- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05578560
The Use of Virtual Reality in Rehabilitation in Patients After Vestibular Schwannoma Surgery.
Is 3D Optokinetic Stimulation in Virtual Reality Space an Efficient Tool for Improvement of Central Compensation in Patients After Vestibular Schwannoma Surgery?
Study Overview
Status
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marketa Bonaventurova
- Phone Number: +420722983690
- Email: bonaventurova.m@seznam.cz
Study Locations
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Prague, Czechia, 15006
- Recruiting
- Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
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Contact:
- Bonaventurova
- Phone Number: +420722983690
- Email: Marketa.Bonaventurova@fnmotol.cz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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chemical labyrinthectomy with intratympanically installed gentamicin
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.
|
Experimental: 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.
|
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.
3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp.
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Experimental: Vestibular training group
Patients with vestibular Schwannoma are indicated for the surgery.
After the surgery, they will perform vestibular training under supervision.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
video Head Impulse Test
Time Frame: 10 days after the surgery
|
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.
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10 days after the surgery
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video Head Impulse Test
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Vestibular evoked myogenic potentials
Time Frame: 10 days after the surgery
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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.
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10 days after the surgery
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Vestibular evoked myogenic potentials
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Videonystagmography
Time Frame: 10 days after the surgery
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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.
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10 days after the surgery
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Videonystagmography
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Dizzines Handicap Inventory
Time Frame: 10 days after the surgery
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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.
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10 days after the surgery
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Dizzines Handicap Inventory
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Generalized Anxiety Disorder - 7item scale
Time Frame: 10 days after the surgery
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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.
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10 days after the surgery
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Generalized Anxiety Disorder - 7item scale
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Penn Acoustic Neuroma Quality-Of-Life scale
Time Frame: 10 days after the surgery
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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.
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10 days after the surgery
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Penn Acoustic Neuroma Quality-Of-Life scale
Time Frame: 3 months after the surgery
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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.
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3 months after the surgery
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Self-rating Depression Scale
Time Frame: 10 days after the surgery
|
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.
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10 days after the surgery
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Self-rating Depression Scale
Time Frame: 3 months after the surgery
|
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.
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3 months after the surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Markéta Bonaventurová, Department of ENT and Head and Neck Surgery, Charles University in Prague and Motol University Hospital
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Nervous System Neoplasms
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurilemmoma
- Neuroma, Acoustic
- Vestibular Neuronitis
Other Study ID Numbers
- CharlesU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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