Reactive Balance Training for Stroke

Overseen By Avril Mansfield, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Rehabilitation Institute

Disqualifiers: Parkinson's, Cognitive impairment, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

63 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

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

Research shows that Reactive Balance Training (RBT) can improve balance reactions and reduce fall risk in people who have had a stroke. Studies found that RBT led to better balance control and fewer falls compared to traditional balance training, and these improvements were maintained over time. ^{1 2 3 4 5}

Is Reactive Balance Training safe for humans?

Reactive Balance Training (RBT) has been used safely in studies with stroke survivors and healthy older adults, showing improvements in balance without reported safety concerns. ^{1 2 4 6 7}

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

Reactive Balance Training (RBT) is unique because it focuses on improving balance reactions by exposing patients to controlled, destabilizing movements, helping them better react to prevent falls. Unlike traditional balance training, RBT specifically targets the ability to take quick, corrective steps, which is crucial for reducing fall risk in stroke survivors. ^{1 2 3 4 5}

What is the purpose of this trial?

Falls in daily life are a serious risk for people with stroke. A new type of balance training, called reactive balance training (RBT). may help to reduce this risk of falling. In some previous studies participants improved their balance reactions a lot after RBT, whereas others did not improve at all. These studies used different types and amounts of training. Differences in training program features might explain differences in the study results. Training intensity is the difficulty or challenge of the training program. For other types of exercise (like 'cardio' or strength training) if the intensity of exercise is increased, someone can get the same benefits in less time than with lower intensity exercise. Physiotherapists report that they have limited time in rehabilitation to do everything they need to do with their stroke patients, so it would be valuable to know if high-intensity RBT improves balance reactions quickly. The goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. People with chronic stroke will be randomly placed in one of three groups: high-intensity RBT, moderate-intensity RBT, or a walking control group. The investigators will find the fastest moving platform speed that participants can respond to with single step (multi-step threshold). There will then be 4 1-hour long training sessions in one week. Participants in the high-intensity group will experience platform movements that are 50% faster than the multi-step threshold. Participants in the moderate-intensity group will experience platform movements at the multi-step threshold. Participants in both RBT groups will experience 36 multi-directional platform movements in each training session, causing them to start to fall forwards, to the left, or to the right. Participants in the walking group will walk on the platform 36 times without any platform movements. The investigators will measure how quickly people improve their balance reactions over the training program.

Research Team

Avril Mansfield, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals who have had a stroke and are at risk of falling. They should be in the chronic phase of their recovery, meaning some time has passed since their stroke. The study aims to find out if high-intensity balance training can improve balance reactions faster than moderate-intensity training or just walking.

Inclusion Criteria

I had a stroke more than 6 months ago.

Exclusion Criteria

I have a neurological condition like Parkinson's that affects my balance.

Cognitive impairment (Montreal Cognitive Assessment score <26) or severe language or communication difficulties affecting understanding instructions

Currently attending in- or out-patient physiotherapy or supervised exercise

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reactive balance training (RBT) or walking control sessions for 1 hour over 4 consecutive days

1 week

4 visits (in-person)

Follow-up

Participants are monitored for retention of learning and adverse outcomes post-training

1 week

1 visit (in-person)

Long-term follow-up

Participants are assessed for falls efficacy and fall incidence over an extended period

12 months

Treatment Details

Interventions

• Reactive Balance Training

Trial Overview The study tests reactive balance training (RBT) intensity levels on improving balance after a stroke. Participants will be randomly assigned to either high-intensity RBT, moderate-intensity RBT, or a walking control group without platform movements, with sessions lasting one hour over one week.

Participant Groups

Group I: High intensity reactive balance training Experimental Treatment 1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days.Participants assigned to the RBT groups will experience 36 multi-directional (left-, right-, and forward-fall) perturbations in each training session, presented in an unpredictable sequence. Balance perturbations will be provided using a custom moving platform. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s\^2 the high intensity will be 3 m/s\^2.

Group II: Moderate intensity reactive balance training Active Control 1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days.Participants assigned to the RBT groups will experience 36 multi-directional (left-, right-, and forward-fall) perturbations in each training session, presented in an unpredictable sequence. Balance perturbations will be provided using a custom moving platform. Participants assigned to the moderate-intensity RBT group will experience perturbations at the multi-step threshold.

Group III: Walking control group Placebo Group 1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days. Participants in the walking control group will complete 36 unperturbed walking trials on the moving platform in each training session.

Who Is Running the Clinical Trial?

Toronto Rehabilitation Institute

Lead Sponsor

Trials

55

Recruited

6,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Findings from Research

Reactive balance training (RBT) significantly improved balance reaction impairments in individuals with sub-acute stroke, showing better outcomes in foot-off times and reduced reliance on preferred limb stepping compared to traditional balance training.

The study demonstrated that RBT not only led to immediate improvements post-intervention but also maintained these benefits at a 6-month follow-up, supporting its effectiveness in inpatient rehabilitation settings.

NCBI (Pubmed)

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. Schinkel-Ivy, A., Huntley, AH., Danells, CJ., et al.[2021]

Perturbation-based balance training (PBT) significantly improved reactive balance control in individuals with chronic stroke, as evidenced by a decrease in the frequency of extra steps taken in response to support-surface perturbations after 6 weeks of training.

In contrast, traditional balance training did not show similar improvements, highlighting the effectiveness of PBT in rehabilitation programs aimed at reducing fall risk in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? Schinkel-Ivy, A., Huntley, AH., Aqui, A., et al.[2019]

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]

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]

A review of nine studies involving 364 participants found insufficient evidence that perturbation-based balance training effectively reduces falls in individuals with stroke.

The training protocols varied widely among studies, leading to inconsistent results regarding the impact of this training on common fall risk factors, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. Brown, D., Simpkins, C., Yang, F.[2023]

The study aims to evaluate whether perturbation-based balance training can effectively reduce fall occurrences in individuals with chronic stroke, addressing a significant post-stroke complication.

Participants will undergo training twice a week for 6 weeks, with follow-up assessments on falls and balance confidence over 12 months, potentially leading to improved mobility and daily activity engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. Mansfield, A., Aqui, A., Centen, A., et al.[2019]

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

Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? [2019]

3. 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]

4. 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]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of perturbation-based balance training on reducing fall risk among individuals with stroke. [2023]

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

Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. [2019]