Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire (VRSQ-F)

June 13, 2024 updated by: Pôle Saint Hélier
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34090
        • Centre de Rééducation Fonctionnelle Neurologique PROPARA
        • Contact:
        • Principal Investigator:
          • Anthony GELIS
        • Sub-Investigator:
          • Béatrice CARRA
        • Sub-Investigator:
          • Sylvain FAZILLEAU
        • Sub-Investigator:
          • Huei Yune BONNIN-KOANG
      • Rennes, France
      • Roscoff, France, 29684
        • Fondation Ildys
        • Contact:
        • Principal Investigator:
          • Patricia BOURGOGNE
        • Sub-Investigator:
          • Catherine LESTIDEAU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group
Participants will be asked to use the measurement instrument VRSQ-F on two separate occasions under identical conditions to assess its test-retest reliability and asked to use the SSQ for validity. Each session will involve completing the measurement protocol as specified.
Diagnostic test: Use of Measurement Instrument
Participants will complete the measurement procedure twice, with sessions scheduled one week apart, using the same instrument under standardized conditions. The results from both sessions will be compared to assess the instrument's consistency and accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Check the reliability of the French version of the VRSQ questionnaire (VRSQ-F)
Time Frame: Immediately after exercises
Reliability of VRSQ-F using the intraclass correlation coefficient between measurements immediately after VR exercises and 15 min after and Cronbach's coefficient of the VRSQ-F questionnaire
Immediately after exercises
Check the validity of the VRSQ-F score by comparing it with the SSQ score
Time Frame: Immediately after exercises
Criteria validity between SSQ and VRSQ-F. SSQ questionnaire with 16 questions scoring from 0 to 48 VRSQ-F questionnaire with 9 questions from 0 to 27
Immediately after exercises

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculate the minimum detectable change in the questionnaire
Time Frame: Immediately after exercises
Clinimetric quality: Calculation of the standard error of measurement SEM and the minimum detectable change MDC
Immediately after exercises

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pôle Saint Hélier

Investigators

  • Principal Investigator: Emilie LEBLONG, Pôle Saint Hélier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A02468-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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