Clinical trial NCT04219696: Determining the Optimal Dose of Reactive Balance Training After Stroke
Official title: Determining the Optimal Dose of Reactive Balance Training After Stroke - a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation Canadian Partnership for Stroke Recovery
First posted: 2020-01-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: Rate of falls in daily life
timeFrame: 6 months post-discharge
Secondary outcomes:
measure: Rate of accrual
timeFrame: Through study completion, an average of 18 months
measure: Rate of missing data
timeFrame: Through study completion, an average of 18 months
measure: Compliance with the intervention
timeFrame: Through study completion, an average of 18 months
Other outcomes:
measure: Chedoke-McMaster Stroke Assessment
timeFrame: Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention
measure: Mini-Balance Evaluation Systems Test
timeFrame: Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention
measure: Activities-specific Balance Confidence Scale
timeFrame: Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention
measure: Reactive balance control following novel unpredictable postural perturbation
timeFrame: Pre-intervention (at admission), post-intervention (before discharge, approximately 4 weeks), and 6 months post-intervention
measure: Physical Activity Scale for Individuals with Physical Disabilities
timeFrame: Average of three scores at approximately 2-, 4- and 6-months post-discharge
measure: Subjective Index of Physical and Social Outcome
timeFrame: Average of three scores at approximately 2-, 4- and 6-months post-discharge
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Avril Mansfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.