Balance After Traumatic Brain Injury (NCT05714150) | Clinical Trial Compass
RecruitingNot Applicable
Balance After Traumatic Brain Injury
United States70 participantsStarted 2024-03-21
Plain-language summary
A moderate traumatic brain injury (TBI) occurring in early or middle adulthood might have long-lasting effects on the brain that can accelerate the decline of physical and cognitive function in older age. The proposed study seeks to better understand the implications of aging with a TBI, in order to help Veterans maintain their health and independence. The overarching hypothesis of this new line of research is that participants who experienced a moderate TBI in early or middle adulthood (at least 15 years prior to study enrollment) will have poorer performance on balance and cognitive tests, despite self-reporting no persistent motor or cognitive impairment from the TBI. The investigators also seek to evaluate the potential for practice-based learning and improvement of complex balance tasks in this population, to gain experience for conducting future rehabilitation studies. The long term goal of this line of research is to design rehabilitative and lifestyle interventions to preserve brain health and function in Veterans who have previously experienced a TBI.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion criteria
* Age 50-75. People of this age normally do not exhibit substantial balance or cognitive impairments, so observing a clear deficit between groups will provide compelling evidence of a TBI-related effect. This "younger old" age group will also help to avoid other comorbid health conditions of older age that would increase variability (uncertainty) in the data set.
* Prior history of moderate closed-head TBI at least 10 years prior to study enrollment. Single or multiple TBIs are acceptable. All participants who self-report a prior TBI will complete a standardized interview called the Ohio State University TBI Identification Method (OSU TBI-ID) to characterize and confirm the occurrence of a prior moderate TBI. Moderate TBI will be defined as any of the following:
* loss of consciousness from 30 minutes to 24 hours
* and/or alteration of consciousness/mental state for greater than 24 hours
* and/or post-traumatic amnesia for \>1 to \<7 days
* and/or abnormal structural imaging confirmed by medical records
* Affirmative response to the question: "At the present time, do you consider yourself to be fully recovered from the TBI?"
* Score on the Activities Specific Balance Confidence Scale of 90 or higher (out of 100 possible points), which indicates absence of self-reported balance/mobility deficits.
* Score of 19 or higher on the telephone version of the Montreal Cognitive …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Center of Pressure (COP) control
Timeframe: Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)