Accidental FallNCT06555016
Optimal Intensity of Reactive Balance Training Post-stroke
A study testing Reactive balance training and Walking in people with Accidental Fall and Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Accidental Fall, Stroke
- What is being tested?
- Reactive balance training and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke (>6 months post-stroke)
Who cannot join
- Are unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Have another neurological condition that could affect balance control (e.g., Parkinson's disease);
- Have cognitive impairment (Montreal Cognitive Assessment8 score <26), or severe language or communication difficulties affecting understanding instructions;
- Have contraindications to RBT (has described by Mansfield et al., 2021), such as osteoporosis, activity restrictions due to cardiac event/surgery, or severe spasticity in the lower extremity; and/or
- Are currently attending in- or out-patient physiotherapy or supervised exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigel Majoni contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
Avril Mansfield, PhD, 416-597-3422 ext. 7831, avril.mansfield@uhn.ca
About this study
Official title: Optimal Intensity of Reactive Balance Training Post-stroke: a Randomized Controlled 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.
Read the detailed description
Remaining active after stroke is essential to recovery, maintaining quality of life, and reducing secondary stroke risk. However, impaired balance control post-stroke increases fall risk, contributes to fear of falling, and reduces overall mobility, activity, and community integration. Therefore, effective interventions to improve balance control and reduce fall risk are essential to ongoing recovery and quality of life post-stroke. However, while there is unequivocal evidence that exercise, specifically balance training, is the most effective intervention for preventing falls in older adults without stroke, it is unclear if exercise prevents falls after stroke. Effective balance reactions (e.g., reactive stepping) are essential to avoid falling following a loss of balance, or balance perturbation. Reactive balance training (RBT), where clients experience repeated balance perturbations, is a novel type of exercise that aims to improve control of balance reactions. The investigators found that RBT improves reactive stepping ability in people with stroke. The investigators' recent meta-analysis found that RBT reduces rate of falls in daily life by ~40% among older adults and people with neurologic conditions, including stroke.
Clinicians are unsure how to optimally prescribe RBT. Exercise is often prescribed considering frequency, intensity, time, and type; these parameters are interdependent. For example, as intensity increases, frequency or time can decrease to achieve similar benefits. Clinicians report that limited time in rehabilitation services and competing rehabilitation goals and priorities mean that there is little time available to include RBT in a client's treatment plan. Therefore, it would be valuable to know if a short duration of high-intensity RBT can improve reactive balance control post-stroke. However, it is possible that people with stroke would not tolerate high intensity perturbations and, therefore, require lower-intensity but long-duration RBT. No study has directly compared different RBT training intensities among people with stroke.
The purpose of this study is to determine the optimal intensity of RBT post-stroke. The 'optimal' intensity is the intensity that improves reactive balance control in fewer sessions, without any apparent negative consequences (i.e., no increase in adverse outcomes). Responses to backward-fall perturbations will be assessed at the end of each session, and at the one-week retention time-point. An untrained perturbation (i.e., backward-fall perturbation) will be used to test transfer of learning to a novel context. Participants will experience 3 forward-directed platform translations, evoking a backward loss of balance, at the multi-step threshold. Because backward falls are more challenging than forward or lateral falls, a backward-fall perturbation at the forward-fall multi-step threshold should evoke a multi-step reaction, at least prior to training. Testing at each participant's multi-step threshold ensures that participants will initially experience challenges responding to the perturbation and there is room for improvement with training. The primary outcome will be number of steps taken to recover balance.
The investigators will calculate the learning rate for each participant by fitting an exponential function, a+b(e^(- t/x) ), to their data (average number of steps taken at each assessment time point), where a and b are constants, t is the assessment time point, and x is the learning rate.
The investigators expect that high-intensity training (50% above the multi-step threshold) will improve reactive stepping ability faster than moderate-intensity training (at the multi-step threshold). If the first reactive step is not effective in avoiding a fall after a loss of balance, additional steps must be taken; therefore, the number of steps needed to recover from a loss of balance is a global indicator of the effectiveness of balance reactions. The investigators will assess reactions to novel, untrained, balance perturbations throughout training, and calculate the rate of decline in average number of steps taken to recover balance (i.e., learning rate). Retention of learning will be assessed one week post-training. The investigators' primary hypotheses are:
- Adaptation rate will be faster for high-intensity RBT than moderate-intensity RBT;
- Adaptation rate will be faster for both RBT groups than a walking control group; and
- Both RBT groups will have better retention of learning than the walking control group; i.e., the RBT groups will take fewer steps to respond to the novel perturbation than the walking control group one week post-training.
Secondary objectives are to compare the rate of adverse outcomes between groups, and to determine the effect of different intensities of RBT on the mechanisms underlying improved reactive stepping ability, functional balance, falls efficacy, and participation in daily activities.
- Conditions
- Accidental Fall, Stroke
- Being tested
- Reactive balance training, Walking
- Keywords
- Postural balance, Rehabilitation, Exercise
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive balance trainingBehavioural
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
WalkingBehavioural
Overground walking.
| Study group | Role | What they receive |
|---|---|---|
| High intensity reactive balance training | Experimental | 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. Receives: Behavioral: Reactive balance training |
| Moderate intensity reactive balance training | Active comparator | 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. Receives: Behavioral: Reactive balance training |
| Walking control group | Sham comparator | 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. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
Learning rate for number of steps to recover from 'backward fall' balance perturbations
Measured: One week
Secondary outcomes (8)
Step initiation time
Time from perturbation onset time to foot off time
Measured: One week post-training
Step execution time
Time from foot off to foot contact of the first step
Measured: One week post-training
Step length
Difference in foot position from foot off to foot contact
Measured: One week post-training
Braking impulse
Antero-posterior shear force generated over time on step contact
Measured: One week post-training
Mechanical margin of stability
Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support
Measured: One week post-training
mini-Balance Evaluation Systems test
Scale range: 0-28; higher values indicate better outcome
Measured: One week post-training
Falls Efficacy Scale International
Scale range: 10-100; higher values indicate worse outcome
Measured: One week and 12 months post-training
Adverse outcomes
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start11 Nov 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Avril Mansfield, Toronto Rehabilitation Institute
- Investigators
- Avril Mansfield, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555016
- Sponsor's protocol ID
- 24-5322
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Majoni N, Inness EL, Jagroop D, Danells CJ, Mansfield A. Investigating the optimal reactive balance training intensity in people with chronic stroke: Study protocol for a randomized control trial. PLoS One. 2025 Sep 9;20(9):e0327937. doi: 10.1371/journal.pone.0327937. eCollection 2025.
PubMed 40924697
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Intensity of Reactive Balance Training Post-stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06555016
- Acronym / sponsor ID
- 24-5322
- Conditions
- Accidental Fall, Stroke
- Keywords
- Postural balance, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Remaining active after stroke is essential to recovery, maintaining quality of life, and reducing secondary stroke risk. However, impaired balance control post-stroke increases fall risk, contributes to fear of falling, and reduces overall mobility, activity, and community integration. Therefore, effective interventions to improve balance control and reduce fall risk are essential to ongoing recovery and quality of life post-stroke. However, while there is unequivocal evidence that exercise, specifically balance training, is the most effective intervention for preventing falls in older adults without stroke, it is unclear if exercise prevents falls after stroke. Effective balance reactions (e.g., reactive stepping) are essential to avoid falling following a loss of balance, or balance perturbation. Reactive balance training (RBT), where clients experience repeated balance perturbations, is a novel type of exercise that aims to improve control of balance reactions. The investigators found that RBT improves reactive stepping ability in people with stroke. The investigators' recent meta-analysis found that RBT reduces rate of falls in daily life by ~40% among older adults and people with neurologic conditions, including stroke.
Clinicians are unsure how to optimally prescribe RBT. Exercise is often prescribed considering frequency, intensity, time, and type; these parameters are interdependent. For example, as intensity increases, frequency or time can decrease to achieve similar benefits. Clinicians report that limited time in rehabilitation services and competing rehabilitation goals and priorities mean that there is little time available to include RBT in a client's treatment plan. Therefore, it would be valuable to know if a short duration of high-intensity RBT can improve reactive balance control post-stroke. However, it is possible that people with stroke would not tolerate high intensity perturbations and, therefore, require lower-intensity but long-duration RBT. No study has directly compared different RBT training intensities among people with stroke.
The purpose of this study is to determine the optimal intensity of RBT post-stroke. The 'optimal' intensity is the intensity that improves reactive balance control in fewer sessions, without any apparent negative consequences (i.e., no increase in adverse outcomes). Responses to backward-fall perturbations will be assessed at the end of each session, and at the one-week retention time-point. An untrained perturbation (i.e., backward-fall perturbation) will be used to test transfer of learning to a novel context. Participants will experience 3 forward-directed platform translations, evoking a backward loss of balance, at the multi-step threshold. Because backward falls are more challenging than forward or lateral falls, a backward-fall perturbation at the forward-fall multi-step threshold should evoke a multi-step reaction, at least prior to training. Testing at each participant's multi-step threshold ensures that participants will initially experience challenges responding to the perturbation and there is room for improvement with training. The primary outcome will be number of steps taken to recover balance.
The investigators will calculate the learning rate for each participant by fitting an exponential function, a+b(e^(- t/x) ), to their data (average number of steps taken at each assessment time point), where a and b are constants, t is the assessment time point, and x is the learning rate.
The investigators expect that high-intensity training (50% above the multi-step threshold) will improve reactive stepping ability faster than moderate-intensity training (at the multi-step threshold). If the first reactive step is not effective in avoiding a fall after a loss of balance, additional steps must be taken; therefore, the number of steps needed to recover from a loss of balance is a global indicator of the effectiveness of balance reactions. The investigators will assess reactions to novel, untrained, balance perturbations throughout training, and calculate the rate of decline in average number of steps taken to recover balance (i.e., learning rate). Retention of learning will be assessed one week post-training. The investigators' primary hypotheses are:
- Adaptation rate will be faster for high-intensity RBT than moderate-intensity RBT;
- Adaptation rate will be faster for both RBT groups than a walking control group; and
- Both RBT groups will have better retention of learning than the walking control group; i.e., the RBT groups will take fewer steps to respond to the novel perturbation than the walking control group one week post-training.
Secondary objectives are to compare the rate of adverse outcomes between groups, and to determine the effect of different intensities of RBT on the mechanisms underlying improved reactive stepping ability, functional balance, falls efficacy, and participation in daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity reactive balance training | Experimental | Behavioral: Reactive balance trainingTraining 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. |
| Moderate intensity reactive balance training | Active comparator | Behavioral: Reactive balance trainingTraining 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. |
| Walking control group | Sham comparator | Behavioral: WalkingTraining 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 may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic stroke (>6 months post-stroke)
Key exclusion criteria (5 listed)
- Are unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Have another neurological condition that could affect balance control (e.g., Parkinson's disease);
- Have cognitive impairment (Montreal Cognitive Assessment8 score <26), or severe language or communication difficulties affecting understanding instructions;
- Have contraindications to RBT (has described by Mansfield et al., 2021), such as osteoporosis, activity restrictions due to cardiac event/surgery, or severe spasticity in the lower extremity; and/or
- Are currently attending in- or out-patient physiotherapy or supervised exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reactive balance trainingReactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance. | Behavioural | High intensity reactive balance training, Moderate intensity reactive balance training |
| WalkingOverground walking. | Behavioural | Walking control group |
Primary outcome
Number of steps
Time frame: One week
Learning rate for number of steps to recover from 'backward fall' balance perturbations
8 secondary outcomes
Step initiation time
Time frame: One week post-training
Step execution time
Time frame: One week post-training
Step length
Time frame: One week post-training
Braking impulse
Time frame: One week post-training
Mechanical margin of stability
Time frame: One week post-training
mini-Balance Evaluation Systems test
Time frame: One week post-training
Falls Efficacy Scale International
Time frame: One week and 12 months post-training
Adverse outcomes
Time frame: Two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 40924697Majoni N, Inness EL, Jagroop D, Danells CJ, Mansfield A. Investigating the optimal reactive balance training intensity in people with chronic stroke: Study protocol for a randomized control trial. PLoS One. 2025 Sep 9;20(9):e0327937. doi: 10.1371/journal.pone.0327937. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nigel Majoni contact
Avril Mansfield, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive balance training and Walking in people with Accidental Fall and Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avril Mansfield, PhD (416-597-3422 ext. 7831, avril.mansfield@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.