Clinical trial NCT06683417: Effectiveness of VestAid App
Official title: Vestibular Rehabilitation Aid (VestAid)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: BlueHalo
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
First posted: 2024-11-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 \&gt;5 on a 10-point pain scale.

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: From enrollment weekly for 6 weeks.
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: From enrollment weekly for 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690.
citation: Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.
citation: Gottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691.
citation: 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.
citation: 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.
citation: 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.