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RECRUITING Not applicable ClinicalTrials.gov

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Sponsor: Mountain Home Research & Education Corporation • ClinicalTrials.gov ID: NCT06222450

Registry updated: 2026-10-08
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Description

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 traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.

Interventions

  • Vestibular Rehabilitation Therapy (VRT) (Behavioral)
    customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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)

Conditions

Mild Traumatic Brain Injury Dizziness

Locations

  • James A Haley VA Hospital — Tampa, Florida, United States
  • Duke University School of Medicine — Durham, North Carolina, United States
  • James H Quillen VAMC — Mountain Home, Tennessee, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record