跳至主要内容
临床试验/NCT05930873
NCT05930873招募中不适用

Evaluating the Effect of Immersive Room Intervention on Visual Attention in Children With Autism Spectrum Disorders

Istituto per la Ricerca e l'Innovazione Biomedica2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)

研究概览

简要总结

Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by language delay, impaired social interactions, and repetitive behaviors. Its manifestation varies among individuals due to genetic and environmental factors. Technology-based interventions, such as robots, serious games, virtual reality and immersive room, have shown better results in the cognitive-behavioral treatment of ASD. Visual attention, which is often deficient in individuals with ASD, is a focus in these interventions, as it can aid stimulus processing. Virtual reality offers a more ecological environment for such interventions.

In this study, it has been demonstrated the effectiveness of virtual reality training by comparing the performance of an ASD group delivering treatment through the immersive room with a control group delivering traditional treatment.

Fifteen children with ASD between the ages of 5 and 10 years, with IQs between 55 and 85 will be included in the trial and, following an assessment related to visual attention processes, will be randomly assigned to the control group and the experimental group. The trial participants will, first, undergo structured sessions to foster or increase the receptive area related to the stimuli to which they will be subjected during the training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with diagnosis of autism

排除标准

  • presence of other medical disorders

结局指标

主要结局

Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)

时间窗: The evaluation session will be scheduled pre-intervention. The test needs approximately 65-80 minutes to complete.

Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.

NEPSY-II

时间窗: The evaluation sessions will be scheduled pre and post intervention.The test needs approximately 90 minutes to complete for preschool children and 120-180 minutes for school-age children

NEPSY-II is the most internationally known battery for assessing neuropsychological development in developmental age.

次要结局

未报告次要终点

研究者

发起方
Istituto per la Ricerca e l'Innovazione Biomedica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

研究点 (2)

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