Determining the Optimal Dose of Reactive Balance Training After Stroke

Toronto Rehabilitation Institute

Status: Active, not recruiting

Conditions: Stroke

Treatments: Other: Reactive balance training

Study type: Interventional

Funder types: Other

Identifiers

NCT04219696

19-6001

Details and patient eligibility

About

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?

Enrollment: 36 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

1 session

Active Comparator group

Description:

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.

Treatment:

Other: Reactive balance training

3 sessions

Experimental group

Description:

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.

Treatment:

Other: Reactive balance training

6 sessions

Experimental group

Description:

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

Treatment:

Other: Reactive balance training