The Use of Virtual Reality in Rehabilitation in Patients After Vestibular Schwannoma Surgery.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabituation, 3D optokinetic stimulation in virtual reality space, Vestibular training.
- Who it may be relevant to
- Registry conditions: Acute Peripheral Vestibulopathy Following Surgical Procedure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is 3D Optokinetic Stimulation in Virtual Reality Space an Efficient Tool for Improvement of Central Compensation in Patients After Vestibular Schwannoma Surgery?
Overview
Resection of the vestibular schwannoma leads to acute peripheral or combined vestibular loss caused by a surgical lesion to the branches of the vestibular nerve and, less frequently also the lesion of the cerebellum. The lesion presents in patients with postural instability, vertigo, oscillopsia, and vegetative symptoms that may accompany it. The organism reacts to this state with the process of central compensation with the significant role of the cerebellum. The goal of the rehabilitation is to support this process and thus to make recovery faster and more efficient since not all patients are capable of complete restoration of the vestibular function. Up to date, rehabilitation includes, apart from the specific vestibular exercise, also the possibility of modern techniques using virtual reality space and prehabituation. Thanks to prehabituation, i.e., chemical labyrinthectomy with intratympanically installed gentamicin, the timing of the origin of the acute vestibular loss and the surgical procedure is separated. Therefore, there is a chance of achieving vestibular compensation before vestibular schwannoma removal. In the last decade, due to the advances in technology in the field of computer games and the applications for smartphones, the tools for virtual reality have become less expensive and more available in common praxis. Virtual reality is a technique for generating an environment that can strengthen three-dimensional optokinetic stimulation, subsequently the process of central compensation. Overall, it may shorten the time of recovery after the surgery and improve patients' quality of life.
Detailed description
This study was approved by institutional ethics committee of the University Hospital Motol and all patients provide inform consent prior to study commencement.
In this prospective randomized single-center study, we will enroll patients who undergo vestibular schwannoma resection in our department. All patients must be found to be indicated for the surgery. The size of the tumor will be classified according to the Koos classification. The patients with hearing loss will undergo prehabituation (group A). The rest of the patients will be randomly divided into either a virtual reality group (group B), or the control group (group C). Two days before the surgery (time 1) all of the patients will undergo a clinical oto-neurological examination as well as examination by objective methods - video-nystagmography (VNG), air calorics, video Head Impulse Test (vHIT), and cervical Vestibular Evoked Myogenic Potentials (cVEMP). They will also fill out a set of questionnaires - the Penn Acoustic Neuroma Quality-Of-Life scale (PANQOL), Dizziness Handicap Inventory (DHI), Generalized Anxiety Disorder 7 - item scale (GAD-7), and Self-rating Depression Scale (SDS). All of them were translated into the Czech language. In addition to it, we used the in-house questionnaire focused on vertigo symptoms.
On the second day after the surgery, all groups of patients begin to practice the vestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session will last around 30 minutes and will happen daily for the whole time of the hospitalization, thus seven days. Additionally, during that time, group B will obtain seven sessions of 30-minute-long optokinetic stimulation via virtual reality goggles. Subjective and objective assessments will be repeated at the hospital discharge which is on the 7-10th postoperative day (time 2) and 3 months after surgery (time 3).
Interventions
- Procedure Prehabituation
chemical labyrinthectomy with intratympanically installed gentamicin - Procedure 3D optokinetic stimulation in virtual reality space
3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp. - Procedure Vestibular training
vestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session lasts around 30 minutes and happened daily for the 7 postoperative days.
Primary outcome measures
- video Head Impulse Test [Time frame: 10 days after the surgery]
- video Head Impulse Test [Time frame: 3 months after the surgery]
- Vestibular evoked myogenic potentials [Time frame: 10 days after the surgery]
- Vestibular evoked myogenic potentials [Time frame: 3 months after the surgery]
- Videonystagmography [Time frame: 10 days after the surgery]
- Videonystagmography [Time frame: 3 months after the surgery]
- Dizzines Handicap Inventory [Time frame: 10 days after the surgery]
- Dizzines Handicap Inventory [Time frame: 3 months after the surgery]
- Generalized Anxiety Disorder - 7item scale [Time frame: 10 days after the surgery]
- Generalized Anxiety Disorder - 7item scale [Time frame: 3 months after the surgery]
Eligibility criteria
Inclusion criteria
- Vestibular Schwannoma appropriate to surgical resection
Exclusion criteria
- Eye disorder
- Oculomotor disorder in patient history
- Nerve palsy other than n. VIII, n. VII.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charl — Prague
Publications
- Balatkova Z, Cada Z, Hruba S, Komarc M, Cerny R. Assessment of visual sensation, psychiatric profile and quality of life following vestibular schwannoma surgery in patients prehabituated by chemical vestibular ablation. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Dec;164(4):444-453. doi: 10.5507/bp.2019.056. Epub 2019 Dec 3. PMID 31796939
- Cada Z, Balatkova Z, Chovanec M, Cakrt O, Hruba S, Jerabek J, Zverina E, Profant O, Fik Z, Komarc M, Betka J, Kluh J, Cerny R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8. PMID 28053986
Identifiers
NCT: NCT05578560 · CharlesU