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Behavioural Intervention

Balance Training for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

For Traumatic Brain Injury: Be between the ages of 18 and 70

For Traumatic Brain Injury: Be able to stand unsupported for 5 minutes

Must not have

For Healthy Individuals: Have any additional medical conditions that affect bones, muscles, or nerves that would interfere with movement or sensation

For Traumatic Brain Injury: Have any previously diagnosed history of balance problems prior to TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess whether a balance training program can help people who have had traumatic brain injuries avoid falls.

Who is the study for?

This trial is for individuals aged 18-70 who have had a traumatic brain injury (TBI) at least 6 months ago, are medically stable for the past 3 months, can stand unaided for 5 minutes, and agree to follow study procedures without changing medications drastically.

What is being tested?

The trial tests a balance training program using Neurocom's Balance Platform. It aims to improve anticipatory and compensatory postural responses in TBI patients through visual cues and platform oscillations over multiple sessions.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort or fatigue from balance exercises. Safety measures like harnesses and spotters are in place to minimize risks such as falls during the intervention.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old with a traumatic brain injury.

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I can stand by myself for 5 minutes.

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I can stand by myself for 5 minutes without support.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I do not have conditions affecting my movement or sensation.

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I had balance issues before my traumatic brain injury.

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I have had a traumatic brain injury that involved an object piercing my skull.

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I have severe heart issues like a heart attack or serious heart failure.

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I have a condition that significantly affects how my leg works or is aligned when I stand.

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I have a condition from a brain injury that affects how my leg works or aligns when I stand.

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I can stand without using an ankle foot brace.

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My blood pressure goes up and down due to a brain injury.

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I have severe heart issues like a heart attack or heart failure.

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I have conditions affecting my balance due to a brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures

Berg Balance Assessment

Fall Efficacy Scale -International

Secondary study objectives

Center of Mass (CoM)

Center of Pressure (CoP)

Joint kinematics

+4 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: TBI Intervention GroupExperimental Treatment1 Intervention

Participants will participate in 16 anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) training sessions using the Neurocom Balance Platform. Each session will last for 1 hour. During the APA portion, a visual cue on the front screen in the form of a countdown timer showing the remaining seconds to the onset of the upcoming perturbation. This information will allow an opportunity for the participant to adjust their posture to handle the upcoming perturbation in the best possible way and also train them to anticipate upcoming disturbances and execute corrective motor outputs. This will ensure the generation of APA in a consistent and repetitive manner. In CPA, after a 5 second pause, the platform will oscillate at 1 Hz, with a constant amplitude, in the anterior-posterior direction for 50 seconds, followed by an additional 5 second quiet period. The participant will wear a safety harness at all times and a spotter will be present at all times.

Group II: TBI Control GroupActive Control1 Intervention

No intervention is provided

Group III: Healthy ControlActive Control1 Intervention

No intervention is provided

0 / 14Eligibility criteria met