StrokeBRAVENCT04928482
Responses to Backward Walking Training Post-Stroke
A study testing Backward Walking Training in people with Stroke, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Backward Walking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Berg Balance Scale < 45
- Self-selected 10 meter gait speed < 0.8 m/s
- Diagnosis of unilateral stroke
- > 2 months < 4 months post-stroke
- Able to ambulate at least 10 feet with maximum 1 person assist
- Medically stable
Who cannot join
- Presence of neurological condition other than stroke
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
- Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, and ankle plantar flexion contracture > 15 degrees)
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest
- Pain upon ambulation
Show all 9Show fewer
- Receiving physical therapy services for mobility and/or gait
- Living in a skilled nursing facility
- Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
Dorian K Rose, PhD MS BS, (352) 273-8307, Dorian.Rose@va.gov
Dorian Kay Rose, PhD MS BS
- Not yet recruiting
Brooks Rehabilitation
Jacksonville, Florida, 32216
Dorian K Rose, PhD, 352-273-8307, dorian.rose@va.gov
Kayla Blunt, BS, 9043458969, kayla.blunt@brooksrehab.org
About this study
Official title: Brain and Behavioral Responses to Backward Walking Training Post-Stroke
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.
Read the detailed description
This prospective, single-blind, randomized controlled trial will enroll individuals between 2- and 4-months post-stroke and is designed to address the study's three Specific Aims (See Figure below). The study will be approved by an ethics review board and all participants will provide written informed consent. Baseline pre-intervention assessment (Assessment A) will consist of clinical gait and balance assessments and resting state Functional Connectivity MRI and functional MRI. Brain imaging at Assessment A will test the hypotheses that rs-FC and fMRI can predict BWTraining intervention response (Specific Aim 2). Following Assessment A, participants will be randomized to receive 1) 18 sessions or 2) 27-sessions of BWTraining 3x/week for six or nine weeks respectively. Participants in the 18-session group will wait 3 weeks following randomization to begin training such that Assessment B will take place at approximately the same time post-stroke for all participants. This will assure that all participants have had the same duration of time post-stroke after study enrollment to experience spontaneous recovery. Gait and balance measures at Assessment B will be compared to Assessment A to test Specific Aim #1. MRI brain measurements at Assessment B will be compared to those at Assessment A to test the hypotheses of exploratory Aim #3. Assessment C, at six weeks post-intervention will evaluate short-term and Assessment D, at 6-months post-intervention will evaluate long-term retention gains in gait and balance. The investigators will recruit 54 individuals post-stroke to allow up to a 10% attrition rate and still provide a sufficient participant pool (n=48) to address the Specific Aims.
- Conditions
- Stroke
- Being tested
- Backward Walking Training
- Keywords
- Rehabilitation, Gait, Physical Therapy Modalities, Magnetic Resonance Imaging, Postural Balance, Accidental Falls
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking TrainingBehavioural
Participants will receive 27 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
Backward Walking TrainingBehavioural
Participants will receive 18 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
| Study group | Role | What they receive |
|---|---|---|
| 27 session group | Experimental | Participants in this arm will receive 27 sessions of backward walking training. Receives: Behavioral: Backward Walking Training |
| 18 session group | Active comparator | Participants in this arm will receive 18 sessions of backward walking training. Receives: Behavioral: Backward Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the time to complete the 10 Meter walk Test
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Measured: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Change in the time to complete the Three-Meter Backward Walk Test
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Measured: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Change in the Functional Gait Assessment
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Measured: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Change in the Activity-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Measured: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Change in the Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.
Measured: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Secondary outcomes (5)
Change in the time to complete the 10 Meter walk Test
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Measured: Change from baseline through study completion, an average of 7 months.
Change in the time to complete the Three-Meter Backward Walk Test
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Measured: Change from baseline through study completion, an average of 7 months.
Change in the Functional Gait Assessment
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Measured: Change from baseline through study completion, an average of 7 months.
Change in the Activity-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Measured: Change from baseline through study completion, an average of 7 months.
Change in the Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.
