Effectiveness of VestAid App
Vestibular Rehabilitation Aid (VestAid)
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 12, 2024
November 1, 2024
12 months
November 8, 2024
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dizziness Handicap Inventory (DHI)
A self report measure of dizziness (questionnaire)
From enrollment weekly for 6 weeks.
Secondary Outcomes (1)
Secondary Endpoint
From enrollment weekly for 6 weeks
Study Arms (2)
VestAid
EXPERIMENTALUse of VestAid tablet application to aid vestibular rehabilitation
Standard of Care vestibular rehabilitation
ACTIVE COMPARATORUse of standard of care vestibular rehabilitation
Interventions
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.
Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BlueHalolead
- University of Pittsburghcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Related Publications (6)
Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690.
PMID: 22027077BACKGROUNDShepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.
PMID: 7816453BACKGROUNDGottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691.
PMID: 22027078BACKGROUNDHall 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: 16796772BACKGROUNDEssery 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: 27097761BACKGROUNDMucha 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: 25106780BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 12, 2024
Study Start
January 15, 2025
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 12, 2024
Record last verified: 2024-11