Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

Study Overview
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Brief Summary
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The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.

Detailed Description
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In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping. The complete study results are published.

Official Title
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Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Locomotor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cerebrovascular accident Single event Unilateral hemiplegia Locomotor disability Ability to walk independently 25' on level ground (may use an assistive device [cane or walker]; may NOT use a brace) Cognitive ability to follow 3-step commands Exclusion Criteria: Unstable or uncontrolled blood pressure Uncontrolled seizures Severe cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Therapist assisted<br>Therapist assisted locomotor training (partial body-weight supported) | Behavioral: Locomotor training<br>* This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.<br>* Other names: partial body-weight supported treadmill training, body-weight supported treadmill training;|
| Experimental: Arm 2: Robot-assisted<br>Robot-assisted locomotor training (partial body-weight supported) | Behavioral: Locomotor training<br>* This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.<br>* Other names: partial body-weight supported treadmill training, body-weight supported treadmill training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-selected Overground Walking Speed | Overground walking speed determined as rate of walking over a 10 meter distance. | 4 weeks (s/p 12 sessions of locomotor training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fast Walking Speed | Fastest comfortable walking speed measured while walking overground | 4 weeks (s/p 12 training sessions) | 
| Six Minute Walk | distance, in meters, walked overground over a six minute interval. | 4 weeks | 
| Step Length Ratio (Abs) | measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)] | 4 weeks | 
| Lower Extremity Fugl-Meyer Motor Assessment | Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0. | 4 weeks | 
| Short Physical Performance Battery | Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points. | 4 weeks | 
| Berg Balance Scale | Clinical measure of balance | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke