Optimal Intensity of Reactive Balance Training Post-stroke
NCT Number: NCT06555016
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Accidental Fall|Stroke
Interventions: BEHAVIORAL: Reactive balance training|BEHAVIORAL: Walking
Sponsor: Toronto Rehabilitation Institute
Collaborators: Heart and Stroke Foundation of Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-04
Locations: Toronto Rehabilitation Institute, Toronto, Ontario, M5G 2A2, Canada

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. 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.

Primary Outcome Measures: Number of steps, Learning rate for number of steps to recover from 'backward fall' balance perturbations, One week
Secondary Outcome Measures: Step initiation time, Time from perturbation onset time to foot off time, One week post-training|Step execution time, Time from foot off to foot contact of the first step, One week post-training|Step length, Difference in foot position from foot off to foot contact, One week post-training|Braking impulse, Antero-posterior shear force generated over time on step contact, 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, One week post-training|mini-Balance Evaluation Systems test, Scale range: 0-28; higher values indicate better outcome, One week post-training|Falls Efficacy Scale International, Scale range: 10-100; higher values indicate worse outcome, One week and 12 months post-training|Adverse outcomes, Two weeks
Other Outcome Measures: Fall incidence, Falls in daily life, 12 months post-training|Injurious fall incidence, 12 months post-training|5-level EuroQoL health status measure (EQ-5D-5L), Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome, One week and 12-months post-training|Number of participants with fear of falling, One week and 12-months post-training|Number of participants with activity curtailment due to fear of falling, One week and 12-months post-training