跳至主要内容
临床试验/NCT05171244
NCT05171244招募中不适用

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, Tours4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
4
主要终点
Vineland Adaptive Behavior Scales II (VABS II) score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Experimental group

Experimental

干预措施: virtual reality training (Behavioral)

Experimental group

Experimental

干预措施: usual care (Behavioral)

Control group

Sham Comparator

干预措施: usual care (Behavioral)

结局指标

主要结局

Vineland Adaptive Behavior Scales II (VABS II) score

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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