Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
NCT05714150

Balance After Traumatic Brain Injury

Led by VA Office of Research and Development · Updated on 2026-04-24

70

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Balance After Traumatic Brain Injury

Who Can Participate

Age: 50Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 75 years
  • Prior moderate closed-head traumatic brain injury at least 10 years before enrollment
  • Confirmation of moderate TBI by standardized interview using criteria including loss of consciousness 30 minutes to 24 hours, altered consciousness over 24 hours, post-traumatic amnesia 1 to 7 days, or abnormal imaging
  • Self-reported full recovery from the TBI
  • Score of 90 or higher on the Activities Specific Balance Confidence Scale
  • Score of 19 or higher on the telephone Montreal Cognitive Assessment
  • Living in the community and able to travel to the research site
Not Eligible

You will not qualify if you...

  • Neurological injury or disease other than prior moderate TBI
  • Current clinically significant post-traumatic stress disorder (PCL score over 30)
  • Severe arthritis interfering with balance or mobility tasks
  • Current substance abuse
  • Uncontrolled major depressive episode or severe psychiatric illness unrelated to TBI
  • Severe obesity (BMI over 35)
  • Unstable cardiovascular disease
  • Lung disease requiring supplemental oxygen
  • Renal disease requiring dialysis
  • Serious uncontrolled diabetes
  • Terminal illness
  • Myocardial infarction or major heart surgery in the past year
  • Cancer treatment in the past year except certain skin or early-stage cancers with excellent prognosis
  • Uncontrolled hypertension at rest (systolic over 180 mmHg or diastolic over 100 mmHg)
  • Bone fracture in the past year
  • Hip joint replacement or metal implants interfering with bone density assessment
  • Use in past 180 days of drugs affecting bone mineral density
  • Chronic use of systemic glucocorticoids over 7.5 mg/day prednisone equivalent
  • Current physical therapy for lower extremity function
  • Enrollment in clinical trials jeopardizing safety or scientific integrity
  • Inability to communicate sufficiently or non-English speaking
  • Other medical conditions adversely affecting balance, cognition, or eye movement
  • Safety or compliance concerns judged by the investigative team

AI-Screening

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Trial Site Locations

Total: 1 location

1

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States, 32608-1135

Actively Recruiting

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Research Team

D

David J Clark, DSc

CONTACT

B

Brigette Cox, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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