Brogårdh et al., 2009a) found no significant change in SHFT scores when compared to baseline or post-treatment data. The MAS was not used on retesting.

A controlled clinical trial (Taub et al., 2006) assigned patients with chronic stroke to a CIMT group or a control group that received time-matched and interaction-matched physical, cognitive and relaxation exercises. Upper extremity motor function was measured at baseline and at 2 weeks (post-treatment) using the WMFT-PT and WMFT-FA. There was a significant between-group difference in WMFT–PT scores at post-treatment, in favour of CIMT compared to the control group. There were no significant between-group differences in WMFT-FA scores. Although measures were also taken at 3 follow-up intervals (4 weeks, 3 months, 2 years), statistical data for between-group differences were not reported at these time points.

A pre-post study without multiple baselines (Kunkel et al., 1999) examined the effects of CIMT in patients with chronic stroke. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and at 3 months (follow-up) using the ARAT and WMFT. There was a significant improvement in ARAT and WMFT scores at both time points.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of CIMT compared to other interventions. Two high quality RCTs and one fair quality RCT reported that CIMT was not more effective than comparison interventions (Bobath Concept therapy, task-oriented training, rTMS+OT); in fact, 1 high quality RCT found that CIMT was less effective than rTMS+OT for improving upper extremity motor function. However, another high quality RCT and a controlled clinical trial reported that CIMT was more effective than comparison interventions (bimanual training, time-matched rehabilitation) on some measures of upper extremity motor function (ARAT and WMFT performance time). Further, 1 pre-post design study found significant improvement in upper extremity motor function following CIMT.

Note: A fair quality RCT found an improved upper extremity motor function after 2 weeks of CIMT, and note that prolonged mitt use following a CIMT program was not more effective than CIMT alone for improving upper extremity motor function in patients with chronic stroke.

Quality of movement (Upper extremity)
Not effective
1B

One high quality RCT (Huseyinsinoglu, Ozdincler, & Krespi, 2012) has investigated the effect of CIMT on quality of movement of the upper extremity in patients with chronic stroke. This high quality RCT randomized patients with chronic stroke to receive CIMT or Bobath Concept therapy. At post-treatment (2 weeks) there was no significant between-group difference in upper extremity quality of movement (Motor Evaluation Scale for Arm in Stroke Patients).

Conclusion: There is moderate (level 1b) evidence from 1 high quality RCT that CIMT is not more effective than a comparison intervention (Bobath Concept therapy) for improving upper extremity quality of movement among patients with chronic stroke.

Sensory discrimination
Not effective
2a

One fair quality RCT (Brogårdh & Sjülund, 2006) examined the effect of CIMT on sensory discrimination in patients with chronic stroke. This fair quality RCT provided patients with a 2-week CIMT program, then randomized patients to prolonged mitt use for a further 3 months, or no further treatment. There were no significant within-group differences in sensory discrimination (Two-Point Discrimination Test) following 2 weeks of CIMT. Further, there were no significant between-group differences in sensory discrimination at 3 months.

Conclusion: There is limited evidence (level 2a) from 1 fairquality RCTthat CIMT does not improve sensory discrimination in chronic stroke. Further, the fairquality RCTfound that prolonged mitt wear is not more effective than control therapy (i.e. no treatment) for improving sensory discrimination in patients with chronic stroke.

Chronic phase: mCIMT vs. control or alternative interventions

Dexterity
Not effective
1b

One high quality RCT (Barzel et al., 2015), 1 poor quality RCT (Kim et al., 2008) and 1 quasi-experimental study (Siebers & Skargren, 2010) investigated the effect of mCIMT on dexterity among patients with chronic stroke.

The high quality RCT (Barzel et al., 2015) randomized patients with chronic stroke to receive home-based mCIMT or conventional rehabilitation. Finger dexterity was measured at baseline, 4 weeks (post-treatment) and 6-month follow-up using the Nine Hole Peg Test. There was no significant between-group difference in finger dexterity any time point.

The poor quality RCT (Kim et al., 2008) randomized patients with chronic stroke to receive mCIMT or a control group (intervention not specified). Patients in the mCIMT group wore a modified opposition restriction orthosis (MORO) on the unaffected hand for at least 5 hours/day, 7 days a week. Dexterity was measured using the Purdue Pegboard Test at baseline and 8 weeks (post-treatment). There were no significant between-group differences in dexterity at post-treatment.

The quasi-experimental study (Siebers & Skargren, 2010) provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Manual dexterity was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Box and Block Test (BBT). There was a significant improvement in manual dexterity from baseline to post-treatment, but this did not remain significant at 6-month follow-up.

Note: As this study did not report between-group differences these results are not used to determine level of evidence below.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT and 1 poorquality RCT that mCIMT is not more effective than comparison interventions (conventional rehabilitation) for improving dexterity among patients with chronic stroke.

Note: One quasi-experimental study reported a significant improvement, in short term, in manual dexterity from baseline to post-treatment but as this study did not report between-group differences these results are not used to determine level of evidence.

Grip strength
Insufficient evidence
5

One quasi-experimental study (Siebers & Skargren, 2010) investigated the effect of mCIMT on grip strength among patients with chronic stroke. This quasi-experimental study provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Grip strength was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Grippit instrument. There was a significant improvement in grip strength from baseline to post-treatment and this persisted at 6-month follow-up.

Conclusion: There is insufficient evidence (level 5) regarding the effectiveness of mCIMT on grip strength compared to other interventions. However, 1 quasi-experimental study reported improved grip strength among patients with chronic stroke following mCIMT.

Functional independence and activities of daily living
Effective
1A

Four high quality RCTs (Lin et al., 2007, Wu et al., 2007c,, Lin et al., 2009b; Barzel et al., 2015) and 2 fair quality RCTs (Lin et al., 2008, Wu et al., 2012b) examined the effectiveness of mCIMT on functional independence in patients with chronic stroke.

The first high quality RCT (Lin et al., 2007) randomized patients with chronic stroke to either mCIMT or traditional rehabilitation. The mCIMT group had their unaffected hand restricted by a mitt for 6 hours per day and received intensive training on the affected arm for 2 hours per weekday. Functional independence was measured at baseline and 3 weeks (post-treatment) using the Functional Independence Measure (FIM). There were significant between-group differences in functional independence at post-treatment, in favour of mCIMT compared to traditional rehabilitation.

The second high quality RCT (Wu et al., 2007c) randomized patients with chronic stroke to either mCIMT or neurodevelopmental therapy. The mCIMT group wore a constraint on the less affected UE 6 hours a day while receiving 2 hours daily of intensive training. Functional independence was measured at baseline and 3 weeks (post-treatment) using the FIM. The mCIMT group had significantly greater gains in functional independence than the control group at post-treatment.

The third high quality RCT (Lin et al., 2009b) randomized patients with chronic stroke to receive mCIMT, bilateral arm training (BAT), or standard UE therapy (control). The mCIMT group received 2 hours per weekday of UE therapy for 12 days for 3 weeks while wearing a restraint on the unaffected UE for 6 hours per day. Functional independence was measured at baseline and 3 weeks (post-treatment) using the FIM. The mCIMT group showed significantly greater functional independence than the BAT group and the control group at post-treatment.

The fourth high quality RCT (Barzel et al., 2015) randomized patients with chronic stroke to receive home-based mCIMT or conventional rehabilitation. Functional independence was measured at baseline, 4 weeks (post-treatment) and 6-month follow-up using the Barthel Index (BI) and the Instrumental Activities of Daily Living (IADL). There were no significant between-group differences in functional independence on either measure at any time point.

The first fair quality RCT (Lin et al., 2008) randomized patients with chronic stroke to either mCIMT or traditional intervention. The mCIMT group wore restraints on the hand and wrist for 3 hours/weekday and received 2-hour training sessions each weekday. Functional independence was measured at baseline and 3 weeks (post-treatment) using the FIM and the Nottingham Extended Activities of Daily Living (NEADL). The mCIMT group showed significantly greater improvements in functional independence (FIM total, self-care and locomotion domains; NEADL mobility domain only) than the control group at post-treatment.

The second fair quality RCT (Wu et al., 2012b) randomized patients with chronic stroke to receive mCIMT, mCIMT with trunk restraint (mCIMT-TR) or conventional rehabilitation based on neurodevelopmental principles. Both mCIMT groups wore a mitt on the non-affected hand and wrist for 5 hours/day, the mCIMT-TR group wore a harness to restrain the trunk during rehabilitation sessions; all groups received their respective intervention for 2 hours/day, 5 days/week. Functional independence was measured at baseline and 3 weeks (post-treatment) using the Functional Activities Index (FAI). There were significant between-group differences in functional independence in favour of mCIMT compared to conventional rehabilitation (FAI total score only) at post-treatment.

Note: There were also significant between-group differences in favour of mCIMT-TR compared to conventional rehabilitation (FAI outdoor and total scores); there were no significant between-group differences on other measures of functional independence (FAI domestic chores, leisure/work subtests).

Conclusion: There is strong evidence (level 1a) from 3 high quality RCTs and 2 fair qualityRCTs that mCIMT is more effective than control therapies (e.g. conventional rehabilitation, neurodevelopmental therapy, bilateral arm training) for improving functional independence in patients with chronic stroke.

Note: However, one high quality RCT found that mCIMT was not more effective than conventional rehabilitation for improving functional independence among patients with chronic stroke. This high quality RCT used different measures of functional independence to the other RCTs reviewed above.

Kinematics (Upper extremity)
Effective
1a

Four high quality RCTs (Wu et al., 2011; Wu et al., 2007c; Lin et al., 2007; Wu et al., 2012a), 1 fair quality RCT (Wu et al., 2012b) and 2 pre-post studies (Caimmi et al., 2008; Richards et al., 2008) have investigated the effect of mCIMT on upper extremity kinematics in patients with chronic stroke.

The first high quality RCT (Wu et al., 2011) randomized patients with chronic stroke to receive mCIMT, bilateral arm therapy (BAT) or conventional therapy. mCIMT comprised use of a restrictive mitt for 6 hours/weekday. All groups received 2 hours of occupational therapy daily over the intervention period. Unilateral and bilateral reach kinematics were measured at baseline and 3 weeks (post-treatment) according to movement efficiency (normalized movement time – NMT), movement smoothness (normalized movement unit – NMU), peak velocity (PV) and movement strategies (percentage of movement time when peak velocity occurred – PPV). At post-treatment there was a significant between-group difference in unilateral and bilateral NMU in favour of the mCIMT group compared to the control group.

Note: There was also a significant between-group difference in unilateral and bilateral NMU and PV, in favour of the BAT group compared to the control group. There were no differences between groups for other kinematic measures.

The second high quality RCT (Wu et al., 2007c) randomized patients with chronic stroke to either mCIMT or neurodevelopmental therapy (NDT). The mCIMT group wore a constraint on the less affected UE 6 hours/ day while receiving 2 hours daily of intensive training. Kinematic measures were taken at baseline and 3 weeks (post-treatment). The mCIMT group showed more temporally and spatially efficient movement and more preplanned movement during bimanual tasks than the NDT group at post-treatment. During unilateral task performance, the mCIMT group produced more ballistic/preplanned reaching movement than the NDT group but did not produce significant between-group differences in temporal or spatial efficiency.

The third high quality RCT (Lin et al., 2007) randomized patients with chronic stroke to receive mCIMT or traditional rehabilitation. The mCIMT group wore a mitt for 6 hours/day and received intensive training on the affected arm for 2 hours/weekday. Kinematic measures were taken at baseline and 3 weeks (post-treatment) and included reaction time, NMT, PPV, NMU, maximum grip aperture, and percentage of movement time where maximum grip aperture occurs. At post-treatment, significant between-group differences were reported for reaction time and PPV, in favour of mCIMT compared to traditional rehabilitation.

The fourth high quality RCT (Wu et al., 2012a) randomized patients with chronic stroke to receive modified CIMT (mCIMT), modified CIMT with trunk restraint (mCIMT+TR) or conventional rehabilitation. The mCIMT groups received therapy for 2 hours/weekday and wore a mitt for 6 hours/day. Upper extremity kinematics were measured at baseline and 3 weeks (post-treatment) and measures included grasp, shoulder and elbow joint range and trunk movement. There were no significant differences in grasping, joint range and trunk movement during reach-to-grasp between mCIMT and conventional rehabilitation.

Note: There were significant differences in grasp kinematics in favour of mCIMT+TR compared to conventional rehabilitation (active shoulder movement, trunk movement), and in favour of mCIMT+TR compared to mCIMT (active shoulder movement, active elbow movement, trunk movement).

The fair quality RCT (Wu et al., 2012b) randomized patients with chronic stroke to receive modified constraint-induced movement therapy (mCIMT), mCIMT with trunk restraint (mCIMT-TR) or conventional rehabilitation based on neurodevelopmental principles. Both mCIMT groups wore a mitt on the non-affected hand and wrist for 5 hours/day and the mCIMT-TR group wore a harness to restrain the trunk during rehabilitation sessions; all groups received their respective intervention for 2 hours/day, 5 days/week. Kinematic measures including trunk slope (start, middle, end reach) and normalized shoulder and elbow flexion were taken at baseline and 3 weeks (post-treatment). There were no significant differences in kinematic measures at post-treatment between mCIMT and conventional rehabilitation.

Note: there were significant between-group differences in kinematics in favour of mCIMT-TR compared to conventional rehabilitation (trunk slope – start), and in favour of mCIMT-TR compared to mCIMT (normalized shoulder flexion).

The first pre-post study without multiple baselines (Caimmi et al., 2008) tested the suitability of a new method of kinematic analysis for evaluating the effects of mCIMT in patients with chronic stroke. Patients wore a splint on the less affected limb for approximately 80% of waking hours for 14 consecutive days and received physiotherapy and occupational therapy for 1 hour/weekday. Movement of the affected arm was measured using kinematic testing at baseline and 2 weeks (post-treatment). The mCIMT group demonstrated an improvement in the movement efficiency of the affected arm at post-treatment.

The second pre-post study without multiple baselines (Richards et al., 2008) examined the effect of CIMT protocols on UE kinematics in patients with chronic stroke. Subjects wore a mitten restraint during 90% of waking hours. Patients 1 and 2 received therapy 6 hours/day (CIMT) while patient 3 received therapy 3 hours/day (mCIMT). All participants demonstrated improved kinematic reaching values post-intervention, with no significant between-patient differences.

Conclusion: There is strong evidence (level 1a) from 3 high quality RCTs that mCIMT is more effective than control therapies (e.g. bilateral arm training, neurodevelopmental therapy and conventional rehabilitation) for improving upper extremity kinematic measures such as movement smoothness or efficiency, reaction time and reaching values in patients with chronic stroke. Further, 2 pre-post studies reported improvement in upper extremity kinematics following mCIMT.

Note: However, one high quality RCT and one fair quality RCT found that mCIMT was not more effective than conventional rehabilitation for improving upper extremity kinematics in patients with chronic stroke. Further, these RCTs reported that mCIMT with trunk restraint is more effective than mCIMT alone and conventional rehabilitation for improving some measures of upper extremity kinematics.

Motor activity (Upper extremity)
Effective
1A

Seven high quality RCTs (Page et al., 2004; Lin et al., 2007; Wu et al., 2007c; Lin et al., 2009b; Wu et al., 2011; Wu et al., 2012a; Barzel et al., 2015), 4 fair quality RCTs (Page et al., 2008; Lin et al., 2008; Lin et al., 2010; Wu et al., 2012b), 3 poor quality RCTs (Wu et al., 2010; Kim et al., 20080; Atteya, 2004) and 4 non-experimental studies (Barzel et al., 2009; Dettmers et al., 2005; Caimmi et al., 2008; Siebers & Skargren, 2010) have examined the effect of mCIMT on upper extremity (UE) motor activity in patients with chronic stroke.

The first high quality RCT (Page et al., 2004) randomized patients with chronic stroke to receive mCIMT + UE therapy, UE therapy alone, or no therapy. The mCIMT group wore a constraint on the affected extremity for 5 hours/day and received UE therapy for 30 minutes, 3 times/week. Upper extremity motor activity was measured at baseline and 10 weeks (post-treatment) using the Motor Activity Log – Amount of Use and – Quality of Movement (MAL-AOU, MAL-QOM). There were no significant differences between any group at post-treatment (10 weeks).

The second high quality RCT (Lin et al., 2007) randomized patients with chronic stroke to receive mCIMT or conventional rehabilitation. The mCIMT group wore a mitt for 6 hours/day and received intensive training on the affected arm for 2 hours/weekday. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL. There were significant between-group differences in motor activity at post-treatment, in favour of mCIMT compared to conventional rehabilitation.

The third high quality RCT (Wu et al., 2007c) randomized patients with chronic stroke to receive mCIMT or neurodevelopmental therapy (NDT). The mCIMT group wore a constraint on the less affected UE 6 hours/day and received 2 hours daily of intensive training. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There was a significant between-group difference in motor activity improvement scores from baseline to post-treatment, in favour of mCIMT compared to NDT.

The fourth high quality RCT (Lin et al., 2009b) randomized patients with chronic stroke to receive mCIMT, bilateral arm training (BAT), or standard UE therapy. The mCIMT group received UE therapy 2 hours/weekday and wore a restraint on the unaffected UE for 6 hours/day. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. The mCIMT group showed significantly better MAL-AOU and MAL-QOM scores than the BAT group or the control group at post-treatment.

The fifth high quality RCT (Wu et al., 2011) randomized patients with chronic stroke to receive mCIMT, bilateral arm therapy (BAT) or conventional rehabilitation. The mCIMT group wore a restrictive mitt for 6 hours/day, 5 days/week and all groups received occupational therapy for 2 hours/day. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There were significant between-group differences in MAL-AOU and MAL-QOM scores at post-treatment, in favour of the mCIMT group compared to BAT and conventional rehabilitation. There were no significant differences in motor activity between BAT and conventional rehabilitation.

The sixth high quality RCT (Wu et al., 2012a) randomized patients with chronic stroke to receive modified CIMT (mCIMT), modified CIMT with trunk restraint (mCIMT+TR) or conventional rehabilitation. The mCIMT groups wore a mitt on the unaffected hand for 6 hours/day and received intervention for 2 hours/weekday. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There were no significant differences in MAL-AOU or MAL-QOM scores between any group pairing at post-treatment.

The seventh high quality RCT (Barzel et al., 2015) randomized patients with chronic stroke to receive home-based mCIMT or conventional rehabilitation. The mCIMT group wore a glove on the unaffected hand for 2-4 hours/day and performed exercises with the affected arm for 2 hours/weekday. Upper extremity motor activity was measured at baseline, 4 weeks (post-treatment) and 6-month follow-up using the MAL-AOU and MAL-QOM. There was a significant between-group difference in MAL-AOU and MAL-QOM scores at post-treatment and follow-up, in favour of home-based mCIMT compared with conventional rehabilitation.

The first fair quality RCT (Page et al., 2008) randomized patients to receive mCIMT, time-matched rehabilitation, or no treatment. Patients in the mCIMT group received functional practice sessions for 30 minutes/day and restricted us of the less-affected arm for 5 hours/weekday. Upper extremity motor activity was measured at baseline and 10 weeks (post-treatment) MAL-AOU and MAL-QOM. The mCIMT group demonstrated significantly improved MAL-AOU and MAL-QOM scores compared to the other treatment groups at post-treatment.

The second fair quality RCT (Lin et al., 2008) randomized patients with chronic stroke to receive mCIMT or conventional intervention. The mCIMT group wore restraints on the hand and wrist for 3 hours/weekday and received training sessions for 2 hours/weekday. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) MAL-AOU and MAL-QOM. There were no significant between-group differences in motor activity at post-treatment.

The third fair quality RCT (Lin et al., 2010) randomized patients with chronic stroke to receive mCIMT or conventional rehabilitation for the same intensity and duration. The mCIMT group wore a restrictive mitt 6 hours/weekday and received upper limb training 2 hours/weekday. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There was a significant between-group difference in MAL-AOU and MAL-QOM scores at post-treatment, in favour of mCIMT compared to conventional rehabilitation.

The fourth fair quality RCT (Wu et al., 2012b) randomized patients with chronic stroke to receive modified constraint-induced movement therapy (mCIMT), mCIMT with trunk restraint (mCIMT-TR) or conventional rehabilitation based on neurodevelopmental principles. Both mCIMT groups wore a mitt on the non-affected hand and wrist for 5 hours/day and the mCIMT-TR group wore a harness to restrain the trunk during rehabilitation sessions; all groups received their respective intervention for 2 hours/weekday. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There were significant between-group differences in MAL-AOU and MAL-QOM scores at post-treatment, in favour of mCIMT compared to conventional rehabilitation.

Note: There were also significant between-group differences in favour of mCIMT-TR compared to conventional rehabilitation (MAL-QOM only).

The first poor quality RCT (Wu et al., 2010) randomized patients with chronic stroke to receive mCIMT with intensive training of the upper extremity for 2 hours/weekday, or bilateral arm therapy training for the same frequency and duration. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. The mCIMT group demonstrated improved MAL-QOU and MAL-QOM scores at post-treatment.

Note: Statistical data and between-group differences were not reported; accordingly, this study is not included in determining level of evidence for the effectiveness of mCIMT compared to other interventions.

The second poor quality RCT (Kim et al., 2008) randomized patients to either mCIMT or a control group (intervention not specified). Patients in the CIMT group wore a modified opposition restriction orthosis (MORO) on the unaffected hand at least 5 hours/day. Upper extremity motor activity was measured at baseline and 8 weeks (post-treatment) using the MAL. Improved motor activity was seen post-treatment, although between-group statistical comparisons were not provided.

The third poor quality RCT (Atteya, 2004) randomized patients with chronic stroke to receive mCIMT, conventional rehabilitation or no therapy. Upper extremity motor activity was measured at baseline and 10 weeks (post-treatment) using the MAL-AOU and MAL-QOM. The mCIMT group demonstrated improved MAL-AOU and MAL-QOM scores at post-treatment compared to the control groups.

Note: Statistical data and between-group differences were not reported; accordingly, this study is not included in determining level of evidence for the effectiveness of mCIMT compared to other interventions.

A quasi-experimental study (Barzel et al., 2009) assigned patients with chronic stroke to receive either CIMT (physiotherapy 6 hours/weekday for 2 weeks and splint worn on unaffected hand for a target of 90% of waking hours) or a mCIMT home program (home-based training with a family member for 2 hours/weekday for 4 weeks and splint worn on the unaffected hand for a target of 60% of waking hours). Upper extremity motor activity was measured using the MAL-AOU and MAL-QOM at baseline, post-treatment and 6-month follow-up. There were no significant between-group differences in motor activity at any time point.

A pre-post study with multiple baselines (Dettmers et al., 2005) examined the effects of mCIMT on patients with chronic stroke. Patients underwent intensive motor training of the more-affected arm for 3 hours/day for 20 days. The unaffected arm was restrained for 9.3 hours/day to limit its use. Upper extremity motor activity was measured at baseline, 3 weeks (post-treatment) and at 6-month follow-up using the MAL. Significant improvements in motor activity MAL were found from pre- to post-treatment and were retained at follow-up (6 months).

A pre-post study without multiple baselines (Caimmi et al., 2008) tested the suitability of a new method of kinematic analysis for evaluating the effects of mCIMT in patients with chronic stroke. Patients wore a splint on the less affected limb for approximately 80% of waking hours for 14 consecutive days and received 1 hour of physiotherapy and occupational therapy every weekday. Upper extremity motor activity was measured at baseline and 2 weeks (post-treatment) using the MAL. The mCIMT group demonstrated significantly improved motor activity at post-treatment.

A quasi-experimental study (Siebers & Skargren, 2010) provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Upper extremity motor activity was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Motor Activity Log – Quality of Movement (MAL-QOM). There was a significant improvement in upper extremity motor activity from baseline to post-treatment but this did not remain significant at 6-month follow-up.

Conclusion: There is strong evidence (level 1a) from 5 high quality RCTs and 3 fair quality RCTs that mCIMT is more effective than other therapies (conventional rehabilitation, neurodevelopmental therapy, bilateral arm therapy or no treatment) for improving upper extremity motor activity in patients with chronic stroke. Further, 3 poor quality RCTs and 3 non-experimental studies found improved motor activity following mCIMT.

Note: However, 2 high quality RCTs and 1 fair quality RCT found that mCIMT was not more effective than control therapies (e.g. conventional rehabilitation or no treatment) for improving upper extremity motor activity in patients with chronic stroke. Also, 1 non experimental study found no improvement in motor activity of the upper extremity after mCIMT.

Note: One of the high quality RCT found that mCIMT alone is not more effective than mCIMT with trunk restraint for improving upper extremity motor activity in patients with chronic stroke and 1 fair quality RCT found that mCIMT alone is as effective as mCIMT with trunk restraint for improving motor activity of the upper extremity, both compared to conventional rehabilitation.

Motor function (Upper extremity)
Effective
1a

Five high quality RCTs (Page et al., 2004; Lin et al., 2009b; Wu et al., 2011; Barzel et al., 2015; Wu et al., 2012a), 5 quality RCTs (Page et al., 2008; Lin et al., 2008; Lin et al., 2010; Hayner, Gibson & Giles, 2010; Wu et al., 2012b), 3 poor quality RCTs (Wu et al., 2010; Kim et al., 2008; Atteya, 2004) and 3 non-experimental studies (Caimmi et al., 2008; Dettmers et al., 2005; Siebers & Skargren, 2010) have examined the effects of mCIMT on upper extremity (UE) motor function in patients with chronic stroke.

The first high quality RCT (Page et al., 2004) randomized patients with chronic stroke to receive mCIMT and UE therapy, conventional UE therapy alone, or no therapy. The mCIMT group wore a constraint on the affected extremity for 5 hours/day and received 30 minutes of UE therapy 3 times/week. Upper extremity motor function was measured at baseline and 10 weeks (post-treatment) using the Fugl-Meyer Assessment (FMA) and the Action Research Arm Test (ARAT). There were significant between-group differences at post-treatment in favour of mCIMT compared to no therapy (FMA, ARAT), and in favour of mCIMT compared to conventional rehabilitation (FMA only).

The second high quality RCT (Lin et al., 2009b) randomized patients with chronic stroke to receive mCIMT, bilateral arm training (BAT), or standard UE therapy. The mCIMT group wore a restraint on the unaffected UE for 6 hours/day and received UE therapy for 2 hours/weekday. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the FMA. At post-treatment there was a significant between-group difference on measures of upper extremity motor function (FMA overall score and distal score) in favour of mCIMT compared to standard UE therapy.

Note: At post-treatment there was also a significant difference in motor function (FMA proximal score only) in favour of the BAT group compared to the mCIMT group.

The third high quality RCT (Wu et al., 2011) randomized patients with chronic stroke to receive mCIMT, bilateral arm therapy (BAT) or conventional therapy. mCIMT comprised use of a restrictive mitt for 6 hours/weekday and all groups received occupational therapy for 2 hours/weekday. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the Wolf Motor Function Test Performance Time (WMFT-PT), Functional Ability (WMFT-FA) and Strength scores. There was a significant between-group difference in WMFT–PT and WMFT-FA scores at post-treatment, in favour of the mCIMT group compared to conventional therapy. There were no significant differences in motor function between the mCIMT and BAT groups, or between the BAT and control groups.

The fourth high quality RCT (Barzel et al., 2015) randomly assigned patients with chronic stroke to receive home-based mCIMT or conventional rehabilitation. The mCIMT group wore a glove on the unaffected hand for 2-4 hours/day and performced exercises with the affected arm for 2 hours/weekday. Upper extremity motor function was measured at baseline, 4 weeks (post-treatment) and 6-month follow-up using the WMFT-PT and WMFT-FA. There was no significant between-group difference in motor function at any time point.

The fifth high quality RCT (Wu et al., 2012a) randomly assigned patients with chronic stroke to receive modified CIMT (mCIMT), modified CIMT with trunk restraint (mCIMT+TR) or conventional rehabilitation. The mCIMT groups wore a mitt on the unaffected hand for 6 hours/day and received intervention for 2 hours/weekday. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the FMA-UE proximal, distal and total scores. There were no significant differences in upper extremity motor function between mCIMT and conventional rehabilitation.

Note: There were no significant differences in upper extremity motor function between mCIMT and mCIMT+TR; there were significant between-group differences in FMA-UE distal and total scores in favour of mCIMT+TR compared to conventional rehabilitation.

The first fair quality RCT (Page et al., 2008) randomized patients with chronic stroke to receive mCIMT, time-matched rehabilitation, or no treatment. The mCIMT group received functional practice sessions for 30 minutes/weekday and restrained the less-affected arm for 5 hours/weekday. Motor function was measured at baseline and 10 weeks (post-treatment) using the FMA and ARAT. The mCIMT group showed significant improvements in motor function (ARAT only) compared to the other 2 groups at post-treatment.

The second fair quality RCT (Lin et al., 2008) randomized patients with chronic stroke to receive mCIMT or traditional intervention. The mCIMT group wore a restraint for 3 hours/weekday and training sessions for 2 hours/weekday. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the FMA. There was a significant between-group difference in motor function (FMA improvement scores) at post-treatment, in favour of mCIMT compared to traditional intervention.

The third fair quality RCT (Lin et al., 2010) randomized patients with chronic stroke to receive either mCIMT or conventional rehabilitation for the same intensity and duration. mCIMT comprised use of a restrictive mitt 6 hours/weekday and upper limb training 2 hours/weekday, 5 days/week. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the FMA upper limb subscale. The mCIMT group demonstrated a significantly greater improvement in motor function than the control group at post-treatment.

The fourth fair quality RCT (Hayner, Gibson & Giles, 2010) randomized patients with chronic stroke to receive mCIMT or bilateral upper extremity training. The mCIMT group wore a restraining mitt 6 hours/day for 10 days. Upper extremity motor function was measured using the WMFT at baseline, 10 days (post-treatment) and at 6-month follow-up. There were no significant between-group differences in motor function at any time point.

Note: A comparison of ‘less impaired’ vs. ‘more impaired’ patients revealed a significant between-group difference in motor function (WMFT), in favour of ‘less impaired’ patients, regardless of intervention group.

The fifth fair quality RCT (Wu et al., 2012b) randomized patients with chronic stroke to receive modified constraint-induced movement therapy (mCIMT), mCIMT with trunk restraint (mCIMT-TR) or conventional rehabilitation based on neurodevelopmental principles. Both mCIMT groups wore a mitt on the non-affected hand and wrist for 5 hours/day and the mCIMT-TR group wore a harness to restrain the trunk during rehabilitation sessions; all groups received their respective intervention for 2 hours/weekday. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the ARAT. At post-treatment there were significant between-group differences in favour of mCIMT compared to conventional rehabilitation (ARAT gross and total scores only).

Note: At post-treatment there was also a significant between-group difference in in favour of mCIMT-TR compared to mCIMT (ARAT grip scores), and in favour of mCIMT-TR compared to conventional rehabilitation (ARAT grip, pinch, gross and total scores).

The first poor quality RCT (Wu et al., 2010) randomized patients with chronic stroke to receive mCIMT for 2 hours/weekday, or bilateral arm therapy training for the same frequency and duration. Upper extremity motor function was measured at baseline and post-treatment (3 weeks) using the ARAT and FMA upper extremity subscale. Patients from both groups demonstrated improved scores on measures of motor function at post-treatment.

Note: Statistical data and between-group differences were not reported; accordingly, this study is not included in determining level of evidence for the effectiveness of mCIMT compared to other interventions.

