Strength Training Effectiveness Post-Stroke (STEPS)

• ClinicalTrials.gov Identifier: NCT00389012
• Recruitment Status: Completed
• First Posted: October 17, 2006
• Last Update Posted: April 6, 2017
• Sponsor: University of Southern California
• Collaborator: Physical Therapy Clinical Research Network
• Information provided by (Responsible Party): University of Southern California

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cerebrovascular Accident	Procedure: exercise therapy; Procedure: walking rehabilitation	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Strength Training Effectiveness Post-Stroke (STEPS)
• Study Start Date: May 2004
• Actual Primary Completion Date: October 31, 2010
• Actual Study Completion Date: October 31, 2010

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. walking speed (meters/second)
2. walking distance (distance walked in 6-minutes)

Secondary Outcome Measures :

1. Lower extremity Fugl-Meyer
2. Berg Balance Score
3. Lower extremity torque
4. Stroke Impact Scale
5. SF-36

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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):

Sullivan KJ, Brown DA, Klassen T, Mulroy S, Ge T, Azen SP, Winstein CJ; Physical Therapy Clinical Research Network (PTClinResNet). Effects of task-specific locomotor and strength training in adults who were ambulatory after stroke: results of the STEPS randomized clinical trial. Phys Ther. 2007 Dec;87(12):1580-602. Epub 2007 Sep 25.

• Responsible Party: University of Southern California
• ClinicalTrials.gov Identifier: NCT00389012
• Other Study ID Numbers: 025024
• 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