Promoting Communication in Minimally Verbal Autistic Children with Social Robot
NCT ID: NCT06805916
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
100 participants
INTERVENTIONAL
2023-01-02
2025-09-30
Brief Summary
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Detailed Description
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The study's outcomes will be measured using standardized communication assessments, including the Test of Verbalization (TVL), and observational data to evaluate engagement, responsiveness, and frequency of communicative behaviors. By leveraging advanced robotic technology, this study aims to explore new avenues for therapeutic interventions, ultimately contributing to the development of evidence-based strategies that improve the quality of life for minimally verbal children with ASD and their families.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NAO-Assisted Intervention (Experimental Group EG)
The treatment group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent a structured rehabilitative program integrated with the use of the NAO humanoid robot. The intervention was tailored to individual needs and aimed at improving communicative initiative, verbalization, and social engagement. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes.
NAO-Assisted Therapy
The intervention sessions included tasks designed to engage the child in verbal and social interactions, such as naming objects, responding to questions, and performing gestures. The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.
Standard Therapy (Control Group)
The control group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent standard therapeutic approaches, which included traditional speech therapy provided by trained therapists. The therapy followed established protocols and was adapted to meet the specific needs of minimally verbal children. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes.
Standard therapeutic
Standard therapeutic approaches included exercises aimed at improving verbal communication and social engagement, such as naming objects, sentence construction, and comprehension tasks. Therapists adapted the intervention to the child's individual communication goals.
Interventions
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NAO-Assisted Therapy
The intervention sessions included tasks designed to engage the child in verbal and social interactions, such as naming objects, responding to questions, and performing gestures. The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.
Standard therapeutic
Standard therapeutic approaches included exercises aimed at improving verbal communication and social engagement, such as naming objects, sentence construction, and comprehension tasks. Therapists adapted the intervention to the child's individual communication goals.
Eligibility Criteria
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Inclusion Criteria
* Minimal verbal communication
* Age between 4 and 12 years.
Exclusion Criteria
* Diagnosis of neurological disorders other than ASD.
* Significant medical conditions that could interfere with study participation.
4 Years
12 Years
ALL
No
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Responsible Party
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Francesca Cucinotta
Principal Investigator
Principal Investigators
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Margherita La Fauci
Role: PRINCIPAL_INVESTIGATOR
IRCCS Centro Neurolesi Bonino Pulejo
Maria Tresoldi
Role: PRINCIPAL_INVESTIGATOR
University Hospital "G. Martino"
Marcella Di Cara
Role: PRINCIPAL_INVESTIGATOR
IRCCS Centro Neurolesi Bonino Pulejo
Locations
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IRCCS Centro Neurolesi Bonino Pulejo
Messina, Messina, Italy
Countries
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References
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Gillingham KK, Makalous DL, Tays MA. G stress on A-10 pilots during JAWS II exercises. Aviat Space Environ Med. 1982 Apr;53(4):336-41.
Rose V, Trembath D, Keen D, Paynter J. The proportion of minimally verbal children with autism spectrum disorder in a community-based early intervention programme. J Intellect Disabil Res. 2016 May;60(5):464-77. doi: 10.1111/jir.12284.
Rybka J, Novosad P. Reaction of human organism to exercise. III. Biochemical response to physical loading. Acta Univ Carol Med (Praha). 1984;30(5-6):387-441. No abstract available.
Korneder J, Louie WG, Pawluk CM, Abbas I, Brys M, Rooney F. Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. Assist Technol. 2022 Nov 2;34(6):707-716. doi: 10.1080/10400435.2021.1930284. Epub 2021 May 28.
Salimi Z, Jenabi E, Bashirian S. Are social robots ready yet to be used in care and therapy of autism spectrum disorder: A systematic review of randomized controlled trials. Neurosci Biobehav Rev. 2021 Oct;129:1-16. doi: 10.1016/j.neubiorev.2021.04.009. Epub 2021 Apr 20.
Other Identifiers
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NAO01
Identifier Type: -
Identifier Source: org_study_id
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