Reactive Balance Training for Stroke

Recruiting in Palo Alto (17 mi)

Overseen by Avril Mansfield, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Toronto Rehabilitation Institute

Disqualifiers: Lower-extremity amputation, Severe spasticity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Falls in daily life are one of the most significant complications for people with stroke. Fall rates are particularly high soon after discharge from stroke rehabilitation. A new type of balance training, called reactive balance training (RBT), can reduce fall rates after discharge from stroke rehabilitation. In our previous study, RBT was implemented as part of routine care, and as a result, the dose of training was different for each participant; participants completed between one and twelve 30-minute sessions of RBT. Previous research in healthy older adults suggests that a single session of RBT is enough to lead to lasting changes in reactive balance control and reduce fall rates in daily life. It is not clear if the same is true for people with stroke, who have more severe impairments and might need a higher dose of training to achieve the same benefits. The overall goal of this work is to determine the optimal dose of reactive balance training for people with stroke who are attending rehabilitation. This pilot study will determine the feasibility of a clinical trial to address this larger goal. People with sub-acute stroke will be randomly assigned to one of three groups: 1 session, 3 sessions, or 6 sessions of RBT. Each session will be 45 minutes long, and will occur as part of participants' routine out-patient rehabilitation. We will use our experiences with this pilot study to help design a larger study. Specifically, we will use this pilot study to answer the following questions: 1) what is the optimal sample size; 2) how long will it take to reach this sample size; 3) what outcome measures should be used; 4) how feasible is it to prescribe a specific dose of RBT to people with sub-acute stroke; and 5) what two intervention groups should be included in the larger trial?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on balance training, so it's best to discuss your medications with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Reactive Balance Training (RBT) for stroke patients?

Research shows that Reactive Balance Training (RBT) helps improve balance reactions in stroke patients, reducing their risk of falls. Studies found that stroke patients who underwent RBT showed better improvements in balance control compared to those who received traditional balance training. ^{1 2 3 4 5}

Is Reactive Balance Training (RBT) safe for humans?

Reactive Balance Training (RBT) is generally considered safe for humans, including those with balance impairments like stroke survivors. While some clinicians may worry about safety due to the nature of the training, studies have shown it can improve balance without significant adverse events. ^{1 2 3 6 7}

How is Reactive Balance Training different from other treatments for stroke?

Reactive Balance Training (RBT) is unique because it focuses on improving the body's ability to react and regain balance after a loss, which can help reduce the risk of falls. Unlike traditional balance training, RBT specifically targets and improves balance reactions, such as foot-off times and stepping strategies, which are crucial for stroke recovery. ^{1 2 3 7 8}

Research Team

Avril Mansfield, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals who have had a stroke, can stand on their own for more than 30 seconds, live in the community, and are receiving outpatient rehab at the Toronto Rehabilitation Institute. They must be able to walk over 10 meters with or without a walking aid but not another person's help.

Inclusion Criteria

I am currently in outpatient rehab at the Toronto Rehabilitation Institute.

I had a stroke not long ago.

Living in the community

Exclusion Criteria

I have recent injuries or conditions affecting my ability to walk or stand.

I have heart-related activity restrictions or unstable reactions to exercise.

I have severe muscle stiffness in my legs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive reactive balance training sessions as part of routine out-patient rehabilitation

4 weeks

1-6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Postcards every 2 weeks, phone calls as needed

Treatment Details

Interventions

• Reactive balance training (Behavioural Intervention)

Trial Overview The study tests how effective different amounts of reactive balance training (RBT) are in improving balance after stroke. Participants will be randomly placed into one of three groups to receive either 1, 3, or 6 sessions of RBT during routine outpatient rehabilitation.

Participant Groups

Group I: 6 sessions Experimental Treatment 1 Intervention

Participants will complete six 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session.

Group II: 3 sessions Experimental Treatment 1 Intervention

Participants will complete three 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session. Participants will also complete 3 45-minute 'traditional' balance training sessions.

Group III: 1 session Active Control 1 Intervention

Participants will complete one 45-minute session of reactive balance training. Participants will experience 40-60 perturbations during this session. Participants will also complete 5 45-minute 'traditional' balance training sessions.

Who Is Running the Clinical Trial?

Toronto Rehabilitation Institute

Lead Sponsor

Trials

55

Recruited

6,000+

Heart and Stroke Foundation Canadian Partnership for Stroke Recovery

Collaborator

Trials

2

Recruited

90+

Findings from Research

This pilot randomized controlled trial involves 36 stroke survivors to evaluate the effects of different doses of reactive balance training (RBT) on balance control and confidence, aiming to inform a larger study on optimal RBT dosage.

Participants will be assessed at multiple time points, including 6 months post-discharge, to track falls and physical activity, which will help determine the feasibility and necessary sample size for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial. Mansfield, A., Inness, EL., Danells, CJ., et al.[2021]

Reactive balance training (RBT) significantly reduces the likelihood of falls in daily life for older adults and individuals with balance impairments, with a fall risk ratio of 0.76 compared to control groups.

While RBT is effective in decreasing falls, it is associated with a higher prevalence of adverse events (29% in RBT vs. 20% in control), indicating that while it is beneficial, caution is needed regarding potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Reactive Balance Training on Falls in Daily Life: An Updated Systematic Review and Meta-Analysis. Devasahayam, AJ., Farwell, K., Lim, B., et al.[2023]

Impaired reactive balance control, particularly in the paretic limb and between-limb synchronization, significantly predicts an increased risk of falls in individuals discharged from stroke rehabilitation, based on a study of 95 participants over 6 months.

Specific measures such as decreased contribution of the affected limb to balance and increased step length variability were strongly associated with fall rates, indicating that rehabilitation should focus on improving these aspects to enhance safety post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do measures of reactive balance control predict falls in people with stroke returning to the community? Mansfield, A., Wong, JS., McIlroy, WE., et al.[2016]

In a study of 183 stroke patients, 42% underwent a reactive balance control assessment using the lean-and-release method, which was implemented in an inpatient rehabilitation program.

Patients who received the assessment were generally younger and had better functional mobility and balance, indicating that the assessment may be more applicable to those with less severe impairments, highlighting a need for further research to adapt the assessment for patients with greater disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. Inness, EL., Mansfield, A., Biasin, L., et al.[2016]

This study investigates the effectiveness of perturbation-based balance training (PBT) compared to conventional intensive balance training (CIBT) in improving reactive stepping ability in 24 adults with chronic incomplete spinal cord injury over 8 weeks.

The primary outcome measures the ability to recover balance using a single step, which will help determine which training method is more effective for enhancing balance control and reducing fall risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial. Unger, J., Chan, K., Scovil, CY., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial. [2021]

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

The Effect of Reactive Balance Training on Falls in Daily Life: An Updated Systematic Review and Meta-Analysis. [2023]

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

Do measures of reactive balance control predict falls in people with stroke returning to the community? [2016]

5. England pubmed.ncbi.nlm.nih.gov

Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. [2016]

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

Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Rehabilitation clinicians' perspectives of reactive balance training. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Test-retest, intra- and inter-rater reliability of the reactive balance test in healthy recreational athletes. [2021]