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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Florida
James A Haley VA Hospital
RECRUITING
Tampa
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Tennessee
James H Quillen VAMC
RECRUITING
Mountain Home
Contact Information
Primary
Courtney Hall
hallcd1@etsu.edu
423-926-1171
Backup
Stephanie Panoncillo
stephanie.panoncillo@va.gov
423-926-1171
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 68
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Congressionally Directed Medical Research Programs
Leads: Mountain Home Research & Education Corporation

This content was sourced from clinicaltrials.gov