- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07318142
Virtual Reality in the Rehabilitation of Visually Induced Motion Sickness (VIMS)
Evaluation of the Effectiveness of Vestibular Rehabilitation With Virtual Reality Systems in Individuals With Visually Induced Motion Sickness
In recent years, rapidly advancing virtual reality (VR) technology has been widely used in many fields, from education to health and from entertainment to therapeutic applications, by creating interactive and highly immersive digital environments. However, the increasing use of VR systems has also been associated with physiological side effects. One of these is Visually Induced Motion Sickness (VIMS), a syndrome characterized by symptoms such as eye strain, fatigue, dizziness, headache, and nausea, especially when individuals experience a sense of motion in virtual environments despite physical immobility. VIMS is thought to occur due to sensory conflicts among the visual, vestibular, and motor systems, and its severity may vary depending on individual factors and the intensity of the visual motion cues.
The aim of this study is to evaluate the effect of a VR-based vestibular rehabilitation program on symptoms associated with VIMS. The VR stimuli consist of real travel videos available on the YouTube VR platform. To enhance familiarity and the sense of presence, 360° videos depicting scenes from Istanbul, Turkey were selected and categorized based on difficulty level.
The study includes two groups: a control group of healthy individuals and an experimental group of individuals diagnosed with VIMS. All participants undergo baseline assessments. The experimental group receives a VR-based vestibular rehabilitation program for 4 weeks, delivered twice per week, with each session lasting 30 minutes. The intervention uses a VR headset and consists of progressively challenging visual motion stimuli.
The effectiveness of the intervention will be evaluated using both subjective and objective outcome measures, including the Simulator Sickness Questionnaire (SSQ), visual analog scale (VAS) symptom ratings, and static posturography assessments (Balance Screening and Limits of Stability - Reaction Time). Pre- and post-intervention assessments will be compared within and between groups to determine the impact of the rehabilitation program.
This study is designed to contribute to the understanding of VR-based vestibular rehabilitation approaches and to support the development of safer and more effective VR applications.
Study Overview
Status
Intervention / Treatment
Detailed Description
This prospective single-arm interventional study was designed to evaluate the effects of a virtual reality (VR)-based rehabilitation program in individuals with visually induced motion sickness (VIMS). Following baseline assessment, participants underwent a structured VR rehabilitation protocol over a four-week period.
The intervention consisted of eight supervised sessions, conducted twice weekly, with each session lasting approximately 30 minutes. VR exposure was delivered using a head-mounted display and included visually complex motion stimuli aimed at gradually increasing visual-vestibular tolerance. The difficulty and visual motion intensity were progressed based on participant tolerance throughout the program.
Outcome assessments were performed at baseline and after completion of the intervention period. Postural control was objectively evaluated using static posturography, and symptom severity was monitored using validated subjective assessment tools.
This design allowed for within-subject comparison of pre- and post-intervention outcomes to examine the potential effectiveness of VR-based rehabilitation in reducing VIMS-related symptoms and improving postural stability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34295
- Istanbul Aydin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
General Inclusion Criteria (n = 46)
- Aged between 18 and 30 years
- No history of otologic surgery
- No history of orthopedic surgery related to the lower extremities
- No claustrophobia
- Female participants not in menstrual or premenstrual periods
- No diagnosed neurological disorders/diseases (e.g., MS, epilepsy, cerebrovascular accident, etc.)
- No diagnosed peripheral vestibular pathologies such as Meniere's disease, BPPV, or vestibular neuritis (participants' lack of peripheral vestibular pathology confirmed by audiovestibular vHIT testing)
- No spontaneous nystagmus
Study Group (21.8 ± 2.9 years, n = 23) Inclusion Criteria
VIMSSQ Questionnaire:
Participants answered "occasionally" or "frequently" to Question 2
Control Group (23.7 ± 3.3 years, n = 23) Inclusion Criteria
GUHHYSA Questionnaire:
Participants answered "never" to Question 2
Exclusion Criteria:
- History of otologic surgery
- History of orthopedic surgery in the lower extremities
- Presence of claustrophobia
- Female participants in menstrual or premenstrual periods
- Diagnosed neurological disorders/diseases (e.g., MS, epilepsy, cerebrovascular accident, etc.)
- Diagnosed peripheral vestibular pathologies such as Meniere's disease, BPPV, or vestibular neuritis (as confirmed by audiovestibular vHIT testing)
- Presence of spontaneous nystagmus
- Participants who did not sign the informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality-Based Vestibular Rehabilitation
The study group consisted of individuals with visually induced motion sickness (VIMS).
