Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

NCT06222450 | Recruiting

• 1 other identifier: TP210512
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mild Traumatic Brain Injury; Dizziness

Keywords

vestibular rehabilitation; digital health; remote therapeutic monitoring

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12

  The DHI is a self-report scale of the impact of dizziness on activities (Jacobson \& Newman, 1990). Total scores range from 0 (no handicap) to 100 (severe handicap).

  baseline, week 4, week 12

Secondary Outcomes (7)

• Change from baseline in modified Clinical Test of Sensory Interaction and Balance (mCTSIB) at week 4

  baseline, week 4

• Change from baseline in Functional Gait Assessment (FGA) at week 4

  baseline, week 4

• Change from baseline in 10 Meter Walk Test (10MWT) at week 4

  baseline, week 4

• Change from baseline in Visual Analogue Scales (VAS) at week 4

  baseline, week 4

• Change from baseline in Activities-specific Balance Confidence scale (ABC) at week 4

  baseline, week 4

Study Arms (2)

Standard VRT

ACTIVE COMPARATOR

The gaze stabilization, habituation and balance/gait HEP will be delivered using standard paper handouts

Behavioral: Vestibular Rehabilitation Therapy (VRT)

Digital VRT

EXPERIMENTAL

The gaze stabilization, habituation and balance/gait HEP will be delivered using a digital home program using the Health in Motion platform

Behavioral: Vestibular Rehabilitation Therapy (VRT)

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

Digital VRT; Standard VRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• Mountain Home Research & Education Corporation: lead

Study Sites (3)

James A Haley VA Hospital

Tampa, Florida, 33612, United States

RECRUITING

Duke University School of Medicine

Durham, North Carolina, 27710, United States

RECRUITING

James H Quillen VAMC

Mountain Home, Tennessee, 37684, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 2317323 BACKGROUND

• 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.

  PMID: 15449976 BACKGROUND

• 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.

  PMID: 17785375 BACKGROUND

• 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.

  PMID: 21820535 BACKGROUND

• 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.

  PMID: 16796772 BACKGROUND

• 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.

  PMID: 7814786 BACKGROUND

• Shepard NT, Telian SA, Smith-Wheelock M. Habituation and balance retraining therapy. A retrospective review. Neurol Clin. 1990 May;8(2):459-75.

  PMID: 2359384 BACKGROUND

• 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.

  PMID: 35970158 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Courtney Hall

CONTACT

423-926-1171; hallcd1@etsu.edu

Stephanie Panoncillo

CONTACT

423-926-1171; stephanie.panoncillo@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)