Strength Training Effectiveness Post-Stroke (STEPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University of Southern California.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Physical Therapy Clinical Research Network
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00389012
First received: October 16, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • walking speed (meters/second)
  • walking distance (distance walked in 6-minutes)

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389012

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
Sponsors and Collaborators
University of Southern California
Physical Therapy Clinical Research Network
Investigators
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 April 17, 2014