Strength Training Effectiveness Post-Stroke (STEPS)

Study Overview
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Brief Summary
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The purpose of this study is to determine if treadmill training with body weight-support (BWST) is more effective at improving walking in individuals post-stroke than a resisted leg-cycling exercise program. In addition, we want to determine if training programs that combine leg strength training to treadmill walking provide an additional benefit to post-stroke walking outcomes.

Detailed Description
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Impaired walking ability is a hallmark residual deficit that contributes to post-stroke walking disability . Impairment in lower extremity muscle strength is a significant contributor to decreased walking speed after stroke. No studies have combined task-specific locomotor training in combination with lower extremity strength training programs designed to improve post-stroke walking outcomes. Participants will include individuals who are ambulatory, but walk slower than 1.0 m/sec and are at least 6 months post unilateral stroke. Participants are stratified by initial comfortable walking speed (moderate >0.5 m/sec; severe <= 0.5 m/sec) and randomized to one of four exercise pairs: 1) body-weight supported treadmill training (BWST) and locomotor-based strength training (resistive cycling task, LBST), 2) BWST and LE muscle-specific strength training (MSST), 3) BWST and upper extremity ergometry (SHAM), and 4) LBST and SHAM. Training will occur 4 times per week for 6 weeks (24 total sessions). Exercise type in each exercise pair is alternated daily. Primary outcomes include comfortable and fast overground walking speed, and distance walked in 6-minutes measured at baseline, after 12 and 24 treatment sessions and at a 6-month follow-up.

Official Title
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Strength Training Effectiveness Post-Stroke (STEPS)

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Procedure: exercise therapy
* Procedure: walking rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older 4 months to 5 years after first-time onset of a ischemic or hemorrhagic cerebrovascular accident (CVA) confirmed by CT, MRI, or clinical criteria able to ambulate at least 14 meters with assistive and/or orthotic device and one person assist (minimum Functional Ambulation Classification Level II self-selected walking velocity of ≤1.0 meters/second approval of primary care physician to participate. Exclusion Criteria: resting systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 110mmHg and/or resting heart rate greater than 100 beats/minute; lower limb orthopedic conditions such as prior joint replacement or range of motion limitations; spasticity management that included Botox injection (< 4 months earlier) or phenol block injection (< 12 months earlier) to affected lower extremity and intrathecal Baclofen or oral Baclofen (within past 30 days); Mini-Mental State Exam score < 24; currently receiving lower extremity strengthening exercises or gait training, past participation in any study examining the effects of long term (>4 weeks training) body weight support treadmill training; limb loaded pedaling, or lower extremity strengthening; plans to move out of the area in the next year, no transportation to the study site for all evaluations and intervention sessions.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: exercise therapy|nan|
|Procedure: walking rehabilitation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking speed (meters/second) |  |  | 
| walking distance (distance walked in 6-minutes) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity Fugl-Meyer |  |  | 
| Berg Balance Score |  |  | 
| Lower extremity torque |  |  | 
| Stroke Impact Scale |  |  | 
| SF-36 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, hemiplegic gait, exercise therapy, physical therapy