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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06144528
Other study ID # CNR-IRIB-PRO-2023-005
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date April 30, 2024

Study information

Verified date November 2023
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact Chiara Failla
Phone +393921985644
Email chiara.failla@irib.cnr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 30, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 13 Years
Eligibility Inclusion Criteria: - Diagnosis of Autism - QI = 75 Exclusion Criteria: - Motor deficits due to another clinical condition

Study Design


Related Conditions & MeSH terms


Intervention

Other:
QT robot
In a single session each child will be video-recorded while performing the task. The participant subjects will perform the same task at two different times, once with the human operator and once with the Qt robot. Both tasks will have a duration of approximately 4 minutes. During the first minute, both the operator and the Qt will introduce themselves and ask four questions to the child to deepen the acquaintance. In the second minute, the operator/Qt will tell a story. In the third minute, the operator/Qt will ask to imitate 4 motor movements, while in the fourth minute, the operator/Qt will ask to imitate 4 facial expressions.

Locations

Country Name City State
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina

Sponsors (2)

Lead Sponsor Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Costa AP, Charpiot L, Lera FR, Ziafati P, Nazarikhorram A, van der Torre L, Steffgen GA (2018) Comparison between a person and a robot in the attention, imitation, and repetitive and stereotypical behaviors of children with Autism Spectrum Disorder. In: Proceedings workshop on Social human-robot interaction of human-care service robots at HRI2018

Zheng Z, Young EM, Swanson AR, Weitlauf AS, Warren ZE, Sarkar N. Robot-Mediated Imitation Skill Training for Children With Autism. IEEE Trans Neural Syst Rehabil Eng. 2016 Jun;24(6):682-91. doi: 10.1109/TNSRE.2015.2475724. Epub 2015 Sep 3. — View Citation

Zorcec T, Ilijoski B, Simlesa S, Ackovska N, Rosandic M, Popcevic K, Robins B, Nitzan N, Cappel D, Blum R. Enriching Human-Robot Interaction with Mobile App in Interventions of Children with Autism Spectrum Disorder. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2021 Oct 26;42(2):51-59. doi: 10.2478/prilozi-2021-0021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Video analysis of performance 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. The video analysis needs approximately 15 minutes per child
Secondary Heart rate The polar sensor detects the electrical activity of the heart and calculates heart rate in beats per minute (bpm).Typically it is worn on the wrist or chest. The test needs approximately 30 minutes
Secondary Heart rate variability The Polar sensor measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms). Typically it is worn on the wrist or chest. The test needs approximately 30 minutes
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