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Exploring New Approaches in Reaching Behavior Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stabilization training
auditory training group
Sponsored by
University of the Sciences in Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, reaching, stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole & Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)

Exclusion Criteria:

  • Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    stabilization training group

    auditory response training group

    Outcomes

    Primary Outcome Measures

    WMFT

    Secondary Outcome Measures

    FM and shoulder flexion

    Full Information

    First Posted
    February 13, 2009
    Last Updated
    February 13, 2009
    Sponsor
    University of the Sciences in Philadelphia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00844870
    Brief Title
    Exploring New Approaches in Reaching Behavior Post Stroke
    Official Title
    Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of the Sciences in Philadelphia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.
    Detailed Description
    Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    rehabilitation, reaching, stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    stabilization training group
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    auditory response training group
    Intervention Type
    Behavioral
    Intervention Name(s)
    stabilization training
    Intervention Description
    training of arm function with the trunk stabilized
    Intervention Type
    Behavioral
    Intervention Name(s)
    auditory training group
    Intervention Description
    response to an auditory signal
    Primary Outcome Measure Information:
    Title
    WMFT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    FM and shoulder flexion
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole & Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006) Exclusion Criteria: Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory T Thielman, Ed.D
    Organizational Affiliation
    University of the Sciences in Philadelphia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Exploring New Approaches in Reaching Behavior Post Stroke

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