Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo
NCT04436783 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-06-16
Summary
Background and Rationale:
Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. The main symptom is the perceived sensation of movement of the surrounding or self, without actual such movement, triggered by changes in position (positional vertigo). It can be dangerous as repetitive symptoms can lead to falls and depression, particularly in the elderly. Additionally, at least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated. The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on physical examination. In-office administration of the Epley maneuver by a specialist yields a 90% success rate at treating the condition; however, at-home administration is much less successful. In a previous paper we demonstrated the development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV.
Research Question and Objectives:
PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley maneuver using an instructional handout (IH) result in improved or resolved symptoms?
Methods:
Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and physical examination including the Dix-Hallpike test will be approached to be recruited into the study. Patients who consent to participating in the study will be allocated to either the VREMS cohort or the control cohort. Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an opportunity to give free-text feedback. For any patient with residual BPPV symptoms following Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the clinic. The primary outcome of the study will be the improvement in and resolution of BPPV symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each of the study arms.
Conditions
- BPPV
- Vertigo, Peripheral
Interventions
- DEVICE
-
Virtual Reality Epley Maneuver System (VREMS)
The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.
- OTHER
-
Instructional Handout (IH)
Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver.
Sponsors & Collaborators
-
University of Calgary
lead OTHER
Principal Investigators
-
Euna Hwang, MD · University of Calgary
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-14
- Primary Completion
- 2023-10-01
- Completion
- 2023-10-01
More Related Trials
-
Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients
NCT05002374 ·Status: RECRUITING ·Phase: NA
-
Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy
NCT04226976 ·Status: SUSPENDED ·Phase: NA
-
Three-dimensional Virtual Reality Procedures in Vestibular Rehabilitation
NCT03553264 ·Status: UNKNOWN ·Phase: NA
-
Effects of Vestibular Training on Postural Control of Healthy Adults Using Virtual Reality
NCT05941039 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Benign Paroxysmal Positional Vertigo
NCT01969513 ·Status: COMPLETED ·Phase: NA
-
Concurrent Vestibular Activation and Postural Training Using Virtual Reality
NCT05942781 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Conventional Versus Virtual Reality Based Vestibular Rehabilitation
NCT01442623 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Dose of Vestibular Rehabilitation for Vestibular Hypofunction
NCT04851184 ·Status: TERMINATED ·Phase: NA
-
Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality Vestibular Therapy
NCT05424302 ·Status: RECRUITING ·Phase: NA
-
Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
NCT06354309 ·Status: COMPLETED ·Phase: NA
-
Subthreshold Vestibular Stimulation as a Strategy for Rehabilitation
NCT06732440 ·Status: RECRUITING ·Phase: NA
-
Canalith Repositioning Procedure for BPPV in Primary Care
NCT00182273 ·Status: COMPLETED ·Phase: PHASE3
-
Virtual Environments for Vestibular Rehabilitation
NCT04268745 ·Status: COMPLETED ·Phase: NA
-
Vibrotactile Feedback During Vestibular Therapy
NCT02867683 ·Status: COMPLETED ·Phase: NA
-
Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV
NCT03624283 ·Status: UNKNOWN ·Phase: NA
-
Vestibular Evoked Myogenic Potentials in Benign Paroxysmal Positional Vertigo (VEMP in BPPV)
NCT01004913 ·Status: COMPLETED
-
Pilot Feasibility of App-supported Vestibular Rehabilitation
NCT05959278 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes
NCT03643354 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients
NCT07238387 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
VR System for Cross-modal Rehabilitation of Hemianopia
NCT04230486 ·Status: COMPLETED ·Phase: NA
-
Objective Examination and Rehabilitation Treatment of Patients With BPPV
NCT04367194 ·Status: COMPLETED ·Phase: NA
-
SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
NCT06267924 ·Status: COMPLETED ·Phase: NA
-
Transcranial Vibrating System for Improving Vestibular Physical Therapy
NCT03795168 ·Status: TERMINATED ·Phase: NA
-
Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction
NCT06517446 ·Status: RECRUITING ·Phase: NA
-
Web-based Rehab After Acute Vertigo
NCT05056324 ·Status: COMPLETED ·Phase: NA