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Not yet recruiting NCT06683417

Effectiveness of VestAid App

No phase Interventional MTBI - Mild Traumatic Brain Injury Vestibular Disease Balance Deficits Vestibular Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vestibular Rehabilitation Aid, Standard of care vestibular rehabilitation.
Who it may be relevant to
Registry conditions: MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Balance Deficits, Vestibular Disorders. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vestibular Rehabilitation Aid (VestAid)

Overview

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.

Interventions

  • Device 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\'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
  • Other Standard of care vestibular rehabilitation
    Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Primary outcome measures

  • Dizziness Handicap Inventory (DHI) [Time frame: From enrollment weekly for 6 weeks.]
Secondary outcome measures (1)
  • Secondary Endpoint [Time frame: From enrollment weekly for 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Publications

  • Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690. PMID 22027077
  • Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25106780

Identifiers

NCT: NCT06683417 · STUDY24060038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