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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 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.
Select...
I am between 18 and 70 years old.

Timeline

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

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 more

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

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,663 Total Patients Enrolled

Media Library

Perturbation-based Training with visual cues using Neurocom (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05268484 — N/A
Traumatic Brain Injury Research Study Groups: TBI Intervention Group, TBI Control Group, Healthy Control
Traumatic Brain Injury Clinical Trial 2023: Perturbation-based Training with visual cues using Neurocom Highlights & Side Effects. Trial Name: NCT05268484 — N/A
Perturbation-based Training with visual cues using Neurocom (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268484 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment seek to include participants who are over 55 years old?

"Qualified applicants must be between the ages of 18 to 70. This trial offers 61 options for minors and 226 opportunities for seniors aged 65 or above."

Answered by AI

Are there any current openings for participants in this clinical trial?

"According to clinicaltrials.gov, the research project is presently looking for volunteers and was first published on June 26th 2019 with the latest update occurring February 25th 2022."

Answered by AI

What is the maximum number of participants that this research project can accommodate?

"Affirmative. As indicated on clinicaltrials.gov, the medical trial first advertised in June 2019 is still actively looking for participants. A total of 45 people need to be recruited from a single site and the most recent update was made two months ago - February 25th 20202."

Answered by AI

What results should we expect from this experiment?

"The primary metric that will be tracked throughout the 4-week trial is the Berg Balance Assessment. Researchers are also using Timed Up and Go (TUG), Mobility Course, and Center of Mass (CoM) as secondary measures for analysis. TUG entails a patient walking 3 meters from sitting to standing, returning back to their chair, and then resuming seated position; during Mobility Course participants wear activity monitors on wrist, ankle, and waist in order measure activities like walking, siting down or up stairs; CoM data collection involves having patients stand with harnesses while small perturbations occur which root mean squared values quantify postural"

Answered by AI

Is enrollment to this trial still available?

"Potential participants of this clinical trial must have sustained a traumatic brain injury, and be between the ages 18 to 70. 45 volunteers are needed for completion of the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI
2019. "Improving Anticipatory and Compensatory Postural Responses to Avoid Falls After TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268484.
~5 spots leftby Dec 2024
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