Augmented Reality Training for Cerebral Palsy

NCT ID: NCT06944613

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2024-11-06

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

Conditions

Cerebral Palsy Infantile; Acquired Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

exergames

There are two exergames: corsi and zoo games

Group Type: OTHER

Augmented reality-based programme/Microsoft Hololens version 2

Intervention Type: DEVICE

Participants play two exergames, the aim of this process is to engage cognitive double tasks

Interventions

Augmented reality-based programme/Microsoft Hololens version 2

Participants play two exergames, the aim of this process is to engage cognitive double tasks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Esquirol

OTHER

Sponsor Role: lead

Responsible Party

Julia HAMONET-TORNY

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia HAMONEt-TORNY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Esquirol

Locations

Julia HAMONET-TORNY

Limoges, , France

Countries

France

Other Identifiers

2023-A00904-41

Identifier Type: -

Identifier Source: org_study_id