About this trial
This parallel-group randomized controlled trial aims to determine if the location of the lesion(s) in the vestibular system (unilateral versus bilateral, lateral semi-circular canal versus otolith) impacts the effectiveness of adjunct take-home head-mounted display (HMD) virtual reality (VR) therapy in improving patient symptomatology. Fifty patients meeting inclusion criteria will be recruited from the principal investigator's neurotology clinic. Baseline symptomatology questionnaires will be completed, followed by random allocation to virtual reality and control groups. Vestibular rehabilitation and virtual reality protocols will be adhered to for 4 to 8 weeks, followed by symptomatology questionnaires. Data analysis will be conducted to answer the study's objectives.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants diagnosed with chronic (≥3 months) unilateral or bilateral peripheral vestibular disorders such as vestibular neuritis, labyrinthitis, Ramsay Hunt syndrome, ischemic lesion and trauma.
Diagnosis made using caloric testing (≥25% reduced vestibular response) and either ocular vestibular evoked myogenic potential (oVEMP) or cervical vestibular evoked myogenic potential (cVEMP) testing.
Participants prescribed vestibular rehabilitation
Participants ≥18 years of age
Disqualifiers
Pregnant participants
Participant diagnosed with a central vestibular disorder
Trial design
Parallel
Treatments tested in this trial
Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation
BehavioralThe virtual reality intervention will involve standard vestibular rehabilitation as described above and adjunct at home virtual reality video game. This video game will be projected on an android or apple device accommodated into a VR headset for 20 minutes daily until the vestibular rehabilitation is complete. This video will be congruent to current vestibular rehabilitation program exercises. Point-of-view games compatible with both Android and iOS devices will be evaluated by professionals to determine the game that is most representative of current evidence based exercises.
Standard Vestibular Rehabilitation with Adjunct Auditory Intervention
BehavioralThe control intervention will involve standard vestibular rehabilitation as described above and adjunct audio intervention while wearing the VR headset for 20 minutes daily until the vestibular rehabilitation is complete.
Treatment groups
Trial outcomes
Primary outcomes
Dizziness Handicap Inventory (DHI) score
The Dizziness Handicap Inventory (DHI) score is a validated symptom index score created in 1990 that measures the functional, emotional and physical impacts of dizziness on the patient. This involves 25 questions which are answered as yes, sometimes or no. Yes response is 4 points, sometimes is 2 points and no is 0 points. The sum of these points are used to determine the severity of functional impairment. This severity is classified by the following ranges: mild 0-30, moderate 31-60 and severe 61-100.
Secondary outcomes
Activities-specific Balance Confidence (ABC) score
The ABC score is a validated measure of balance that includes 16 items which assesses balance confidence using a variety of activities with various difficulties. These 16 items are ranked from 0 (no confidence in completing task) to 100% (complete confidence in completing task).
Other outcomes
Simulator Sickness Questionnaire (SSQ) score
The simulator sickness questionnaire is a validated tool for assessing simulator sickness which can help identify simulators that illicit significant side effects. Individuals are to rate the listed symptoms in the questionnaire using a four point scale: 0 (none), 1 (slight), 2 (moderate), 3 (severe). These individual symptom scores are multiplied by their listed weights and then summed for each Simulator Sickness Questionnaire (SSQ) section: Nausea (N), Oculomotor (O) and Disorientation (D). These total scores are inputted into a conversion formulas to get the individual N, O and D scores. Total score (TS) is calculated by summing all weighted totals and inputting them into a TS conversion formula above.
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