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临床试验/NCT03254992
NCT03254992已完成不适用

Motor Learning Transfer Between Real and Virtual Environments in Autism Spectrum Disorder.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Change in performance, measured by coincident timing task

研究概览

简要总结

Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with socio-communicative functioning and restricted or repetitive behaviors or interests, and there is considerable evidence that the majority also struggle with associated emotional problems. Speech is typically delayed or may regress, comprehension is impaired, if not at the word level, then at the level of sentences, nonverbal and verbal language are affected, and pretend play is delayed or absent, some children are nonverbal or have sparse, impoverished, poorly articulated, and grammatical speech. Objective: To assess in which interface has ASD best performance or functionality. Method: Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with typical development (TD-group) matched by age and sex to the ASD-group. Individuals with comorbidities and functional disabilities that would impede the completion of the task were excluded.

详细描述

Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with typical development (TD-group) matched by age and sex to the ASD-group. The ASD-group will be recruited from GAPI - Special Education in São Bernardo do Campo, São Paulo, Brazil, which is a school for children and adolescents with pervasive developmental disorders.

For a diagnosis of ASD, apart from qualitative alterations in social communication and interaction (criterion A) in addition to stereotyped, repetitive, restricted behavior patterns (criterion B), that present in the early developmental period (criterion C), it is also required that these "symptoms cause clinically significant impairment in social, occupational and other important areas of current functioning" (criterion D), and that they are not better explained otherwise (criterion E). Given this information these items will be taken into consideration and the group was well evaluated.

With the purpose to homogenize the sample, will be only included ASD with the 1st level to 5th education to grade elementary.

Instrument For data collection will be used a gaming software created in partnership with the Information Systems group of School of Arts, Sciences and Humanities, EACH-USP.

The game offers task of "Timing" Coincident, which when executed are displayed on the computer screen 10 balls accessing (red light) in sequence until the last ball, which is considered the target (green light). The participant can have immediate feedback of hit or task error by different sounds (Auditory Interaction) and through visual images (Visual Interaction) that change colors, that will be previously shown to him.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.

排除标准

  • of incomprehension.
  • no completion of the task.

研究组 & 干预措施

ASD - Abstract task

Experimental

Experimental group using Kinect with more virtual activity.

干预措施: ASD - Abstract task (Device)

ASD - Tangible task

Experimental

Experimental group using Keyboard with more real activity.

干预措施: ASD - Tangible task (Device)

TD - Abstract task

Active Comparator

Control group using Kinect with more virtual activity.

干预措施: TD - Abstract task (Device)

TD - Tangible task

Active Comparator

Control group using Keyboard with more real activity.

干预措施: TD - Tangible task (Device)

结局指标

主要结局

Change in performance, measured by coincident timing task

时间窗: 1 day

The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Bandeira de Mello Monteiro

Associate Professor

University of Sao Paulo

研究点 (2)

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