NCT06657989

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

October 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 27, 2025

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

October 23, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

Postural balanceAgingBiomechanicsRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Number of reactive steps

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

    Two weeks

Secondary Outcomes (7)

  • Step initiation time

    One week and 12 weeks post-training

  • Step execution time

    One week and 12 weeks post-training

  • Step length

    One week and 12 weeks post-training

  • Braking impulse

    One week and 12 weeks post-training

  • Mechanical margin of stability

    One week and 12 weeks post-training

  • +2 more secondary outcomes

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, 12 weeks, and 12 months post-training

  • +2 more other outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Walking

Interventions

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.

Also known as: Perturbation-based balance training
High intensity reactive balance trainingModerate intensity reactive balance training
WalkingBEHAVIORAL

Overground walking

Walking control group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling older adults (65-80 years old)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Avril Mansfield, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avril Mansfield, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 26, 2024

Study Start

January 21, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 27, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations