Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI
NCT ID: NCT06222450
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
68 participants
INTERVENTIONAL
2024-12-01
2026-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During the pre-test session, the researcher will perform a standard vestibular evaluation including tests of balance and walking as well as questionnaires about dizziness impact on activities, balance confidence, motion sensitivity, and disability.
The treating clinician will create and provide a customized VRT home exercise program (HEP) per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training. Gaze stabilization exercises involve head movement while maintaining fixation on a target which may be stationary or moving. Habituation exercises are chosen based on movements (of self or the visual environment) that provoke symptoms and the participant performs several repetitions of motions that cause mild to moderate symptoms. Balance and gait exercises are chosen based on identified impairments and limitations and are performed under challenging sensory and dynamic conditions to optimize balance. General conditioning, such as a customized graduated walking program for endurance will be included.
All participants will receive verbal instructions (in Health in Motion the text instruction is accompanied with voice over), demonstration of, and feedback on, accurate performance of the gaze stabilization/habituation HEP per group assignment. The S-VRT group will only receive these instructions and feedback at the weekly clinic visit from the supervising clinician. The D-VRT group will receive exercise instructions and demonstration via the Rock Steady app the first time using a game and as requested thereafter. The supervising clinician will evaluate the participant's ability to accurately perform the exercises at each follow-up visit (1x/week) and will provide additional training/feedback as needed for both S-VRT and D-VRT groups.
All participants will be instructed to complete the gaze stabilization/habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. All participants will use a paper exercise log to record the performance of the HEP, regardless of group assignment. After completing the 4-week intervention, participants will be offered the option to continue using their current method or try the alternate method for the 3- month maintenance phase. After the 3-month maintenance phase, participants will complete the questionnaire about dizziness impact on daily activities.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard VRT
The gaze stabilization, habituation and balance/gait HEP will be delivered using standard paper handouts
Vestibular Rehabilitation Therapy (VRT)
customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training
Digital VRT
The gaze stabilization, habituation and balance/gait HEP will be delivered using a digital home program using the Health in Motion platform
Vestibular Rehabilitation Therapy (VRT)
customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vestibular Rehabilitation Therapy (VRT)
customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Congressionally Directed Medical Research Programs
FED
Mountain Home Research & Education Corporation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.
Walker ML, Austin AG, Banke GM, Foxx SR, Gaetano L, Gardner LA, McElhiney J, Morris K, Penn L. Reference group data for the functional gait assessment. Phys Ther. 2007 Nov;87(11):1468-77. doi: 10.2522/ptj.20060344. Epub 2007 Sep 4.
Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11.
Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
Shepard NT, Telian SA, Smith-Wheelock M. Habituation and balance retraining therapy. A retrospective review. Neurol Clin. 1990 May;8(2):459-75.
Heusel-Gillig L, Santucci V, Hall CD. Development and Validation of the Modified Motion Sensitivity Test. Otol Neurotol. 2022 Sep 1;43(8):944-949. doi: 10.1097/MAO.0000000000003641.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TP210512
Identifier Type: -
Identifier Source: org_study_id