Status:
RECRUITING
Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI
Lead Sponsor:
Mountain Home Research & Education Corporation
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Mild Traumatic Brain Injury
Dizziness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild ...
Detailed Description
A single blind randomized controlled trial (RCT) will be performed with pre- and post-treatment assessment and a 3-month follow-up assessment. Study groups are defined by the method that the home exer...
Eligibility Criteria
Inclusion
- at least 18 years of age,
- diagnosis of mTBI,
- documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score \< 23/30 or \< age-referenced norms)
Exclusion
- severe neurological disease (e.g., Parkinson's disease, neuropathy),
- moderate to severe cognitive impairment (\< 23/30 on the Montreal Cognitive Assessment),
- significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),
- vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and
- severe depression/anxiety (≥ 9 on the 4-item Patient health Questionnaire)
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06222450
Start Date
December 1 2024
End Date
September 15 2026
Last Update
December 17 2025
Active Locations (3)
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1
James A Haley VA Hospital
Tampa, Florida, United States, 33612
2
Duke University School of Medicine
Durham, North Carolina, United States, 27710
3
James H Quillen VAMC
Mountain Home, Tennessee, United States, 37684