Backward Walking Training for Stroke Recovery
(BRAVE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Neurological conditions, Cardiac conditions, Severe arthritis, Hypertension, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Backward Walking Training for stroke recovery?
Research shows that Backward Walking Training can help improve balance and walking speed in people recovering from a stroke. Studies found that patients who participated in this training showed significant improvements in their ability to walk and maintain balance, which are crucial for reducing fall risk and enhancing mobility.
12345Is backward walking training safe for humans?
Backward walking training has been shown to be safe and feasible for stroke patients, even those with severe walking impairments, as it has been successfully used in rehabilitation without reported safety issues.
12456How is Backward Walking Training different from other treatments for stroke recovery?
Backward Walking Training is unique because it focuses on walking backward to improve balance and walking speed, which are often impaired after a stroke. This approach is different from traditional therapies as it specifically targets postural and motor control in a novel way, potentially offering benefits not addressed by standard rehabilitation methods.
12345Eligibility Criteria
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.Inclusion Criteria
I had a stroke between 2 and 4 months ago.
I can walk at least 10 feet with help from one person.
I have had a stroke affecting one side of my brain.
+3 more
Exclusion Criteria
I have severe joint problems that limit my leg movement.
My blood pressure is very high, over 200/110 mmHg.
I am currently receiving physical therapy for walking or moving around.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline pre-intervention assessment including clinical gait and balance assessments and resting state Functional Connectivity MRI and functional MRI
1 week
1 visit (in-person)
Treatment
Participants receive backward walking training, either 18 sessions over 6 weeks or 27 sessions over 9 weeks
6-9 weeks
3 visits per week (in-person)
Post-Treatment Assessment
Assessment B to compare gait and balance measures and MRI brain measurements to baseline
1 week
1 visit (in-person)
Short-term Follow-up
Assessment C to evaluate short-term retention gains in gait and balance
6 weeks post-intervention
1 visit (in-person)
Long-term Follow-up
Assessment D to evaluate long-term retention gains in gait and balance
6 months post-intervention
1 visit (in-person)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brooks RehabilitationJacksonville, FL
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, FL
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. [2021]Backward walking (BW) training is increasingly used in rehabilitation for stroke, but relevant evidence remains unclear.
Clinical application of backward walking training to improve walking function, balance, and fall-risk in acute stroke: a case series. [2020]Background: With limited inpatient rehabilitation (IR) length of stays for patients post-stroke, it is critical to maximize the effectiveness of interventions to address their balance and gait speed deficits. Backward walking (BW) is an emerging training approach; however, its application to patient populations consistent with those in IR is limited. Objectives: To describe the effects of an additional BW training program to standard IR care on balance, walking ability and fall-risk in a heterogenic caseload of adults <2 weeks post-stroke with a broad range of lesion locations and physical sequelae. Methods: Eight patients with first-time stroke (5 male; average age 66.5 ± 11.7 years; average stroke onset 7.6 ± 1.6 days; 6 right hemiparesis) participated in 10-daily sessions that included 20 min of over ground BW training for each session, in addition to standard IR. Standard outcome measures were used to assess balance, walking ability and fall-risk at admission and post-intervention. Results: All eight patients demonstrated improvements in all outcomes with a clinically meaningful increase in forward walking speed, as measured by 10MWT. Four participants exceeded fall-risk cut-off scores for all balance-related outcome measures. Conclusions: In a diverse patient population early after stroke, individuals successfully participated in an additional BW training program. Despite the patients' acuity and severe impairments in walking, significant gains in balance and walking function were noted. This program may be useful in improving outcomes with patient characteristics commonly seen in IR.
A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. [2019]Strategies to address gait and balance deficits early poststroke are minimal. The postural and motor control requirements of Backward Walking Training (BWT) may provide benefits to improve balance and walking speed in this population. This pilot study (1) determined the feasibility of administering BWT during inpatient rehabilitation and (2) compared the effectiveness of BWT to Standing Balance Training (SBT) on walking speed, balance, and balance-related efficacy in acute stroke.
Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. [2022]To examine the effectiveness of additional backward walking training on gait outcome of patients post stroke.
Backward Walking Training Impacts Positive Effect on Improving Walking Capacity after Stroke: A Meta-Analysis. [2023]Objective: The meta-analysis aimed to investigate the potential effect of backward walking training (BWT) on walking function improvement among stroke patients. Data sources: Eligible studies were systematically searched in PubMed, Embase, Web of Science, and Cochrane Library. Methods: Heterogeneity among enrolled studies was assessed. Weighted mean difference (WMD) with its 95% confidence interval (CI) was used to pool the outcomes. Results: Seven articles were included. BWT significantly improved motor functions of stroke patients including 10-meter walk test (WMD (95% CI) = 0.11 (0.01, 0.21) meters/second; p = 0.03); cadence (WMD (95% CI) = 4.00 (0.99, 7.02) step/minute; p
Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels. [2022]Post-stroke walking impairment is a significant cause of chronic disability worldwide and often leads to loss of life roles for survivors and their caregivers. Walking impairment is traditionally classified into mild (>0.8 m/s), moderate (0.41-0.8 m/s), and severe (≤0.4 m/s), and those categorized as "severe" are more likely to be homebound and at greater risk of falls, fractures, and rehospitalization. In addition, there are minimal effective walking rehabilitation strategies currently available for this subgroup. Backward locomotor treadmill training (BLTT) is a novel and promising training approach that has been demonstrated to be safe and feasible across all levels of impairment; however, its benefits across baseline walking impairment levels (severe (≤0.4 m/s) vs. mild-moderate (>0.4 m/s)) have not been examined.