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

NCT05424302 | Recruiting

• 1 other identifier: VR PVD RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Vestibular Disorder; Benign Paroxysmal Positional Vertigo; Meniere Disease; Vestibular Neuritis; Vestibular Neuronitis; Labyrinthitis; Herpes Zoster Oticus

Keywords

Virtual reality; Video games; Peripheral vestibular disorders; Benign paroxysmal positional vertigo; Meniere disease; Vestibular Neuritis; Vestibular Neuronitis; Labyrinthitis; Herpes Zoster Oticus

Outcome Measures

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.

  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

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

Other Outcomes (1)

• Simulator Sickness Questionnaire (SSQ) score

  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.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Lastly, VR headset will be mailed to patients home address. A date for VR device tutorial will be discussed during this interview. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at home VR vestibular rehabilitation protocol that involves playing a video game projected on an android or apple device in a VR headset for 20 minutes daily.

Behavioral: Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation

Control Group

ACTIVE COMPARATOR

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at-home regime that consists of auditory stimulation while wearing a VR headset for 20 minutes daily.

Behavioral: Standard Vestibular Rehabilitation with Adjunct Auditory Intervention

Interventions

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.

Virtual Reality Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Access to an android or iOS smart phone

You may not qualify if:

• Pregnant participants
• Participant diagnosed with a central vestibular disorder

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6K2E8, Canada

RECRUITING

Related Publications (3)

• Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.

  PMID: 28723718 BACKGROUND

• Micarelli A, Viziano A, Micarelli B, Augimeri I, Alessandrini M. Vestibular rehabilitation in older adults with and without mild cognitive impairment: Effects of virtual reality using a head-mounted display. Arch Gerontol Geriatr. 2019 Jul-Aug;83:246-256. doi: 10.1016/j.archger.2019.05.008. Epub 2019 May 10.

  PMID: 31102927 BACKGROUND

• Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.

  PMID: 26913496 BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Meniere Disease; Vestibular Neuronitis; Labyrinthitis; Herpes Zoster Oticus

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases; Otitis; Herpes Zoster; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Desmond A Nunez, MD, MBA

  Division of Otolaryngology, Department of Surgery, The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Heffernan, BMSc

CONTACT

604-875-4111; aheff12@student.ubc.ca

Lindsay E Booth, BSc

CONTACT

604-875-4111; lbooth98@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider(s) being masked to interventions assigned to participants in this clinical trial are the physiotherapists providing standard vestibular rehabilitation sessions to study participants. No other parties will be masked in this clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Otolaryngology - Head and Neck Surgery, The University of British Columbia; Staff Otolaryngologist, Vancouver Hospital & Health Sciences Centre

Model Details: Patients will be divided into two groups using a computer-generated randomization schedule. These groups will undergo 4 or 8 weeks of vestibular rehabilitation for patients diagnosed with unilateral vestibular hypofunction or bilateral vestibular hypofunction respectively (Hall et al. 2016). This involves once a week 40-45 minute in-person sessions with a registered physiotherapist and three 20 minute sessions a day of at-home independent exercises (Hall et al. 2016). Standard vestibular rehabilitation involves a combination of exercises to promote gaze stability, to habituate symptoms, balance and gait training, and aerobic exercise (Hall et al. 2016). The virtual reality (VR) group will undergo an additional VR vestibular rehabilitation protocol. This will require them to utilize a head-mounted display device to play a video game projected on an android or apple device in a VR headset for 20 minutes daily until vestibular rehabilitation is complete (Micarelli et al. 2017, 2019).

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: June 21, 2022
• Study Start: June 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: This time frame depends on the date of publication and the data registry guidelines.
• Access Criteria: Data required by the data registry affiliated with the respective open access journal will be shared to enable publication of the manuscript.

Locations

CA (1)