RECRUITINGINTERVENTIONAL

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

BEHAVIORAL

Vestibular Rehabilitation Therapy (VRT)

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

Locations (3)

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