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临床试验/NCT06144528
NCT06144528尚未招募不适用

Exploring Imitative Abilities and Stereotypies: Comparing Robots and Human Operators in Autistic Children

Istituto per la Ricerca e l'Innovazione Biomedica1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Video analysis of performance

研究概览

简要总结

Virtual QT is a social robot designed to interact with humans in social and educational contexts. Equipped with visual and vocal interfaces, the robot can recognize and respond to various human inputs, providing emotional support and social interaction.

It uses facial expressions, gestures, and movements to communicate, encouraging engagement and supporting learning through playful and educational activities. Its ergonomic design and interactive approach make it suitable for both clinical and educational settings.

The aim of this study is to examine the effectiveness of the QTrobot in interventions for children with Autism Spectrum Disorder (ASD) and to assess whether children's attention and imitation are equally effective with the QTrobot compared to interacting with a human being.

Furthermore, the presence of significant differences between motor and expressive imitation, when interacting with the robot as opposed to a human interlocutor, will be investigated. A key aspect of this investigation is to assess whether the presence of the QTrobot can positively influence the repetitive or stereotyped behaviors exhibited by the children, compared to interaction with a person. Additionally, to further understanding, the children's heart rate will be monitored through the use of a sensor that will allow to evaluate how heart rate affects performance outcomes during interaction with the QTrobot and with a human being.

In this study, children will be recruited to take part in two separate sessions, both involving the same task. During the first session, the task will be carried out between the child and the human operator. Subsequently, in the same task, the child will interact with the QT robot. Throughout both task administrations, the child will wear a sensor to detect their heart rate. Furthermore, all task sessions will be video-recorded to conduct subsequent video analysis and make notes on imitation behaviors and stereotypical actions relevant to the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Diagnosis of Autism

排除标准

  • •Motor deficits due to another clinical condition

结局指标

主要结局

Video analysis of performance

时间窗: The video analysis needs approximately 15 minutes per child

The videos of the interviews were analyzed by a single observer. For each child, the observer evaluated both the child's interactions, one with a person and another with the robot. The assessment included the child's attention, measured by the frequency and duration of the child's gazes towards the interaction partner. Additionally, the observer recorded the number of imitations of the partner's actions, limited to a maximum of four imitations. Finally, to evaluate repetitive and stereotyped behaviors, the observer counted the sequences of these behaviors and the number of repetitions within each sequence. A sequence was defined as a continuous repetition of the same behavior type, with pauses or interruptions considered as separate sequences. If the child paused and resumed the same or a different behavior, each restart was counted as a new sequence.

次要结局

  • Heart rate(The test needs approximately 30 minutes)
  • Heart rate variability(The test needs approximately 30 minutes)

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 (1)

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