Cerebrovascular AccidentPhase 2NCT00389012
Strength Training Effectiveness Post-Stroke (STEPS)
A Phase 2 study testing exercise therapy and walking rehabilitation in people with Cerebrovascular Accident, run by University of Southern California at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- exercise therapy and walking rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2004to 31 Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Rancho Los Amigos
Downey, California, 90242
University of Southern California
Los Angeles, California, 90089
About this study
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.
Read the 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
- Being tested
- exercise therapy, walking rehabilitation
- Keywords
- rehabilitation, hemiplegic gait, exercise therapy, physical therapy
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise therapyProcedure or surgery
walking rehabilitationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed (meters/second)
walking distance (distance walked in 6-minutes)
Secondary outcomes (5)
Lower extremity Fugl-Meyer
Berg Balance Score
Lower extremity torque
Stroke Impact Scale
SF-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startMay 2004
- Primary completion31 Oct 2010
- Study completion31 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Katherine J Sullivan, PhD, PT, Principal investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CaliforniaDavid A Brown, PhD, PT, Principal investigator, Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IllinoisSara Mulroy, PhD, PT, Principal investigator, Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389012
- Sponsor's protocol ID
- 025024
- Status last verified
- Apr 2010
- First submitted
- 16 Oct 2006
- Last updated
- 6 Apr 2017
- Results posted
- No
Publications
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.
PubMed 17895349
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Effectiveness Post-Stroke (STEPS)
- ClinicalTrials.gov ID
- NCT00389012
- Acronym / sponsor ID
- 025024
- Conditions
- Cerebrovascular Accident
- Keywords
- rehabilitation, hemiplegic gait, exercise therapy, physical therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Study start
- May 2004
- Primary completion
- 31 Oct 2010 (actual)
- Study completion
- 31 Oct 2010 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise therapy | Procedure or surgery | – |
| walking rehabilitation | Procedure or surgery | – |
Primary outcome
walking speed (meters/second)
walking distance (distance walked in 6-minutes)
5 secondary outcomes
Lower extremity Fugl-Meyer
Berg Balance Score
Lower extremity torque
Stroke Impact Scale
SF-36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 17895349Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine J Sullivan, PhD, PT principal investigator
Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
David A Brown, PhD, PT principal investigator
Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
Sara Mulroy, PhD, PT principal investigator
Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exercise therapy and walking rehabilitation in people with Cerebrovascular Accident, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (meters/second). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017; AzTrials last refreshed its copy on 28 Oct 2026.