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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)

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05171244
Acronym
SEVIRE
Enrollment
50
Registered
2021-12-28
Start date
2022-03-03
Completion date
2028-08-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

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.

Interventions

BEHAVIORALvirtual reality training

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

BEHAVIORALusual care

usual program of interventions in usual care

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single-center Randomized Pilot Study in Parallel Groups

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vineland Adaptive Behavior Scales II (VABS II) scoreBaseline, week 15 (after training), 6 months after trainingBehavioral scale VABS II is a test for assessing autonomy of child/adolescent in everyday life. From 0 to 108, higher is the score, more independent the person is in the rated field.

Secondary

MeasureTime frameDescription
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)Baseline, week 15 (after training), 6 months after trainingECA2 provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)baseline, week 15 (after training), 6 months after trainingECA2P provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)
Measures of autistic behaviour by Dunn sensory profileBaseline, week 15 (after training), 6 months after trainingDunn sensory profile is completed by the parents. From 0 to 110, higher is the score more important is the comportement
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)Baseline, week 15 (after training), 6 months after trainingVABS-II provides an assessment of problematic behaviour. From 0 to 108, higher is the score, more independent the person is in the rated field.
Cognitive rigidity measureBaseline, week 15 (after training), 6 months after trainingNeuropsycological tests
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)Baseline, week 15 (after training), 6 months after trainingEvaluation of intensity scores for signs of stereotyped and repetitive activity on the EC2R.Factor sensory-motor stereotypies is evaluated by a score from 0 to 44. Factor reaction to change and modulating insufficiency factor are evaluated by a score from 0 to 28. Factor restricted behaviors is evaluated by a score from 0 to 32. Higher is the score more important is the severity.

Countries

France

Contacts

CONTACTRemi CLAIRE
r.claire@chu-tours.fr02 47 47 88 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026