Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality Vestibular Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation

    Behavioral

    The 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

    Behavioral

    The 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

50 Participants
are divided into 2 treatment groups
Group A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline DHI score at 2 weeks post-intervention will be recorded for each patient.

Secondary outcomes

1

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).

Time frame
This ABC score will be calculated 2 weeks before intervention and 2 weeks after intervention.

Other outcomes

1

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.

Time frame
The SSQ will be completed at the baseline visit and every day of the home exercise program or virtual reality game intervention which can range from 28 days to 56 days depending on laterality of the peripheral vestibular disorder.

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