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

NCT05578560 | Recruiting

• 1 other identifier: CharlesU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Peripheral Vestibulopathy Following Surgical Procedure

Outcome Measures

Primary Outcomes (14)

• video Head Impulse Test

  Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.

  10 days after the surgery

• video Head Impulse Test

  Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.

  3 months after the surgery

• Vestibular evoked myogenic potentials

  Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.

  10 days after the surgery

• Vestibular evoked myogenic potentials

  Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.

  3 months after the surgery

• Videonystagmography

  Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.

  10 days after the surgery

• Videonystagmography

  Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.

  3 months after the surgery

• Dizzines Handicap Inventory

  Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.

  10 days after the surgery

• Dizzines Handicap Inventory

  Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.

  3 months after the surgery

• Generalized Anxiety Disorder - 7item scale

  Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.

  10 days after the surgery

• Generalized Anxiety Disorder - 7item scale

  Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.

  3 months after the surgery

• Penn Acoustic Neuroma Quality-Of-Life scale

  Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.

  10 days after the surgery

• Penn Acoustic Neuroma Quality-Of-Life scale

  Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.

  3 months after the surgery

• Self-rating Depression Scale

  Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.

  10 days after the surgery

• Self-rating Depression Scale

  Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.

  3 months after the surgery

Study Arms (3)

Prehabituation group

EXPERIMENTAL

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.

Procedure: Prehabituation; Procedure: Vestibular training

Virtual reality group

EXPERIMENTAL

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.

Procedure: 3D optokinetic stimulation in virtual reality space; Procedure: Vestibular training

Vestibular training group

EXPERIMENTAL

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

Procedure: Vestibular training

Interventions

Prehabituation PROCEDURE

chemical labyrinthectomy with intratympanically installed gentamicin

Prehabituation group

3D optokinetic stimulation in virtual reality space PROCEDURE

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

Virtual reality group

Vestibular training 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.

Prehabituation group; Vestibular training group; Virtual reality group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vestibular Schwannoma appropriate to surgical resection

You may not qualify if:

• Eye disorder
• Oculomotor disorder in patient history
• Nerve palsy other than n. VIII, n. VII.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

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

Prague, 15006, Czechia

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Markéta Bonaventurová

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marketa Bonaventurova

CONTACT

+420722983690; bonaventurova.m@seznam.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 13, 2022
• Study Start: January 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CZ (1)