Benign Paroxysmal Positional Vertigo Clinical Trial
— VR-PVD-RCTOfficial title:
Effect of Peripheral Vestibular Pathology Location on the Ability of Home-based Virtual Reality to Improve Symptoms of Peripheral Vestibular Disorders
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Pregnant participants - Participant diagnosed with a central vestibular disorder |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 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. | |
Primary | 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 | 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). | This ABC score will be calculated 2 weeks before intervention and 2 weeks after intervention. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03425786 -
Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program
|
N/A | |
Completed |
NCT02046980 -
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
|
Phase 2 | |
Withdrawn |
NCT00978809 -
Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients
|
N/A | |
Completed |
NCT02029508 -
The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo
|
Phase 3 | |
Completed |
NCT02809599 -
Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo
|
N/A | |
Completed |
NCT03230513 -
Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms
|
N/A | |
Completed |
NCT03643354 -
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
|
N/A | |
Completed |
NCT00641797 -
Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients
|
N/A | |
Recruiting |
NCT06001047 -
Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV
|
N/A | |
Not yet recruiting |
NCT04578470 -
Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients
|
Phase 2 | |
Not yet recruiting |
NCT04578262 -
Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo
|
N/A | |
Completed |
NCT05748249 -
Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
|
Phase 1 | |
Active, not recruiting |
NCT06314581 -
Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
|
||
Completed |
NCT04715282 -
The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
|
N/A | |
Terminated |
NCT03161470 -
Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
|
N/A | |
Completed |
NCT05425199 -
Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo
|
N/A | |
Recruiting |
NCT05922774 -
Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
|
||
Recruiting |
NCT05013684 -
Benign Paroxysmal Positional Vertigo in Older Adults
|
N/A | |
Not yet recruiting |
NCT05863949 -
Clinical Trial of Vit D and Calcium for Recurrent BPPV
|
N/A | |
Suspended |
NCT04026516 -
CAVA: Dizziness Trial
|
N/A |