- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297862
Virtual Reality Sickness Questionnaire: Psychometrics in Stroke Patients
Investigation of the Psychometric Properties of the Virtual Reality Sickness Questionnaire in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the proven advantages of virtual reality approximately 30% of users report nausea and up to 40% experience eye strain as a result of prolonged exposure to virtual environments and simulators. These problems are referred to as motion sickness (MS) a side effect of virtual reality use.
The Motion Sickness Assessment Questionnaire (MSAQ) and the Simulator Sickness Questionnaire (SSQ), which evaluates the symptoms under four titles (gastrointestinal, central, peripheral and fatigue), are used in the literature to evaluate this effect. However, these questionnaires may not be sufficient to assess the MS symptoms that develop after virtual reality (VR) applications. Because MS symptoms occur differently in VR and simulation systems. For this reason, the Virtual Reality Sickness Questionnaire (VRSQ) was developed by Kim and his colleagues to evaluate the symptoms that occur after virtual reality. The Turkish validity and reliability of the VRSQ, which consists of 9 questions, was also conducted by Cetin and his friends.
The aim of this study to investigate how virtual reality affects physiological factors (heart rate, blood pressure) in stroke patients and to evaluate the psychometric properties of the Virtual Reality Sickness Questionnaire in assessing VR-induced motion sickness.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Bolu, Turkey (Türkiye), 14300
- Abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This prospective study will be conducted in BAIBU Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation on healthy individuals and individuals with stroke who agree to participate in the study.
Individuals between the ages of 18-80 will be included in the study. Individuals will be asked to experience VR for 15 minutes and then fill out the Virtual Reality Sickness Questionnaire. Individuals whose score in this questionnaire is not 10 and above will be excluded from the study. Individuals who meet the inclusion criteria will be divided into two groups as healthy and stroke patients after demographic information is obtained.
Description
Inclusion criteria for individuals with stroke:
- Stroke diagnosis,
- A minimum score of 24 on the Standardised Mini Mental Test (SMMT), 2.18-80 years old,
- showing symptoms of MS with a minimum score of 10 on the Virtual Reality Sickness Questionnaire
- Titmus test result of 3552 arc/s
- Not having neglect syndrome
Exclusion criteria:
- Not volunteering for the study,
- Presence of a diagnosis of neurological disease other than stroke,
- Presence of a history of previous stroke,
- Complete or partial loss of vision in one eye,
- Previous use of Virtual Reality
- Having diseases affecting the vestibular system such as Vertigo, Benign Paroxysmal Vertigo, Meniere's
Inclusion criteria for Healthy Individuals:
1. A minimum score of 24 on the Standardised Mini Mental Test (SMMT), 2.18-80 years old, 3. showing symptoms of MS with a minimum score of 10 on the Virtual Reality Sickness Questionnaire 4. Titmus test result of 3552 arc/s
Exclusion criteria:
- Not volunteering for the study,
- Presence of a diagnosis of neurological disease,
- Complete or partial loss of vision in one eye,
- Previous use of Virtual Reality
- Having diseases affecting the vestibular system such as Vertigo, Benign Paroxysmal Vertigo, Meniere's
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy Group
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Participants will experience a 15-minute roller coaster virtual reality (VR) for three consecutive days, once a day.
During this study, the virtual reality application will be performed while sitting in a chair and while fixed to the chair.
The practitioner will be present with the participant throughout the VR application.
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Stroke Group
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Participants will experience a 15-minute roller coaster virtual reality (VR) for three consecutive days, once a day.
During this study, the virtual reality application will be performed while sitting in a chair and while fixed to the chair.
The practitioner will be present with the participant throughout the VR application.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Virtual Reality Sickness Questionnaire
Time Frame: immediately after roller coaster application
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The Virtual Reality Sickness Questionnaire (VRSQ), which consists of 9 items and two main headings: oculomotor discomfort and disorientation, will be used to assess Motion Sickness symptoms.
The items will be scored between 0-3.
As a result of VRSQ oculomotor, disorientation and total scores will be obtained.
Oculomotor and disorientation scores will be calculated by dividing the individual's component score by the total score obtained (as a percentage).
Minimum score is 0 and maximum score is 100.
Higher scores mean more symptoms.
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immediately after roller coaster application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Titmus Test
Time Frame: Baseline
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Three-dimensional vision of the participants will be evaluated with the Titmus test with special glasses designed for three-dimensional vision called Binocular vision stereoacuity and a brochure held 40 cm away from eye level.
The participant will be asked whether they can see the butterfly on the brochure in three dimensions while wearing the glasses as a yes or no question.
Participants who answer yes will proceed to the second stage.
In the second stage, they will be asked to say which of the nine squares and four circles in each square they see in three dimensions.
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Baseline
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National Institutes of Health Stroke Scale (NIHSS)
Time Frame: Baseline
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With the 15-item National Institutes of Health Stroke Scale (NIHSS), patients with stroke; Very Severe: >25 Severe: 15 - 24 Mild to Moderate: 5 - 14 Mild: 1-5 will be used to classify patients.
The test will last 10 minutes and items will be scored as 0-2, 0-3 or 0-4.
The maximum score to be obtained from the test is 42.
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Baseline
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Standardized Mini Mental Test (SMMT)
Time Frame: Baseline
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For the brief and objective measurement of cognitive function, the Standardized Mini Mental Test (SMMT) will be used, which consists of eleven items grouped under five main headings: orientation, recording memory, attention and calculation, recall and language, and takes 10-15 minutes to administer. Severe cognitive impairment: 0-17, Mild cognitive impairment: 18-23, No cognitive impairment: 24-30. |
Baseline
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The Motion Sensitivity Test (MST)
Time Frame: immediately after roller coaster application
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The Motion Sensitivity Test (MST) assesses movement-induced dizziness through 16 rapid head and body position changes.
For each position, participants report the start and end of dizziness, and duration is scored from 1 to 3 based on time.
They also rate dizziness intensity from 0 to 5. Duration and intensity scores are summed to obtain a raw score.
The MST quotient is calculated by dividing the total symptom scores by 20.48, with 0 indicating no symptoms and 100 indicating severe symptoms in all positions.
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immediately after roller coaster application
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Tolerance Period
Time Frame: During application
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The patient's tolerance period, the time until symptoms become apparent, will be recorded
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During application
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Heart Rate
Time Frame: baseline and immediately after roller coaster application
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Participants' heart rate will be recorded with a device before and after the virtual reality experience
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baseline and immediately after roller coaster application
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Feeling of discomfort
Time Frame: immediately after roller coaster application
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Discomfort will be calculated by measuring the area marked by the individual from 0 (very comfortable) to 10 (not comfortable at all).
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immediately after roller coaster application
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Blood Pressure
Time Frame: baseline and immediately after roller coaster application
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Participants' blood pressure will be recorded with a device before and after the virtual reality experience
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baseline and immediately after roller coaster application
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Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- AIBU-FTR-BS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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