Accidental FallsNCT06657989
Optimal Intensity of Reactive Balance Training for Healthy Older Adults
A study testing Reactive balance training and Walking in people with Accidental Falls, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- 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
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2025to 31 Dec 2027
- Phase
- Interventional
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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling older adults (65-80 years old)
Who cannot join
- Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
- Score below normative values on the Montreal Cognitive Assessment;
- Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
- Have insufficient English language comprehension such that they cannot understand instructions;
- Have contraindications to reactive balance training such as severe osteoporosis; and/or
- Are currently attending 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.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2A2
David Jagroop, 416-597-3422 ext. 7614, david.jagroop@uhn.ca
About this study
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.
- Conditions
- Accidental Falls
- Being tested
- Reactive balance training, Walking
- Keywords
- Postural balance, Aging, Biomechanics, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive balance trainingBehavioural
Also called Perturbation-based balance training
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 | Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. 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 perturbation will be 3 m/s^2. Receives: Behavioral: Reactive balance training |
| Moderate intensity reactive balance training | Active comparator | Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2. Receives: Behavioral: Reactive balance training |
| Walking control group | Sham comparator | Participants assigned to the walking control group will complete 36 trials of unperturbed walking 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 reactive steps
Learning rate for number of steps to recover from 'backward fall' balance perturbations
Measured: Two weeks
Secondary outcomes (7)
Step initiation time
Time from perturbation onset time to foot off time
Measured: One week and 12 weeks post-training
Step execution time
Time from foot off to foot contact of the first step
Measured: One week and 12 weeks post-training
Step length
Difference in foot position from foot off to foot contact
Measured: One week and 12 weeks post-training
Braking impulse
Antero-posterior shear force generated over time on step contact
Measured: One week and 12 weeks 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 and 12 weeks post-training
Balance evaluation systems test
Scale ranges from 0-100, with higher scores indicating better outcome
Measured: One week and 12 weeks post-training
Falls efficacy scale - International
Scale range: 10-100; higher values indicate worse outcome
Measured: One week, 12 weeks, and 12 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start21 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- 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
- NCT06657989
- Sponsor's protocol ID
- 24-5665
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No