Clinical Trial

Promoting Communication in Minimally Verbal Autistic Children with Social Robot

Enrolling by Invitation
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Record status
This record was last updated February 11, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Current therapeutic approaches, such as speech therapy and augmentative communication systems, often have variable efficacy due to engagement and responsiveness challenges. This pilot study investigates using of the humanoid robot NAO as part of a rehabilitative program designed for MV children with ASD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either an NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, social interaction, and observational data. This research aims to explore the potential of social robots as an innovative tool to addressing the unique needs of MV children with ASD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-28.
Trial Details
NCT Number NCT06805916
Lead Sponsor IRCCS Centro Neurolesi Bonino Pulejo
Conditions Autism Spectrum Disorder
Enrollment 100 participants
Start Date 2023-01-02
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-11