Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders

Study Overview
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Brief Summary
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The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function. The SG is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes. Participants will be subjected to SG as part of routine medical care, and researchers will study the effect of SG. The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response to Adversity'.

Official Title
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Serious gaMe Come Interventi Emergenti di E-health Per i Giovani Con distuRbi neuroLogici o rEspiratori (SMILER) - Progetto@Cnr

Conditions
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Serious Game, Asthma in Children, Children, Only

Intervention / Treatment
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* Device: Serious Game (SG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of controlled asthma according to GINA recommendations (http://ginasthma.org) Exclusion Criteria: flare-ups requiring oral corticosteroids within the last four weeks use of leukotriene receptor antagonists or therapy as required in the last four weeks respiratory infections within the last four weeks immunological, metabolic, cardiac or neurological diseases obesity preterm birth major malformations of the respiratory system active smoking pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>with 'Serious Game' to support the asthma treatment plan | Device: Serious Game (SG)<br>* SG which was conceived as a running game, in which an Avatar runs through the forest and overcomes obstacles through the player's performance of physical exercises. Children will play while watching an imaginary Avatar, who shows the right movements to perform in order to collect rewards. SG will be projected with a 4K projector and controlled by the child's movements, which will be tracked in markerless mode using Azure's Kinect sensor. SG will include an adaptive tool to enable the experience based on the child's specific motor skills. The dynamics of SG will be adapted by considering real motor and physiological data acquired during each SG session via a wristband. These data are necessary to keep the child in the aerobic zone (60-80% of maximum heart rate). The movements are: Side bending: Moving an obstacle to open a passage. High jump: Overcoming a low, frontal obstacle. Side lunge: Avoiding a side obstacle. Squat: Passing under a low, frontal obstacle.<br>|
| Group 2<br>without 'Serious Game' and will follow the standard treatment plan | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory (PedsQL) | Questionnaires | 6 months | 
| Skills and Difficulties Questionnaire (SDQ-Ita) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conserved Transcriptional Response to Adversity (CTRA) |  | 6 months |