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NCT Number: NCT06683417

Effectiveness of VestAid App

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: VestAid

Standard of care vestibular rehabilitation

Other

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

Primary outcomes

  1. Dizziness Handicap Inventory (DHI)

    Time frame: From enrollment weekly for 6 weeks.

    A self report measure of dizziness (questionnaire)

Secondary outcomes

  1. Secondary Endpoint

    Time frame: From enrollment weekly for 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea J Manetta, PT, DPT, NCS

CONTACT

[email protected]

4126487964

Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA

CONTACT

[email protected]

412-383-6642

Sponsors and collaborators

Lead sponsor

BlueHalo

Industry

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Vestibular Rehabilitation Aid (VestAid)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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