Backward Walking Training for Stroke Recovery

(BRAVE Trial)

Recruiting at 1 trial location

Overseen By David J. Clark, DSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological conditions, Cardiac conditions, Severe arthritis, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6-9 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of backward walking training for stroke recovery. Researchers seek to determine whether 18 or 27 sessions better improve walking and balance post-stroke. They will also use MRI scans to study brain activity and understand how the training might alter brain function. Individuals who had a stroke 2–4 months ago and can walk with some assistance may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke rehabilitation techniques.

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 prior data suggests that this backward walking training is safe for stroke recovery?

Research has shown that walking backward is safe and well-tolerated for people recovering from a stroke. One study found that this type of walking, when combined with other therapies, was both feasible and safe for stroke recovery. Participants in that study generally managed the training well, without major problems. While more research is needed, these findings suggest that backward walking can safely be included in stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about backward walking training for stroke recovery because it offers a fresh approach to rehabilitation. Unlike traditional stroke recovery therapies, which often focus on forward movement and general physical therapy, backward walking targets specific neural pathways and muscle groups that are crucial for balance and coordination. The unique aspect of this method is its potential to improve gait and stability by challenging the brain and body in new ways, which could lead to more effective recovery outcomes. Additionally, the simplicity and low-cost nature of backward walking make it an accessible option for many patients, potentially enhancing adherence and long-term benefits.

What evidence suggests that backward walking training is effective for stroke recovery?

Research shows that practicing walking backward can significantly aid stroke recovery by improving walking and balance. Studies have found that this training increases walking speed more effectively than walking forward. A review of several studies found that walking backward is as effective, if not more so, for enhancing walking speed after a stroke. Another study found that participants who practiced walking backward showed noticeable improvements in balance and walking ability. In this trial, participants will be assigned to different groups to receive either 27 or 18 sessions of backward walking training. These findings suggest that backward walking training is a promising method to help stroke survivors regain mobility. ^{2 6 7 8 9}

Who Is on the Research Team?

Dorian Kay Rose, PhD MS BS

Principal Investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Backward Walking Training

Trial Overview

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.

How Is the Trial Designed?

Group I: 27 session group Experimental Treatment 1 Intervention

Participants in this arm will receive 27 sessions of backward walking training.

Group II: 18 session group Active Control 1 Intervention

Participants in this arm will receive 18 sessions of backward walking training.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Backward Walking Training (BWT) is a feasible and effective addition to rehabilitation for individuals one week post-stroke, showing significant improvements in both forward and backward walking speed compared to Standing Balance Training (SBT).

In a pilot study involving 18 participants, BWT led to greater enhancements in balance-related confidence and functional mobility, indicating its potential as a beneficial intervention in acute stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. Rose, DK., DeMark, L., Fox, EJ., et al.[2019]

Backward walking (BW) training significantly improves gait velocity and balance in stroke patients compared to conventional treatments, based on a meta-analysis of ten studies.

The improvements in balance (Berg balance score) and walking performance were statistically significant, indicating that BW training can be an effective rehabilitation strategy for stroke patients, although more high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. Chen, ZH., Ye, XL., Chen, WJ., et al.[2021]

Backward locomotor treadmill training (BLTT) is a safe and effective rehabilitation method for improving walking ability in stroke survivors, regardless of their initial walking impairment level, as shown in a study of 39 adults over 2 weeks.

Both individuals with severe walking impairment (≤0.4 m/s) and those with mild-moderate impairment (>0.4 m/s) experienced similar improvements in walking metrics, suggesting that BLTT can benefit a wide range of patients, although those with severe impairment may start at a functional disadvantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels. Awosika, OO., Chan, D., Sucharew, HJ., et al.[2022]

In a randomized controlled trial with 25 stroke patients, those who received additional backward walking training showed significant improvements in walking speed, stride length, and gait symmetry compared to a control group after three weeks of training.

The experimental group, which included 30 minutes of backward walking training three times a week, demonstrated greater enhancements in gait outcomes, indicating that this method can effectively address asymmetric gait patterns in post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. Yang, YR., Yen, JG., Wang, RY., et al.[2022]

An additional backward walking (BW) training program, combined with standard inpatient rehabilitation, led to significant improvements in balance and walking ability in eight patients less than two weeks post-stroke, despite their severe impairments.

All participants showed clinically meaningful increases in forward walking speed, indicating that BW training can be an effective intervention for enhancing rehabilitation outcomes in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of backward walking training to improve walking function, balance, and fall-risk in acute stroke: a case series. DeMark, L., Fox, EJ., Spigel, PM., et al.[2020]

Backward walking training (BWT) significantly improved various motor functions in stroke patients, including walking speed, cadence, balance, and step lengths, based on a meta-analysis of seven studies.

The analysis showed that BWT led to measurable improvements in the 10-meter walk test, cadence (4 steps/minute increase), and balance (4.38 points on the Berg balance scale), indicating its effectiveness as a rehabilitation strategy for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Backward Walking Training Impacts Positive Effect on Improving Walking Capacity after Stroke: A Meta-Analysis. Wen, H., Wang, M.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7337570/

Effectiveness of backward walking for people affected by ...

BW training, as an adjunct an adjunct to conventional treatment, can improve Berg balance score (moderate evidence), walk test performance (very low evidence), ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0021929023002130

The influence of backward versus forward locomotor ...

Backward walking training has been reported to improve gait speed and balance post-stroke. However, it is not known if gains are achieved through recovery ...

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pedro.org.au

pedro.org.au/english/systematic-review-found-that-training-backward-walking-is-as-or-more-effective-than-forward-walking-training-when-improving-walking-speed-after-stroke/

Systematic review found that training backward walking is as ...

Systematic review found that training backward walking is as or more effective than forward walking training when improving walking speed after stroke.

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.122.038956

Current Evidence for Walking Recovery After Stroke, Future ...

Approximately one-quarter of stroke survivors, however, do not achieve independent walking by 3-months poststroke. For those who do achieve ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32629648/

Effectiveness of backward walking for people affected by ...

Compared to control group, there is a statistically significant improvement for BW group in gait velocity (mean difference [MD] = 6.87, 95%CI: [ ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12110432/

Exploring the Impact of Backward and Forward Locomotor ...

Exploring the impact of backward and forward locomotor treadmill training in chronic stroke survivors with severe post-stroke walking impairment.

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academic.oup.com

academic.oup.com/braincomms/article/2/1/fcaa045/5823288

Backward locomotor treadmill training combined with ...

Our findings suggest BLTT and tsDCS are safe, feasible and well-tolerated approaches for walking rehabilitation training in stroke. Moreover, ...

8.

journals.lww.com

journals.lww.com/md-journal/fulltext/2020/07020/effectiveness_of_backward_walking_for_people.27.aspx

Effectiveness of backward walking for people affected by...

Backward walking (BW) training is increasingly used in rehabilitation for stroke, but relevant evidence remains unclear.

9.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/ijn.70020

Effectiveness of Treadmill Training Intervention for the ...

Studies employing BWSTT show greater improvements in walking outcomes, highlighting the added value of this technique in stroke rehabilitation.