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Completed

NCT Number: NCT00681434

Bilateral Training Versus Unilateral Training 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral upper extremity training

Behavioral

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

Unilateral upper extremity training

Behavioral

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

Primary outcomes

  1. Motor Assessment Scale

    Time frame: pre and post (week one and week 8)

  2. Motor Status Scale

    Time frame: pre and post, Week 0 and Week eight

Secondary outcomes

  1. Reaching Performance Scale

    Time frame: pre and post training (Week 0 and week 8)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Shirley Ryan AbilityLab

Registry information

Official study title

Bilateral Training for Upper Extremity Hemiparesis in Stroke

Important dates

Study start
2005
Primary completion
2007
First posted
May 21, 2008
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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