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Behavioural Intervention

Reactive Balance Training for Stroke

N/A

Recruiting

Led By Avril Mansfield, PhD

Research Sponsored by Toronto Rehabilitation Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-training

Summary

"This trial aims to see if a new type of balance training called reactive balance training (RBT) can help reduce the risk of falls for people with stroke. The study will compare high-intensity R

Who is the study for?

This trial is for individuals who have had a stroke and are at risk of falling. They should be in the chronic phase of their recovery, meaning some time has passed since their stroke. The study aims to find out if high-intensity balance training can improve balance reactions faster than moderate-intensity training or just walking.

What is being tested?

The study tests reactive balance training (RBT) intensity levels on improving balance after a stroke. Participants will be randomly assigned to either high-intensity RBT, moderate-intensity RBT, or a walking control group without platform movements, with sessions lasting one hour over one week.

What are the potential side effects?

While specific side effects are not detailed here, participants may experience fatigue or muscle soreness due to the physical nature of the exercises. There's also an inherent risk of falls during the activities designed to challenge balance.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like Parkinson's that affects my balance.

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I cannot stand by myself for more than 30 seconds or walk 10 meters without help.

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I don't have severe bone loss, recent heart issues, or extreme muscle stiffness in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-training

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of steps

Secondary study objectives

Braking impulse

Falls Efficacy Scale International

Mechanical margin of stability

+4 more

Other study objectives

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

Fall incidence

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: High intensity reactive balance trainingExperimental Treatment1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days.Participants assigned to the RBT groups will experience 36 multi-directional (left-, right-, and forward-fall) perturbations in each training session, presented in an unpredictable sequence. Balance perturbations will be provided using a custom moving platform. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s\^2 the high intensity will be 3 m/s\^2.

Group II: Moderate intensity reactive balance trainingActive Control1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days.Participants assigned to the RBT groups will experience 36 multi-directional (left-, right-, and forward-fall) perturbations in each training session, presented in an unpredictable sequence. Balance perturbations will be provided using a custom moving platform. Participants assigned to the moderate-intensity RBT group will experience perturbations at the multi-step threshold.

Group III: Walking control groupPlacebo Group1 Intervention

Training sessions will be overseen by a physiotherapist and will last for 1 hour over 4 consecutive days. Participants in the walking control group will complete 36 unperturbed walking trials on the moving platform in each training session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reactive balance training

2018

N/A

~40

0 / 3Eligibility criteria met