Bilateral Training Versus Unilateral Training in Stroke
Primary Purpose
Stroke, Hemiparesis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bilateral upper extremity training
Unilateral upper extremity training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity, hemiparesis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
bilateral training
Unilateral training
Outcomes
Primary Outcome Measures
Motor Assessment Scale
Motor Status Scale
Secondary Outcome Measures
Reaching Performance Scale
Full Information
NCT ID
NCT00681434
First Posted
May 19, 2008
Last Updated
August 1, 2014
Sponsor
University of Illinois at Chicago
Collaborators
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT00681434
Brief Title
Bilateral Training Versus Unilateral Training in Stroke
Official Title
Bilateral Training for Upper Extremity Hemiparesis in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Shirley Ryan AbilityLab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, upper extremity, hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
bilateral training
Arm Title
2
Arm Type
Active Comparator
Arm Description
Unilateral training
Intervention Type
Behavioral
Intervention Name(s)
bilateral upper extremity training
Intervention Description
Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Unilateral upper extremity training
Intervention Description
Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.
Primary Outcome Measure Information:
Title
Motor Assessment Scale
Time Frame
pre and post (week one and week 8)
Title
Motor Status Scale
Time Frame
pre and post, Week 0 and Week eight
Secondary Outcome Measure Information:
Title
Reaching Performance Scale
Time Frame
pre and post training (Week 0 and week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Stoykov, PhD
Organizational Affiliation
University of Illinois at Chicago Department of Kinesiology and Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel M Corcos, PhD
Organizational Affiliation
University of Illinois at Chicago Department of Kinesiology and Nutrition
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
19531608
Citation
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.
Results Reference
result
Learn more about this trial
Bilateral Training Versus Unilateral Training in Stroke
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