Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

Completed

Phase N/A Results

Trial Description

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.

Detailed Description

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 upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. 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-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.

Conditions

Interventions

  • Upper Extremity Rehabilitation Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Arm 1
  • Experimental Other
    Intervention Desc: 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 Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). 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 entire 20 week therapy program.
    ARM 1: Kind: Experimental
    Label: Experimental
    Description: POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)
  • Control Device
    Intervention Desc: 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 Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic 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 entire 20 week therapy program.
    ARM 1: Kind: Experimental
    Label: Control
    Description: FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Shoulder, Arm, Hand Kinematics Up to 18 months No
Primary Change in Trunk Displacement baseline, 10 weeks, 20 weeks
Primary Change in Shoulder Flexion baseline, 10 weeks, 20 weeks
Primary Change in Elbow Extension Range of Motion baseline, 10 weeks, 20 weeks
Primary Upper-extremity Fugl-Meyer Motor Assessment baseline, 10 weeks, 20 weeks
Secondary Movement Speed baseline, 10 weeks, 20 weeks
Secondary Movement Accuracy (Reach Path Ratio, RPR) baseline, 10 weeks, 20 weeks
Secondary Movement Smoothness baseline, 10 weeks, 20 weeks

Sponsors