Bilateral Training Versus Unilateral Training in Stroke

Phase 2

Completed

• Conditions: Stroke; Hemiparesis
• Interventions: Behavioral: bilateral upper extremity training; Behavioral: Unilateral upper extremity training

• Registration Number: NCT00681434
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-08
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• cortical or subcortical stroke
• chronic condition (at least six months prior)
• ability to follow 2-step commands
• ability to give consent

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Exclusion Criteria

• lesion in brain stem or cerebellum
• visual field cut
• neglect
• uncontrolled hypertension
• angina
• COPD

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bilateral upper extremity training	bilateral training
2	Unilateral upper extremity training	Unilateral training

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Reaching Performance Scale	pre and post training (Week 0 and week 8)