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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05628220
Other study ID # 17-083
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date February 28, 2023

Study information

Verified date August 2022
Source University Hospital, Caen
Contact stephane besnard, MD, PhD
Phone +33677978649
Email stephane.besnard@unicaen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of a virtual reality desensitization protocol on subjects with severe motion sickness and study of the role of the emotional component on the effectiveness of the therapy.


Description:

Motion sickness is a well-known syndrome, particularly at risk in children, with a maximum around the age of 12. All people are sensitive to motion sickness in childhood, probably related to the maturation of certain cognitive functions of a spatial nature, namely the perception of oneself and one's movements in one's environment. These symptoms regress with age for a part of the population but a large number of people will remain sensitive to certain conditions of displacement and generate symptoms that can be extremely disabling and handicapping in everyday life, particularly for professional activities. For example, some people can no longer use their car, some can no longer take the boat for professional activities in restrictive and/or extreme environments (sailors, scientists, workers, etc.). Behavioral, respiratory or medicinal therapies remain partially effective due to the lack of sufficient knowledge on the physiopathology of this syndrome classified in the field of sensory disorders. Very recently, techniques of sensory desensitization by visual stimulation have appeared, either optokinetic or in virtual reality mimicking the environment that causes this syndrome. This therapeutic approach seems to give empirically good results but only one study has shown it with optokinetic stimulation but it is to be evaluated for virtual reality. The main objective of the study is therefore to evaluate the effectiveness of a sensory conflict protocol generated in virtual reality to reduce the severity of motion sickness. Each subject being his own control. An observational study was then designed to quantify the effectiveness of this technique carried out in a current way by the physiotherapists in the form of questionnaires supplemented by a posturographic evaluation of the sensory profile of the subjects. If the effectiveness is proven, this desensitization protocol could be optimized and more widely distributed. Furthermore, the analysis of the visuo-dependence variable (from the sensory profile) will indicate whether the use of a visual stimulus by virtual reality alone is sufficient or should be combined or compared with desensitization of other sensory modalities. The use of galvanic vestibular stimulation for the rehabilitation of vestibular pathologies or training programs based on the resolution of sensory conflicts could be envisaged in the future.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria: - Suffering from motion sickness inducing a functional disability requiring a change in the mode of travel, or suffering from motion sickness disabling to exercise a leisure or professional activity involving a mode of locomotion. Exclusion Criteria: - Pregnant woman - History of severe ENT or ophthalmologic pathologies. - Chronic treatment with an anticholinergic or anti-histamine medication. - Participating in another biomedical research protocol during the same period - Person under guardianship or curatorship

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physiotherapy
rehabilitation through using session of virtual reality desensitization

Locations

Country Name City State
France Caen University Hospital Caen
France Frédéric Xavier Vitrolles

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary motion sickness severity simulator sickness questionnaire (0-64) day 0 (day before the first session of rehabilitation)
Primary motion sickness severity simulator sickness questionnaire (0-64) day 30 (day after the end of rehabilitation)
Secondary Emotion The State-Trait Anxiety Questionnaire (0-80) day 0 (day before the first session of rehabilitation)
Secondary Emotion The State-Trait Anxiety Questionnaire (0-80) day 30 (day after the end of rehabilitation)
Secondary Posture postural measurement (gravity center ellipse) day 0 (day before the first session of rehabilitation)
Secondary Posture postural measurement (gravity center ellipse) day 30 (day after the end of rehabilitation)
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