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

July 26, 2023 updated by: Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)

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

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'.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Male and female children aged 12 to 17 years. According to a computer-generated list, thirty children with controlled persistent asthma will be randomised into two groups: Asthma Group 1 and Asthma Group 2 'standard care'.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:

  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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Conserved Transcriptional Response to Adversity (CTRA)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Verbale N° 01/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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