Clinical trial NCT06627049: Virtual Reality Implantation in Paediatric Rehabilitation (IMPLANT-VR4 CHILD)
Official title: Virtual Reality Implantation in Paediatric Rehabilitation (IMPLANT-VR4 CHILD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Children with Undergoing Rehabilitation
Keywords: Virtual Reality
Active Video Games
Paediatric rehabilitation
Implementation Science
Action Research
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric rehabilitation professionals ; Children in paediatric rehabilitation services ; Decision makers of the rehabilitation centre

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 children\&amp;#39;s 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.

Eligibility criteria: Inclusion Criteria for rehabilitation professionals::

* Rehabilitation professional
* Be fluent in French.
* Work in the paediatric wards at Ty Yann or Perharidy.
* Consent to data processing

Inclusion Criteria for Children :

* Be aged between 6 and 18.
* Be fluent in French.
* Have received rehabilitation treatment in the Ty Yann or Perharidy paediatric services.
* Have already used virtual reality in a rehabilitation session.
* Have the consent of the child and his/her legal representative to take part in the study.

Inclusion Criteria for decision makers:

* Work at the ILDYS Foundation as a health executive or within the management team.
* Be fluent in French.
* Consent to data processing

Exclusion Criteria:

* Not being able to understand focus group or interview questions.
* Not being able to communicate during focus groups or interviews.

Primary outcomes:
measure: Form of the number of uses per week
timeFrame: October 2024 - november 2025
measure: Focus group and interviews based on the Consolidated Framework for Implementation Research (CFIR)
timeFrame: October 2024 - november 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Fondation ILDYS, Site de Ty Yann
city: Roscoff
country: France
facility: Fondation ILDYS, Site de Perharidy
Study officials:
affiliation: Fondation Ildys
name: Jéromine HERVO
role: PRINCIPAL_INVESTIGATOR
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