Bilateral Training Versus Unilateral Training in Stroke

This study has been completed.
Sponsor:
Collaborator:
Rehabilitation Institute of Chicago
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00681434
First received: May 19, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiparesis
Behavioral: bilateral upper extremity training
Behavioral: Unilateral upper extremity training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilateral Training for Upper Extremity Hemiparesis in Stroke

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Motor Assessment Scale [ Time Frame: pre and post (week one and week 8) ] [ Designated as safety issue: No ]
  • Motor Status Scale [ Time Frame: pre and post, Week 0 and Week eight ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reaching Performance Scale [ Time Frame: pre and post training (Week 0 and week 8) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2005
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bilateral training
Behavioral: bilateral upper extremity training
Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
Active Comparator: 2
Unilateral training
Behavioral: Unilateral upper extremity training
Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00681434

Sponsors and Collaborators
University of Illinois at Chicago
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Mary E Stoykov, PhD University of Illinois at Chicago Department of Kinesiology and Nutrition
Study Chair: Daniel M Corcos, PhD University of Illinois at Chicago Department of Kinesiology and Nutrition
  More Information

Publications:
Responsible Party: Daniel M. Corcos, PhD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00681434     History of Changes
Other Study ID Numbers: 2006-0234
Study First Received: May 19, 2008
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
stroke
upper extremity
hemiparesis

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014