Bilateral Training Versus Unilateral Training in Stroke

Stroke Clinical Trial

Official title:

Bilateral Training for Upper Extremity Hemiparesis in Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681434
• Other study ID #: 2006-0234
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2008
• Last updated: August 1, 2014
• Start date: May 2005

Study information

• Verified date: August 2014
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Stroke

Intervention

Behavioral:
• bilateral upper extremity training
Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
• Unilateral upper extremity training
Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Rehabilitation Institute of Chicago

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Assessment Scale		pre and post (week one and week 8)	No
Primary	Motor Status Scale		pre and post, Week 0 and Week eight	No
Secondary	Reaching Performance Scale		pre and post training (Week 0 and week 8)	No