NCT05714150 · VA Office of Research and Development
Balance After Traumatic Brain Injury
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Complex Balance Tasks
The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform.
Primary outcome measures
Center of Pressure (COP) control
Time frame: Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)
Participants will receive real-time feedback of their center of pressure location, by observing a tracing on a television screen. They will shift their body weight in order to move the center of pressure, and will attempt to follow a pre-defined trajectory that is shown on the screen.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Assessment, which indicates absence of major cognitive impairment.
- living in the community and able to travel to the research site
Exclusion criteria
- Enrollment Criteria for Participant with TBI (TBI+ group) Exclusion criteria
- Neurological injury or disease other than prior history of moderate TBI
- Current clinically significant post-traumatic stress disorder (PCL score \>30)
- severe arthritis, such as awaiting joint replacement, that would interfere with participation balance/mobility tasks
- Current substance abuse
- Current uncontrolled major depressive episode, history of severe psychiatric illness unrelated to TBI (e.g., bipolar 1 or schizophrenia).
- severe obesity (body mass index \> 35)
- unstable cardiovascular disease (for example, recent angina or uncontrolled high blood pressure)
- lung disease requiring use of supplemental oxygen
- renal disease requiring dialysis
- serious uncontrolled diabetes
- terminal illness
- myocardial infarction or major heart surgery in the previous year
- cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
- uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
- bone fracture in the previous year
- hip joint replacement or metal implants that would preclude accurate assessment of lean mass or hip bone mineral density
- Use of any pharmacologic agents (within past 180-days) that are known to influence BMD, including anti-resorptive or bone anabolic therapies, any compounded or over-the-counter androgenic hormone or androgen precursor, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone?
- Chronic use of systemic glucocorticoids \>7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg)
- current participation in physical therapy for lower extremity function
- current enrollment in a clinical trial that might jeopardize safety or scientific integrity of either trial
- unable to communicate sufficiently with study personnel, and/or non-English speaking
- other medical conditions other that would adversely affect balance, cognition, or oculomotor function.
- clinical judgment of investigative team regarding safety or non-compliance.
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations