Strength Training Effectiveness Post-Stroke (STEPS)
- Conditions
- Cerebrovascular Accident
- Registration Number
- NCT00389012
- Lead Sponsor
- University of Southern California
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method walking speed (meters/second) walking distance (distance walked in 6-minutes)
- Secondary Outcome Measures
Name Time Method Lower extremity Fugl-Meyer Berg Balance Score Lower extremity torque Stroke Impact Scale SF-36
Trial Locations
- Locations (3)
Northwestern University
🇺🇸Chicago, Illinois, United States
Rancho Los Amigos
🇺🇸Downey, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States