Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatments exercise therapy, walking rehabilitation
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
walking speed (meters/second)
time frame:
walking distance (distance walked in 6-minutes)
time frame:

Secondary Outcomes

Measure
Lower extremity Fugl-Meyer
time frame:
Berg Balance Score
time frame:
Lower extremity torque
time frame:
Stroke Impact Scale
time frame:
SF-36
time frame:

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by University of Southern California.