Bilateral Training Versus Unilateral Training in Stroke

August 1, 2014 updated by: University of Illinois at Chicago

Bilateral Training for Upper Extremity Hemiparesis in Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Motor Assessment Scale
Time Frame: pre and post (week one and week 8)
pre and post (week one and week 8)
Motor Status Scale
Time Frame: pre and post, Week 0 and Week eight
pre and post, Week 0 and Week eight

Secondary Outcome Measures

Outcome Measure
Time Frame
Reaching Performance Scale
Time Frame: pre and post training (Week 0 and week 8)
pre and post training (Week 0 and week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Shirley Ryan AbilityLab

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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