Bilateral Training Versus Unilateral Training in Stroke

Study Overview
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Brief Summary
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This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

Detailed Description
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Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy. This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.

Official Title
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Bilateral Training for Upper Extremity Hemiparesis in Stroke

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Behavioral: bilateral upper extremity training
* Behavioral: Unilateral upper extremity training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cortical or subcortical stroke chronic condition (at least six months prior) ability to follow 2-step commands ability to give consent Exclusion Criteria: lesion in brain stem or cerebellum visual field cut neglect uncontrolled hypertension angina COPD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bilateral training | Behavioral: bilateral upper extremity training<br>* Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.<br>|
| Active Comparator: 2<br>Unilateral training | Behavioral: Unilateral upper extremity training<br>* Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Assessment Scale |  | pre and post (week one and week 8) | 
| Motor Status Scale |  | pre and post, Week 0 and Week eight | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaching Performance Scale |  | pre and post training (Week 0 and week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, upper extremity, hemiparesis