Clinical trial NCT06466590: Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire
Official title: Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality Cyber Sickness
Keywords: virtual reality
cyber sickness
assessment
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will perform 4 exercises in virtual reality with HMD (Head Mounted Display). Then, they will use the VRSQ-F instrument under study on 2 times separated by 15 minutes. The primary objective is to assess the reliability and validity of this instrument through repeated measures and comparison to SSQ
Primary purpose: DIAGNOSTIC

Brief summary: This is a multicenter, controlled, non-randomized interventional clinical study, with minimal risks and constraints, aimed at verifying the reliability of the French version of the VRSQ questionnaire (VRSQ-F) and the validity of the VRSQ-F score by comparing it with the SSQ score.


Eligibility criteria: Inclusion Criteria:

For Healthy people :

* Men or women aged 18 to 65
* Person affiliated to a social security scheme
* Healthy person with no particular medical condition
* Having given their consent to participate in the research

For patients :

* Men or women aged 18 to 65
* Persons affiliated to a social security scheme
* People undergoing regular rehabilitation, walking or in a wheelchair, who can use a virtual reality solution as part of their care.
* Having given their consent to take part in the research

Exclusion Criteria:

* Vestibular and cardiac pathologies, and major visual disorders not compatible with virtual reality rehabilitation
* Cognitive and language disorders
* Persons under legal protection
* Pregnant women
* MSSQ greater than 15
* People suffering from photosensitive epilepsy
* Persons under the influence of medication that may impair drugs or alcohol
* Participant with an implanted medical device that may be affected by radio waves emitted by compatible third-party equipment (e.g. : Pacemaker)

Primary outcomes:
measure: Check the validity of the VRSQ-F score by comparing it with the SSQ score
timeFrame: Immediately after exercises
measure: Reliability of VRSQ-F (Virtual Reality Sickness Questionnaire) using the intraclass correlation coefficient between measurements immediately after VR exercises and 15 min after and Cronbach coefficient of the VRSQ-F questionnaire
timeFrame: Immediately after exercises
Secondary outcomes:
measure: Calculate the minimum detectable change in the questionnaire
timeFrame: Immediately after exercises
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre de Rééducation Fonctionnelle Neurologique PROPARA
city: Rennes
country: France
facility: Pôle Saint-Hélier
city: Roscoff
country: France
facility: Fondation Ildys
Study officials:
affiliation: Pôle Saint Hélier
name: Emilie LEBLONG
role: PRINCIPAL_INVESTIGATOR
References: