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

Cerebrovascular Accident Clinical Trial

Official title:

The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00361660
• Other study ID #: 407-2005A
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2006
• Last updated: June 25, 2015
• Start date: August 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiplegia
• Stroke

Intervention

Behavioral:
• functional task practice - distributed
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.
• functional task practice - condensed
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper extremity subscale of the Fugl-Meyer Motor Assessment		immediately after therapy ends	No
Secondary	Wolf Motor Function Test		Immediately after therapy ends	No

External Links

•   Click here for more information about this study: The impact of functional task practice dosing on motor control in hemiplegia from chronic stroke