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Clinical Trials/NCT05171244
NCT05171244
Recruiting
N/A

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)

University Hospital, Tours2 sites in 1 country50 target enrollmentMarch 3, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Tours
Enrollment
50
Locations
2
Primary Endpoint
Vineland Adaptive Behavior Scales II (VABS II) score
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2022
End Date
November 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Vineland Adaptive Behavior Scales II (VABS II) score

Time Frame: Baseline, week 15 (after training), 6 months after training

Behavioral 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 Outcomes

  • Cognitive rigidity measure(Baseline, week 15 (after training), 6 months after training)
  • Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)(Baseline, week 15 (after training), 6 months after training)
  • Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)(Baseline, week 15 (after training), 6 months after training)
  • Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)(baseline, week 15 (after training), 6 months after training)
  • Measures of autistic behaviour by Dunn sensory profile(Baseline, week 15 (after training), 6 months after training)
  • Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)(Baseline, week 15 (after training), 6 months after training)

Study Sites (2)

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