xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974917</url>
    </required_header>
    <id_info>
      <org_study_id>Verbale N° 01/2023</org_study_id>
      <nct_id>NCT05974917</nct_id>
    </id_info>
    <brief_title>Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders</brief_title>
    <acronym>SMILER</acronym>
    <official_title>Serious gaMe Come Interventi Emergenti di E-health Per i Giovani Con distuRbi neuroLogici o rEspiratori (SMILER) - Progetto@Cnr</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive&#xD;
        learning and training. They are well-accepted instruments in therapeutic interventions and&#xD;
        have been found to be efficient to improve cognitive areas, social interaction and motor&#xD;
        skill function.&#xD;
  &#xD;
        The SG is expected to improve asthmatic children's behaviour by providing a positive&#xD;
        psychosocial experience with positive effects on asthma outcomes.&#xD;
  &#xD;
        Participants will be subjected to SG as part of routine medical care, and researchers will&#xD;
        study the effect of SG.&#xD;
  &#xD;
        The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural&#xD;
        patterns through a randomised controlled pilot study in adolescents with controlled asthma&#xD;
        and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response&#xD;
        to Adversity'.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>6 months</time_frame>
      <description>Questionnaires</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skills and Difficulties Questionnaire (SDQ-Ita)</measure>
      <time_frame>6 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Conserved Transcriptional Response to Adversity (CTRA)</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Serious Game</condition>
    <condition>Asthma in Children</condition>
    <condition>Children, Only</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>with 'Serious Game' to support the asthma treatment plan</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>without 'Serious Game' and will follow the standard treatment plan</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Serious Game (SG)</intervention_name>
      <description>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.&#xD;
  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.&#xD;
  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:&#xD;
  Side bending: Moving an obstacle to open a passage.&#xD;
  High jump: Overcoming a low, frontal obstacle.&#xD;
  Side lunge: Avoiding a side obstacle.&#xD;
  Squat: Passing under a low, frontal obstacle.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Male and female children aged 12 to 17 years. According to a computer-generated list,&#xD;
          thirty children with controlled persistent asthma will be randomised into two groups:&#xD;
          Asthma Group 1 and Asthma Group 2 'standard care'.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of controlled asthma according to GINA recommendations&#xD;
               (http://ginasthma.org)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  flare-ups requiring oral corticosteroids within the last four weeks&#xD;
  &#xD;
            -  use of leukotriene receptor antagonists or therapy as required in the last four weeks&#xD;
  &#xD;
            -  respiratory infections within the last four weeks&#xD;
  &#xD;
            -  immunological, metabolic, cardiac or neurological diseases&#xD;
  &#xD;
            -  obesity&#xD;
  &#xD;
            -  preterm birth&#xD;
  &#xD;
            -  major malformations of the respiratory system&#xD;
  &#xD;
            -  active smoking&#xD;
  &#xD;
            -  pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Stefania La Grutta, MD</last_name>
      <phone>+39 091 680 9111</phone>
      <email>stefania.lagrutta@ift.cnr.it</email>
    </overall_contact>
    <reference>
      <citation>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.</citation>
      <PMID>30221968</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31592179</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29109260</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>34142656</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33238032</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32332757</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27018497</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26796331</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29988370</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33144726</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29324745</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31425835</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974917
  org study id: Verbale N° 01/2023
  nct id: NCT05974917
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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'.
  observational model: Case-Control
  time perspective: Prospective
  measure: Pediatric Quality of Life Inventory (PedsQL)
  time frame: 6 months
  description: Questionnaires
  measure: Skills and Difficulties Questionnaire (SDQ-Ita)
  time frame: 6 months
  measure: Conserved Transcriptional Response to Adversity (CTRA)
  time frame: 6 months
  arm group label: Group 1
  description: with 'Serious Game' to support the asthma treatment plan
  arm group label: Group 2
  description: without 'Serious Game' and will follow the standard treatment plan
  intervention type: Device
  intervention name: Serious Game (SG)
  description: 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.
  arm group label: Group 1
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  last name: Stefania La Grutta, MD
  phone: +39 091 680 9111
  email: stefania.lagrutta@ift.cnr.it
  citation: 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.
  PMID: 30221968
  citation: 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.
  PMID: 31592179
  citation: 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.
  PMID: 29109260
  citation: 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.
  PMID: 34142656
  citation: 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.
  PMID: 33238032
  citation: 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.
  PMID: 32332757
  citation: 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.
  PMID: 27018497
  citation: 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.
  PMID: 26796331
  citation: 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.
  PMID: 29988370
  citation: 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.
  PMID: 33144726
  citation: 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.
  PMID: 29324745
  citation: 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.
  PMID: 31425835
  responsible party type: Sponsor
  sharing ipd: No