A Story for Pepper & Nao

NCT06797050 | Recruiting

• 1 other identifier: LbyT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Children and Adolescents With Neuromotor Impairment

Keywords

Learning by teaching; Social robot; Children; Neuromotor impairment; Executive Functions; Engagement

Outcome Measures

Primary Outcomes (2)

• score of Picture Arrangement subtest at WISC-III

  In this study, examiners will administer the Picture Arrangement subtest of the WISC-III (Wechsler, 1991), in which children are presented with a series of cards in random order that need to be placed in the correct order to tell a meaningful story.

  1-16 months

• score of a Motor Planning test

  In this study, examiners will assess changes in motor planning skills as measured by a purpose-built test.

  1-16 months

Secondary Outcomes (14)

• score of Corsi block-tapping subtest at the BVS-Corsi

  1-16 months

• score of Tower of London test

  1-16 months

• score of the Sustained Attention subtest at the Leiter-3

  1-16 months

• score of Behaviour Rating Inventory of Executive Function for parents (BRIEF-2)

  1-16 months

• score of Inhibition subtest at the NEPSY-II

  1-16 months

Study Arms (2)

Group 1 (Experimental Group)

EXPERIMENTAL

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.

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

Group 2 (Control group)

NO INTERVENTION

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.

Interventions

Training in reordering figurative stories with a social robot through the Learning by Teaching approach 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 1 (Experimental Group)

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• IRCCS Eugenio Medea: collaborator
• Fondazione Mondino: collaborator
• University of Florence: collaborator

Study Sites (3)

IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

ACTIVE NOT RECRUITING

IRCCS Istituto Neurologico Naz.le C.Mondino

Pavia, Pavia, 27100, Italy

ACTIVE NOT RECRUITING

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

RECRUITING

Related Publications (12)

• Wotherspoon J, Whittingham K, Sheffield J, Boyd RN. Cognition and learning difficulties in a representative sample of school-aged children with cerebral palsy. Res Dev Disabil. 2023 Jul;138:104504. doi: 10.1016/j.ridd.2023.104504. Epub 2023 Apr 24.

  PMID: 37099882 BACKGROUND

• Fuglerud KS, Solheim I. The Use of Social Robots for Supporting Language Training of Children. Stud Health Technol Inform. 2018;256:401-408.

  PMID: 30371501 BACKGROUND

• Fluss J, Lidzba K. Cognitive and academic profiles in children with cerebral palsy: A narrative review. Ann Phys Rehabil Med. 2020 Oct;63(5):447-456. doi: 10.1016/j.rehab.2020.01.005. Epub 2020 Feb 19.

  PMID: 32087307 BACKGROUND

• Fiorini L, D'Onofrio G, Sorrentino A, Cornacchia Loizzo FG, Russo S, Ciccone F, Giuliani F, Sancarlo D, Cavallo F. The Role of Coherent Robot Behavior and Embodiment in Emotion Perception and Recognition During Human-Robot Interaction: Experimental Study. JMIR Hum Factors. 2024 Jan 26;11:e45494. doi: 10.2196/45494.

  PMID: 38277201 BACKGROUND

• Fiorini L, De Mul M, Fabbricotti I, Limosani R, Vitanza A, D'Onofrio G, Tsui M, Sancarlo D, Giuliani F, Greco A, Guiot D, Senges E, Cavallo F. Assistive robots to improve the independent living of older persons: results from a needs study. Disabil Rehabil Assist Technol. 2021 Jan;16(1):92-102. doi: 10.1080/17483107.2019.1642392. Epub 2019 Jul 22.

  PMID: 31329000 BACKGROUND

• Dionne E, Bolduc ME, Majnemer A, Beauchamp MH, Brossard-Racine M. Academic Challenges in Developmental Coordination Disorder: A Systematic Review and Meta-Analysis. Phys Occup Ther Pediatr. 2023;43(1):34-57. doi: 10.1080/01942638.2022.2073801. Epub 2022 May 24.

  PMID: 35611495 BACKGROUND

• Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

  PMID: 23020641 BACKGROUND

• Di Lieto MC, Pecini C, Castro E, Inguaggiato E, Cecchi F, Dario P, Cioni G, Sgandurra G. Empowering Executive Functions in 5- and 6-Year-Old Typically Developing Children Through Educational Robotics: An RCT Study. Front Psychol. 2020 Feb 5;10:3084. doi: 10.3389/fpsyg.2019.03084. eCollection 2019.

  PMID: 32116879 BACKGROUND

• https://doi.org/10.1007/s11145-021-10205-x

  BACKGROUND

• Belpaeme T, Kennedy J, Ramachandran A, Scassellati B, Tanaka F. Social robots for education: A review. Sci Robot. 2018 Aug 15;3(21):eaat5954. doi: 10.1126/scirobotics.aat5954. Epub 2018 Aug 15.

  PMID: 33141719 BACKGROUND

• Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.

  PMID: 34923256 BACKGROUND

• Adams IL, Lust JM, Wilson PH, Steenbergen B. Compromised motor control in children with DCD: a deficit in the internal model?-A systematic review. Neurosci Biobehav Rev. 2014 Nov;47:225-44. doi: 10.1016/j.neubiorev.2014.08.011. Epub 2014 Sep 1.

  PMID: 25193246 BACKGROUND

Central Study Contacts

Giuseppina Sgandurra, PhD, MD

CONTACT

050/886233; giuseppina.sgandurra@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)