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Strength Training Effectiveness Post-Stroke (STEPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389012
First Posted: October 17, 2006
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Physical Therapy Clinical Research Network
Information provided by (Responsible Party):
University of Southern California
  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
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Strength Training Effectiveness Post-Stroke (STEPS)

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
Study Completion Date: October 31, 2010
Primary Completion Date: October 31, 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00389012     History of Changes
Other Study ID Numbers: 025024
First Submitted: October 16, 2006
First Posted: October 17, 2006
Last Update Posted: April 6, 2017
Last Verified: April 2010

Keywords provided by University of Southern California:
rehabilitation
hemiplegic gait
exercise therapy
physical therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases