App-based vestibular rehabilitation for adults with mTBI-related dizziness
Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury
This trial tests whether an app-based vestibular rehab program helps adults with dizziness from mild traumatic brain injury more than the usual home program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mountain Home Research & Education Corporation Academic / other |
| Locations | 3 sites (Tampa, Florida and 2 other locations) |
| Trial ID | NCT06222450 on ClinicalTrials.gov |
What this trial studies
This single-blind randomized controlled trial compares a standard home vestibular rehabilitation program to a digital program delivered via the Health in Motion app in adults with dizziness related to mTBI. Sixty-eight participants with sub-acute or chronic dizziness after mTBI will be randomized in blocks to either standard VRT (S-VRT) or digital VRT (D-VRT), complete prescribed gaze stabilization, habituation, balance and gait exercises for four weeks, and be supervised by a treating physical therapist. Blinded researchers will perform clinical balance and gait assessments before and after the 4-week intervention and again at three months, while treating therapists and participants are unblinded to group assignment. The primary comparison is improvement at discharge between the two delivery methods, with randomization stratified by symptom severity and recruitment across three U.S. medical centers.
Who should consider this trial
Good fit: Ideal participants are adults (≥18 years) with mTBI-related dizziness or imbalance (DHI ≥16 or functional gait assessment <23) in the sub-acute (2 weeks–3 months) or chronic (>3 months) phase.
Not a fit: Patients with severe neurological disease, significant cognitive impairment (MoCA <23), major orthopedic or vision limitations, or severe depression/anxiety are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app-based program could improve recovery or exercise adherence by making vestibular exercises easier to follow at home.
How similar studies have performed: Past studies and telehealth programs indicate vestibular rehabilitation is effective and digital delivery is promising, but randomized comparisons of app-based versus standard home programs are still limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Tampa, Florida and 2 other locations
- James A Haley VA Hospital — Tampa, Florida, United States (Recruiting)
- Duke University School of Medicine — Durham, North Carolina, United States (Recruiting)
- James H Quillen VAMC — Mountain Home, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Courtney Hall
- Email: hallcd1@etsu.edu
- Phone: 423-926-1171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.