Determining the Optimal Dose of Reactive Balance Training After Stroke

NCT ID: NCT04219696

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1 session

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.

Group Type: ACTIVE_COMPARATOR

Reactive balance training

Intervention Type: 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.

3 sessions

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.

Group Type: EXPERIMENTAL

Reactive balance training

Intervention Type: 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.

6 sessions

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

Group Type: EXPERIMENTAL

Reactive balance training

Intervention Type: 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.

Interventions

Reactive balance training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation Canadian Partnership for Stroke Recovery

UNKNOWN

Sponsor Role: collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Avril Mansfield

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avril Mansfield, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32847916 (View on PubMed)

Other Identifiers

19-6001

Identifier Type: -

Identifier Source: org_study_id