Strength Training Effectiveness Post-Stroke (STEPS)
This trial is active, not recruiting.
|Treatments||exercise therapy, walking rehabilitation|
|Sponsor||University of Southern California|
|Collaborator||Physical Therapy Clinical Research Network|
|Start date||May 2004|
|End date||January 2006|
|Trial size||80 participants|
|Trial identifier||NCT00389012, 025024|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
walking speed (meters/second)
walking distance (distance walked in 6-minutes)
Lower extremity Fugl-Meyer
Berg Balance Score
Lower extremity torque
Stroke Impact Scale
Male or female participants at least 18 years old.
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.
|Official title||Strength Training Effectiveness Post-Stroke (STEPS)|
|Principal investigator||Katherine J Sullivan, PhD, PT|
|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.|
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