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

This study has been withdrawn prior to enrollment.
(project was only internally funded and would complete for subjects with 2 newer externally funded projects)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00361660
First received: August 7, 2006
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Hemiplegia
Behavioral: functional task practice - distributed
Behavioral: functional task practice - condensed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Upper extremity subscale of the Fugl-Meyer Motor Assessment [ Time Frame: immediately after therapy ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: Immediately after therapy ends ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2006
Estimated Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).
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.
Other Name: constraint-Induced Movement Therapy
Active Comparator: 2
The same therapy is provided daily Monday through Friday
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.
Other Name: Constraint-Induced Movement Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361660

Sponsors and Collaborators
Investigators
Principal Investigator: Lorie G Richards, PhD North Florida/South Georgia Veterans Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Richards, Lorie - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00361660     History of Changes
Other Study ID Numbers: 407-2005A
Study First Received: August 7, 2006
Last Updated: September 30, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Motor skills
Occupational Therapy
Physical Therapy Techniques
Rehabilitation
Upper Extremity
Stroke

Additional relevant MeSH terms:
Hemiplegia
Cerebral Infarction
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014