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

NCT ID: NCT00361660

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-12-31

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.

Conditions

Cerebrovascular Accident; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

functional task practice - distributed

Intervention Type: BEHAVIORAL

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.

2

The same therapy is provided daily Monday through Friday

Group Type: ACTIVE_COMPARATOR

functional task practice - condensed

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

constraint-Induced Movement Therapy; Constraint-Induced Movement Therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Department of Veterans Affairs

Principal Investigators

Lorie G Richards, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Other Identifiers

407-2005A

Identifier Type: -

Identifier Source: org_study_id