Measured: Change from baseline through study completion, an average of 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Nov 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized to receive either: 1) 27 sessions of backward walking training or 2) 18 sessions of backward walking training
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dorian Kay Rose, PhD MS BS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928482
- Sponsor's protocol ID
- B3542-R
- Acronym
- BRAVE
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Behavioral Responses to Backward Walking Training Post-Stroke
- ClinicalTrials.gov ID
- NCT04928482
- Acronym / sponsor ID
- BRAVE / B3542-R
- Conditions
- Stroke
- Keywords
- Rehabilitation, Gait, Physical Therapy Modalities, Magnetic Resonance Imaging, Postural Balance, Accidental Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2021 (actual)
- 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.
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.
Detailed description
This prospective, single-blind, randomized controlled trial will enroll individuals between 2- and 4-months post-stroke and is designed to address the study's three Specific Aims (See Figure below). The study will be approved by an ethics review board and all participants will provide written informed consent. Baseline pre-intervention assessment (Assessment A) will consist of clinical gait and balance assessments and resting state Functional Connectivity MRI and functional MRI. Brain imaging at Assessment A will test the hypotheses that rs-FC and fMRI can predict BWTraining intervention response (Specific Aim 2). Following Assessment A, participants will be randomized to receive 1) 18 sessions or 2) 27-sessions of BWTraining 3x/week for six or nine weeks respectively. Participants in the 18-session group will wait 3 weeks following randomization to begin training such that Assessment B will take place at approximately the same time post-stroke for all participants. This will assure that all participants have had the same duration of time post-stroke after study enrollment to experience spontaneous recovery. Gait and balance measures at Assessment B will be compared to Assessment A to test Specific Aim #1. MRI brain measurements at Assessment B will be compared to those at Assessment A to test the hypotheses of exploratory Aim #3. Assessment C, at six weeks post-intervention will evaluate short-term and Assessment D, at 6-months post-intervention will evaluate long-term retention gains in gait and balance. The investigators will recruit 54 individuals post-stroke to allow up to a 10% attrition rate and still provide a sufficient participant pool (n=48) to address the Specific Aims.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either: 1) 27 sessions of backward walking training or 2) 18 sessions of backward walking training
| Arm | Type | Receives |
|---|---|---|
| 27 session group | Experimental | Behavioral: Backward Walking TrainingParticipants in this arm will receive 27 sessions of backward walking training. |
| 18 session group | Active comparator | Behavioral: Backward Walking TrainingParticipants in this arm will receive 18 sessions of backward walking training. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Berg Balance Scale < 45
- Self-selected 10 meter gait speed < 0.8 m/s
- Diagnosis of unilateral stroke
- > 2 months < 4 months post-stroke
- Able to ambulate at least 10 feet with maximum 1 person assist
Key exclusion criteria (9 listed)
- Presence of neurological condition other than stroke
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, and ankle plantar flexion contracture > 15 degrees)
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest
- Pain upon ambulation
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 |
|---|---|---|
| Backward Walking TrainingParticipants will receive 27 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground. | Behavioural | 27 session group |
| Backward Walking TrainingParticipants will receive 18 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground. | Behavioural | 18 session group |
Primary outcome
Change in the time to complete the 10 Meter walk Test
Time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Change in the time to complete the Three-Meter Backward Walk Test
Time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Change in the Functional Gait Assessment
Time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Change in the Activity-Specific Balance Confidence Scale
Time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Change in the Berg Balance Scale
Time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.
5 secondary outcomes
Change in the time to complete the 10 Meter walk Test
Time frame: Change from baseline through study completion, an average of 7 months.
Change in the time to complete the Three-Meter Backward Walk Test
Time frame: Change from baseline through study completion, an average of 7 months.
Change in the Functional Gait Assessment
Time frame: Change from baseline through study completion, an average of 7 months.
Change in the Activity-Specific Balance Confidence Scale
Time frame: Change from baseline through study completion, an average of 7 months.
Change in the Berg Balance Scale
Time frame: Change from baseline through study completion, an average of 7 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Dorian Kay Rose, PhD MS BS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Training in people with Stroke, run by VA Office of Research and Development at 2 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorian K Rose, PhD MS BS ((352) 273-8307, Dorian.Rose@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the time to complete the 10 Meter walk Test (time frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)). The study lists 5 primary outcomes in all. 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 8 Apr 2026.