Effectiveness of VestAid App

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
BlueHalo
Study ID
NCT06683417
Status
Not Yet Recruiting

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Conditions

  • Balance Deficits
  • Dizziness
  • MTBI - Mild Traumatic Brain Injury
  • Vestibular Disease
  • Vestibular Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Vestibular Rehabilitation Aid — DEVICE
    The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI. Each participant\'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\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10.
  • Standard of care vestibular rehabilitation — OTHER
    Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2024
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VestAid
    Use of VestAid tablet application to aid vestibular rehabilitation
  • Active Comparator: Standard of Care vestibular rehabilitation
    Use of standard of care vestibular rehabilitation

Primary Outcome Measure

Dizziness Handicap Inventory (DHI) [ Time Frame: From enrollment weekly for 6 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15219
Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA
[email protected]
412-383-6642

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By research site
University of Pittsburgh· Pittsburgh, PA

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