Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Part of paid clinical trials in Tampa, Florida.

Sponsor
Mountain Home Research & Education Corporation
Study ID
NCT06222450
Status
Recruiting
Apply to this trial

Conditions

  • Dizziness
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vestibular Rehabilitation Therapy (VRT) — BEHAVIORAL
    customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (3)

FacilityCityStateZIPSite coordinators
James A Haley VA HospitalTampaFlorida33612
Jemy Delikat
[email protected]
813-972-2000
Karen Skop (PRINCIPAL_INVESTIGATOR)
Duke University School of MedicineDurhamNorth Carolina27710
Kristal Riska, PhD
[email protected]
919-681-9458
Kristal Riska (PRINCIPAL_INVESTIGATOR)
James H Quillen VAMCMountain HomeTennessee37684
Stephanie Panoncillo
[email protected]
423-926-1171
Courtney Hall (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
James A Haley VA Hospital· Tampa, FLDuke University School of Medicine· Durham, NCJames H Quillen VAMC· Mountain Home, TN

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