A Story for Pepper & Nao

NCT ID: NCT06797050

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-04-01

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.

Conditions

Children and Adolescents With Neuromotor Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (Experimental Group)

The experimental group, following an initial assessment, will carry out the training. The child will be asked to help the social robot, which will provide relational and learning feedback, to reorder sequences of images from figurative stories, in order to create a story that respects temporal or causal links, or motor actions of increasing complexity, according to the Learning by Teaching paradigm. The images, which will appear on the social robot's tablet, will be presented with increasing complexity and numerosity, and in the case of difficulty, facilitation will be provided in such a way as to encourage 'mistake-free' learning. In each session (approx. 20-25), on a bi-weekly basis, will be an operator will be present. The engagement experienced by the child on an emotional, behavioural and cognitive level will be measured. A second assessment is scheduled at the end of the training and a third after about 4 months.

Group Type: EXPERIMENTAL

Training in reordering figurative stories with a social robot through the Learning by Teaching approach

Intervention Type: DEVICE

A test session of the 'picture sequencing' task with the social robot is planned. The selected children will undergo an initial neuropsychological, motor and school learning assessment and will be divided into Group 1 and Group 2: Group 1 (Experimental) will be offered training with the social robot, while Group 2 (Control) will continue standard care. Both groups will be re-evaluated after approximately about 4 months. After which Group 2 will be able to start treatment. After about 4 months, the children in both groups will again undergo the planned assessments. During the training, the child will be asked to help the social robot to reorder sequences of pictures from figurative stories in order to create a story that respects temporal or causal links, or motor actions of increasing complexity, according to the Learning by Teaching paradigm.

Group 2 (Control group)

After an initial assessment, children assigned to the control group will be asked to continue with what they normally do (standard care). Only after a period of about four months, following the second assessment they will begin treatment with the social robot, described for the experimental group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training in reordering figurative stories with a social robot through the Learning by Teaching approach

A test session of the 'picture sequencing' task with the social robot is planned. The selected children will undergo an initial neuropsychological, motor and school learning assessment and will be divided into Group 1 and Group 2: Group 1 (Experimental) will be offered training with the social robot, while Group 2 (Control) will continue standard care. Both groups will be re-evaluated after approximately about 4 months. After which Group 2 will be able to start treatment. After about 4 months, the children in both groups will again undergo the planned assessments. During the training, the child will be asked to help the social robot to reorder sequences of pictures from figurative stories in order to create a story that respects temporal or causal links, or motor actions of increasing complexity, according to the Learning by Teaching paradigm.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

Fondazione Mondino

OTHER

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: collaborator

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: lead

Responsible Party

Giuseppina Sgandurra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy

IRCCS Istituto Neurologico Naz.le C.Mondino

Pavia, Pavia, Italy

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy

Countries

Italy

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Other Identifiers

LbyT

Identifier Type: -

Identifier Source: org_study_id