Nao assisted therapy: The sessions included tasks designed to engage children in verbal and social interactions (e.g., naming objects, responding to questions, performing gestures). The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.
Standard therapeutic protocol: The therapy included exercises aimed at improving verbal communication and social engagement (e.g., naming objects, sentence construction, and comprehension tasks). Therapists adjusted the intervention to match each child's communication goals.
Study summary
Developmental Language Disorder (DLD) is a communication disorder that interferes with learning, understanding, and using language. This pilot study investigates the use of the humanoid robot NAO as part of a rehabilitative program designed for children with DLD. 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 a NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, motivation, and observational data. This research aims to explore the potential of social robots as an innovative tool for addressing the unique needs of individuals with DLD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.
Eligibility
Sex
ALL
Min age
4 Years
Max age
5 Years
Healthy volunteers
No
Inclusion Criteria:
* Developmental language disorder
* Age between 4 and 5 years.
Exclusion Criteria:
* Presence of severe intellectual disability.
* Diagnosis of neurological disorders.
* Significant medical conditions that could interfere with study participation.
Primary outcome measure(s)
Language Development Level Test (TVL) — T0(baseline)-T1(6months) The Test of Verbalization and Language Development is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.
The Child Behavior Checklist (CBCL) — T0(baseline)-T1(6months) The Child Behavior Checklist (CBCL) is a caregiver-reported questionnaire used to identify emotional and behavioral problems in children. It measures multiple domains, including emotional reactivity, anxiety, attention problems, and social difficulties. The T-scores do not have a specific range, but values between 50 and 70 are considered within the normal range, while 70 to 100 indicates clinical significance. Higher scores indicate greater behavioral problems.
Conners' Parent Rating Scale Long Form — T0(baseline)-T1(6 months) The Conners' Parent Rating Scale - Revised: Long Form (CPRS-R:L) is a standardized parent-report questionnaire used to assess Attention Deficit/Hyperactivity Disorder (ADHD) symptoms and other behavioral problems in children aged 6 to 18 years. The scale includes 80 items, each rated from 0 (Not True at All) to 3 (Very Much True). Subscale scores and a total score are derived. Total scores typically range from 0 to 240, with higher scores indicating more severe behavioral and attentional problems (i.e., a worse outcome).
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) — T0(baseline)-T1(6 months) The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) is a standardized parent-report questionnaire used to assess executive function behaviors in children aged 2 to 5 years. The scale consists of 63 items, each rated on a 3-point Likert scale (Never = 1, Sometimes = 2, Often = 3). Raw scores are converted to T-scores, which typically range from 30 to 90.
Higher T-scores indicate greater executive function difficulties (i.e., a worse outcome). T-scores above 65 are considered clinically elevated.
Motivation Requests During Sessions — Each therapy session over 24 weeks (48 sessions total) This observational measure tracks and records the number of spontaneous and prompted requests initiated by the child to express needs or desires during therapy sessions. Frequency count per session. Higher frequencies indicate greater communicative initiative
Trial sites (1)
Facility
City
Region
Status
IRCCS Neurolesi Bonino Pulejo, Messina,
Messina
Messina
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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