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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I can stand by myself for 5 minutes without support.
Select...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anticipatory Postural Adjustment- Compensatory Postural Adjustment measures
Berg Balance Assessment
Fall Efficacy Scale -International
Secondary outcome measures
Center of Mass (CoM)
Center of Pressure (CoP)
Joint kinematics
+4 moreTrial 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
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,693 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have conditions affecting my movement or sensation.I had balance issues before my traumatic brain injury.I am between 18 and 70 years old with a traumatic brain injury.I struggle to follow or respond to commands, affecting my study participation.I have been stable for 3 months since my last traumatic brain injury.I have had a traumatic brain injury that involved an object piercing my skull.I have had a lower limb injury in the last 3 months.I have severe heart issues like a heart attack or serious heart failure.I can stand by myself for 5 minutes.I have a condition that significantly affects how my leg works or is aligned when I stand.I won't change my medications significantly for the next month.I have a condition from a brain injury that affects how my leg works or aligns when I stand.I can stand without using an ankle foot brace.My blood pressure goes up and down due to a brain injury.I haven't had any injuries or diseases in the last 3 months.I can stand by myself for 5 minutes without support.I have severe heart issues like a heart attack or heart failure.I was diagnosed with a traumatic brain injury at least 6 months ago.I don't plan to change my medications significantly soon.I have conditions affecting my balance due to a brain injury.I am between 18 and 70 years old.I am taking medication that could affect my balance or muscle coordination due to a brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: TBI Intervention Group
- Group 2: TBI Control Group
- Group 3: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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