Clinical trial NCT06944613: Augmented Reality Training for Cerebral Palsy
Official title: Study of the Usability of an Augmented Reality Exercise for the Cognitive-motor Rehabilitation of Cerebral Palsy (CP) or Acquired Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Infantile
Acquired Brain Injury
Keywords: Cognitive rehabilitation
Augmented reality-based programme
Double tasks
Users experiences
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cross-sectional pilot study
Primary purpose: OTHER

Brief summary: Rehabilitation programmes for children and adolescents with CP or ABI are not easily accessible, which hinders the development of their physical and cognitive abilities. The Covid-19 pandemic has highlighted the need for specific care for these children and their families. As part of the rehabilitation of these children, it is necessary to offer cognitive-motor or spatial navigation rehabilitation programmes incorporating different sensory stimuli (visual, auditory). In this context, new technologies appear to be a relevant solution for offering fun, personalised rehabilitation with the possibility of remote self-education. Virtual reality is commonly used for paediatric rehabilitation, unlike augmented reality, which is a very recent and promising technology. Before studying the effectiveness of a new augmented reality-based programme, it is essential to assess the usability, user experience, acceptance and potential benefits of this type of device in the cognitive-motor rehabilitation of this population.

The investigators have developed an exergame, using an augmented reality (AR) headset, which will eventually offer a new form of rehabilitation, both fun and interactive, for children and teenagers with CP or ABIs.

Principal Objective:

Assessing the usability of an AR exercise game for children with CP or ABI.

Secondary Objectives:

Evaluating the user experience (attractiveness, emotions) of an AR exergame for children with CP or ABI Evaluating the acceptance of an AR exergame before and after its use in children with CP or ABI To assess the intrinsic motivation associated with AR exercise for CP and ABI children.

To assess the fatigue (mental and physical) associated with exercise in RA in children with CP or ABI.

Detailed description: The study is divided into 3 stages:

* V0 → Pre-inclusion visit carried out during a follow-up consultation (routine care): carried out by the investigator during which a clinical examination to check the inclusion and non-inclusion criteria will be performed. The child and his/her legal guardians are informed of the study (24-hour cooling-off period), and are given a written consent form.
* V1 → Inclusion visit + session 1: Collection of signed consent form and opening of data collection file

The session lasts approximately 2h15 (including breaks) and includes :

i. A pre-session evaluation with : Clinical tests (walking parameters with the helmet (walking speed, step length) + Eyetracking), an acceptance questionnaire before using the device, and a pre-session fatigability scale.

ii. The main body of the session is made up of a phase in which the children familiarise themselves with one of the mini games + a phase of use.

iii. A post-session evaluation with : A questionnaire on usability, user experience, acceptance after using the device, motivation and fatigue after the session.

- V2 → Session 2 (second mini-game): The session lasts approximately 2 hours (including breaks) and includes: i. A pre-session evaluation with : A pre-use acceptance questionnaire and a pre-session fatigue scale ii. The main body of the session is made up of a phase in which the children familiarise themselves with the second mini-game + a phase of use.

iii. A post-session evaluation with : A questionnaire on usability, user experience, acceptance after using the device, motivation and fatigue after the session.

The order of the mini-games is randomised between participants

Eligibility criteria: Inclusion Criteria:

* Children with CP or ABI, aged between 10 and 16.
* Children with sufficient listening comprehension skills
* Membership of the French social security system
* Children who have given their consent
* Obligation to obtain written informed consent from legal representatives

Exclusion Criteria:

* Children with a Gross Motor Function Classification System (GMFCS) motor score of over 3
* Children with contraindications to the use of new technologies (e.g. photosensitive epilepsy)
* Children with atypical or uncorrected visual and/or hearing impairment
* Children with unstable medical conditions
* Simultaneous participation in another research protocol that could have an influence on the evaluation of the PLAR system
* Refusal by the child or the family

Primary outcomes:
measure: System Usability Scale
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Semantic user experience
timeFrame: Immediately after the intervention
measure: Emotionnal user experience
timeFrame: Immediately after the intervention
measure: Acceptance
timeFrame: Before and Immediately after the intervention
measure: Motivation
timeFrame: Immediately after the intervention
measure: Fatigue
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: Limoges
country: France
facility: Julia HAMONET-TORNY
Study officials:
affiliation: Centre Hospitalier Esquirol
name: Julia HAMONEt-TORNY, MD
role: PRINCIPAL_INVESTIGATOR
References: