App-based vestibular rehabilitation for adults with mTBI-related dizziness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.