CClinicalTrials.gg
CompletedNCT04219696Updated Sep 29, 2026

Determining the Optimal Dose of Reactive Balance Training After Stroke

An interventional study of Reactive balance training in Stroke, sponsored by Toronto Rehabilitation Institute. Completed at 1 site in Canada. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Toronto Rehabilitation Institute · Not applicable, Interventional, and Treatment

Updated Sep 29, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Toronto Rehabilitation Institute is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Reactive balance training

  • Experimental
    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.

    Other: Reactive balance training

  • Experimental
    6 sessions

    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

  • OtherReactive 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.

06

What researchers measure

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.

    Time frame: 6 months post-discharge

Secondary outcomes

  1. Rate of accrual

    Number of participants recruited per month

    Time frame: Through study completion, an average of 18 months

  2. Rate of missing data

    Number of complete datasets for each of the other pre-specified outcomes

    Time frame: Through study completion, an average of 18 months

  3. Compliance with the intervention

    Number of prescribed training sessions attended

    Time frame: Through study completion, an average of 18 months

Other outcomes

  1. Chedoke-McMaster Stroke Assessment

    Construct: motor recovery. Range: 1-7. Higher scores indicate improved recovery.

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

  2. Mini-Balance Evaluation Systems Test

    Construct: Anticipatory balance control, reactive balance control, gait, and sensory orientation in balance. Scale range: 0-28 (total), 0-6 (anticipatory balance control), 0-6 (reactive balance control), 0-10 (gait), 0-6 (sensory orientation). Higher values represent improved outcome. The total score is created by adding the sub-scale scores

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

  3. Activities-specific Balance Confidence Scale

    Construct: balance confidence. Scale range: 0-100. Higher values represent improved outcome

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

  4. Reactive balance control following novel unpredictable postural perturbation

    Participants will be outfitted with reflective markers, and will complete 8-10 walking trials on a movable platform. On one trial, the platform will move forward suddenly on heel strike to trigger a slip-like perturbation. On another trial, the platform will move backward suddenly on toe-off to trigger a trip-like perturbation. The platform will only move during these two trials, such that the perturbation will be unpredictable to participants. These perturbations differ from what will be used during training, and will measure transfer of training to novel and ecological loss of balance. Biomechanical stability when responding to the perturbation will be measured using an established method that considers the distance between the centre of mass and base of support; in general, a more posteriorly- (slip) or anteriorly-located (trip) centre of mass is considered less stable.

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

  5. Physical Activity Scale for Individuals with Physical Disabilities

    Construct: physical activity in daily life. Scale range: not applicable (the maximum score that is technically achievable would not be feasible). Higher scores represent improved outcome

    Time frame: Average of three scores at approximately 2-, 4- and 6-months post-discharge

  6. Subjective Index of Physical and Social Outcome

    Construct: participation Scale range: 0-40 (total); 0-20 (social sub-scale), 0-20 (physical sub-scale). Higher scores represent improved outcome. The total score is the sum of the sub-scale scores

    Time frame: Average of three scores at approximately 2-, 4- and 6-months post-discharge

07

Study locations

1 site
  • Toronto Rehabilitation Institute
    Toronto, Ontario M5G 2A2, Canada
08

References and documents

Publications

  • 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. PubMed 32847916 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 29, 2026
Primary completion
Sep 2025→Oct 22, 2025 (actual)
Sep 29, 2026
Study completion
Sep 2026→Oct 22, 2025 (actual)
Sep 29, 2026
Also revised
sponsor
Show all 1 update
  1. Sep 29, 2026
    Active, not recruiting→Completed
    Primary completion Sep 2025→Oct 22, 2025 (now actual)
    Study completion Sep 2026→Oct 22, 2025 (now actual)
    Sponsor Collaborators changed
    + 2 other changes: site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04219696
Lead sponsor
Toronto Rehabilitation Institute
Collaborators
Heart and Stroke Foundation of Canada
Responsible party
Avril Mansfield (Scientist, Toronto Rehabilitation Institute) — Principal investigator
First posted
Jan 7, 2020
Start date
Aug 20, 2020
Primary completion
Oct 22, 2025
Completion
Oct 22, 2025
Last update
Sep 29, 2026

Study contacts

Avril Mansfield, PhD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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