An interventional study of Nao assisted therapy and Standard therapeutic protocol in Development Language Disorder, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Enrolling by invitation at 1 site in Italy. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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.
Developmental Language Disorder (DLD) is a communication disorder that interferes with learning, understanding, and using language. DLD is a neurodevelopmental disorder caused by complex interactions between genes and the environment that affect brain development. The exact causes of the brain differences that lead to DLD are unknown. Like other neurodevelopmental disorders, DLD often shows familial aggregation. Children with DLD are more likely than their typically developing peers to have first-degree relatives-such as parents and siblings-who have experienced language-related difficulties or delays. In fact, it is estimated that 5-7% of the population is affected by DLD, and many children with DLD have at least one family member with the disorder. In addition, other potentially related neurodevelopmental disorders, such as dyslexia or autism, are more common among the family members of children with DLD.
Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, conventional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among children with DLD. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in neurodevelopmental disorders. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with DLD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it a promising tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children, yet their potential remains underexplored in Developmental Language Disorder. This single-blind, randomized controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for children with DLD.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 50 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.
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This group includes 50 children diagnosed with Developmental Language Disorder (DLD). Participants were randomly assigned to a structured rehabilitative program integrated with the NAO humanoid robot. The intervention was tailored to individual needs and aimed to improve communicative initiative, verbalization, and social engagement. Each child received therapy over 24 weeks, for a total of 48 sessions (2 per week, 45 minutes each).
Behavioral: Nao assisted therapy
This group includes 50 children diagnosed with Developmental Language Disorder (DLD). Participants were randomly assigned to receive standard therapeutic approaches, including traditional speech therapy provided by trained therapists. The intervention was adapted to meet the specific needs of minimally verbal children. Each child received therapy over 24 weeks, for a total of 48 sessions (2 per week, 45 minutes each).
Behavioral: Standard therapeutic protocol
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.
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.
Language Development Level Test (TVL)
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.
Time frame: T0(baseline)-T1(6months)
The Child Behavior Checklist (CBCL)
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.
Time frame: T0(baseline)-T1(6months)
Conners' Parent Rating Scale Long Form
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).
Time frame: T0(baseline)-T1(6 months)
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
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.
Time frame: T0(baseline)-T1(6 months)
Motivation Requests During Sessions
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
Time frame: Each therapy session over 24 weeks (48 sessions total)
Started Feb 2025 (actual). Primary completion is estimated for Apr 2026, 14 months after the start.
Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 14 months is below that.
Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.
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Language Development Disorders →
IRCCS Centro Neurolesi Bonino Pulejo