NCT04219696Completed
Determining the Optimal Dose of Reactive Balance Training After Stroke
Determining the Optimal Dose of Reactive Balance Training After Stroke - a Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 17 Dec 2019
- Start date
- Aug 2020
- Primary completion date
- Oct 2025
- Lead sponsor
- Toronto Rehabilitation Institute
- Diseases
- Stroke
- NCT number
- NCT04219696
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From Aug 2020 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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.
Other
- Completed reactive balance training during in-patient rehabilitation;
- Severe spasticity in the legs;
Who the study is looking for
- 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.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Rehabilitation Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.