Health TrialsbyHealthPanel

A Story for Pepper & Nao

ConditionChildren and Adolescents With Neuromotor Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-16
SponsorIRCCS Fondazione Stella Maris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Psychiatric comorbidity such as to preclude the feasibility of training

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group 1 (Experimental Group)Experimental treatment 1 intervention
Group B: Group 2 (Control group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1-16 months
2

score of a Motor Planning test

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

Time frame
1-16 months

Secondary outcomes

1

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

In this study, examiners will administer the Corsi block-tapping subtets at the BVS-Corsi (Mammarella et al., 2008), to evaluate visuo-spatial short term and working memory. The child is asked to retrieve a sequences previously seen by the examiner by tapping blocks with the preferred finger following the same order for the forward condition or reversing the order for the backward condition.

Time frame
1-16 months
2

score of Tower of London test

In this study, examiners will administer the Tower of London test (Fancello et al., 2006; Gugliotta et al., 2009) to assesses the planning ability. There are three pegs of different lengths, into which three marbles are threaded the subject has to move these marbles in a certain number of moves in order to achieve the configuration indicated by the examiner

Time frame
1-16 months
3

score of the Sustained Attention subtest at the Leiter-3

In this study, the examininers will use the Sustained Attention subtest at the Leiter International Performance Scale Leiter-3 (Roid et al., 2013), which assesses visual attention and consist of repetitive barrage tasks to be performed in a predefinited time.

Time frame
1-16 months
4

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

In this study, examiners will administer the BRIEF-2 questionnaire (Gioia et al., 2015). This questionnaire is filled by the parents/legal guardians and dives into everyday bahaviour associated with specific domains of the Exefutive Functions (i.e., mental processes that enable us to plan, focus attention, remember instructions). Parents rate items on a three-point scale ranging from 1 (never) to 3 (often)

Time frame
1-16 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Fondazione Stella Maris

Lead sponsor

IRCCS Eugenio Medea

Collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborator

University of Florence

Collaborator

Source ClinicalTrials.gov
Apply now