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Not yet recruitingNCT06683417Updated Nov 12, 2024

Effectiveness of VestAid App

An interventional study of Vestibular Rehabilitation Aid and Standard of care vestibular rehabilitation in MTBI - Mild Traumatic Brain Injury, Vestibular Disease and Balance Deficits, sponsored by BlueHalo. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by BlueHalo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

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

Keywords

  • mTBI
  • vestibular rehabilitation
  • vestibular disorder
  • technology
  • application
  • dizziness
  • balance disorder
  • image processing
  • eye gaze compliance
  • VOR
03

In context

Brain Concussion

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 80 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

BlueHalo is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    VestAid

    Use of VestAid tablet application to aid vestibular rehabilitation

    Device: Vestibular Rehabilitation Aid

  • Active comparator
    Standard of Care vestibular rehabilitation

    Use of standard of care vestibular rehabilitation

    Other: Standard of care vestibular rehabilitation

Interventions

  • DeviceVestibular 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\'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.

    Also known as: VestAid

  • OtherStandard of care vestibular rehabilitation

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

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Publications

  • Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690. PubMed 22027077 ↗
  • Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9. PubMed 7816453 ↗
  • Gottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691. PubMed 22027078 ↗
  • 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. PubMed 16796772 ↗
  • Essery R, Geraghty AW, Kirby S, Yardley L. Predictors of adherence to home-based physical therapies: a systematic review. Disabil Rehabil. 2017 Mar;39(6):519-534. doi: 10.3109/09638288.2016.1153160. Epub 2016 Apr 21. PubMed 27097761 ↗
  • Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8. PubMed 25106780 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06683417
Lead sponsor
BlueHalo
Collaborators
University of Pittsburgh
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Jan 15, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Nov 12, 2024

Study contacts

Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA
Contact
whitney@pitt.edu
412-383-6642
Chelsea J Manetta, PT, DPT, NCS
Contact
cjm294@pitt.edu
4126487964

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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