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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00125658 |
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Condition | Intervention | Phase |
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Cerebrovascular Accident |
Other: Upper Extremity Rehabilitation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Mechanisms of Upper-Extremity Motor Recovery in Post-Stroke Hemiparesis |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Other: Upper Extremity Rehabilitation
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of activity practice and 10 weeks of resistance exercise. Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the 20 week therapy program.
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This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to receive either 10 weeks of functional training followed by 10 weeks of high-intensity resistance training or resistance training followed by functional training. Re-evaluation will occur following each block of treatment, and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including strength, muscle activation, reflex modulation and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-cerebrovascular accident (CVA), having completed all inpatient and outpatient therapies, with continued experience of residual motor deficits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeff D Fox | (352) 376-1611 ext 5989 | jeffrey.fox@va.gov |
Contact: Carolynn Patten, PhD | (352) 376-1611 ext 4160 | patten@phhp.ufl.edu |
United States, Florida | |
North Florida/South Georgia Veterans Health System | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Jeff D Fox 352-376-1611 ext 5989 jeffrey.fox@va.gov | |
Principal Investigator: Carolynn Patten, PhD |
Principal Investigator: | Carolynn Patten, PhD | North Florida/South Georgia Veterans Health System |
Responsible Party: | Department of Veterans Affairs ( Patten, Carolynn - Principal Investigator ) |
Study ID Numbers: | B3964R |
Study First Received: | July 28, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00125658 |
Health Authority: | United States: Federal Government |
biomechanics Cerebrovascular Accident electromyography muscular weakness |
recovery of function reflex variability stroke upper-extremity kinematics |
Paresis Cerebral Infarction Asthenia Stroke Vascular Diseases Central Nervous System Diseases Ischemia Muscle Weakness |
Brain Diseases Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |