Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)

NCT ID: NCT05171244

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2025-11-30

Brief Summary

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Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.

Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.

The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center Randomized Pilot Study in Parallel Groups
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

virtual reality training

Intervention Type BEHAVIORAL

training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care

usual care

Intervention Type BEHAVIORAL

usual program of interventions in usual care

Control group

Group Type SHAM_COMPARATOR

usual care

Intervention Type BEHAVIORAL

usual program of interventions in usual care

Interventions

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virtual reality training

training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care

Intervention Type BEHAVIORAL

usual care

usual program of interventions in usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child / adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).
* Without intellectual delay (QNV\> 70, WISC-IV or V, WAIS-III or IV).
* Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).
* Schooled in the ordinary school context (primary school, middle school, high school, ULIS).
* Having expressed their agreement to participate in the study.

* Whose parents or legal representatives have signed written consent.
* Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.

Exclusion Criteria

* Neuromotor disorders.
* Uncorrected visual disorders.
* Hearing impairment.
* Known epilepsy.
* Anxiety syndromes identified.
* Hyper ADD / H type activity.
* Treatment with methylphenidate. - Rare genetic syndrome.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Le Centre universitaire de pédopsychiatrie

Tours, , France

Site Status RECRUITING

Pedopsychiatry, University Hospital, Tours

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Remi CLAIRE

Role: CONTACT

02 47 47 88 47 ext. +33

Facility Contacts

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Remi CLAIRE

Role: primary

02 47 47 88 47 ext. +33

Other Identifiers

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DR200078

Identifier Type: -

Identifier Source: org_study_id

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