StrokeNCT01180738
Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
A study testing Body weight supported treadmill training and Overground walking training in people with Stroke and Difficulty Walking, run by Stephanie Miller at 1 site in United States.
Trial summary
The purpose of this study is to compare two different walking training programs for persons with chronic stroke. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke, Difficulty Walking
- What is being tested?
- Body weight supported treadmill training and Overground walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2011
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of 6 months post-stroke
- Single episode of stroke
- Between the ages of 21-80
- Able to walk with or without the use of an assistive device or orthoses
- Able to ambulate at a self-selected gait speed < 0.8 m/s as determined by the 10-meter comfortable walk test
- Medically stable with a physician release stating approval to enter an exercise program
Show all 9Show fewer
- Able to follow at least two-step verbal instructions
- Available for the entire period of the study
- Able to travel to and from research measurement and intervention sessions
Who cannot join
- Currently receiving physical therapy services
- Co-morbidities or pre-existing cardiovascular conditions that would prohibit gait training and exercise
- Pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke
- Complications from other health conditions that could influence walking
- Currently known to be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Indianapolis, Krannert School of Physical Therapy
Indianapolis, Indiana, 46227
About this study
Official title: Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
The purpose of this study is to compare two different walking training programs for persons with chronic stroke.
Read the detailed description
Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are two interventions commonly applied for enhancing gait and balance in patients with chronic stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various aspects of the two interventions have been investigated in the past, limited research has been conducted to compare the effects of the two interventions in patients with chronic stroke.
Longer training durations may not always be feasible due to limited reimbursement options, lack of clinic accessibility, or transportation restrictions for patients with chronic deficits following stroke. A short burst of training consisting of a ''booster''-like protocol may provide a convenient option for some patients with chronic stroke to improve necessary functional skills in a short period of time.
The primary purpose of this pilot study is to compare walking speed immediately and 3-months after a short-burst of body-weight support treadmill training (BWSTT) or overground walking training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will be recruited and screened to determine eligibility for the study. Participants will be randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome measures will include assessments of gait speed, endurance, walking pattern, fear of falling, balance confidence, anxiety, and activity and participation in daily life. Outcomes will be tested prior to (pre-test) and immediately after (post-test) the assigned intervention and again 3-months after completing the intervention (retention).
- Conditions
- Stroke, Difficulty Walking
- Being tested
- Body weight supported treadmill training, Overground walking training
- Keywords
- chronic stroke, walking training, rehabilitation, body weight supported treadmill training, physical therapy, balance
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body weight supported treadmill trainingBehavioural
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system.
Overground walking trainingBehavioural
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.
| Study group | Role | What they receive |
|---|---|---|
| Body weight supported treadmill training | Active comparator | Not described Receives: Behavioral: Body weight supported treadmill training |
| Overground walking training | Active comparator | Not described Receives: Behavioral: Overground walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed: measured with the comfortable 10-meter walk test
Measured: The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).
Secondary outcomes (1)
Gait endurance: measured with the 6-minute walk test; Fear of falling: measured with the Fear of Falling questionnaire and Falls Efficacy Scale-International
Measured: The outcome measures will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Miller
- Sponsor type
- University, hospital or other
- Collaborators
- University of Indianapolis, Richard L. Roudebush VA Medical Center
- Responsible party
- Sponsor-investigator, Stephanie Miller, University of Indianapolis
- Investigators
- Stephanie A Combs, PT, PhD, NCS, Principal investigator, University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, INArlene A Schmid, OTR, PhD, Principal investigator, Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180738
- Sponsor's protocol ID
- BWSTTvsOWT_UIndy
- Status last verified
- Mar 2020
- First submitted
- 9 Aug 2010
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
- ClinicalTrials.gov ID
- NCT01180738
- Acronym / sponsor ID
- BWSTTvsOWT_UIndy
- Conditions
- Stroke, Difficulty Walking
- Keywords
- chronic stroke, walking training, rehabilitation, body weight supported treadmill training, physical therapy, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stephanie MillerUniversity, hospital or other
- Collaborators
- University of Indianapolis, Richard L. Roudebush VA Medical Center
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Aug 2010 (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 compare two different walking training programs for persons with chronic stroke.
Detailed description
Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are two interventions commonly applied for enhancing gait and balance in patients with chronic stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various aspects of the two interventions have been investigated in the past, limited research has been conducted to compare the effects of the two interventions in patients with chronic stroke.
Longer training durations may not always be feasible due to limited reimbursement options, lack of clinic accessibility, or transportation restrictions for patients with chronic deficits following stroke. A short burst of training consisting of a ''booster''-like protocol may provide a convenient option for some patients with chronic stroke to improve necessary functional skills in a short period of time.
The primary purpose of this pilot study is to compare walking speed immediately and 3-months after a short-burst of body-weight support treadmill training (BWSTT) or overground walking training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will be recruited and screened to determine eligibility for the study. Participants will be randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome measures will include assessments of gait speed, endurance, walking pattern, fear of falling, balance confidence, anxiety, and activity and participation in daily life. Outcomes will be tested prior to (pre-test) and immediately after (post-test) the assigned intervention and again 3-months after completing the intervention (retention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body weight supported treadmill training | Active comparator | Behavioral: Body weight supported treadmill training |
| Overground walking training | Active comparator | Behavioral: Overground walking training |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Minimum of 6 months post-stroke
- Single episode of stroke
- Between the ages of 21-80
- Able to walk with or without the use of an assistive device or orthoses
- Able to ambulate at a self-selected gait speed < 0.8 m/s as determined by the 10-meter comfortable walk test
Key exclusion criteria (5 listed)
- Currently receiving physical therapy services
- Co-morbidities or pre-existing cardiovascular conditions that would prohibit gait training and exercise
- Pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke
- Complications from other health conditions that could influence walking
- Currently known to be pregnant
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 |
|---|---|---|
| Body weight supported treadmill trainingTraining will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system. | Behavioural | Body weight supported treadmill training |
| Overground walking trainingTraining will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground. | Behavioural | Overground walking training |
Primary outcome
Gait speed: measured with the comfortable 10-meter walk test
Time frame: The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).
1 secondary outcome
Gait endurance: measured with the 6-minute walk test; Fear of falling: measured with the Fear of Falling questionnaire and Falls Efficacy Scale-International
Time frame: The outcome measures will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).
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 2 Apr 2020.
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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.
Stephanie A Combs, PT, PhD, NCS principal investigator
University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, IN
Arlene A Schmid, OTR, PhD principal investigator
Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body weight supported treadmill training and Overground walking training in people with Stroke and Difficulty Walking, run by Stephanie Miller at 1 site 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 9 inclusion and 5 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Gait speed: measured with the comfortable 10-meter walk test (time frame: The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2020.