Effectiveness of VestAid App

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBlueHalo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: VestAidExperimental treatment 1 intervention
Group B: Standard of Care vestibular rehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dizziness Handicap Inventory (DHI)

A self report measure of dizziness (questionnaire)

Time frame
From enrollment weekly for 6 weeks.

Secondary outcomes

1

Secondary Endpoint

Subjective symptom reporting of dizziness, headache, nausea, and fogginess

Time frame
From enrollment weekly for 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BlueHalo

Lead sponsor

University of Pittsburgh

Collaborator

This trial is not recruiting at the moment. You can still explore other options: