Bilateral Training Versus Unilateral Training in Stroke

NCT ID: NCT00681434

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31

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.

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

bilateral training

Group Type: EXPERIMENTAL

bilateral upper extremity training

Intervention Type: BEHAVIORAL

Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.

2

Unilateral training

Group Type: ACTIVE_COMPARATOR

Unilateral upper extremity training

Intervention Type: BEHAVIORAL

Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.

Interventions

bilateral upper extremity training

Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.

Intervention Type: BEHAVIORAL

Unilateral upper extremity training

Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

University of Illinois at Chicago

Principal Investigators

Mary E Stoykov, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago Department of Kinesiology and Nutrition

Daniel M Corcos, PhD

Role: STUDY_CHAIR

University of Illinois at Chicago Department of Kinesiology and Nutrition

References

Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.

Reference Type: RESULT

PMID: 19531608 (View on PubMed)

Other Identifiers

2006-0234

Identifier Type: -

Identifier Source: org_study_id