Strength Training Effectiveness Post-Stroke (STEPS)

April 4, 2017 updated by: University of Southern California
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos
      • Los Angeles, California, United States, 90089
        • University of Southern California
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
walking speed (meters/second)
walking distance (distance walked in 6-minutes)

Secondary Outcome Measures

Outcome Measure
SF-36
Stroke Impact Scale
Lower extremity Fugl-Meyer
Berg Balance Score
Lower extremity torque

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 31, 2010

Study Completion (Actual)

October 31, 2010

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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