Effectiveness of VestAid App

NCT06683417 · tracked via the Priya Life Science USA tracker

Sponsor

BlueHalo

Phase

Not applicable

Started

2025-01-15

Last updated

2024-11-12

Condition(s) studied

MTBI - Mild Traumatic Brain InjuryVestibular DiseaseBalance DeficitsVestibular DisordersDizziness

Investigational drug(s) / intervention(s)

Vestibular Rehabilitation AidStandard of care vestibular rehabilitation

Vestibular Rehabilitation Aid: The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI. Each participant\&#39;s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\&#39;s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\&#39;s symptoms are greater than or equal to 8/10.

Standard of care vestibular rehabilitation: Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Study summary

This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion: * Snellen visual acuity (corrected) greater than 20/40 * No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz * Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity * At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale) * Internet access at home * No significant residual from past musculoskeletal or neuromuscular conditions * Ability ambulates unassisted * Diagnosed with a concussion or inner ear problem the last 30 days * Between 18-60 years of age * Can read and understand English * Has complaints of dizziness Exclusion criteria: * Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem * No access to internet at home * Younger than 18 years of age or older than 60 years of age * Cannot read or understand English * No complaints of dizziness and/or balance deficits * Have significant neuropathy * Cannot see tablet clearly at 1 meter * Neck pain \>5 on a 10-point pain scale.

Primary outcome measure(s)

Dizziness Handicap Inventory (DHI) — From enrollment weekly for 6 weeks.
A self report measure of dizziness (questionnaire)

Trial sites (1)

Facility	City	Region	Status
University of Pittsburgh	Pittsburgh	Pennsylvania

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06683417 on ClinicalTrials.gov ↗ ← All trials in the USA