NCT06222450 Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI
| NCT ID | NCT06222450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mountain Home Research & Education Corporation |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2024-12-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06222450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06222450 currently recruiting?
Yes, NCT06222450 is actively recruiting participants. Contact the research team at hallcd1@etsu.edu for enrollment information.
Where is the NCT06222450 trial being conducted?
This trial is being conducted at Tampa, United States, Durham, United States, Mountain Home, United States.
Who is sponsoring the NCT06222450 clinical trial?
NCT06222450 is sponsored by Mountain Home Research & Education Corporation. The trial plans to enroll 68 participants.