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

June 25, 2015 updated by: US Department of Veterans Affairs

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

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.

Study Overview

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • constraint-Induced Movement Therapy
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:
  • Constraint-Induced Movement Therapy

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lorie G Richards, PhD, North Florida/South Georgia Veterans Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

August 7, 2006

First Submitted That Met QC Criteria

August 7, 2006

First Posted (Estimate)

August 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

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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