RECRUITING

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-01
Study Completion:2026-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06222450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * at least 18 years of age,
  2. * diagnosis of mTBI,
  3. * documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score \< 23/30 or \< age-referenced norms)
  1. * severe neurological disease (e.g., Parkinson's disease, neuropathy),
  2. * moderate to severe cognitive impairment (\< 23/30 on the Montreal Cognitive Assessment),
  3. * significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),
  4. * vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and
  5. * severe depression/anxiety (≥ 9 on the 4-item Patient health Questionnaire)

Contacts and Locations

Study Contact

Courtney Hall
CONTACT
423-926-1171
hallcd1@etsu.edu
Stephanie Panoncillo
CONTACT
423-926-1171
stephanie.panoncillo@va.gov

Study Locations (Sites)

James A Haley VA Hospital
Tampa, Florida, 33612
United States
Duke University School of Medicine
Durham, North Carolina, 27710
United States
James H Quillen VAMC
Mountain Home, Tennessee, 37684
United States

Collaborators and Investigators

Sponsor: Mountain Home Research & Education Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2026-09-15

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2026-09-15

Terms related to this study

Keywords Provided by Researchers

  • vestibular rehabilitation
  • digital health
  • remote therapeutic monitoring

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury
  • Dizziness