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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05974917
Acronym
SMILER
Enrollment
30
Registered
2023-08-03
Start date
2023-09-01
Completion date
2023-12-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children, Children, Only, Serious Game

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'.

Interventions

DEVICESerious 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: 1. Side bending: Moving an obstacle to open a passage. 2. High jump: Overcoming a low, frontal obstacle. 3. Side lunge: Avoiding a side obstacle. 4. Squat: Passing under a low, frontal obstacle.

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Quality of Life Inventory (PedsQL)6 monthsQuestionnaires
Skills and Difficulties Questionnaire (SDQ-Ita)6 months

Secondary

MeasureTime frame
Conserved Transcriptional Response to Adversity (CTRA)6 months

Contacts

Primary ContactStefania La Grutta, MD
stefania.lagrutta@ift.cnr.it+39 091 680 9111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026