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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 5 6}

How 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. ^{1 2 3 4 5}

Research Team

Dorian Kay Rose, PhD MS BS

Principal Investigator

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

Eligibility 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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of backward walking for people affected by stroke: A systematic review and meta-analysis of randomized controlled trials. [2021]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels. [2022]