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Backward Walking Training for Stroke Recovery (BRAVE Trial)

N/A
Recruiting
Led By Dorian Kay Rose, PhD MS BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
> 2 months < 4 months post-stroke
Able to ambulate at least 10 feet with maximum 1 person assist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline through study completion, an average of 7 months.
Awards & highlights

BRAVE Trial Summary

This trial will test the effects of two doses of backward walking training on gait and balance in post-stroke Veterans, as well as brain activity before and after the intervention.

Who is the study for?
This trial is for post-stroke Veterans who are medically stable, had a unilateral stroke, and have balance and walking speed challenges. They must be 2-4 months post-stroke and able to walk at least 10 feet with minimal assistance. Excluded are those with other neurological conditions, severe heart disease, pain when walking, current physical therapy for mobility/gait, MRI contraindications like metal implants or claustrophobia, serious cardiac issues or severe joint problems.Check my eligibility
What is being tested?
The study tests how effective backward walking training is in improving gait and balance after a stroke by comparing two different amounts of training sessions (18 vs. 27). It also examines brain activity through MRI scans before and after the intervention to predict rehabilitation outcomes and understand the brain's response to this unique form of physical therapy.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from backward walking training may include muscle soreness or strain due to unusual movement patterns. The risk of falls could potentially increase during training sessions without proper supervision.

BRAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stroke between 2 and 4 months ago.
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I can walk at least 10 feet with help from one person.
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I have had a stroke affecting one side of my brain.
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My balance score is less than 45.
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I walk slower than 0.8 meters per second.
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My health condition is currently stable.

BRAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline through study completion, an average of 7 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline through study completion, an average of 7 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in the Activity-Specific Balance Confidence Scale
Change in the Berg Balance Scale
Change in the Functional Gait Assessment
+2 more

BRAVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 27 session groupExperimental Treatment1 Intervention
Participants in this arm will receive 27 sessions of backward walking training.
Group II: 18 session groupActive Control1 Intervention
Participants in this arm will receive 18 sessions of backward walking training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Backward Walking Training
2017
N/A
~130

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,987 Total Patients Enrolled
83 Trials studying Stroke
6,670 Patients Enrolled for Stroke
Dorian Kay Rose, PhD MS BSPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
3 Previous Clinical Trials
95 Total Patients Enrolled
3 Trials studying Stroke
95 Patients Enrolled for Stroke

Media Library

Backward Walking Training Clinical Trial Eligibility Overview. Trial Name: NCT04928482 — N/A
Stroke Research Study Groups: 27 session group, 18 session group
Stroke Clinical Trial 2023: Backward Walking Training Highlights & Side Effects. Trial Name: NCT04928482 — N/A
Backward Walking Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04928482 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research protocol accept participants aged 25 and over?

"This medical study seeks out patients aged 18 to 85. 37 trials have been launched for minors, whereas 1007 are available for elderly individuals with the corresponding criteria."

Answered by AI

Are there still openings available within this trial for participants?

"According to the details posted on clinicaltrials.gov, this research study is currently welcoming participants. It was initially published on November 8th 2021 and its information was most recently updated during November 18th 2022."

Answered by AI

Would I be able to partake in this research program?

"This research is seeking 48 volunteers aged between 18 and 85 who have suffered a stroke. Participants also need to satisfy additional requirements, including being less than 4 months post-stroke, having a Berg Balance Scale score of under 42 and the aptitude to walk 10 feet with maximum one person support."

Answered by AI

What is the total number of participants in this research project?

"Affirmative. As per the information available on clinicaltrials.gov, this medical research was initially made public on November 8th 2021 and is currently looking for 48 participants from two different sites. The data has been last updated as of November 18th 2022."

Answered by AI
~19 spots leftby Sep 2025