Strength Training Effectiveness Post-Stroke (STEPS)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Procedure: exercise therapy Procedure: walking rehabilitation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Strength Training Effectiveness Post-Stroke (STEPS) |
- walking speed (meters/second)
- walking distance (distance walked in 6-minutes)
- Lower extremity Fugl-Meyer
- Berg Balance Score
- Lower extremity torque
- Stroke Impact Scale
- SF-36
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Rancho Los Amigos | |
| Downey, California, United States, 90242 | |
| University of Southern California | |
| Los Angeles, California, United States, 90089 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Katherine J Sullivan, PhD, PT | Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California |
| Principal Investigator: | David A Brown, PhD, PT | Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois |
| Principal Investigator: | Sara Mulroy, PhD, PT | Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California |
More Information
No publications provided by University of Southern California
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00389012 History of Changes |
| Other Study ID Numbers: | 025024 |
| Study First Received: | October 16, 2006 |
| Last Updated: | October 16, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Southern California:
|
rehabilitation hemiplegic gait exercise therapy physical therapy |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013