Health TrialsbyHealthPanel

Optimal Intensity of Reactive Balance Training Post-stroke

ConditionsAccidental FallStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorToronto Rehabilitation Institute

About this trial

Falls in daily life are a serious risk for people with stroke. A new type of balance training, called reactive balance training (RBT). may help to reduce this risk of falling. In some previous studies participants improved their balance reactions a lot after RBT, whereas others did not improve at all. These studies used different types and amounts of training. Differences in training program features might explain differences in the study results.

Training intensity is the difficulty or challenge of the training program. For other types of exercise (like 'cardio' or strength training) if the intensity of exercise is increased, someone can get the same benefits in less time than with lower intensity exercise. Physiotherapists report that they have limited time in rehabilitation to do everything they need to do with their stroke patients, so it would be valuable to know if high-intensity RBT improves balance reactions quickly. The goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT.

People with chronic stroke will be randomly placed in one of three groups: high-intensity RBT, moderate-intensity RBT, or a walking control group. The investigators will find the fastest moving platform speed that participants can respond to with single step (multi-step threshold). There will then be 4 1-hour long training sessions in one week. Participants in the high-intensity group will experience platform movements that are 50% faster than the multi-step threshold. Participants in the moderate-intensity group will experience platform movements at the multi-step threshold. Participants in both RBT groups will experience 36 multi-directional platform movements in each training session, causing them to start to fall forwards, to the left, or to the right. Participants in the walking group will walk on the platform 36 times without any platform movements. The investigators will measure how quickly people improve their balance reactions over the training program.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic stroke (>6 months post-stroke)

Disqualifiers

Are unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;

Have another neurological condition that could affect balance control (e.g., Parkinson's disease);

Have cognitive impairment (Montreal Cognitive Assessment8 score <26), or severe language or communication difficulties affecting understanding instructions;

Have contraindications to RBT (has described by Mansfield et al., 2021), such as osteoporosis, activity restrictions due to cardiac event/surgery, or severe spasticity in the lower extremity; and/or

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reactive balance training

    Behavioral

    Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.

  • Walking

    Behavioral

    Overground walking.

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: High intensity reactive balance trainingExperimental treatment 1 intervention
Group B: Moderate intensity reactive balance trainingActive comparator 1 intervention
Group C: Walking control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of steps

Learning rate for number of steps to recover from 'backward fall' balance perturbations

Time frame
One week

Secondary outcomes

1

Step initiation time

Time from perturbation onset time to foot off time

Time frame
One week post-training
2

Step execution time

Time from foot off to foot contact of the first step

Time frame
One week post-training
3

Step length

Difference in foot position from foot off to foot contact

Time frame
One week post-training
4

Braking impulse

Antero-posterior shear force generated over time on step contact

Time frame
One week post-training

Other outcomes

1

Fall incidence

Falls in daily life

Time frame
12 months post-training
2

Injurious fall incidence

Time frame
12 months post-training
3

5-level EuroQoL health status measure (EQ-5D-5L)

Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome

Time frame
One week and 12-months post-training
4

Number of participants with fear of falling

Time frame
One week and 12-months post-training

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Toronto Rehabilitation Institute

Lead sponsor

Heart and Stroke Foundation of Canada

Collaborator

Source ClinicalTrials.gov
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