Viewing Study NCT06627049



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06627049
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-23

Brief Title: Virtual Reality Implantation in Paediatric Rehabilitation IMPLANT-VR4 CHILD
Sponsor: None
Organization: None

Study Overview

Official Title: Virtual Reality Implantation in Paediatric Rehabilitation IMPLANT-VR4 CHILD
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMPLANT-VR4
Brief Summary: Virtual Reality Implementation in Paediatric Rehabilitation IMPLANT-VR 4 CHILD Virtual Reality VR and Active Video Games AVG are promising devices for children in need of rehabilitation VR and AVG have been widely studied in research with promising results in a number of areas including motor function cognitive function pain management and attention disorders

However despite these promising results and the enthusiasm they generate in research VR and AVG are rarely used in clinical practice particularly in the paediatric services of Ty Yann and Perharidy of the ILDYS Foundation There is a strong demand from professionals for these tools to be better integrate these devices into their clinical practice

The project is to conduct an action research with rehabilitation professionals health managers and children in need of rehabilitation in order to facilitate the implementation of VR and AVG in the paediatric rehabilitation services of Ty Yann and Perharidy Firstly the facilitators and barriers present in these services will be identified Then specific strategies to facilitate the implementation of VR will be used Finally the impact of these strategies on the use of VR will be evaluated
Detailed Description: Children with chronic conditions and rehabilitation needs may require long periods of care Some rehabilitation interventions can cause stress anxiety or pain and may be unmotivating for children However in the context of motor learning for example current scientific research supports the intensification of training

Motivation is a fundamental part of rehabilitation treatment Sometimes the length of treatment can lead to a lack of motivation If motivation decreases in children this may lead to a reduction in the intensity required to be effective in rehabilitation Finding efficient solutions to facilitate the rehabilitation process is therefore a major challenge Virtual reality VR may be interesting to increase the duration of motor rehabilitation while maintaining motivation

VR is a promising tool to address these challenges VR can be defined as the digital simulation of a virtual environment with which the user can interact using our own movements Immersive VR devices use a head-mounted display that allows full visual immersion in the virtual environment Non-immersive VR devices involve two-dimensional virtual environment in flat-screen displays and include the category of AVG It has been studied in many areas of paediatric rehabilitation motor function pain management attention disorders cognitive function For example in motor rehabilitation the playful aspect of VR helps to maintain childrenamp39s motivation while facilitating motor learning VR games can be played at high intensity Rehabilitation goals can also be set by the child when using VR increasing the effectiveness of rehabilitation management

The aim of implementation science is to facilitate the integration and use of evidence in clinical practice There are often differences between research findings and the methods used in clinical practice It often takes several years for research findings to be implemented in clinical practice It is estimated that it takes about 17 years in some fields for a scientific discovery to be used in clinical practice There are a number of factors that may explain this long delay First of all there are several stages in the research process to develop practice guidelines These stages are relatively long In addition clinicians often have little time to read newly published data and these data are not always easily accessible

VR is still rarely used into routine clinical practice despite promising results and the enthusiasm it generates in research There are barriers such as the time required to prepare sessions and a lack of knowledge about the devices Some barriers to the implementation of VR are common to several rehabilitation centres and are frequently found in the literature while others are specific to one rehabilitation centre In order to address the specific barriers it is necessary to identify them within the rehabilitation centre itself

Several studies have identified the facilitators and barriers present among rehabilitation professionals To our knowledge this work has not been carried out among decision makers managers and directors of rehabilitation centres nor among children undergoing rehabilitation However the facilitators and barriers to the implementation of VR may come from different levels within the rehabilitation centre For example national care policies funding for VR the organisation of services and the beliefs of professionals and children are all factors that can influence the way care is provided and whether or not VR devices are used Therefore in order to be as effective and comprehensive as possible when implementing VR in paediatric rehabilitation it is recommended to consider the facilitators and barriers related to rehabilitation professionals decision makers and children

The ILDYS Foundation is a rehabilitation centre Every week this institution welcomes around 200 children with disabilities in its different services located in two sites Perharidy and Ty Yann Both sites provide rehabilitation for children and adolescents with chronic conditions that limit their activities and participation and therefore require rehabilitation treatment

There is a demand from rehabilitation professionals and the decision makers to facilitate the integration of VR which is currently little used in the services However during informal discussions many barriers were mentioned that could explain the lack of use of VR during rehabilitation sessions

Action research can be defined as work carried out in collaboration between researchers and participants This collaboration makes it possible to involve clinicians decision makers and patients in the study which can facilitate the implementation of new care strategies

The main objective of this project is to improve the use of VR in the Ty Yann and Perharidy paediatric rehabilitation centre In order to carry out this implementation project the study is divided into three stages

First the facilitators and barriers that exist in the services at Ty Yann and Perharidy will be identified Several focus groups with rehabilitation professionals and children in rehabilitation in Ty Yann and Perharidy will be conducted The investigator will conduct some interviews with decision makers at the ILDYS Foundation The investigator will collect socio-demographic data from the participants in order to characterise the population involved in this research project The investigator will also collect data on the use of VR and the ease of use of VR by rehabilitation professionals Tne investigator will collect socio-demographic data from the participants in order to characterise the population taking part in this research project Data will also be collected on the use of VR and the ease of use of VR by rehabilitation professionals
Secondly specific strategies to improve the use of VR according to the focus group and interview responses will be implemented
Thirdly the strategies in terms of the number of uses of the VR devices will be evaluated On the other hand focus groups and interviews will be used to collect the views of rehabilitation professionals decision makers and children on the implemented strategies

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None