Determining the Optimal Dose of Reactive Balance Training After Stroke

NCT04219696 | Active Not Recruiting

• 1 other identifier: 19-6001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Falls in daily life are one of the most significant complications for people with stroke. Fall rates are particularly high soon after discharge from stroke rehabilitation. A new type of balance training, called reactive balance training (RBT), can reduce fall rates after discharge from stroke rehabilitation. In our previous study, RBT was implemented as part of routine care, and as a result, the dose of training was different for each participant; participants completed between one and twelve 30-minute sessions of RBT. Previous research in healthy older adults suggests that a single session of RBT is enough to lead to lasting changes in reactive balance control and reduce fall rates in daily life. It is not clear if the same is true for people with stroke, who have more severe impairments and might need a higher dose of training to achieve the same benefits. The overall goal of this work is to determine the optimal dose of reactive balance training for people with stroke who are attending rehabilitation. This pilot study will determine the feasibility of a clinical trial to address this larger goal. People with sub-acute stroke will be randomly assigned to one of three groups: 1 session, 3 sessions, or 6 sessions of RBT. Each session will be 45 minutes long, and will occur as part of participants' routine out-patient rehabilitation. We will use our experiences with this pilot study to help design a larger study. Specifically, we will use this pilot study to answer the following questions: 1) what is the optimal sample size; 2) how long will it take to reach this sample size; 3) what outcome measures should be used; 4) how feasible is it to prescribe a specific dose of RBT to people with sub-acute stroke; and 5) what two intervention groups should be included in the larger trial?

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Rate of falls in daily life

  Participants will be asked to report falls ("an event that results in a person coming to rest unintentionally on the ground or other lower level") in the 6 months post-training. Participants will be provided with stamped, addressed postcards to mail to the research team every 2 weeks for 6 months post-training. Postcards will contain a calendar, on which participants will record falls. The research assistant will call participants who do not return the postcard to determine if any falls occurred. The research assistant will contact participants reporting a fall to complete a short questionnaire determining the cause and consequences of the fall.

  6 months post-discharge

Secondary Outcomes (3)

• Rate of accrual

  Through study completion, an average of 18 months

• Rate of missing data

  Through study completion, an average of 18 months

• Compliance with the intervention

  Through study completion, an average of 18 months

Other Outcomes (6)

• Chedoke-McMaster Stroke Assessment

  Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention

• Mini-Balance Evaluation Systems Test

  Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention

• Activities-specific Balance Confidence Scale

  Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention

Study Arms (3)

1 session

ACTIVE COMPARATOR

Participants will complete one 45-minute session of reactive balance training. Participants will experience 40-60 perturbations during this session. Participants will also complete 5 45-minute 'traditional' balance training sessions.

Other: Reactive balance training

3 sessions

EXPERIMENTAL

Participants will complete three 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session. Participants will also complete 3 45-minute 'traditional' balance training sessions.

Other: Reactive balance training

6 sessions

EXPERIMENTAL

Participants will complete six 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session.

Other: Reactive balance training

Interventions

Reactive balance training OTHER

A research physiotherapist will oversee reactive balance training (RBT) to ensure consistent RBT delivery across participants. Training strategies will be individualized to each participant, based on their balance impairments and rehabilitation goals. The RBT program includes multi-directional 'internal' and 'external' balance perturbations. Internal perturbations are achieved by asking the participant to complete tasks that challenge balance control, such that they lose balance when attempting to perform the task (e.g., kicking a soccer ball). External perturbation are delivered manually using a push or pull from the physiotherapist. As participants improve their reactive balance control, difficulty will be increased by shifting task requirements along a continuum from stable to mobile, and from predictable to unpredictable, and by increasing perturbation magnitude or imposing sensory or environmental challenges.

1 session; 3 sessions; 6 sessions

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sub-acute stroke;
• Receiving out-patient rehabilitation at the Toronto Rehabilitation Institute;
• Can stand independently for \>30 seconds;
• Can walk with or without a gait aid (but without assistance of another person) for \>10 metres; and
• Living in the community.

You may not qualify if:

• Completed reactive balance training during in-patient rehabilitation;
• Lower-extremity amputation, weight-bearing restrictions, recent lower-extremity injury or surgery (e.g., fracture), acute back or lower-limb pain, halo, aspen collar, history of fragility fracture and/or severe osteoporosis/osteopenia, contractures that prevent neutral hip or ankle;
• Activity restrictions following cardiac event/surgery, abnormal or unstable cardiovascular responses to exercise, arterial dissection;
• Severe spasticity in the legs;
• Cognitive impairment (i.e., unable to understand the purpose of training and/or to provide informed consent); and/or
• Acute illness (e.g., vomiting, fever), extreme obesity (exceeds safety harness weight limits), colostomy bags, indwelling catheter, infection, pressure sore on pelvis or trunk.

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Heart and Stroke Foundation Canadian Partnership for Stroke Recovery: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (1)

• Mansfield A, Inness EL, Danells CJ, Jagroop D, Bhatt T, Huntley AH. Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial. BMJ Open. 2020 Aug 26;10(8):e038073. doi: 10.1136/bmjopen-2020-038073.

  PMID: 32847916 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Avril Mansfield, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be obtained by a research assistant who will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 7, 2020
• Study Start: August 20, 2020
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)