The second poor quality RCT (Kim et al., 2008) randomized patients with chronic stroke to a mCIMT group or a control group (intervention not specified). Patients in the mCIMT group wore a modified opposition restriction orthosis (MORO) on the unaffected hand at least 5 hours/day. Upper extremity motor function was measured at baseline and 8 weeks (post-treatment) using the Manual Function Test. There were no significant between-group differences in motor function at post-treatment.

The third poor quality RCT (Atteya, 2004) randomized patients with subacute stroke to receive mCIMT, conventional rehabilitation or no therapy. Upper extremity motor function was measured at baseline and 10 weeks (post-treatment) using the FMA, WMFT and ARAT. The mCIMT group demonstrated improved scores on all measures of motor function at post-treatment.

Note: Statistical data and between-group differences were not reported; accordingly, this study is not included in determining level of evidence for the effectiveness of mCIMT compared to other interventions.

A pre-post study without multiple baselines (Caimmi et al., 2008) tested the suitability of a new method of kinematic analysis for evaluating the effects of mCIMT in patients with chronic stroke. The patients wore a splint on the less affected limb for approximately 80% of waking hours for 14 consecutive days and received 1 hour of physiotherapy and occupational therapy every weekday. Motor function was assessed at baseline and 2 weeks (post-treatment) using the WMFT and the Motricity Index upper extremity subtests. At post treatment the patients demonstrated significantly improved within-subject pre-post scores on the WMFT but not on the Motricity Index.

A pre-post study with multiple baselines (Dettmers et al., 2005) examined the effects of mCIMT in patients with chronic stroke. Patients received intensive motor training of the more-affected arm for 3 hours/day for 20 days. The unaffected arm was restrained for 9.3 hours daily to limit its use. Upper extremity motor function was measured at baseline, 3 weeks (post-treatment) and at 6-month follow-up using the WMFT, Frenchay Arm Test, and grip strength. There were significant improvements on all measures of motor function from pre- to post-treatment, and results were retained at 6-month follow-up.

A quasi-experimental study (Siebers & Skargren, 2010) provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Sollerman hand function test. There was a significant improvement in motor function from baseline to post-treatment and this persisted at 6-month follow-up.

Conclusion: There is strong evidence (level 1a) from 3 high quality RCTs and 4 fair quality RCTs that mCIMT is more effective than control interventions (conventional rehabilitation, bilateral arm training or no treatment) for improving upper extremity motor function in patients with chronic stroke. Further, one poor quality RCTs and 3 non-randomized studies also found significant improvement in upper extremity motor function following mCIMT.

Note: However, 2 high quality RCTs and 1 fair quality RCT reported that mCIMT is not more effective than comparison interventions (conventional rehabilitation, mCIMT with trunk restraint or bilateral arm training) for improving upper extremity motor function among patients with chronic stroke. Further, two poor quality RCTs did not find any significant between group difference when comparing mCIMT to a control intervention.

Note: Interestingly, one high quality RCT found a significant between group difference in favour of bilateral arm training when compared to mCIMT for one subscale of upper extremity motor function.

Range of motion
Insufficient evidence
5

One non-randomized study (Siebers & Skargren, 2010) has investigated the effect of mCIMT on range of motion among patients with chronic stroke. This quasi-experimental study provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Active range of motion on elbow extension and wrist dorsiflexion was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using a goniometer. There was a significant improvement in elbow extension from baseline to post-treatment and this persisted at 6-month follow-up; there was a significant improvement in wrist dorsiflexion from baseline to post-treatment, but this did not remain significant at 6-month follow-up.

Conclusion: There is insufficient evidence (level 5) regarding the effect of mCIMT on upper extremity range of motion when compared with other interventions. However, 1 non-randomized study reported improved active range of motion among patients with chronic stroke following mCIMT.

Spasticity
Insufficient evidence
5

One non-randomized study (Siebers & Skargren, 2010) has investigated the effect of mCIMT on spasticity among patients with chronic stroke. This quasi-experimental study provided patients with chronic stroke with mCIMT that comprised restraint for 90% of waking hours and an individualized training program for 6 hours/weekday. Spasticity at the elbow and wrist was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Modified Ashworth Scale. There was a significant improvement in wrist spasticity from baseline to post-treatment and this persisted at 6-month follow-up; there was a significant improvement in elbow spasticity from baseline to follow-up.

Conclusion: There is insufficient evidence (level 5) regarding the effect of mCIMT on upper extremity spasticity when compared with other interventions. However, 1 non-randomized study reported improved upper extremity spasticity among patients with chronic stroke following mCIMT.

Stroke outcomes
Effective
1B

Two high quality RCTs (Lin et al., 2009b; Barzel et al., 2015), 1 fair quality RCT (Wu et al., 2012b), and 1 pre-post study with multiple baselines (Dettmers et al., 2005) examined the effects of mCIMT on stroke outcomes in patients with chronic stroke.

The first high quality RCT (Lin et al., 2009b) randomized patients with chronic stroke to receive mCIMT, bilateral arm training (BAT), or standard UE therapy (control). The mCIMT group received UE therapy for 2 hours/weekday and wore a restraint on the unaffected UE for 6 hours/day. Stroke outcomes were measured at baseline and 3 weeks (post-treatment) using the Stroke Impact Scale (SIS). There were significant between-group differences in stroke outcomes at post-treatment, in favour of mCIMT compared to standard UE therapy (SIS overall score, ADL/IADL and hand function domains), and in favour of mCIMT compared to BAT (SIS overall score, ADL/IADL and social participation domains).

The second high quality RCT (Barzel et al., 2015) randomized patients with chronic stroke to receive home-based mCIMT or conventional rehabilitation. Stroke outcomes were measured at baseline, 4 weeks (post-treatment) and 6-month follow-up using the SIS. There was no significant between-group difference in hand function (SIS – Hand function) at post-treatment (4 weeks) or follow-up (6 months post-treatment).

The fair quality RCT (Wu et al., 2012b) randomized patients with chronic stroke to receive modified constraint-induced movement therapy (mCIMT), mCIMT with trunk restraint (mCIMT-TR) or conventional rehabilitation based on neurodevelopmental principles. Both mCIMT groups wore a mitt on the non-affected hand and wrist for 5 hours/day and the mCIMT-TR group wore a harness to restrain the trunk during rehabilitation sessions; all groups received their respective intervention for 2 hours/weekday. Stroke outcomes were measured at baseline and 3 weeks (post-treatment) using the SIS. At post-treatment there were significant between-group differences in stroke outcomes in favour of mCIMT compared to conventional rehabilitation (SIS strength and hand function scores); and in favour of mCIMT compared to mCIMT-TR (SIS strength scores).

Note: There were also significant between-group differences in favour of mCIMT-TR compared to conventional rehabilitation (SIS hand function scores only).

The pre-post study with multiple baselines (Dettmers et al., 2005) examined the effects of CIMT on patients with chronic stroke. Patients underwent intensive motor training of the more-affected arm for 3 hours a day for 20 days. The unaffected arm was restrained for 9 hours daily to limit its use. Stroke outcomes were assessed at baseline and 3 weeks (post-treatment) by the SIS. Participants displayed improved stroke outcomes (SIS physical, social participation and communication domains).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT and 1 fair qualityRCT that mCIMT is more effective than control therapies (e.g. bilateral arm training, conventional rehabilitation or mCIMT with trunk restraint) for improving stroke outcomes in patients with chronic stroke. One non-experimental study also found improvements following mCIMT.

Note: One high quality RCT found that home-based mCIMT was not more effective than conventional rehabilitation for improving stroke outcomes, where the only measure used was the SIS hand function domain.

Chronic phase: CIMT vs. mCIMT

Motor activity (Upper extremity)
Not effective
1B

One high quality RCT(Sterr et al., 2002) and 2 non-experimental studies (Barzel et al., 2009; Richards et al., 2008) have compared the effect of CIMT and mCIMT on upper extremity motor activity in patients with chronic stroke.

The high quality RCT (Sterr et al., 2002) randomized patients with chronic stroke to receive CIMT (6 hours of UE therapy) or mCIMT (3 hours of UE therapy). Both groups wore a restraining splint or mitt for 90% of waking hours. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 4-week follow-up using the Motor Activity Log – Amout of Use and – Quality of Movement (MAL-AOU, MAL-QOM). Both groups demonstrated significantly improve MAL-AOU and MAL-QOM scores at post-treatment. Comparison of scores from baseline to 4-week follow-up revealed a greater improvement in motor activity in favour of CIMT compared to mCIMT.

A quasi-experimental study (Barzel et al., 2009) assigned patients with chronic stroke to receive either CIMT (physiotherapy 6 hours/weekday for 2 weeks and splint worn on unaffected hand for a target of 90% of waking hours) or a mCIMT home program (home-based training with a family member for 2 hours/weekday for 4 weeks and splint worn on the unaffected hand for a target of 60% of waking hours). Upper extremity motor activity was measured using the MAL-AOU and MAL-QOM at baseline, post-treatment and 6-month follow-up. There were no significant between-group differences in motor activity at any time point.

A pre-post study without multiple baselines (Richards et al., 2008) examined the effect of CIMT protocols on motor activity in patients with chronic stroke. Subjects wore a mitten restraint during 90% of waking hours. Patients 1 and 2 received therapy 6 hours/day (CIMT) while patient 3 received therapy 3 hours/day (mCIMT). At post-treatment all patients demonstrated improved motor activity (MAL-AOU, MAL-QOM).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that CIMT is not more effective than mCIMT for improving upper extremity motor activity among patients with chronic stroke in the short-term. Further, 2 non-experimental studies found no significant difference on motor activity when comparing CIMT with mCIMT.

Note: However, the high quality RCT found that CIMT was more effective than mCIMT four weeks post-treatment.

Motor function (Upper extremity)
Not effective
1B

One high quality RCT (Sterr et al., 2002) and 2 non-experimental studies (Barzel et al., 2009; Richards et al., 2008) have compared the effects of CIMT and mCIMT on motor function in patients with chronic stroke.

The high quality RCT (Sterr et al., 2002) randomized patients with chronic stroke to receive CIMT (6 hours of UE therapy), or mCIMT (3 hours of UE therapy). Both groups were required to wear a restraining splint or mitt for 90% of waking hours. Upper extremity motor function was measured at baseline and 2 weeks (post-treatment) using the Wolf Motor Function Test (WMFT). There were no significant between-group differences in motor function at post-treatment.

A quasi-experimental study (Barzel et al., 2009) assigned patients with chronic stroke to receive traditional CIMT (restraint for a target of 90% of waking hours and physiotherapy for 6 hours/weekday for 2 weeks) or a mCIMT home program (restraint for a target of 60% of waking hours and home-based training with a family member for 2 hours/weekday for 4 weeks). Upper extremity motor function was measured at baseline, 2 weeks and 6-month follow-up using the WMFT – Performance Time and – Functional Ability scales. There were no significant between-group differences in motor function at post-treatment or follow-up

A pre-post study without multiple baselines (Richards et al., 2008) examined the effect of CIMT protocols on UE function in patients with chronic stroke. Subjects wore a mitten restraint during 90% of waking hours. Patients 1 and 2 received therapy 6 hours/day (CIMT) while patient 3 received therapy 3 hours/day (mCIMT). At post-treatment all patients demonstrated improved motor function (FMA, WMFT).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that CIMT is not more effective than mCIMT for improving upper extremity motor function in patients with chronic stroke. Further, 2 non-experimental studies found no significant difference on motor function when comparing CIMT with mCIMT.

Phase of stroke recovery not specific to one period: CIMT vs. control or alternative interventions

Functional independence
Not effective
1b

One high quality RCT (Dahl et al., 2008) examined the effects of CIMT on functional independence in patients with stroke. This high quality RCT randomized patients between 1 and 92 months post stroke to CIMT plus conventional rehabilitation or conventional rehabilitation alone. Functional independence was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the Functional Independence Measure (FIM). There were no significant between-group differences in functional independence at any time point.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that CIMT is not more effective than conventional rehabilitation in improving functional independence in patients with stroke.

Motor activity (Upper extremity)
Conflicting
4

Two high quality RCTs (Wolf et al., 2006, – Wolf et al., 2008, 2 year follow-up of 2006 study participants; Wolf et al., 2010 , crossover follow-up of 2006 study participants –; Dahl et al., 2008) examined the effects of CIMT on motor activity in patients with stroke.

Motor function (Upper extremity)
Conflicting
4

Three high quality RCTs (Wolf et al., 2006, – Wolf et al., 2008, 2 year follow-up of 2006 study participants; Wolf et al., 2010, crossover follow-up of 2006 study participants –; Dahl et al., 2008; Underwood et al., 2006), 1 fair quality RCT (Alberts et al., 2004) and 1 poor quality RCT (Lang, Thompson & Wolf, 2013) examined the effects of CIMT on upper extremity motor function in patients with stroke.

The first high quality RCT (Wolf et al., 2006) randomized patients between 3 and 9 months post stroke to CIMT with intensive UE therapy or usual care. Upper extremity motor function was measured at baseline, 2 weeks (pst-treatment) and 4-month, 8-month and 12-month follow-up using the Wolf Motor Function Test Performance Time (WMFT-PT), Functional Ability (WMFT-FA), grip strength and weight subtests. The CIMT group had significant improvements in WMFT-PT and WMFT-FA scores at post-treatment compared to the usual care group; differences in WMFT-PT scores remained significant at 4-month, 8-month and 12-month follow-up. There was no significant between-group difference in WMFT grip strength or weight scores at post-treatment, but the CIMT group showed significantly larger improvement in scores on these items than the usual care group at 12-month follow-up.

In the follow-up study of the study group described above (Wolf et al., 2008), differences were found to remain significant at 24 months, with further gains in the WMFT grip strength and weight items.

Further to the 2006 study, a crossover RCT (Wolf et al., 2010) was conducted to compare the effects of early CIMT (CIMT provided 3-9 months after stroke) and delayed CIMT (CIMT provided 15-24 months after stroke) among patients with subacute and chronic stroke. Comparison of scores at 12 months revealed a significant between-group difference in motor function (WMFT-PT, WMFT-FA) in favour of the group who had received CIMT compared to those who had not yet commenced CIMT. These results did not remain significant at 24 months, by which stage both groups had received CIMT.

The second high quality RCT (Dahl et al., 2008) randomized patients between 1 and 92 months post stroke to CIMT plus traditional rehabilitation or traditional rehabilitation alone. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 6-month follow-up using the WMFT-PT and WMFT-FA subtests. There was a significant between-group difference post treatment in WMFT-PT and WMFT-FA scores at post-treatment, in favour of the CIMT group. However, differences were no longer significant at follow-up.

The third high quality RCT (Underwood et al., 2006) randomized participants from the EXCITE trial with subacute or chronic stroke to receive CIMT or no CIMT (CIMT delayed to 1 year after enrollment in the study). Upper extremity motor function was measured at baseline and 2 weeks (post-treatment) using the WMFT. There were no significant between-group differences in upper extremity motor function at post-treatment between the group who had received CIMT and those who had not yet commenced CIMT.

The fair quality RCT (Alberts et al., 2004) randomized patients from the EXCITE trial with subacute or chronic stroke to receive CIMT or no CIMT (CIMT delayed to 1 year after baseline assessment). Upper extremity function was measured at baseline and 2 weeks (post-treatment) using the WMFT, Fugl-Meyer Assessment (FMA) and a key turning activity. There was a significant difference in maximum precision grip force in favour of the group that had received CIMT compared to the group that had not yet commenced CIMT. There were no other significant differences between groups.

The poor quality RCT (Lang, Thompson & Wolf, 2013) randomized participants from the EXCITE Trial with subacute to chronic stroke to receive immediate CIMT or delayed CIMT. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 12-month follow-up using the WMFT. There was a significant between-group difference in only one measure of upper extremity motor function (WMFT lift pencil task) at post-treatment, in favour of immediate compared to delayed CIMT. There were no significant between-group differences at follow-up.

Conclusion: There is conflicting evidence (level 4) regarding the effectiveness of CIMT for improving motor function in stroke. While 2 high quality RCTs found that CIMT was more effective than control therapies (e.g. conventional rehabilitation, no-CIMT*), 1 high quality RCT, 1 fair quality RCT and 1 poor quality RCT found that CIMT was not more effective than no-CIMT*.

* Several studies used ‘delayed CIMT’ control groups, which received CIMT approximately 12 months later than the intervention groups. Given that the ‘delayed CIMT’ groups had not yet received CIMT at the point of comparison, these control groups are referred to as ‘no CIMT’ for the purpose of comparison of effectiveness.

NOTE: Results from 1 high quality RCT show that providing CIMT 12 months post-stroke can still benefit upper extremity function.

Pain
Not effective
1B

One high quality RCT (Underwood et al., 2006) examined the effects of CIMT on pain in patients with stroke. This high quality RCT randomized participants from the EXCITE trial with subacute or chronic stroke to receive immediate CIMT or delayed CIMT (1 year after enrollment in the study). Pain was measured at baseline and 2 weeks (post-treatment) using the Fugl-Meyer Assessment joint pain subtest and a non-standardized scale of pain. There were no significant between-group differences in pain at post-treatment.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that CIMT does not cause more pain than a control therapy (no-CIMT*) in subacute or chronic stroke.

* The study used a ‘delayed CIMT’ control group, which received CIMT approximately 12 months later than the intervention group. Given that the control group had not yet received CIMT at 2 weeks, the control group is considered to have received ‘no CIMT’.

Stroke outcomes
Conflicting
4

Two high quality RCTs (Wolf et al., 2006, – Wolf et al., 2008, follow-up of 2006 study group, Wolf et al., 2010, crossover follow-up of 2006 study group –; Dahl et al., 2008) examined the effects of CIMT on stroke outcomes in patients with stroke.

The first high quality RCT (Wolf et al., 2006) randomized patients between 3 and 9 months post stroke to CIMT plus intensive UE therapy or usual care. Stroke outcomes were measured at baseline and at 4-month and 12-month follow-up using the Stroke Impact Scale (SIS – hand function, physical function subtests). There were no significant between-group differences in SIS physical function scores at either follow-up time point. The CIMT recipients displayed larger gains than the control group on the SIS hand function domain at both follow-up time points.

A follow-up study (Wolf et al., 2008), found that differences remained significant at 24 months.

Further to the 2006 study, a crossover RCT (Wolf et al., 2010) was conducted to compare the effects of early CIMT (CIMT provided 3-9 months after stroke) and delayed CIMT (CIMT provided 15-24 months after stroke) among patients with subacute and chronic stroke. At 12 months there were significant between-group differences in stroke outcomes (SIS hand function, ADL/IADL domains), in favour of the group who received CIMT compared to those who had not yet received CIMT. At 24 months, by which stage both groups had received CIMT, there were significant between-group differences in stroke outcomes (SIS hand function, ADL/IADL and communication domains), in favour of the early CIMT compared to the delayed CIMT group.

The second high quality RCT (Dahl et al., 2008) randomized patients between 1 and 92 months post stroke to CIMT plus traditional rehabilitation or traditional rehabilitation alone. Stroke outcomes were measured at baseline, 2 weeks (post-treatment) and 6-month follow-up. There were no significant between-group differences in SIS scores at any time point.

Conclusion: There is conflicting evidence (level 4) between 1 high quality RCT that found CIMT is not more effective than conventional rehabilitation for improving stroke outcomes, and 1 highquality RCTthat found CIMT is more effective than control therapies (usual care, no-CIMT*) for improving stroke outcomes.

* One study used ‘delayed CIMT’ control groups, which received CIMT approximately 12 months later than the intervention groups. Given that the ‘delayed CIMT’ group had not yet received CIMT at 12 months, at this time point the control group is considered to have received ‘no CIMT’. Comparison at 24 months, by which time both groups had received CIMT, is considered ‘early CIMT’ vs. ‘delayed CIMT’.

NOTE: There is evidence from 1 high quality RCT that providing CIMT in the subacute phase of stroke is more effective than delaying CIMT for 12 months after stroke for improving stroke outcomes.

Phase of stroke recovery not specific to one period: mCIMT vs. control or alternative interventions

Functional independence
Effective
1a

Two high quality RCTs (Wu et al., 2007b; Batool et al., 2015) examined the effects of mCIMT on functional independence in patients with stroke.

The first high quality RCT (Wu et al., 2007b) randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or neurodevelopmental therapy (NDT). Functional independence was measured at baseline and 3 weeks (post-treatment) using the Functional Independence Measure (FIM). There were significant between-group differences in functional independence at post-treatment, in favour of mCIMT compared to NDT.

The second high quality RCT (Batool et al., 2015) randomized patients who were 2 weeks to 3 months post-stroke to receive mCIMT or a motor relearning program. The mCIMT group wore a mitt during 2-hour training sessions, 6 times/week. Functional independence was measured at baseline and 3 weeks (post-treatment) using the Functional Independence Measure (FIM) – eating, grooming, bathing, dressing upper body, dressing lower body and total scores. There were significant between-group differences on all FIM domains except FIM – dressing upper body at post-treatment, in favour of mCIMT compared to the motor relearning program.

Conclusion: There is strong evidence (level 1a) from 2 high quality RCTs that mCIMT is more effective than control therapy (e.g. neurodevelopmental therapy, motor relearning program) for improving functional independence following stroke.

Kinematics (Upper extremity)
Effective
1B

One high quality RCT (Wu et al., 2007a) examined the effects of mCIMT on upper extremity kinematics in patients with stroke. This high quality RCT randomized patients between 3 weeks and 35 months since stroke to either mCIMT or neurodevelopmental therapy. Patients in the mCIMT group received intensive functional training of the affected UE for 2 hours/day and wore a restraining mitt on the less-affected UE for 6 hours /day. Kinematic measures were taken at baseline and 3 weeks (post-treatment). At post-treatment the mCIMT group had significantly better strategies for reaching control than the control group on the kinematic movement analysis, specifically on reaction time, movement time, total upper extremity displacement, and smoothness of movement units. There was no significant between-group difference for the kinematic variable peak velocity at post-treatment.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is more effective than control therapy (e.g. neurodevelopmental therapy) for improving upper extremity kinematics in patients with stroke.

Motor activity (Upper extremity)
Conflicting
4

Five high quality RCTs (Wu et al., 2007a, Wu et al., 2007b; Abu Tariah et al., 2010; Khan et al., 2011; Smania et al., 2012) examined the effect of mCIMT on motor activity in patients with stroke.

The first high quality RCT (Wu et al., 2007a) randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or neurodevelopmental therapy. The mCIMT group received intensive functional training of the affected UE for 2 hours/day and wore a restraining mitt on the less-affected UE 6 hours/day. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the Motor Activity Log – Amount of Use and – Quality of Movement (MAL-AOU, MAL-QOM). There were significant between-group differences in MAL-AOU and MAL-QOM scores at post-treatment, in favour of mCIMT compared to NDT.

The second high quality RCT (Wu et al., 2007b) randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or NDT. The mCIMT group received intensive functional training of the affected UE for 2 hours/day and wore a restraining mitt on the less-affected UE 6 hours/day. Upper extremity motor activity was measured at baseline and 3 weeks (post-treatment) using the MAL-AOU and MAL-QOM. There were significant between-group differences in MAL-AOU and MAL-QOM scores at post-treatment, in favour of mCIMT compared to NDT.

The third high quality RCT (Abu Tariah et al., 2010) randomized patients with subacute or chronic stroke to receive mCIMT or NDT. Upper extremity motor activity was measured at baseline, 2 months (post-treatment) and 6-month follow-up using the MAL-AOU and MAL-QOM. There were no significant differences in motor activity at any time point.

The fourth high quality RCT (Khan et al., 2011) randomized patients with subacute to chronic stroke to receive mCIMT, conventional neurological therapy or therapeutic climbing. The mCIMT group received physiotherapy and occupational therapy for 5 hours/week while wearing a mitt, and an additional 5 hours/week of self-training of repetitive task-oriented activities. Upper extremity motor activity was measured at baseline, 5 weeks (post-treatment) and 6-month follow-up using the MAL-AOU and MAL-QOM. There were no significant between-group differences in upper extremity motor activity at any time point.

The fifth high quality RCT (Smania et al., 2012) randomized patients with subacute to chronic stroke to receive mCIMT or conventional rehabilitation. The mCIMT group wore a splint on the unaffected arm for 12 or more hours/day and received rehabilitation two hours/weekday. Upper extremity motor activity was measured at baseline, 2 weeks (post-treatment) and 3-month follow-up using the MAL-AOU and MAL-QOM. There were significant between-group differences in MAL-AOU and MAL-QOM scores at post-treatment and follow-up, in favour of mCIMT compared to conventional rehabilitation.

Conclusion: There is conflicting evidence (level 4) from 5 high quality RCTs regarding the effectiveness of mCIMT in comparison to other interventions (neurodevelopmental therapy, conventional rehabilitation) for improving upper extremity motor activity following stroke. While 3 high quality RCTs reported significant difference in favour of mCIMT, 2 high quality RCTs found no significant difference in upper extremity motor activity following mCIMT compared to other therapies (neurodevelopmental therapy, conventional neurological therapy, therapeutic climbing). Interestingly, these studies provided mCIMT over a longer time period (5 weeks, 2 months) than the contrasting studies (2-3 weeks).

Motor function (Upper extremity)
Effective
1A

Six high quality RCTs (Wu et al., 2007a, Wu et al., 2007b; Abu Tariah et al., 2010; Khan et al., 2011;Smania et al., 2012; Batool et al., 2015) and 1 fair quality RCT (Wang et al., 2011) examined the effects of mCIMT on motor function in patients with stroke.

The first high quality RCT (Wu et al., 2007a) randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or neurodevelopmental therapy (NDT). Patients in the mCIMT group received intensive functional training of the affected UE for 2 hours/day and wore a restraining mitt on the less-affected UE 6 hours/day. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the Fugl-Meyer Assessment (FMA). There was a significant between-group difference in motor function at post-treatment, in favour of mCIMT compared to NDT.

The second high quality RCT (Wu et al., 2007b) randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or NDT. Patients in the mCIMT group received intensive functional training of the affected UE for 2 hours/day and wore a restraining mitt on the less-affected UE 6 hours/day. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the FMA. There was a significant between-group difference in motor function at post-treatment, in favour of mCIMT compared to NDT.

The third high quality RCT (Abu Tariah et al., 2010) randomized patients with subacute or chronic stroke to receive mCIMT or NDT for 2 hours/day, 7 days/week. Upper extremity motor function was measured at baseline, 2 months (post-treatment) and 6-month follow-up using the Wolf Motor Function Test – Performance Time, Functional Ability (WMFT-PT, WMFT-FA) and the Fugl-Meyer Assessment (FMA). There was a significant between-group difference in WMFT–FA scores at post-treatment in favour of mCIMT compared to NDT. No significant difference in WMFT–PT or FMA was seen between groups at either time point.

The fourth high quality RCT (Khan et al., 2011) randomized patients with subacute to chronic stroke to receive mCIMT, conventional neurological therapy or therapeutic climbing. The mCIMT group received physiotherapy and occupational therapy for 5 hours/week while wearing a mitt, and an additional 5 hours/week of self-training of repetitive task-oriented activities. Upper extremity motor function was measured at baseline, 5 weeks (post-treatment) and 6-month follow-up using the WMFT-PT and WMFT-FA. There was a significant between-group difference in one measure of upper extremity motor function (WMFT – Time) at post-treatment (approximately 32 days) and at 6-month follow-up, in favour of mCIMT compared to therapeutic climbing. There were no significant differences in WMFT–FA scores at either time point.

The fifth high quality RCT (Smania et al., 2012) randomized patients with subacute to chronic stroke to receive modified constraint-induced movement therapy or conventional rehabilitation. The mCIMT group wore a splint on the unaffected arm for 12 or more hours/day and received rehabilitation two hours/weekday. Upper extremity motor function was measured at baseline, 2 weeks (post-treatment) and 3-month follow-up using the WMFT-PT and WMFT-FA. There was a significant between-group difference in WMFT-FA scores at post-treatment and follow-up, in favour of mCIMT compared to conventional rehabilitation. There was no significant between-group difference in WMFT-PT scores at either time point.

The sixth high quality RCT (Batool et al., 2015) randomized patients who were 2 weeks to 3 months post-stroke to receive mCIMT or a motor relearning program. The mCIMT group wore a mitt during 2-hour training sessions, 6 times/week. Upper extremity motor function was measured at baseline and 3 weeks (post-treatment) using the Motor Assessment Scale (MAS) – upper arm function, hand movements, advanced hand activities and total scores. There were significant between-group differences on all MAS domains at post-treatment, in favour of mCIMT compared to the motor relearning program.

The fair quality RCT (Wang et al., 2011) randomized patients with acute or subacute stroke to receive mCIMT, intensive conventional rehabilitation, or conventional rehabilitation. The mCIMT group received occupational therapy 3 hours/weekday and wore a resting hand splint 90% of the time. Upper extremity motor function was measured at baseline and at 2 weeks and 4 weeks (post-treatment) using the WMFT-PT and WMFT-FA. There were significant between-group differences in WMFT-FA scores at 2 weeks, and in WMFT-PT scores at 4 weeks, in favour of mCIMT compared to conventional rehabilitation. There were no significant differences between mCIMT and intensive conventional rehabilitation, or between intensive conventional rehabilitation and conventional rehabilitation.

Conclusion: There is strong evidence (level 1a) from 6 high quality RCTs and 1 fair quality RCT that mCIMT is more effective than control therapies (neurodevelopmental therapy, conventional rehabilitation, therapeutic climbing, motor relearning program) for improving upper extremity motor function in patients with stroke.

Note: One high quality RCT found no significant difference between mCIMT and conventional neurological therapy; one fair quality RCT found no significant difference between mCIMT and intensive conventional rehabilitation.

Range of motion
Not effective
1b

One high quality RCT (Khan et al., 2011) investigated the effect of mCIMT on upper extremity range of motion in patients with stroke. This high quality RCT randomized patients with subacute to chronic stroke to receive mCIMT, conventional neurological therapy, or therapeutic climbing. The mCIMT group received physiotherapy and occupational therapy for 5 hours/week while wearing a mitt, and an additional 5 hours/week of self-training of repetitive task-oriented activities. Upper extremity active range of motion (shoulder flexion) was measured using a goniometer at baseline, 5 weeks (post-treatment) and 6-month follow-up. There were no significant between-group differences in active range of motion on shoulder flexion at any time point.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is not more effective than comparison interventions (conventional neurological therapy, therapeutic climbing) for improving upper extremity range of motion in patients with stroke.

Shoulder pain
Effective
1B

One high quality RCT (Khan et al., 2011) investigated the effect of mCIMT on shoulder pain among patients with stroke. This high quality RCT randomized patients with subacute to chronic stroke to receive conventional neurological therapy, modified CIMT or therapeutic climbing. The mCIMT group received physiotherapy and occupational therapy for 5 hours/week while wearing a mitt, and an additional 5 hours/week of self-training of repetitive task-oriented activities. Pain was measured at baseline, 5 weeks (post-treatment) and 6-month follow-up using the Chedoke McMaster Impairment Inventory. There were significant between-group differences in pain at post-treatment and follow-up, in favour of mCIMT compared to therapeutic climbing. There were significant between-group differences in pain at follow-up only in favour of mCIMT compared to conventional neurological therapy.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is more effective than comparison intervention (therapeutic climbing) for reducing shoulder pain in patients with stroke.

Note: mCIMT was also found to be more effective than conventional neurological therapy for minimizing shoulder pain long-term.

