Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis|
- Shoulder, Arm, Hand Kinematics [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125658
|United States, Florida|
|North Florida/South Georgia Veterans Health System|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Carolynn Patten, PhD||North Florida/South Georgia Veterans Health System|