Strength Training Effectiveness Post-Stroke (STEPS)
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exercise therapy
walking rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring rehabilitation, hemiplegic gait, exercise therapy, physical therapy
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.
Sites / Locations
- Rancho Los Amigos
- University of Southern California
- Northwestern University
Outcomes
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
Full Information
NCT ID
NCT00389012
First Posted
October 16, 2006
Last Updated
April 4, 2017
Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00389012
Brief Title
Strength Training Effectiveness Post-Stroke (STEPS)
Official Title
Strength Training Effectiveness Post-Stroke (STEPS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 31, 2010 (Actual)
Study Completion Date
October 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
rehabilitation, hemiplegic gait, exercise therapy, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
exercise therapy
Intervention Type
Procedure
Intervention Name(s)
walking rehabilitation
Primary Outcome Measure Information:
Title
walking speed (meters/second)
Title
walking distance (distance walked in 6-minutes)
Secondary Outcome Measure Information:
Title
Lower extremity Fugl-Meyer
Title
Berg Balance Score
Title
Lower extremity torque
Title
Stroke Impact Scale
Title
SF-36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine J Sullivan, PhD, PT
Organizational Affiliation
Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Brown, PhD, PT
Organizational Affiliation
Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Mulroy, PhD, PT
Organizational Affiliation
Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17895349
Citation
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.
Results Reference
derived
Learn more about this trial
Strength Training Effectiveness Post-Stroke (STEPS)
We'll reach out to this number within 24 hrs