Determining the Optimal Dose of Reactive Balance Training After Stroke - a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Toronto Rehabilitation Institute
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Rate of falls in daily life
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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?
Investigators
Avril Mansfield
Scientist
Toronto Rehabilitation Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Rate of falls in daily life
Time Frame: 6 months post-discharge
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.
Secondary Outcomes
- 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)