Spasticity (Upper extremity)
Not effective
1B

One high quality RCT (Smania et al., 2012) has examined the effect of mCIMT on spasticity following stroke. This high quality RCT randomized patients with subacute to chronic stroke to receive mCIMT or conventional rehabilitation. The mCIMT group received rehabilitation two hours/weekday and wore a splint on the unaffected arm for 12 or more hours/day. Spasticity was measured at baseline, 2 weeks (post-treatment) and 3-month follow-up using the Ashworth Scale. There were no significant between-group differences in upper extremity spasticity at post-treatment or follow-up.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is not more effective than conventional rehabilitation for improving spasticity following stroke.

Strength (Upper extremity)
Not effective
1B

One high quality RCT (Khan et al., 2011) investigated the effect of mCIMT on upper extremity strength in patients with stroke. This high quality RCT randomized patients with subacute to chronic stroke to receive conventional neurological therapy, modified CIMT or therapeutic climbing. Modified CIMT comprised group-based physiotherapy and occupational therapy for 5 hours/week while wearing a mitt, and an additional 5 hours/week of self-training of repetitive task-oriented activities. Upper extremity strength was measured at baseline, 5 weeks (post-treatment) and 6-month follow-up using the WMFT-Strength domain and a hand-held dynamometer. There were no significant between-group differences in isometric strength on shoulder or elbow flexion/extension at either time point.

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is not more effective than comparison interventions (conventional neurological therapy, therapeutic climbing) for improving upper extremity strength in patients with stroke.

Stroke outcomes
Effective
1B

One high quality RCT (Wu et al., 2007b) has examined the effect of mCIMT on stroke outcomes. This high quality RCT randomized patients between 3 weeks and 35 months since stroke to receive mCIMT or neurodevelopmental therapy (NDT). Stroke outcomes were measured at baseline and 3 weeks (post-treatment) using the Stroke Impact Scale (SIS). There were significant between-group differences in stroke outcomes (SIS strength, ADL/IADL and stroke recovery domains) at post-treatment, in favour of mCIMT compared to NDT. There were no significant between-group differences in other SIS domains (hand function, memory and thinking, emotion, communication, participation, mobility).

Conclusion: There is moderate evidence (level 1b) from 1 high quality RCT that mCIMT is more effective than control therapy (e.g. neurodevelopmental therapy) for improving some stroke outcomes.

References

Abo, M., Kakuda, W., Momosaki, R., Harashima, H., Kojima, M., Watanabe, S., Sato, T., Yokoi, A., Umemori, T., & Sasanuma, J. (2014). Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study. International Journal of Stroke, 9(5), 607-12. http://www.ncbi.nlm.nih.gov/pubmed/24015934

Abu Tariah, H., Almalty, A-M., Sbeih, Z., & Al-Oraibi, S. (2010). Constraint induced movement therapy for stroke Abu Tariah, H., Almalty, A-M., Sbeih, Z., & Al-Oraibi, S. (2010). Constraint induced movement therapy for stroke survivors in Jordan: a home-based model. International Journal of Therapy and Rehabilitation, 17(12), 638-46.

Alberts, J.L., Butler, A.J., & Wolf, S.L. (2004). The effects of constraint-induced therapy on precision grip: A preliminary study. Neurorehabilitation and Neural Repair, 18(4), 250-8. http://www.ncbi.nlm.nih.gov/pubmed/15537995

Atteya, A-A.A. (2004). Effects of modified constraint induced therapy on upper limb function in sub-acute stroke patients. Neurosciences, 9(1), 24-9. http://www.ncbi.nlm.nih.gov/pubmed/23377299

Azab M, Al-Jarrah M, Nazzal M, Maayah M, Sammour MA, Jamous M. (2009). Effectiveness of constraint-induced movement therapy (CIMT) as home-based therapy on Barthel Index in patients with chronic stroke. Top Stroke Rehabil, 16(3), 207-211. http://www.ncbi.nlm.nih.gov/pubmed/19632965

Bang, D.H., Shin, W.S., & Choi, H.S. (2015). Effects of modified constraint-induced movement therapy combined with trunk restraint in chronic stroke: A double-blinded randomized controlled pilot trial. NeuroRehabilitation, 37(1), 131-7. http://www.ncbi.nlm.nih.gov/pubmed/26409698

Barzel A, Liepert J, Haevernick K, Eisele M, Ketels G, Rijntjes M, van den Bussche H. Comparison of two types of Constraint-Induced Movement Therapy in chronic stroke patients: A pilot study. Restor Neurol Neurosci. 2009;27(6):673-80. https://www.ncbi.nlm.nih.gov/pubmed/20042791

Barzel, A., Ketels, G., Stark, A., Tetzlaff, B., Daubmann, A., Wegscheider, K., van den Bussche, H., & Scherer, M. (2015). Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurology, 14(9), 893-902. http://www.ncbi.nlm.nih.gov/pubmed/26231624

Batool., S., Soomro, N., Amjad, F., & Fauz, R. (2015). To compare the effectiveness of constraint induced movement therapy versus motor relearning programme to improve motor function of hemiplegic upper extremity after stroke. Pakistan Journal of Medical Sciences, 31(5), 1167-71. http://www.ncbi.nlm.nih.gov/pubmed/26649007

Boake C., Noser E., Ro,T., Barabiuk S., Gaber M., Johnson R., Salmeron E.T., Tran T.M., Lai J.M., Taub E., Moye L.A., Grotta J.C. & Levin, H.S. (2007). Constraint-induced movement therapy during early stroke rehabilitation. Neurological Neural Repair, 21, 14-24. http://www.ncbi.nlm.nih.gov/pubmed/17172550

Brogårdh, C. & Lexell, J. (2010). A 1-year follow-up after shortened constraint-induced movement therapy with and without mitt poststroke. Archives of Physical Medicine and Rehabilitation, 91, 460-4. http://www.ncbi.nlm.nih.gov/pubmed/20298840

Brogårdh, C., & Sjülund, B.H. (2006). Constraint-induced movement therapy in patients with stroke: a pilot study on effects of small group training and of extended mitt use. Clinical Rehabilitation, 20, 218-27. http://www.ncbi.nlm.nih.gov/pubmed/16634340

Brogårdh, C., Sjülund, B.H., & Lexell, J. (2009a). What is the long-term benefit of constraint-induced movement therapy? A four-year follow-up. Clinical Rehabilitation, 23, 418-23. http://www.ncbi.nlm.nih.gov/pubmed/19349341

Brogårdh, C., Vestling M., & B.H.Sjölund. (2009b). Shortened constraint-induced movement therapy in subacute stroke – No effect of using a restraint: a randomized controlled study with independent observers. J Rehabil Med, 41, 231-236. http://www.ncbi.nlm.nih.gov/pubmed/19247541

Brunner IC, Skouen JS, Strand LI. Is modified constraint-induced movement therapy more effective than bimanual training in improving arm motor function in the subacute phase post stroke? A randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1078-86. https://www.ncbi.nlm.nih.gov/pubmed/22561098

Brunner, I.C., Skouen, J.S., & Strand, L.I. (2012). Is modified constraint-induced movement therapy more effective than bimanual training in improving upper arm motor function in the subacute phase post stroke? A randomized controlled trial. Clinical Rehabilitation, 26(12), 1078-86. http://www.ncbi.nlm.nih.gov/pubmed/22561098

Caimmi M., Carda S., Giovanzana C., Maini E.S., Sabatini A.M., Smania N. & Molteni F. (2008).Using kinematic analysis to evaluate constraint-induced movement therapy in chronic stroke patients. Neurorehabil Neural Repair, 22, 31-39. http://www.ncbi.nlm.nih.gov/pubmed/17595381

Corbetta, D., Sirtori, V., Moja, L., & Gatti, R. (2010). Constraint-induced movement therapy in stroke patients: systematic review and meta-analysis. European Journal of Physical Rehabilitation and Medicine, 46, 537-44. http://www.ncbi.nlm.nih.gov/pubmed/21224785

Dahl A.E., Askim T., Stock R., Langørgen E., Lydersen S. & Indredavik B., (2008). Short- and long-term outcome of constraint-induced movement therapy after stroke: A randomized controlled feasibility trial. Clinical Rehabilitation, 22, 436-447. http://www.ncbi.nlm.nih.gov/pubmed/18441040

Dettmers C., Teske U., Hamzei F., Uswatte G., Taub E., & Weiller, C. (2005). Distributed form of constraint-induced movement therapy improves functional outcome and quality of life after stroke. Arch Phys Med Rehabil, 86(2), 204-209. http://www.ncbi.nlm.nih.gov/pubmed/15706544

Dromerick A. W., Edwards D. F., & Hahn, M. (2000). Does the application of constraint-induced movement therapy during acute rehabilitation reduce arm impairment after ischemic stroke? Stroke, 31(12), 2984-2988. http://www.ncbi.nlm.nih.gov/pubmed/11108760

Dromerick A.W, Lang C.E, Birkenmeier, R.L., Wagner J.M., Miller J.P., Videen T.O., Powers W.J., Wolf S.L., Edwards D.F. (2009) Very Early Constraint-Induced Movement during troke Rehabilitation (VECTORS): a single-center RCT. Neurology, 73(3), 195. http://www.ncbi.nlm.nih.gov/pubmed/19458319

El-Helow, M.R., Zamzam, M.L., Fathalla, M.M., El-Badawy, M.A., El Nahhas, N., El-Nabil, L.M., Awad, M.R., & Von Wild, K. (2015). Efficacy of modified constraint-induced movement therapy in acute stroke. European Journal of Physical and Rehabilitation Medicine, 51(4), 371-9. http://www.ncbi.nlm.nih.gov/pubmed/25030204

Hammer, A. & Lindmark, B. (2009a). Is forced use of the paretic upper limb beneficial? A randomized pilot study during sub-acute post-stroke recovery. Clinical Rehabilitation, 23, 424-33. http://www.ncbi.nlm.nih.gov/pubmed/19321522

Hammer, A. M. & Lindmark, B. (2009b). Effects of forced use on arm function in the sub-acute phase after stroke: A randomized, clinical pilot study. Physical Therapy, 89(6), 526-39. http://www.ncbi.nlm.nih.gov/pubmed/19372172

Hayner K, Gibson G, Giles GM. Comparison of constraint-induced movement therapy and bilateral treatment of equal intensity in people with chronic upper-extremity dysfunction after cerebrovascular accident. Am J Occup Ther. 2010 Jul-Aug;64(4):528-39. https://www.ncbi.nlm.nih.gov/pubmed/20825123

http://www.ncbi.nlm.nih.gov/pubmed/25229024

Huseyinsinoglu, B.E., Ozdincler, A.R., & Krespi, Y. (2012). Bobath Concept versus constraint-induced movement therapy to improve arm functional recovery in stroke patients: A randomized controlled trial. Clinical Rehabilitation, 26(8), 705-15. http://www.ncbi.nlm.nih.gov/pubmed/22257503

Khan, C.M., Oesch, P.R., Gamper, U.N., Kool, J.P., & Beer, S. (2011). Potential effectiveness of three different treatment approaches to improve minimal to moderate arm and hand function after stroke – a pilot randomized clinical trial. Clinical Rehabilitation, 25(11), 1032-41. http://www.ncbi.nlm.nih.gov/pubmed/21788267

Kim D.G., Cho Y.W., Hong J.H., Song J.C., Chung H.-A., Bai D.-S., Lee C.-H. & Jang S.H. (2008). Effect of constraint-induced movement therapy with modified opposition restriction orthosis in chronic hemiparetic patients with stroke. NeuroRehabilitation, 23(3), 239-244. http://www.ncbi.nlm.nih.gov/pubmed/18560140

Kunkel A, Kopp B, Müller G, Villringer K, Villringer A, Taub E, Flor H. Constraint-induced movement therapy for motor recovery in chronic stroke patients. Arch Phys Med Rehabil. 1999 Jun;80(6):624-8. https://www.ncbi.nlm.nih.gov/pubmed/10378486

Lang, K.C., Thompson, P.A., & Wolf, S.L. (2013). The EXCITE Trial: Reacquiring upper-extremity task performance with early versus late delivery of constraint therapy. Neurorehabilitation and Neural Repair, 27(7), 654-63. http://www.ncbi.nlm.nih.gov/pubmed/23542218

Lin K., Chang Y., Wu C., Chen Y. (2009b). Effects of constraint-induced therapy versus bilateral arm training on motor performance, daily functions, and quality of life in stroke survivors. Neurorehabilitation and Neural Repair, 23(5), 441-448. http://www.ncbi.nlm.nih.gov/pubmed/19118130

Lin K., Wu C., Liu J.S. (2008). A randomized controlled trial of constraint-induced movement therapy after stroke. Acta Neurochir Suppl, 101, 61-64. http://www.ncbi.nlm.nih.gov/pubmed/18642635

Lin K.C., Wu C.Y., Liu J.S., Chen Y.T., Hsu C.J. (2009a). Constraint-Induced Therapy Versus Dose-Matched Control Intervention to Improve Motor Ability, Basic/Extended Daily Functions, and Quality of Life in Stroke. Neurorehabilitation and Neural Repair, 23(2), 160-165. http://www.ncbi.nlm.nih.gov/pubmed/18981188

Lin K.C., Wu C.Y., Wei T.H., Lee C.Y., & Liu J.S. (2007). Effects of modified constraint – induced movement therapy on reach to grasp movements and functional performance after chronic stroke: A randomized controlled study. Clinincal Rehabilitation, 21(12), 1075-1086. http://www.ncbi.nlm.nih.gov/pubmed/18042603

Lin, K-C., Chung, H-Y., Wu, C-Y., Liu, H-L., Hsieh, Y-W., Chen, I-H., Chen, C-L., Chuang, L-L., Liu, J-S. & Wai, Y-Y. (2010). Constraint-induced therapy versus control intervention in patients with stroke. A functional magnetic resonance imaging study. American Journal of Physical Medicine and Rehabilitation, 89, 177-85. http://www.ncbi.nlm.nih.gov/pubmed/20173425

Liu KP, Balderi K, Leung TL, Yue AS, Lam NC, Cheung JT, Fong SS, Sum CM, Bissett M, Rye R, Mok VC. A randomized controlled trial of self-regulated modified constraint-induced movement therapy in sub-acute stroke patients. Eur J Neurol. 2016 Aug;23(8):1351-60. doi: 10.1111/ene.13037. Epub 2016 May 19. https://www.ncbi.nlm.nih.gov/pubmed/27194393

Myint J., Yuen G., Kng C., Wong A., Chow K., & Li H. (2008). A study of constraint-induced movement therapy in subacute stroke patients in Hong Kong. Clinical Rehabilitation, 22, 112-124. http://www.ncbi.nlm.nih.gov/pubmed/18212033

Page S. J., Levine P., & Leonard, A. C. (2005). Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair, 19(1), 27-32. http://www.ncbi.nlm.nih.gov/pubmed/15673841

Page S. J., Sisto S., Johnston M. V., & Levine, P. (2002). Modified constraint-induced therapy after subacute stroke: A preliminary study. Neurorehabil Neural Repair, 16(3), 290-295. http://www.ncbi.nlm.nih.gov/pubmed/12234091

Page S. J., Sisto S., Levine P., & McGrath, R. E. (2004). Efficacy of modified constraint-induced movement therapy in chronic stroke: A single-blinded randomized controlled trial. Arch Phys Med Rehabil, 85(1), 14-18. http://www.ncbi.nlm.nih.gov/pubmed/14970962

Page S.J., Levine P., Leonard A., Szaflarski J.P., & Kissela, B.M. (2008). Modified constraint-induced therapy in chronic stroke: Results of a single-blinded randomized controlled trial. Physical Therapy, 88(3), 333-340. http://www.ncbi.nlm.nih.gov/pubmed/18174447

Page, S.J., Sisto, SA., Levine, P., Johnston, M.V., & Hughes, M. (2001). Modified constraint induced therapy: a randomized feasibility and efficacy study. Journal of Rehabilitation Research and Development, 38(5), 583-90. http://www.ncbi.nlm.nih.gov/pubmed/11732835

Ploughman M., & Corbett, D. (2004). Can forced-use therapy be clinically applied after stroke? An exploratory randomized controlled trial. Arch Phys Med Rehabil, 85(9), 1417-1423. http://www.ncbi.nlm.nih.gov/pubmed/15375810

Richards L, Senesac C, McGuirk T, Woodbury M, Howland D, Davis S, Patterson T. Response to intensive upper extremity therapy by individuals with ataxia from stroke. Top Stroke Rehabil. 2008 May-Jun;15(3):262-71. https://www.ncbi.nlm.nih.gov/pubmed/18647730

Sawaki L., Butler A.J., Leng X., Wassenaar P.A., Mohammad Y.M., Blanton S., Sathian K., Nichols-Larsen D.S., Wolf S.L., Good D.C. & Wittenberg G.F. (2008). Constraint-induced movement therapy results in increased motor map area in subjects 3 to 9 months after stroke. Neurorehabilitation and Neural Repair. 22(5), 505-513. http://www.ncbi.nlm.nih.gov/pubmed/18780885

Shi, Y. X., Tian, J. H., Yang, K. H., & Zhao, Y. (2011). Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: A systematic review and meta-analysis. Archives of Physical Medicine and Rehabilitation, 92, 972-982. http://www.ncbi.nlm.nih.gov/pubmed/21621674

Siebers, A. & Skargren, O.E. (2010). The effect of modified constraint-induced movement therapy on spasticity and motor function of the affected arm in patients with chronic stroke. Physiotherapy Canada, 62(4), 388-96. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958081/

Sirtori, V., Corbetta, D., Moja, L., & Gatti, R. (2009). Constraint-induced movement therapy for upper extremities in stroke patients. Cochrane Database of Systematic Reviews, 4. Art. No.: DC004433. DOI: 10.1002/14651858.CD004433.pub2. http://www.ncbi.nlm.nih.gov/pubmed/19821326

Smania, N., Gandolfi, M., Paolucci, S., Iosa, M., Ianes, P., Recchia, S., Giovanzana, C., Molteni, F., Avesani, R., di Paolo, P., Zaccala, M., Agostini, M., Tassorelli, C., Fiaschi, A., Primon, D., Ceravolo, M.G., & Farina, S. (2012). Reduced-intensity modified constraint-induced movement therapy versis conventional therapy for upper extremity rehabilitation after stroke: A multicenter trial. Neurorehabilitation and Neural Repair, 26(9), 1035-45. http://www.ncbi.nlm.nih.gov/pubmed/22661278

Sterr A., Elbert T., Berthold I., Kolbel S., Rockstroh B., & Taub, E. (2002). Longer versus shorter daily constraint-induced movement therapy of chronic hemiparesis: An exploratory study. Arch Phys Med Rehabil, 83(10), 1374-1377. http://www.ncbi.nlm.nih.gov/pubmed/12370871

Suputtitada A., Suwanwela N.C. & Tumvitee S. (2004). Effectiveness of constraint-induced movement therapy in chronic stroke patients. J Med Assoc Thai, 87(12), 1482-90. http://www.ncbi.nlm.nih.gov/pubmed/15822545

Taub E., Miller N. E., Novack T. A., Cook E. W., 3rd, Fleming W. C., Nepomuceno C. S., et al. (1993). Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil, 74(4), 347-354. http://www.ncbi.nlm.nih.gov/pubmed/8466415

Taub, E., Uswatte, G., King, D.K., Morris, D., Crago, J.E., & Chatterjee, A. (2006). A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke, 37, 1045-9. http://www.ncbi.nlm.nih.gov/pubmed/16514097

Thrane, G., Askim, T., Stock, R., Indredavik, B., Gjone, R., Erichsen, A., & Anke, A. (2015). Efficacy of constraint-induced movement therapy in early stroke rehabilitation: A randomized controlled multisite trial. Neurorehabilitation and Neural Repair, 29(6), 517-25. http://www.ncbi.nlm.nih.gov/pubmed/25398726

Treger, I., Aidinof, L., Lehrer, H., & Kalichman, L. (2012). Modified constraint-induced movement therapy improved upper limb function in subacute poststroke patients: A small-scale clinical trial. Topics in Stroke Rehabilitation, 19(4), 287-93. http://www.ncbi.nlm.nih.gov/pubmed/22750958

Underwood, J., Clark, P.C., Blanton, S., Aycock, D.M., & Wolf, S.L. (2006). Pain, fatigue and intensity of practice in people with stroke who are receiving constraint-induced movement therapy. Physical Therapy, 86(9), 1241-50. http://www.ncbi.nlm.nih.gov/pubmed/16959672

van der Lee J. H., Wagenaar R. C., Lankhorst G. J., Vogelaar T. W., Deville W. L., & Bouter, L. M. (1999). Forced use of the upper extremity in chronic stroke patients: results from a single-blind randomized clinical trial. Stroke, 30(11), 2369-2375. http://www.ncbi.nlm.nih.gov/pubmed/10548673

Wang, Q., Zhao, J-l., Zhu, Q-x., Li, J., & Meng, P-p. (2011). Comparison of conventional therapy, intensive therapy and modified constraint-induced movement therapy to improve upper extremity function after stroke. Journal of Rehabilitation Medicine, 43, 619-25. http://www.ncbi.nlm.nih.gov/pubmed/21603848

Wittenberg G. F., Chen R., Ishii K., Bushara K. O., Taub E., Gerber L.H., Hallett M., Cohen L.G. (2003). Constraint-induced therapy in stroke: magnetic-stimulation motor maps and cerebral activation. Neurorehabil Neural Repair, 17(1), 48-57. http://www.ncbi.nlm.nih.gov/pubmed/12645445

Wolf S.L., Winstein C.J., Miller J.P., Thompson P.A., Taub E., Uswatte G., Morris D., Blanton S., Nichols-Larsen D., Clark P.C. (2008). Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. The Lancet Neurology, 7(1), 33-40. http://www.ncbi.nlm.nih.gov/pubmed/18077218

Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D (2006). Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: The EXCITE randomized clinical trial. JAMA; 296 (17): 2095-2104. http://www.ncbi.nlm.nih.gov/pubmed/17077374

Wolf, S.L., Thompson, P.A., Winstein, C.J., Miller, J.P., Blanton, S.R., Nichols-Larsen, D.S., Morris, D.M., Uswatte, G., Taub, E., Light, K.E., Sawaki, L. (2010). The EXCITE stroke trial: Comparing early and delayed constraint-induced movement therapy. Stroke, 41, 2309-15. http://www.ncbi.nlm.nih.gov/pubmed/20814005

Wu C.Y, Chen C.L., Tang S.F., Lin K.C., & Huang Y.Y. (2007a). Kinematic and clinical analysis of upper-extremity movement after constraint-induced movement therapy in patients with stroke: A randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 88, 964-970. http://www.ncbi.nlm.nih.gov/pubmed/17678656

Wu C.Y., Chen C.L., Tsai W.C., Lin K.C., Chou, S.H. (2007b). A randomized controlled trial of modified constraint-induced movement therapy for elderly stroke survivors: Changes in motor impairment, daily functioning, and quality of life. Arch Phys Med Rehabil, 88, 273-278. http://www.ncbi.nlm.nih.gov/pubmed/17321816

Wu C.Y., Lin K.C., Chen H.C., Chen I.H., Hong W.H. (2007c). Effects of modified constraint-induced movement therapy on movement kinematics and daily function in patients with stroke: A kinematic study of motor control mechanisms. Neurorehabil Neural Repair, 21, 460. http://www.ncbi.nlm.nih.gov/pubmed/17601803

Wu, C., Chen, Y., Chen, H., Lin, K., & Yeh, I. (2012a). Pilot trial of distributed constraint-induced therapy with trunk restraint to improve poststroke reach to grasp and trunk kinematics. Neurorehabilitation and Neural Repair, 26(3), 247-55. http://www.ncbi.nlm.nih.gov/pubmed/21903975

Wu, C., Chen, Y., Lin, K., Chao, C., & Chen, Y. (2012b). Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Physical Therapy, 92(4), 483-92. http://www.ncbi.nlm.nih.gov/pubmed/22228607

Wu, C-y., Chuang, L-l., Lin, K-c., Chen, H-c., & Tsay, P-k. (2011). Randomized trial of distributed constraint-induced therapy versus bilateral arm training for the rehabilitation of upper-limb motor control and function after stroke. Neurorehabilitation and Neural Repair, 25, 130-9. http://www.ncbi.nlm.nih.gov/pubmed/20947493

Wu, C-Y., Hsieh, Y-W., Lin, K-C., Chuang, L-L., Chang, Y-F., Liu, H-L., Chen, C-L., Lin, K-W., & Wai, Y-Y. (2010). Brain reorganization after bilateral arm training and distributed constraint-induced therapy in stroke patients: A preliminary functional magnetic resonance imaging study. Chang Gung Medical Journal, 33, 628-38. http://www.ncbi.nlm.nih.gov/pubmed/21199608

Yoon, J.A., Koo, B.I., Shin, M.J., Shin, Y.B., Ko, H.Y., & Shin, Y.I. (2014). Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Annals of Rehabilitation Medicine, 38(4), 458-66

Excluded Studies

Bang, D.H., Shin, W.S., & Choi, H.S. (2015) Effects of modified constraint-induced movement therapy combined with trunk restraint in chronic stroke: A double-blinded randomized controlled pilot trial. NeuroRehabilitation, 37(1), 131-7.
Reason for exclusion: Both groups received mCIMT.

Fuzaro, A.C., Guerreiro, C.T., Galetti, F.C., Juca, R.B.V.M., & de Araujo, J.E. (2012). Modified constraint-induced movement therapy and modified forced-use therapy for stroke patients are both effective to promote balance and gait improvements. Revista Brasileira de Fisioterapia [Brazilian Journal of Physical Therapy], 16(2), 157-65.
Reason for exclusion: Outcomes pertained to balance, gait and lower extremity function.

Gauthier, L.V., Taub, E., Perkins, C., Ortmann, M., Mark, V.W., & Uswatte, G. (2008). Remodeling the brain: Plastic structural brain changes produced by different motor therapies after strokeStroke, 39, 1520-5.
Reason for exclusion: Both groups received some form of mCIMT.

Krawczyk, M., Sidaway, M., Radwariska, A., Zaborska, J., Ujma, R., & Czlonkowska, A. (2012). Effects of sling and voluntary constraint during constraint-induced movement therapy for the arm after stroke: a randomized, prospective, single-centre, blinded observer rated study. Clinical Rehabilitation, 26(11), 990-8.
Reason for exclusion: Both groups received some form of constraint therapy.

Lima, R.C.M., Michaelsen, S.M., Nascimento, L.R., Polese, J.C., Pereira, N.D., & Teixeira-Salmela, L.F. (2014). Addition of trunk restraint to home-based modified constraint-induced movement therapy does not bring additional benefits in chronic stroke individuals with mild and moderate upper limb impairments: a pilot randomized controlled trial. NeuroRehabilitation, 35, 391-404.
Reason for exclusion: Both groups received mCIMT.

Functional Electrical Stimulation – Hemiplegic Shoulder

Evidence Reviewed as of before: 29-10-2010
Author(s)*: Marc-André Roy, MSc; Nicol Korner-Bitensky, PhD; Robert Teasell, MD; Norine Foley, BASc; Sanjit Bhogal, MSc; Jamie Bitensky, MScOT; Mark Speechley, MD
Patient/Family Information Table of contents

Introduction

Functional electrical stimulation (FES), also called functional neuromuscular stimulation (FNS), is a technique used to replace or assist a voluntary muscle contraction during a functional task by applying low-level electrical current to the nerves that control muscles or directly over the motor end-plate of the muscle (just like a pacemaker makes a heart beat).

The term “FES” is commonly used to describe electrical stimulation used as a treatment modality for loss of shoulder function, pain, spasticity and subluxation following stroke. The U.S. AHCPR Post Stroke Rehabilitation Guidelines defines FES as “bursts of electrical stimulation applied to the nerves or muscles affected by the stroke, with the goal of strengthening muscle contraction and improving motor control.”

Neuromuscular electrical stimulation, or simply “electrical stimulation” (ES), is a modality used for strengthening muscles. ES may be considered a FES when a muscle contraction is facilitated during a functional task. Despite the use of all three terms in the literature (FES, FNS and ES) the applications to the hemiplegic shoulder all focus on the stimulation of the supraspinatus and deltoid muscles. Therefore, this module includes the modalities that elicit muscular contraction of the rotator cuff muscles. TENS and other therapeutic electrical stimulation that do not elicit muscular contraction are reviewed in other modules.

Theoretically, FES should help to compensate or facilitate flaccid shoulder muscles, which in turn should reduce the risk of shoulder subluxation, by involuntary muscle contractions. The effectiveness of FES in improving function, tone, EMG activity and in reducing pain and subluxation has been reported.

Patient/Family Information

Author: Marc-André Roy, MSc.

What is functional electrical stimulation (FES)?

The term FES is used to describe a technique used to make a muscle move using electrical current. While this may seem bizarre or unnatural to some, we should point out that the body naturally uses electrical current to make muscles move! To do this, the brain sends these currents through our nerves. The nerves relay the message to the muscle and then the muscle shortens.

FES works in a very similar way. Current is applied to either the skin over the nerve or over the muscle belly to cause a muscle contraction (muscle shortening). So people paralyzed by injuries to their necks or backs may be able to move their muscles and maybe even do things such as walking thanks to FES.

However, this module will look at FES used for a different purpose. Strokes often result in loss of function, pain, spasticity (stiffness) and subluxation (joint out of socket) in the shoulder. This module of StrokEngine reviews the use of FES for reducing or reversing these effects of the stroke in the shoulder.

There are also types of electrical stimulation that do not cause muscle contraction. These are described elsewhere (see TENS).

Are there different kinds?

Despite the use of different terms (functional electrical stimulation, functional neuromuscular stimulation and electrical stimulation), these all have the same goal: to make the shoulder muscles contract in order to increase function and decrease pain, spasticity (stiffness) and subluxation (joint out of socket). Different terms are often used to describe the same technique.

Why use FES applied to the shoulder after stroke?

Loss of shoulder function, pain, spasticity, subluxation and shoulder pain after stroke are common and can profoundly affect quality of life. FES is used for increasing shoulder function and for preventing pain and dysfunction in hemiplegic stroke patients.

Does it work for stroke?

Research has studied how FES can help stroke patients with a hemiplegic shoulder:

  • Muscle function: There is limited evidence that FES in combination with regular physical therapy can improve muscle function. There is moderate evidence that FES treatment does not prevent the loss of shoulder function after a stroke.
  • Shoulder Subluxation: There is limited evidence that FES improves and prevents shoulder subluxation after stroke. There is conflicting evidence as to whether there is a lasting effect after the treatment is stopped.
  • Shoulder Pain: There is moderate evidence that FES does reduce shoulder pain post-stroke when there is shoulder subluxation.
  • Shoulder Muscle Tone: There is limited evidence that FES treatment, in combination with conventional physical therapy, can improve tone in the shoulder of post-stroke patients.
  • Shoulder EMG Activity: There is limited evidence that FES treatment, in combination with conventional physical therapy, can improve EMG activity in the shoulder of post-stroke patients.

What can I expect?

Small square stickers (electrodes) are placed over the centre of the muscle belly. Wires connect the electrodes to a stimulator, a small machine that produces the current. The stimulation is usually started at a very low level causing a tingling “pins & needles” feeling on the skin. The current will then slowly be increased after each stimulation until it is strong enough to make the muscle contract. This level (the smallest current necessary to make the muscle contract) will be used for the treatment. Although some people find it uncomfortable, it is usually well tolerated. Treatment times may vary. However, the time is usually divided into 3 to 5 sessions per day ranging in duration from 45 minutes to 2 hours, 5 to 7 days per week.

Side effects/risks?

