Recruiting

Digital & Standard Vestibular Rehabilitation

Sponsor:

Mountain Home Research & Education Corporation

Code:

NCT06222450

Conditions

Mild Traumatic Brain Injury

Dizziness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vestibular Rehabilitation Therapy (VRT)

Study Details

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.

Conditions

Mild Traumatic Brain Injury

Dizziness

Study ID

NCT06222450

Start date

Dec 1, 2024

Status verified date

Dec, 2025

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard VRT

The gaze stabilization, habituation and balance/gait HEP will be delivered using standard paper handouts

experimental: Digital VRT

The gaze stabilization, habituation and balance/gait HEP will be delivered using a digital home program using the Health in Motion platform

Interventions

Vestibular Rehabilitation Therapy (VRT)

customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training

Primary outcome measure

  • Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12 [ Time Frame: baseline, week 4, week 12 ]

Central Contacts and Locations

Central contacts

Courtney Hall

423-926-1171hallcd1@etsu.edu

Stephanie Panoncillo

423-926-1171stephanie.panoncillo@va.gov

Locations

James A Haley VA Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jemy Delikat

813-972-2000jemy.delikat@va.gov

Principal Investigator:

Karen Skop

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kristal Riska, PhD

919-681-9458kristal.riska@duke.edu

Principal Investigator:

Kristal Riska

James H Quillen VAMC

Recruiting

Mountain Home, Tennessee, United States, 37684

Contacts

Stephanie Panoncillo

423-926-1171stephanie.panoncillo@va.gov

Principal Investigator:

Courtney Hall

More Information

Sponsor

Mountain Home Research & Education Corporation

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • vestibular rehabilitation
  • digital health
  • remote therapeutic monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mountain Home Research & Education Corporation on 2025-12-17.