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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00629005 |
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
Condition | Intervention | Phase |
---|---|---|
Stroke |
Behavioral: Constraint-Induced Movement Therapy + strength training Behavioral: Constraint-Induced Movement Therapy + range of motion |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Should We Train Strength or Skill in Post-Stroke Rehabilitation? |
Estimated Enrollment: | 40 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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
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Behavioral: Constraint-Induced Movement Therapy + strength training
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
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2: Active Comparator
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
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Behavioral: Constraint-Induced Movement Therapy + range of motion
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
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
contraindications to MRI or TMS including:
Contact: Sandra B Davis, BS | (352) 376-1611 ext 5227 | Sandra.Davis2@med.va.gov |
United States, Florida | |
North Florida/South Georgia Veterans Health System | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Lorie G Richards, PhD lrichard@phhp.ufl.edu | |
Principal Investigator: Lorie G Richards, PhD |
Principal Investigator: | Lorie G Richards, PhD | North Florida/South Georgia Veterans Health System |
Responsible Party: | Department of Veterans Affairs ( Richards, Lorie - Principal Investigator ) |
Study ID Numbers: | B5033W |
Study First Received: | February 19, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00629005 |
Health Authority: | United States: Federal Government |
rehabilitation upper extremity motor skills |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |