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

C

Charles University, Czech Republic

Status

Enrolling

Conditions

Acute Peripheral Vestibulopathy Following Surgical Procedure

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05578560
CharlesU

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Prehabituation group
Experimental group
Description:
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.
Treatment:
Procedure: Prehabituation
Procedure: Vestibular training
Virtual reality group
Experimental group
Description:
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.
Treatment:
Procedure: Vestibular training
Procedure: 3D optokinetic stimulation in virtual reality space
Vestibular training group
Experimental group
Description:
Patients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision.
Treatment:
Procedure: Vestibular training

Trial contacts and locations

1

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Central trial contact

Marketa Bonaventurova

Data sourced from clinicaltrials.gov

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