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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

Sub-acute stroke

Can stand independently for >30 seconds

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of three scores at approximately 2-, 4- and 6-months post-discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial will help determine the optimal dose of balance training for people with stroke in order to reduce falls.

Who is the study for?

This trial is for individuals who have had a stroke, can stand on their own for more than 30 seconds, live in the community, and are receiving outpatient rehab at the Toronto Rehabilitation Institute. They must be able to walk over 10 meters with or without a walking aid but not another person's help.

What is being tested?

The study tests how effective different amounts of reactive balance training (RBT) are in improving balance after stroke. Participants will be randomly placed into one of three groups to receive either 1, 3, or 6 sessions of RBT during routine outpatient rehabilitation.

What are the potential side effects?

Since this trial involves physical training exercises designed to improve balance post-stroke, potential side effects may include muscle soreness or fatigue. However, as it is a non-drug intervention, severe side effects are less likely compared to medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke not long ago.

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I can stand on my own for more than 30 seconds.

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I can walk more than 10 meters by myself, with or without a walking aid.

Exclusion Criteria

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

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I have recent injuries or conditions affecting my ability to walk or stand.

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I have heart-related activity restrictions or unstable reactions to exercise.

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I have severe muscle stiffness in my legs.

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I understand the purpose of the study and can give informed consent.

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I do not have an acute illness, extreme obesity, colostomy bags, catheters, infections, or pressure sores on my pelvis or trunk.

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I completed balance training in a hospital rehab program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average of three scores at approximately 2-, 4- and 6-months post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average of three scores at approximately 2-, 4- and 6-months post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of three scores at approximately 2-, 4- and 6-months post-discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of falls in daily life

Secondary study objectives

Compliance with the intervention

Rate of accrual

Rate of missing data

Other study objectives

Activities-specific Balance Confidence Scale

Chedoke-McMaster Stroke Assessment

Mini-Balance Evaluation Systems Test

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 6 sessionsExperimental Treatment1 Intervention

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

Group II: 3 sessionsExperimental Treatment1 Intervention

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.

Group III: 1 sessionActive Control1 Intervention

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.

0 / 9Eligibility criteria met