The electrodes can irritate the skin, but this is not common. Using hypoallergenic electrodes or changing the type of stimulation used can often solve this problem. After the treatment, there may be pink marks on the skin under the electrodes. Usually the pink marks fade out within an hour. Although very rare, this type of therapy can increase spasticity (muscle tightness).

Some people should not use FES. These include people with: epilepsy, poor skin condition, hypersensitivity to the electrical stimulation, cancer, cardiac pacemakers.

Who provides the treatment?

Physical therapists will usually provide the FES treatment. However, due to the long duration of the stimulation it is possible for the treatment to be done at home after discharge from the hospital. This will require having a stimulator at home.

How many treatments?

Some patients continue to use FES for many years. To maximize the benefits after stroke, it should be used for at least 6 weeks.

How much does it cost? Does Insurance Pay For It?

Although the cost of an FES machine varies, some systems are relatively inexpensive. Rental or lease options bring the cost down to the equivalent of 1 or 2 clinical visits per month.

Is FES for me?

While there haven’t been many high quality studies of FES for treating the hemiplegic shoulder, most of the studies have reported good results from its use. More specifically, FES has been reported to improve function, reduce subluxation, reduce pain, reduce tone and increase EMG activity.

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.

Five studies (two high quality RCTs and three fair quality RCTs) have explored the use of Functional electrical stimulation (FES) applied to the shoulder in patients with stroke. These studies have reported significant improvement in muscle tone, EMG activity and a reduction in shoulder subluxation and pain.

Results Table

View results table

Outcomes

Global health status
Not effective
1b

One high quality RCT (Church et al., 2006) has investigated the use of FES for improving global health status in patients with acute stroke.

The high quality RCT (Church et al., 2006) investigated the use of FES applied to the hemiplegic shoulder to improve global health status (Nottingham E-ADL Index, Nottingham Health Profile) in 176 patients with acute stroke. Those randomized to the FES group received 4 weeks (3 times daily for an hour each) of FES applied to the shoulder, while the control group received sham stimulation. Both groups also received standard stroke unit care. No significant between group difference on global health status was seen at 3 months.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in addition to standard stroke unit care is not more effective than sham stimulation in addition to standard stroke unit care for improving global health status in patients with acute stroke.

Preventative measure for shoulder function
Not effective
1B

One high quality RCTs (Linn et al. 1999) investigated the use of electrical stimulation (FES) as a preventative measure for shoulder function loss in 40 subjects with no preexisting shoulder subluxation. No difference was reported in motor function for those receiving FES and conventional therapy versus conventional therapy alone, as assessed using the upper arm section of the Motor Assessment Scale.

Conclusion: There is moderate evidence (Level 1b) based on one high quality RCT, that FES treatment does not prevent the loss of shoulder function after a stroke.

Preventative measure for shoulder subluxation
Effective
1B

One high quality RCT (Linn et al., 1999) has investigated the use of FES for preventing shoulder subluxation in patients with acute stroke.

The high quality RCT (Linn et al., 1999) investigated the use of FES for preventing shoulder subluxation (measured by X-ray) in 40 patients with acute stroke. Those randomized to the FES group received stimulation 4 times per day for 4 weeks, while the control group received no treatment. Both groups also received conventional occupational therapy and physical therapy. Immediately after treatment, the FES group had significantly less subluxation and pain compared to the control group, however, no significant between group differences in subluxation were reported at follow-up (8 weeks and 3 months).

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in addition to conventional therapy is more effective than conventional therapy alone for preventing shoulder subluxation in patients with acute stroke, however, the gains were not maintained at follow-up.

Shoulder EMG activity
Effective
2A

One fair quality RCT reported in two publications (Faghri et al., 1994, Faghri and Rodgers, 1997) investigated the use of FES for improving electromyographic (EMG) activity of the shoulder in patients with acute stroke.

The fair quality RCT (Faghri et al., 1994, Faghri and Rodgers, 1997), investigated the use of FES for improving EMG activity of the shoulder in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received standard physical therapy. At 5 weeks during treatment and at post- intervention, there was a significant difference in favor of the experimental group in EMG activity of the shoulder. This difference was not maintained at the 6 week follow-up, however, the significant difference in favour of the experimental group re-emerged at the 12 week follow-up (Faghri and Rodgers, 1997).

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that FES in combination with conventional physiotherapy is more effective than sham stimulation in combination with conventional physiotherapy for improving shoulder EMG activity in patients with acute stroke.

Shoulder impairment
Not effective
1b

One high quality RCT (Church et al., 2006) investigated the use of FES for improving shoulder impairment in patients with acute stroke.

The high quality RCT (Church et al., 2006) investigated the use of FES applied to the hemiplegic shoulder to improve shoulder impairment (Frenchay Arm Test, arm section of the Motricity Index) in 176 patients with acute stroke. Those randomized to the FES group received 4 weeks (3 times daily for an hour each) of FES applied to the shoulder, while the control group received sham stimulation. Both groups also received standard stroke unit care. Following the 4-week intervention, there were no significant differences between the groups on shoulder impairment on both measures, however, at 3 months, there was a significant difference in favor of the control group, where they experienced a greater reduction in shoulder impairment than the FES group.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in combination with conventional therapy is not more effective than sham stimulation in combination with conventional therapy for improving shoulder impairment in patients with acute stroke.

Shoulder muscle tone
Effective
2a

One fair quality RCT reported in two publications (Faghri et al., 1994, Faghri and Rodgers, 1997) has investigated the use of FES for improving shoulder muscle tone in patients with acute stroke.

The fair quality RCT (Faghri et al., 1994, Faghri and Rodgers, 1997) investigated the use of FES for improving shoulder muscle tone (Modified Gross Clinical Scales and the Modified Ashworth Clinical Scale) in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received 6 weeks of standard physical therapy. At 2-4 weeks during treatment and at post-treatment there was a significant difference in favour of the experimental group in shoulder muscle tone compared to the control group. This difference was not maintained at 6 week follow-up, however, the significant difference in favor of the experimental group re-emerged at the 12 week follow-up (Faghri and Rodgers, 1997).

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that FES in combination with conventional therapy is more effective than sham stimulation in combination with conventional therapy for improving shoulder muscle tone in patients with acute stroke.

Shoulder pain (with subluxation)
Effective
2A

One fair quality RCT reported in two publications (Faghri et al., 1994, Faghri and Rodgers, 1997) and an additional fair quality RCT (Chantraine et al., 1999) have investigated the use of FES for improving shoulder pain associated with shoulder subluxation in patients with acute stroke.

The first fair quality RCT (Faghri et al., 1994, Faghri and Rodgers, 1997) investigated the use of FES for improving shoulder pain (measured with a goniometer) in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received standard physical therapy. After the 6 week intervention, there was a significant difference in favor of the experimental group in shoulder pain (a reduction) compared to the control group, which was maintained at the 6 and 12 week follow-up (Faghri and Rodgers, 1997).

The second fair quality RCT (Chantraine et al., 1999) investigated the use of FES for improving shoulder pain (measured by a 10-cm visual analog scale) associated with subluxation (measured by X-ray) in 120 patients with acute stroke. Those assigned to the FES group received stimulation applied to the affected limb for 130 minutes per session in the first week, and increased by five minutes each week for 5 weeks, while the control group received no treatment. Both groups also received conventional Bobath therapy. At 3, 6, 12, and 24 months post-intervention, the FES group had significantly less shoulder pain compared to the control group.

Conclusion: There is limited (Level 2a) evidence from two fair quality RCTs that FES in combination with conventional therapy is more effective than conventional therapy (alone or in combination with sham stimulation) for decreasing pain associated with shoulder subluxation in patients with acute stroke.

Shoulder pain (without subluxation)
Not effective
1a

Two high quality RCTs (Linn et al., 1999, Church et al., 2006) have investigated the use of FES for improving shoulder pain in patients without subluxation in acute stroke.

The first high quality RCT (Linn et al., 1999) investigated the use of FES for improving shoulder pain (five-point pain scale) without subluxation in 40 patients with acute stroke. Those randomized to the FES group received stimulation 4 times per day for 4 weeks, while the control group received no treatment. Both groups received conventional occupational and physical therapy. At 4 weeks (immediately post-intervention) 8 weeks, and 3 month follow-up, there were no significant between group differences on the five-point pain scale.

The second high quality RCT (Church et al., 2006) investigated the use of FES applied to the hemiplegic shoulder to improve shoulder pain (upper limb pain assessed by a visual analogue scale – VAS) in 176 patients with acute stroke without subluxation. Those randomized to the FES group received 4 weeks (3 times daily for an hour each) of FES applied to the shoulder, while the control group received sham stimulation. Both groups also received standard stroke unit care. Following the 4-week intervention and at 3 months, there were no significant differences between the groups in upper limb pain.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that FES in combination with conventional therapy is not more effective than conventional therapy (alone or in combination with sham stimulation) for improving shoulder pain in those without subluxation in acute stroke.

Shoulder subluxation in hemiplegic shoulder
Effective
1B

One high quality RCT (Linn et al. 1999) investigated the use of FES for preventing shoulder subluxation in subjects with no preexisting shoulder subluxation. The treatment group received electrical stimulation 4 times per day for 4 weeks in addition to conventional occupational and physical therapy. The control group received conventional occupational and physical therapy only. The treatment group had significantly less subluxation and pain after the treatment period. However, no significant differences between groups were reported at follow-up (8 weeks).

Conclusion: Based on the findings of one high quality RCT, there is moderate evidence (Level 1b) that FES helps prevent shoulder subluxation after stroke. However, there is no evidence of a lasting effect.

Treatment for shoulder subluxation
Effective
2A

Three fair quality RCTs (Faghri et al., 1994, Chantraine et al., 1999, Wang et al., 2000) have investigated the effectiveness of FES for reducing shoulder subluxation in patients with acute or chronic stroke.

The first fair quality RCT (Faghri et al., 1994) investigated the use of FES for reducing shoulder subluxation (measured by X-ray) in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received 6 weeks of standard physical therapy. At post-treatment, there was a significantly different reduction in subluxation in favor of the experimental group compared to the control group. This difference was not maintained at the 6 week follow-up.

The second fair quality RCT (Chantraine et al., 1999) investigated the use of FES for improving shoulder subluxation (measured by X-ray) in 120 patients with acute stroke. Those assigned to the FES group received stimulation applied to the affected limb for 130 minutes per session in the first week, and increased by five minutes each week for 5 weeks, while the control group received no treatment. Both groups also received conventional Bobath therapy. At 6 weeks, and 12 and 24 months post-intervention a significant reduction in shoulder subluxation was found in the experimental group compared to the control group.

The third fair quality RCT (Wang et al., 2000) investigated the use of FES for reducing shoulder subluxation (measured by X-ray) in 32 patients with acute (called short duration) and chronic (called long duration) post-stroke hemiplegia. Participants in the acute and chronic phase were further randomly assigned to either an experimental group that received FES 5 times a week for 6 weeks, followed by 6 weeks of standard rehabilitation, followed by an additional 6 weeks of FES, or to a control group that received no stimulation. After the first 6 weeks, significantly reduced shoulder subluxation was found in the FES group versus the control group but only for those in the acute phase: not for those in the chronic phase. These results were maintained after the second 6 weeks of FES treatment.

Conclusion: There is limited evidence (Level 2a) from three fair quality RCTs that FES in combination with conventional therapy is more effective than conventional therapy (alone or in combination with sham stimulation) for reducing shoulder subluxation in patients with acute stroke.

Treatment of shoulder function
Not effective
1A

Two high quality RCTs (Church et al., 2006, Linn et al., 1999), one fair quality RCT reported in two publications (Faghri et al., 1994, Faghri and Rodgers, 1997) and an additional fair quality RCT (Chantraine et al., 1999) have investigated the use of FES for improving shoulder function in patients with acute stroke.

The first high quality RCT (Church et al., 2006) investigated the use of FES applied to the hemiplegic shoulder to improve shoulder functioning (Action Research Arm Test- ARAT) in 176 patients with acute stroke. Those randomized to the FES group received 4 weeks (3 times daily for an hour each) of FES applied to the shoulder, while the control group received sham stimulation. Both groups also received standard stroke unit care. Following the 4-week intervention, no significant differences were observed between the two groups on the ARAT. However, at 3 months, the control group performed significantly better than the intervention group on the ARAT – grasp and gross movement sections.

The second high quality RCT (Linn et al., 1999) investigated the use of FES for improving shoulder function (Pain-free range of passive lateral rotation assessment and the Motor Assessment Scale- MAS) in 40 patients with acute stroke. Those randomized to the FES group received stimulation 4 times per day for 4 weeks, while the control group received no treatment. Both groups also received conventional occupational and physical therapy. At post-treatment and at 8 week and 3 month follow-up, there were no significant between group differences on the pain-free range of passive lateral rotation assessment, or on the upper arm section of the MAS.

The first fair quality RCT (Faghri et al., 1994, Faghri and Rodgers, 1997) investigated the use of FES for improving shoulder function (Modified Bobath Assessment Chart) in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received standard physical therapy. At weeks 4 and 5 during treatment and at post-treatment (6 weeks) there was a significant difference in favor of the experimental group in shoulder function compared to the control group. This was not maintained at the 6 week follow-up, however, the significant difference re-emerged at the 12 week follow-up (Faghri and Rodgers, 1997).

The second fair quality RCT (Chantraine et al., 1999) investigated the use of FES for improving shoulder function (range of motion) in 120 patients with acute stroke. Those assigned to the FES group received stimulation applied to the affected limb for 130 minutes per session in the first week, and increased by five minutes each week for 5 weeks, while the control group received no treatment. Both groups also received conventional Bobath therapy. At 6 weeks, 12, and 24 months post-intervention, the intervention group showed significantly better range of motion in the shoulder compared to the control group.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that FES in combination with conventional therapy is not more effective than conventional therapy (alone or in combination with sham stimulation) for improving shoulder function in patients with acute stroke.

Note: However, two fair quality RCTs found a significant difference in favor of the experimental group in shoulder function compared to the control group but this was not maintained at the 6 week follow-up in one of the RCT.

Upper arm girth
Not effective
1B

One high quality RCT (Linn et al., 1999) and one fair quality RCT (Faghri et al., 1994) have investigated the use of FES for maintaining upper arm girth in patients with acute stroke.

The high quality RCT (Linn et al., 1999) investigated the use of FES for maintaining upper arm girth in 40 patients with acute stroke. Those randomized to the FES group received stimulation 4 times per day for 4 weeks, while the control group received no treatment. Both groups also received conventional occupational therapy and physical therapy. At post-treatment and at 8 week and 3 month follow-up, there were no significant between group differences on the measurement of upper arm girth.

The fair quality RCT (Faghri et al., 1994) investigated the use of FES for improving upper arm girth in 26 patients with acute stroke. Those randomized to the FES group received 1.5 to 6 hours of stimulation daily for 6 weeks while the control group received sham stimulation. Both groups also received standard physical therapy. After the 6 week intervention and at the 6 week follow-up, there was no significant difference between the groups on upper arm girth.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in combination with conventional therapy is not more effective than conventional therapy (alone or in combination with sham stimulation) for maintaining upper arm girth in patients with acute stroke.

References

Chantraine A., Baribeault A., Uebelhart D., & Gremion, G. (1999). Shoulder pain and dysfunction in hemiplegia: effects of functional electrical stimulation. Arch Phys Med Rehabil, 80(3), 328-331.

Church C., Price C., Pandyan A., Huntley S., Curless R., Rodgers H. (2006). Randomized controlled trial to evaluate the effect of surface neuromuscular electrical stimulation to the shoulder after acute stroke. Stroke, 37(12), 2995-3001.

Faghri P. D., Rodgers M. M., Glaser R. M., Bors J. G., Ho C., & Akuthota, P. (1994). The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil, 75(1), 73-79.