Participants underwent a four-week virtual reality-based rehabilitation program consisting of eight sessions (30 minutes per session).
The effects of VR exposure were assessed using posturography.
|
The study group (individuals with VIMS) underwent a four-week VR rehabilitation program consisting of 8 sessions, each lasting 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulator Sickness Questionnaire (SSQ) Total Score Unit of Measure: points (0-42; higher scores indicate worse symptoms) Time Frame: Baseline and 4 weeks
Time Frame: Time Frame: Baseline and 4 weeks
|
Assessment of VIMS-related symptoms using the Simulator Sickness Questionnaire.
|
Time Frame: Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) Symptom Score
Time Frame: Time Frame: Baseline and 4 weeks
|
Self-reported symptom severity using a 0-10 point Visual Analog Scale.
Unit of Measure: points (0 = no symptoms, 10 = worst symptoms; higher scores indicate worse symptoms)
|
Time Frame: Baseline and 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Posturography - Balance Screening Score
Time Frame: Time Frame: Baseline and 4 weeks
|
Postural stability is objectively assessed using static posturography balance screening parameters.
The balance screening score is expressed in degrees and is calculated based on individual anthropometric characteristics, including body height and weight.
Higher scores indicate poorer postural stability.
|
Time Frame: Baseline and 4 weeks
|
|
Static Posturography - Limits of Stability Reaction Time
Time Frame: Time Frame: Baseline and 4 weeks
|
Assessment of reaction time during limits of stability testing.
Unit of Measure: seconds (lower values indicate better performance)
|
Time Frame: Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rukiye Tanisir Disci, Istanbul Aydın University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 28/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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.
Clinical Trials on Vestibular Rehabilitation in MS
-
October 6 UniversityCompletedVestibular Rehabilitation in MSEgypt
-
Medipol UniversityIstanbul Medeniyet UniversityCompletedRehabilitation | Vestibular Hypofunction | Vestibulopathy | Vestibular Exercises | Vestibular Assessment | Unilateral Vestibular DeficitTurkey (Türkiye)
-
hanaa mohsenCompletedVestibular RehabilitationEgypt
-
Istanbul Medipol University HospitalCompletedVestibular Disease | Vestibular RehabilitationTurkey
-
Synergy Health Concepts, Inc.UnknownVenous Irregularities, Flow and Perfusion in MS and Non-MS ParticipantsUnited States
-
Istanbul Gedik UniversityCompletedVestibular Rehabilitation | Bilateral Vestibular LossTurkey
-
Duke UniversityCompletedVestibular Function in Cochlear Implant PatientsUnited States
-
Universidade Estadual de Ciências da Saúde de AlagoasCompletedNormal Vestibular Evoked Potentials in Frequency Domain
-
Stefania CostiArcispedale Santa Maria Nuova-IRCCSCompletedComplex Patients in Rehabilitation PhaseItaly
-
Far Eastern Memorial HospitalUnknownHorticulture Therapy in Psychiatric RehabilitationTaiwan
Clinical Trials on The effects of virtual reality exposure were assessed using posturography.
-
Clinica Gema LeonCompleted
-
Ankara UniversityRecruiting
-
Centre Hospitalier de MontaubanRecruiting
-
Laboratoire de Psychologie des CognitionsUniversity Hospital, Strasbourg, France; ICube Laboratory - Team IGG; Ithaque... and other collaboratorsCompletedCocaine Use Disorder | Virtual Reality Exposure TherapyFrance
-
University of DerbyCompletedAcute Effects of Elastic Band Resistance on Postural Stability and Physical Function in Older AdultsOld Age; Debility | Stability | Balance | PosturographyUnited Kingdom
-
Emory UniversityCompleted
-
Seoul National University HospitalCompletedSpinal Anesthesia | SedationKorea, Republic of
-
Thomas LehouxNational Cancer Institute, France; GIRCI SOHO; Laboratoire de Psychologie des... and other collaboratorsRecruitingCocaine Use DisorderMartinique
-
Emory UniversityNational Institute of Mental Health (NIMH)CompletedStress Disorder, Post TraumaticUnited States
-
University of SydneyMonash University; Sydney Local Health DistrictRecruitingAlcohol Dependence | PTSD | Alcohol Use Disorder | Post-traumatic Stress Disorder | Comorbidities and Coexisting ConditionsAustralia