Strength Training Effectiveness Post-Stroke (STEPS)

NCT ID: NCT00389012

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2010-10-31

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.

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

exercise therapy

Intervention Type: PROCEDURE

walking rehabilitation

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physical Therapy Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine J Sullivan, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California

David A Brown, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

Sara Mulroy, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California

Locations

Rancho Los Amigos

Downey, California, United States

University of Southern California

Los Angeles, California, United States

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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. doi: 10.2522/ptj.20060310. Epub 2007 Sep 25.

Reference Type: DERIVED

PMID: 17895349 (View on PubMed)

Other Identifiers

025024

Identifier Type: -

Identifier Source: org_study_id