Clinical trial NCT06797050: A Story for Pepper & Nao
Official title: A Story for Pepper and Nao: Applying the Learning by Teaching Paradigm in Children With Patterns of Neuromotor Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Children and Adolescents With Neuromotor Impairment
Keywords: Learning by teaching
Social robot
Children
Neuromotor impairment
Executive Functions
Engagement
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: IRCCS Eugenio Medea
name: Fondazione Mondino
name: University of Florence
First posted: 2025-01-28
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to improve cognitive processes that are frequently impaired in children characterised by neuromotor impairment, such as the skills of visual-perceptual analysis and selective attention, working memory, narrative organisation, logical-inferential reasoning and motor planning. For this purpose, a task of reordering figurative stories and action sequences, which include the aforementioned processes, will be used through an innovative Learning by Teaching training paradigm with a social robot. Furthermore, the study aims to verify the children's level of behavioural, cognitive and emotional engagement during the interaction with the social robot and to test the generalisation effects of the intervention on other processes, such as working memory, inhibition and planning.

Detailed description: The use of social robots in children with Neurodevelopmental Disorders and Disabilities is becoming increasingly common in both educational and clinical settings. Several studies have shown that the presence of social robots during learning can increase children's engagement, consequently improving academic achievement, as the presence of the robot appears to positively influence attention, satisfaction, and engagement in the proposed activities. Engagement is a complex component that includes emotional, cognitive, and behavioral aspects. The emotional component concerns the emotions felt during the activity, the cognitive component involves attention and active participation, and the behavioral component refers to the user's proactivity and adaptability in the interaction. An innovative approach of using social robots is the Learning by Teaching paradigm, where children teach the robots, thus promoting their sense of self-efficacy and motivation, as well as the ability to put themselves in each other's shoes (Theory of Mind). This method helps develop Executive Functions, such as planning, problem solving and reasoning, which are crucial to various aspects of daily life. Skills that are often vulnerable in children with Neurodevelopmental Disorders and Disabilities, consequently associating with poor performance in school learning, including text comprehension and production, which require good decoding skills, logical reasoning, selective attention, interference control, working memory and metacognitive strategies. Several studies have also shown that children with neuromotor impairment pictures, such as Motor Coordination Disorder (DCD) or Cerebral Palsy (CP), often have difficulties in motor planning skills, which become worse with the specificity of the motor problem. A "picture sequencing" task, which involves arranging pictures in order to create a finalized story or movement, can support multiple higher cognitive processes, such as working memory, attention, reasoning, and planning. This task, embedded in the Learning by Teaching paradigm with a social robot, could amplify the development of these processes due to the high levels of engagement and the requirement to take on the robot's role as teacher. In order to test the effectiveness of the treatment in improving the skills of visual-perceptual analysis, selective attention, working memory, narrative organization, logical-inferential reasoning and motor planning, 80 children with neuromotor difficulties will be randomly assigned to either the Experimental Group, which will immediately begin treatment with the social robot for about 4 months on a biweekly schedule, or to the Control Group, which will begin training after about 4 months. In addition, the study aims to test the children's level of behavioral, cognitive and emotional engagement during interaction with the social robot, through the use of sensors, eye-tracking and video cameras; as well as to test the generalization effects of the intervention on other processes, such as working memory, inhibition and planning.

Eligibility criteria: Inclusion Criteria:

* Children characterized by neuromotor impairment
* Presence of at least one cognitive index \>70 at WISC-IV or WISC V
* Age between 7 and 16 years at the time of recruitment

Exclusion Criteria:

* Severe neurological, motor, or sensory deficit such as to preclude the feasibility of training
* Psychiatric comorbidity such as to preclude the feasibility of training

Primary outcomes:
measure: score of Picture Arrangement subtest at WISC-III
timeFrame: 1-16 months
measure: score of a Motor Planning test
timeFrame: 1-16 months
Secondary outcomes:
measure: score of Corsi block-tapping subtest at the BVS-Corsi
timeFrame: 1-16 months
measure: score of Tower of London test
timeFrame: 1-16 months
measure: score of the Sustained Attention subtest at the Leiter-3
timeFrame: 1-16 months
measure: score of Behaviour Rating Inventory of Executive Function for parents (BRIEF-2)
timeFrame: 1-16 months
measure: score of Inhibition subtest at the NEPSY-II
timeFrame: 1-16 months
measure: score of Verbal Fluency subtest at the NEPSY-II
timeFrame: 1-16 months
measure: score of Animal Sorting subtest at the NEPSY-II
timeFrame: 1-16 months
measure: score of Go/No-Go subtest at the TeleFE
timeFrame: 1-16 months
measure: score of Text comprehension test at Prove MT-3, MT Avanzate and MT 16-19
timeFrame: 1-16 months
measure: score of Invent a story task
timeFrame: 1-16 months
measure: score of TVPS-4 test
timeFrame: 1-16 months
measure: score of DCDDaily-Q
timeFrame: 1-16 months
measure: score of Abilhand/Abilhand kids questionnaire
timeFrame: 1-16 months
measure: Evaluation of engagement levels during interaction with the social robot
timeFrame: 1-16 months
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
state: Lecco
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Pisa
city: Pavia
country: Italy
facility: IRCCS Istituto Neurologico Naz.le C.Mondino
Study officials:
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