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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
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity, hemiparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 19, 2008
    Last Updated
    August 1, 2014
    Sponsor
    University of Illinois at Chicago
    Collaborators
    Shirley Ryan AbilityLab
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    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

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    Bilateral Training Versus Unilateral Training in Stroke

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