Optimal Intensity of Reactive Balance Training Post-stroke

NCT06555016 | Recruiting

• 1 other identifier: 24-5322
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Accidental Fall; Stroke

Keywords

Postural balance; Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• Number of steps

  Learning rate for number of steps to recover from 'backward fall' balance perturbations

  One week

Secondary Outcomes (8)

• Step initiation time

  One week post-training

• Step execution time

  One week post-training

• Step length

  One week post-training

• Braking impulse

  One week post-training

• Mechanical margin of stability

  One week post-training

Other Outcomes (5)

• Fall incidence

  12 months post-training

• Injurious fall incidence

  12 months post-training

• 5-level EuroQoL health status measure (EQ-5D-5L)

  One week and 12-months post-training

Study Arms (3)

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.

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.

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.

Behavioral: Walking

Interventions

Reactive balance training BEHAVIORAL

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.

High intensity reactive balance training; Moderate intensity reactive balance training

Walking BEHAVIORAL

Overground walking.

Walking control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stroke (\>6 months post-stroke)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 40924697 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Avril Mansfield, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avril Mansfield, PhD

CONTACT

416-597-3422; avril.mansfield@uhn.ca

Nigel Majoni

CONTACT

nigel.majoni@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 15, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)