Balance Deficits, Dizziness, MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Vestibular Disorders
Conditions
Keywords
mTBI, vestibular rehabilitation, vestibular disorder, technology, application, dizziness, balance disorder, image processing, eye gaze compliance, VOR
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.
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.
OTHERStandard of care vestibular rehabilitation
Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades
Sponsors
University of Pittsburgh
BlueHalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dizziness Handicap Inventory (DHI) | From enrollment weekly for 6 weeks. | A self report measure of dizziness (questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | From enrollment weekly for 6 weeks | Subjective symptom reporting of dizziness, headache, nausea, and fogginess |
Countries
United States
Contacts
Primary ContactSusan L Whitney, DPT, PhD, NCS, ATC, FAPTA
Backup ContactChelsea J Manetta, PT, DPT, NCS
Outcome results
None listed