- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361660
The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke
The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).
|
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.
Other Names:
|
Active Comparator: 2
The same therapy is provided daily Monday through Friday
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Upper extremity subscale of the Fugl-Meyer Motor Assessment
Time Frame: immediately after therapy ends
|
immediately after therapy ends
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wolf Motor Function Test
Time Frame: Immediately after therapy ends
|
Immediately after therapy ends
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lorie G Richards, PhD, North Florida/South Georgia Veterans Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 407-2005A
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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