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

Not Applicable

Withdrawn

• Conditions: Cerebrovascular Accident; Hemiplegia
• Interventions: Behavioral: functional task practice - distributed; Behavioral: functional task practice - condensed

• Registration Number: NCT00361660
• Lead Sponsor: US Department of Veterans Affairs

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-08
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	functional task practice - distributed	Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).
2	functional task practice - condensed	The same therapy is provided daily Monday through Friday

Primary Outcome Measures

Name	Time	Method
Upper extremity subscale of the Fugl-Meyer Motor Assessment	immediately after therapy ends

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	Immediately after therapy ends