The Use of Virtual Reality in Rehabilitation in Patients After Vestibular Schwannoma Surgery.

NCT ID: NCT05578560

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2026-06-30

Brief Summary

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).

Conditions

Acute Peripheral Vestibulopathy Following Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prehabituation group

Patients with vestibular Schwannoma are indicated for the surgery. The patients in this group undergo chemical labyrinthectomy via intratympanically installed gentamicin before the vestibular Schwannoma resection. After the operation, vestibular training under supervision will be performed.

Group Type: EXPERIMENTAL

Prehabituation

Intervention Type: PROCEDURE

chemical labyrinthectomy with intratympanically installed gentamicin

Vestibular training

Intervention Type: PROCEDURE

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.

Virtual reality group

Patients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision and in addition to this, they will be exposed to 3D optokinetic stimulation in virtual reality space.

Group Type: EXPERIMENTAL

3D optokinetic stimulation in virtual reality space

Intervention Type: PROCEDURE

3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp.

Vestibular training

Intervention Type: PROCEDURE

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.

Vestibular training group

Patients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision.

Group Type: EXPERIMENTAL

Vestibular training

Intervention Type: PROCEDURE

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.

Interventions

Prehabituation

chemical labyrinthectomy with intratympanically installed gentamicin

Intervention Type: PROCEDURE

3D optokinetic stimulation in virtual reality space

3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Marketa Bonaventurova

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markéta Bonaventurová

Role: PRINCIPAL_INVESTIGATOR

Department of ENT and Head and Neck Surgery, Charles University in Prague and Motol University Hospital

Locations

Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Marketa Bonaventurova

Role: CONTACT

bonaventurova.m@seznam.cz

+420722983690

Facility Contacts

Bonaventurova

Role: primary

Marketa.Bonaventurova@fnmotol.cz

+420722983690

References

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.

Reference Type: BACKGROUND

PMID: 31796939 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28053986 (View on PubMed)

Other Identifiers

CharlesU

Identifier Type: -

Identifier Source: org_study_id