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

Sponsor

Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05974917

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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'.

Condition or Disease	Intervention/Treatment	Phase
Serious Game Asthma in Children Children, Only	Device: Serious Game (SG)

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1 with 'Serious Game' to support the asthma treatment plan	Device: Serious Game (SG) 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.
Group 2 without 'Serious Game' and will follow the standard treatment plan

Arm

Intervention/Treatment

Group 1

with 'Serious Game' to support the asthma treatment plan

Device: Serious Game (SG)

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.

Group 2

without 'Serious Game' and will follow the standard treatment plan

Outcome Measures

Primary Outcome Measures

Pediatric Quality of Life Inventory (PedsQL) [6 months]
Questionnaires
Skills and Difficulties Questionnaire (SDQ-Ita) [6 months]

Secondary Outcome Measures

Conserved Transcriptional Response to Adversity (CTRA) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)

ClinicalTrials.gov Identifier:

NCT05974917

Other Study ID Numbers:

Verbale N° 01/2023

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2023