Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
NCT ID: NCT05974917
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2023-09-01
2023-12-31
Brief Summary
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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'.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
with 'Serious Game' to support the asthma treatment plan
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:
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.
Group 2
without 'Serious Game' and will follow the standard treatment plan
No interventions assigned to this group
Interventions
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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:
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
12 Years
17 Years
ALL
No
Sponsors
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Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)
NETWORK
Responsible Party
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Central Contacts
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References
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Uchida Y, Kitayama S, Akutsu S, Park J, Cole SW. Optimism and the conserved transcriptional response to adversity. Health Psychol. 2018 Nov;37(11):1077-1080. doi: 10.1037/hea0000675. Epub 2018 Sep 17.
Cole SW. The Conserved Transcriptional Response to Adversity. Curr Opin Behav Sci. 2019 Aug;28:31-37. doi: 10.1016/j.cobeha.2019.01.008. Epub 2019 Feb 25.
Mehl MR, Raison CL, Pace TWW, Arevalo JMG, Cole SW. Natural language indicators of differential gene regulation in the human immune system. Proc Natl Acad Sci U S A. 2017 Nov 21;114(47):12554-12559. doi: 10.1073/pnas.1707373114. Epub 2017 Nov 6.
Resztak JA, Farrell AK, Mair-Meijers H, Alazizi A, Wen X, Wildman DE, Zilioli S, Slatcher RB, Pique-Regi R, Luca F. Psychosocial experiences modulate asthma-associated genes through gene-environment interactions. Elife. 2021 Jun 18;10:e63852. doi: 10.7554/eLife.63852.
Ferrante G, Licari A, Marseglia GL, La Grutta S. Digital health interventions in children with asthma. Clin Exp Allergy. 2021 Feb;51(2):212-220. doi: 10.1111/cea.13793. Epub 2020 Dec 6.
Montalbano L, Ferrante G, Montella S, Cilluffo G, Di Marco A, Bozzetto S, Di Palmo E, Licari A, Leonardi L, Caldarelli V, Ghezzi M, La Grutta S, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) Program of Italian Paediatric Respiratory Society (IPRS). Relationship between quality of life and behavioural disorders in children with persistent asthma: a Multiple Indicators Multiple Causes (MIMIC) model. Sci Rep. 2020 Apr 24;10(1):6957. doi: 10.1038/s41598-020-62264-9.
Montalbano L, Cilluffo G, Gentile M, Ferrante G, Malizia V, Cibella F, Viegi G, Passalacqua G, La Grutta S. Development of a nomogram to estimate the quality of life in asthmatic children using the Childhood Asthma Control Test. Pediatr Allergy Immunol. 2016 Aug;27(5):514-20. doi: 10.1111/pai.12571. Epub 2016 May 6.
Montella S, Baraldi E, Cazzato S, Aralla R, Berardi M, Brunetti LM, Cardinale F, Cutrera R, de Benedictis FM, di Palmo E, Di Pillo S, Fenu G, La Grutta S, Lombardi E, Piacentini G, Santamaria F, Ullmann N, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) on behalf of the Italian Society of Pediatric Respiratory Diseases (SIMRI). Severe asthma features in children: a case-control online survey. Ital J Pediatr. 2016 Jan 22;42:9. doi: 10.1186/s13052-016-0217-z.
Ferrante G, La Grutta S. The Burden of Pediatric Asthma. Front Pediatr. 2018 Jun 22;6:186. doi: 10.3389/fped.2018.00186. eCollection 2018.
Waltz E. First video game to treat disease gains FDA okay. Nat Biotechnol. 2020 Nov;38(11):1224-1225. doi: 10.1038/s41587-020-0726-6. No abstract available.
Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018 Jan 11;13(1):e0189749. doi: 10.1371/journal.pone.0189749. eCollection 2018.
Licari A, Ferrante G, Marseglia Md GL, Corsello Md G, La Grutta S. What Is the Impact of Innovative Electronic Health Interventions in Improving Treatment Adherence in Asthma? The Pediatric Perspective. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2574-2579. doi: 10.1016/j.jaip.2019.08.008. Epub 2019 Aug 16.
Other Identifiers
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Verbale N° 01/2023
Identifier Type: -
Identifier Source: org_study_id
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