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The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke

Primary Purpose

Cerebrovascular Accident, Hemiplegia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
functional task practice - distributed
functional task practice - condensed
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Motor skills, Occupational Therapy, Physical Therapy Techniques, Rehabilitation, Upper Extremity, Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: hemiparesis due to unilateral stroke at least 3 months prior 18-90 years of age able to extend the paretic wrist 200 and at least 1 finger 100 able to follow 2-step commands score < 3 on the Motor Activity Log Amount of Use scale Exclusion Criteria: have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).

    The same therapy is provided daily Monday through Friday

    Outcomes

    Primary Outcome Measures

    Upper extremity subscale of the Fugl-Meyer Motor Assessment

    Secondary Outcome Measures

    Wolf Motor Function Test

    Full Information

    First Posted
    August 7, 2006
    Last Updated
    June 25, 2015
    Sponsor
    US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00361660
    Brief Title
    The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke
    Official Title
    The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    project was only internally funded and would complete for subjects with 2 newer externally funded projects
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    December 2007 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    US Department of Veterans Affairs

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.
    Detailed Description
    Intense skill practice with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplastic changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. In this study, using parallel group design methodology, we will test the effect of 2 practice parameter (i.e. spacing of practice and number of repetitions per task practiced per session) modifications on UE function following skill practice. Forty subjects will complete multiple baseline testing and then be randomized, using random number table, to one of 4 groups: condensed functional task practice modeled after Constraint-Induced Movement Therapy (6 hours of practice/day, 5 days/week, 2 weeks), condensed functional task practice with a restricted number of tasks practiced, distributed, distributed functional task practice (Monday, Wednesday, Friday, 6 hours/session, 10 sessions), distributed functional task practice with a restricted number of tasks practiced. During therapy sessions, subjects will practice performing common activities with their paretic upper extremity. They will wear a mitt on their non-paretic upper extremity for up to 90% of their waking hours. Post-testing sessions will follow within one week of completing therapy with an additional follow-up testing session 3 months later.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Accident, Hemiplegia
    Keywords
    Motor skills, Occupational Therapy, Physical Therapy Techniques, Rehabilitation, Upper Extremity, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    The same therapy is provided daily Monday through Friday
    Intervention Type
    Behavioral
    Intervention Name(s)
    functional task practice - distributed
    Other Intervention Name(s)
    constraint-Induced Movement Therapy
    Intervention Description
    This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
    Intervention Type
    Behavioral
    Intervention Name(s)
    functional task practice - condensed
    Other Intervention Name(s)
    Constraint-Induced Movement Therapy
    Intervention Description
    This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
    Primary Outcome Measure Information:
    Title
    Upper extremity subscale of the Fugl-Meyer Motor Assessment
    Time Frame
    immediately after therapy ends
    Secondary Outcome Measure Information:
    Title
    Wolf Motor Function Test
    Time Frame
    Immediately after therapy ends

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: hemiparesis due to unilateral stroke at least 3 months prior 18-90 years of age able to extend the paretic wrist 200 and at least 1 finger 100 able to follow 2-step commands score < 3 on the Motor Activity Log Amount of Use scale Exclusion Criteria: have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lorie G Richards, PhD
    Organizational Affiliation
    North Florida/South Georgia Veterans Health System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke

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