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Идёт набор NCT05171244

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)

Без фазы С лечением Autism Spectrum Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: virtual reality training, usual care.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 8 лет — 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 2 центра
  • Le Centre universitaire de pédopsychiatrie — Tours
  • Pedopsychiatry, University Hospital, Tours — Tours

Идентификаторы

NCT: NCT05171244 · DR200078

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