Faghri PD, Rodgers MM. (1997) The effects of functional electrical stimulation – augmented physical therapy program in the functional recovery of hemiplegic arm in stroke patients, J Clin Kinesiol, 51, 9-15.

Linn S. L., Granat M. H., & Lees, K. R. (1999). Prevention of shoulder subluxation after stroke with electrical stimulation. Stroke, 30(5), 963-968.

Wang R. Y., Chan R. C., & Tsai, M. W. (2000). Functional electrical stimulation on chronic and acute hemiplegic shoulder subluxation.Am J Phys Med Rehabil, 79(4), 385-390; quiz 391-384.

Functional Electrical Stimulation – Upper Extremity

Evidence Reviewed as of before: 26-10-2010
Author(s)*: Jamie Bitensky, MSc. OT; Nicol Korner-Bitensky, Ph. D OT
Patient/Family Information Table of contents

Introduction

Functional electrical stimulation (FES), also called functional neuromuscular stimulation (FNS), is a technique used to replace or help a muscle contraction during a functional activity by applying electrical current to the nerves that control muscles. The goal of this treatment modality is to strengthen muscle contraction and improve motor control. The most familiar type of electrical stimulation is probably the use of pacemakers to control heart contractions.

Neuromuscular electrical stimulation, or simply ‘electrical stimulation’ (ES), is a modality used primarily for strengthening muscles, without the purpose of integrating a functional task as done with FES. Despite the use of all three terms in the literature (FES, FNS and ES), these modalities basically focus on eliciting muscular contractions.

This module summarizes the electrical stimulation modalities used to elicit muscular contraction of the upper extremities (FES of the shoulder is reviewed independently). Transcutaneous electrical nerve stimulation (TENS) and other therapeutic electrical stimulation that do not elicit muscular contraction are reviewed in other modules. The effectiveness of FES for improving functional independence/burden of care, strength, spasticity, range of motion, hand function, motor function and reaction time has been reported.

Patient/Family Information

What is functional electrical stimulation (FES)?

Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. While this might sound strange, we should point out that the body naturally uses electrical current to make muscles move! Normally, when a part of the body needs to move, the brain sends electrical signals through the nervous system. The nerves, acting like electrical wires, relay these signals to the muscles, directing them to contract. This contraction causes the body part – for example, the elbow, wrist or finger joints – to move. After a stroke, some of these electrical signals do not function as well as they should.

When using FES as an intervention after a stroke, the therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, to cause a muscle contraction

The idea behind FES is that this intervention allows the muscles that are paralyzed or partially paralyzed to move.

This module will look at the use of FES for loss of function, pain or spasticity (stiffness) of the arm, wrist and hand. Two other modules in StrokEngine focus on FES for the leg and on the shoulder. There is also an intervention using electrical stimulation that does not cause muscle contraction. This is called Transcutanious Electrical Neuromuscular Stimulation (TENS) and it is described in another module of StrokEngine (soon to come).

Are there different kinds of FES?

Yes, and you will see different names including: functional electrical stimulation, functional neuromuscular stimulation and electrical stimulation. But, they all have the same goal: to stimulate muscle contraction which in turn may lead to an increase in function, strength, and movement as well as a decrease in pain and spasticity. Also, FES may provide benefits such as increased reaction time and improved hand function (dexterity).

Why use FES for the arm and hand after stroke?

Loss of arm and hand function, movement, and strength are common after a stroke. Pain and spasticity are also common after a stroke. FES may be useful for increasing arm and hand function and for preventing pain and dysfunction after a stroke.

Does it work for stroke?

Researchers have studied how FES can help patients with stroke who experience a weak or painful hand.

  • Hand function and dexterity: Both in acute and chronic individuals with stroke, researchers have found that FES is helpful in re-training hand function and dexterity.
  • Functional independence: Research studies have shown that FES for the arm and hand were not effective in improving overall functional independence. In other words, patients who were treated with FES did not necessarily improve in their ability to take care of themselves.
  • Strength: The research in this area is still inconclusive meaning we don’t know if FES is better than other treatments for strengthening the hand after a stroke.
  • Spasticity (stiffness): There is limited evidence that FES reduces spasticity for patients in the chronic stroke phase.
  • Range of motion (movement of joints): FES has not been shown to be effective for increasing movements of the hand and arm soon after a stroke (acute patients). But for clients who are in rehabilitation (in the sub-acute or chronic phases), FES applied to specific muscles has been shown to be more effective than regular therapy for increasing movement.
  • Motor function (general functioning of muscles and nerves): There is conflicting evidence as to whether FES treatment, in combination with conventional physical therapy, can improve motor function in patients with acute stroke. However, for patients with sub-acute stroke, FES treatment combined with task specific exercises has been shown to improve motor function. For patients with chronic stroke, it has been shown that FES treatment in combination with conventional therapy does not improve motor function.
  • Reaction time (how fast you move your hand in response to instructions): Researchers found that FES does help to improve reaction time in those with an acute stroke. But, for more chronic stroke patients, FES does not seem to be more beneficial than regular therapy.

What can I expect?

Small square stickers (electrodes) are placed over the centre of the bulk of the muscle. Wires connect the electrodes to a stimulator, a small machine that produces the current. The stimulation is usually started at a very low level causing a tingling “pins and needles” feeling on the skin. The current will then slowly be increased after each stimulation until it is strong enough to make the muscle contract. This level (the smallest current necessary to make the muscle contract) will be used for the treatment.

Although some people find the treatment uncomfortable, it is usually well tolerated because FES may give some discomfort, but it is virtually painless. Treatment times may vary. However, the time is usually divided into a number of daily sessions. FES treatments are usually done for 30 – 45 minutes, but once you are setup, you can typically perform the treatments on your own or with a family member.

Side effects/risks?

The electrodes can irritate the skin, but this is not common. Using non-latex hypoallergenic electrodes can often solve this problem. Some people may find that certain types of electrical stimulations are irritating, but this can be easily fixed by changing the level of the current. After the treatment, there may be pink marks left on the skin where the electrodes were placed, but these usually fade within an hour. Although very rare, this type of therapy can increase spasticity (muscle tightness).

Some people should not use FES.

NOTE: People with epilepsy, poor skin condition, hypersensitivity to the electrical stimulation, cancer, and cardiac pacemakers should not receive FES treatment.

Who provides the treatment?

Physical therapists or occupational therapists will usually provide the FES treatment. However, due to the long duration of the stimulation it is possible for the treatment to be done at home after discharge from the hospital. This will require having a stimulator at home. If it so happens that you are provided with a home stimulator, family members or friends will be given instructions on how to assist with treatments. Usually, once the electrodes are placed, the rest of the procedure is very simple.To operate an FES machine, you simply switching it on and increase (slowly and gradually) the intensity of the current on a knob – just like switching on a radio and increasing the volume.

NOTE: Consult with your therapist or medical professional on the exact use of specific models of FES equipment.

How many treatments?

Some patients continue to use FES for many years. To maximize the benefits after stroke, it should be used for at least 6 weeks.

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

Although the cost of an FES machine varies, some systems are relatively inexpensive. Rental or lease options bring the cost down to the equivalent of 1 or 2 clinical visits per month. Some insurance plans cover the purchase or rental of such equipment. Check with your insurance company.

Is FES for me?

While there have not been many high quality studies on FES for treating the arm and hand, those available generally report good overall results. More specifically, some studies on FES have reported it to be “ineffective” for independence in function, strength, spasticity or range of motion. These studies have compared FES to standard therapy. However, FES, when used on its own, does help recovery after stroke, although the differences between regular therapy and FES therapy might not have been large. There is clear evidence that there are benefits to using FES in comparison to regular therapy, including improved motor hand functioning and dexterity, and increased reaction times.

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.

Fourteen studies (12 RCTs, one non-RCT and one review article) have examined the efficacy of functional electrical stimulation (FES) as a means to improve hemiparetic upper extremity function post-stroke. Specifically, studies have investigated the effect of ES for improving muscle strength, spasticity, range of motion (ROM), motor function, manual dexterity, activities of daily living (ADL), reaction time and hand function post-stroke.

Results Table

View results table

Outcomes

Acute Phase

Functional independence
Not effective
1a

Three high quality RCTs (Mangold et al., 2009; Powell et al., 1999; Chae et al., 1998) have investigated the effectiveness of FES for improving functional independence in patients with acute stroke.

The first high quality RCT (Mangold et al., 2009) investigated the effectiveness of FES for improving functional independence in 23 patients with acute and sub-acute stroke. The participants were assigned to receive FES and conventional occupational therapy or conventional therapy only. Both groups received 45 minutes of occupational therapy, 3 to 5 times per week for 4 weeks, where the intervention group replaced 3 of their sessions with FES. Outcomes were measured at post-treatment and at six months. At post-treatment there was a significant difference between the groups in favour of the stimulation group on the Extended Barthel Index. Scores were not reported at the six month follow-up.

The second high quality RCT (Powell et al., 1999) investigated the use of FES for improving functional independence in 60 patients with acute stroke. The participants were assigned to receive either FES in addition to conventional (Bobath) therapy or conventional (Bobath) therapy only. Sessions were given for 30 mins/day, 3 times a week for 8 weeks. Outcomes were measured at eight weeks and a 32 week follow-up. At eight weeks and at a 32 week follow-up, there were no significant between group differences on the Barthel Index or the Rankin scale.

The third high quality RCT (Chae et al., 1998) investigated the effectiveness of FES for improving functional independence in 46 patients with acute stroke. The participants were randomized to receive either FES to produce wrist and finger extension exercises or sham stimulation (control group). The sessions were 1 hour a day for 15 sessions (3 weeks). Outcomes were measured at post-treatment (four weeks) and at a 12 week follow-up. At both the four and 12 week assessment, there were no significant between group differences on the Functional Independence Measure (FIM).

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that FES in combination with conventional therapy is not more effective than conventional therapy (alone or in combination with sham stimulation) for improving functional independence in patients with acute stroke.

Note: However, one high quality RCT found a significant difference between the groups in favour of the stimulation group on the Extended Barthel Index but scores were not reported at the six month follow-up.

Hand function and dexterity
Effective
1B

One high quality RCT (Powell et al., 1999) and one fair quality RCT (Alon et al., 2008) have investigated the effectiveness of FES for improving hand function and dexterity in patients with acute stroke.

The high quality RCT (Powell et al., 1999) investigated the use of FES for improving hand function and dexterity in 60 patients with acute stroke. The participants were assigned to receive either FES in addition to conventional (Bobath) therapy or conventional (Bobath) therapy only. Sessions were given for 30 mins/day, 3 times a week for 8 weeks. Outcomes were measured at eight weeks and at 32 weeks. At post-treatment (eight weeks) there was a significant difference in favour of the stimulation group on hand function and dexterity measured on the grip and grasp items of the Action Research Arm test. This difference was not maintained at the 32 week follow-up.

The fair quality RCT (Alon et al., 2008) investigated the effectiveness of FES for improving hand function and dexterity in 26 patients with acute stroke. The participants were assigned to receive either FES in combination with task-specific exercise or task-specific exercise only. Sessions were given 2 times/day for 30 minutes, 5 days/week for 12 weeks. The FES group practiced the exercises while receiving FES as well as received additional FES without exercises for up to an additional 90 minutes twice a day. Outcomes were measured at baseline and at 12 weeks. At 12 weeks, there were no significant between group differences on hand function and dexterity, measured by the Box and Blocks test, or the Jebsen-Taylor light object lift test.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in addition to conventional therapy is more effective than conventional therapy only for improving hand function and dexterity in patients with acute stroke. However these improvements were not maintained in the long-term.

Note: However, one fair quality RCT did not find any significant between group differences on hand function and dexterity.

Motor function
Not effective
1A

Three high quality RCTs (Mangold et al., 2009; Powell et al., 1999.; Chae et al., 1998) and one fair quality RCT (Alon et al., 2008) have investigated the effectiveness of FES for improving motor function in patients with acute stroke.

The first high quality RCT (Mangold et al., 2009) investigated the effectiveness of FES for improving motor function in 23 patients with acute and sub-acute stroke. The participants were assigned to receive FES and conventional occupational therapy or conventional therapy only. Both groups received 45 minutes of occupational therapy, 3 to 5 times per week for 4 weeks, where the intervention group replaced 3 of their sessions with FES. Outcomes were measured at post-treatment (four weeks). At post-treatment there was no significant difference between the groups on the Chedoke McMaster Stroke Assessment. Scores at the six month follow-up were not reported.

The second high quality RCT ( Powell et al., 1999) investigated the effectiveness of FES for improving motor function in 60 patients with acute stroke. The participants were assigned to receive either FES in addition to conventional (Bobath) therapy or conventional (Bobath) therapy only. Sessions were given for 30 mins/day, three times a week for eight weeks. Outcomes were measured at eight weeks and at a 32 week follow-up. At post treatment (8 weeks) and at the 32 week follow-up, there were no significant between group differences on the Nine-hole peg test.

The third high quality RCT ( Chae et al., 1998) investigated the effectiveness of FES for improving motor function in 46 patients with acute stroke. The participants were randomized to receive either FES to produce wrist and finger extension exercises or sham stimulation (control group). The sessions were 1 hour a day for 15 sessions (3 weeks). Outcomes were measured at four weeks and at 12 weeks. At post-treatment, there was a significant between group difference in favour of the experimental group on the Fugl-Meyer Assessment, however, this difference was not maintained at the 12 week follow-up.

The fair quality RCT (Alon et al., 2008) investigated the effectiveness of FES for improving motor function in 26 patients with acute stroke. The participants were assigned to receive either FES in combination with task-specific exercise or task-specific exercise only. Sessions were given 2 times/day for 30 minutes, 5 days/week for 12 weeks. The FES group practiced the exercises while receiving FES as well as received additional FES without exercises for up to an additional 90 minutes twice a day. Outcomes were measured at post-treatment (12 weeks). At post-treatment, there was a significant between group difference on the upper extremity section of the modified Fugl-Meyer Assessment in favour of the experimental group.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that FES in addition to conventional therapy or no therapy is not more effective than conventional therapy or no therapy alone for improving motor function in patients with acute stroke.

Note: However, one high quality RCT and one fair quality RCT found a significant difference between the groups in favour of the stimulation group (this difference was not maintained at the 12 week follow-up for the high quality RCT).

Range of motion
Not effective
1B

One high quality RCT (Powell et al., 1999) has investigated the effectiveness of FES for improving range of motion in patients with acute stroke.

The high quality RCT (Powell et al., 1999) investigated the effectiveness of FES for improving range of motion in 60 patients with acute stroke. The participants were assigned to receive either FES in addition to conventional (Bobath) therapy or conventional (Bobath) therapy only. Sessions were given for 30 mins/day, 3 times a week for 8 weeks. Outcomes were measured at eight weeks, and at a 32 weeks follow-up. At post-treatment and at the 32 week follow-up, there were no significant between group differences on passive and active range of motion.

Conclusion: There is moderate evidence (Level 1b) from one high RCT that FES in addition to conventional therapy is not more effective than conventional therapy alone for improving range of motion in patients with acute stroke.

Reaction time
Effective
1b

One high quality RCT (Powell et al., 1999) has investigated the effectiveness of FES for improving reaction time in patients with acute stroke.

The high quality RCT (Powell et al., 1999) investigated the effectiveness of FES for improving reaction time in 60 patients with acute stroke. The participants were assigned to receive either FES in addition to conventional (Bobath) therapy or conventional (Bobath) therapy only. Sessions were given for 30 mins/day, 3 times a week for 8 weeks. Outcomes were measured at post-treatment (eight weeks) and at a 32 weeks. At post-treatment and at the 32 week follow-up, there was a significant difference between the groups in favour of the experimental group on reaction time.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that FES in addition to conventional therapy is more effective than conventional therapy only for improving reaction time in patients with acute stroke.

Spasticity
Not effective
1A

Two high quality RCTs (Mangold et al., 2009, Powell et al., 1999) have investigated the effectiveness of FES for improving spasticity in patients with acute