Strength Training Effectiveness Post-Stroke (STEPS)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- University of Southern California
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- walking speed (meters/second)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
walking speed (meters/second)
walking distance (distance walked in 6-minutes)
Secondary Outcomes
- Lower extremity Fugl-Meyer
- Berg Balance Score
- Lower extremity torque
- Stroke Impact Scale
- SF-36