- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629005
Strength Training and Stroke
January 28, 2013 updated by: US Department of Veterans Affairs
Should We Train Strength or Skill in Post-Stroke Rehabilitation?
People with stroke experience weakness and incoordination.
Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent.
This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone
Study Overview
Status
Completed
Conditions
Detailed Description
To date most investigations of UE rehabilitation have examined single interventions.
However, combining 2 efficacious interventions may enhance effectiveness.
Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy.
The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training.
Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months.
Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group.
Each group will train 4 hours/day, 3 days/week for 4 weeks.
Each will perform 3 hours of functional task training per session.
The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour.
All subjects will be post-tested and then complete follow-up testing 6 months later.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System
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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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 40-85;
- a single unilateral middle cerebral artery ischemic stroke;
- no history of drug/alcohol abuse;
- ability to follow 3-step commands and provide informed consent;
- no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
- at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
- ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
- permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.
Exclusion Criteria:
- spasticity in elbow or hand (Modified Ashworth Scale > 2);
- Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
- ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
- ataxia, major sensory deficits, or hemi-inattention/neglect;
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: Arm 1
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week
|
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
Other Names:
|
Active Comparator: Arm 2
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week
|
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fugl-Meyer Motor Assessment - UE Subscale
Time Frame: Immediately after the end of therapy and 6 months later
|
Immediately after the end of therapy and 6 months later
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wolf Motor Function Test
Time Frame: Immediately after the end of therapy and 6 months later
|
Immediately after the end of therapy and 6 months later
|
Cortical mapping using transcranial magnetic stimulation
Time Frame: Immediately after the end of therapy
|
Immediately after the end of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 26, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 29, 2013
Last Update Submitted That Met QC Criteria
January 28, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B5033-W
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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