Augmented Reality Training for Cerebral Palsy

NCT06944613 | Completed

• 1 other identifier: 2023-A00904-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Infantile; Acquired Brain Injury

Keywords

Cognitive rehabilitation; Augmented reality-based programme; Double tasks; Users experiences

Outcome Measures

Primary Outcomes (1)

• System Usability Scale

  The children will score 10 statements using a 5-point Likert scale with anchor points at either end ("Strongly disagree" or "Strongly agree"). The scale employs a numerical rating system, with scores ranging from 0 to 100. A score of 85 or above is typically regarded as 'excellent', 75 or above as 'good', and 50 to 75 as 'fair' or 'correct'. A score below 50 indicates a low level of user satisfaction

  Immediately after the intervention

Secondary Outcomes (5)

• Semantic user experience

  Immediately after the intervention

• Emotionnal user experience

  Immediately after the intervention

• Acceptance

  Before and Immediately after the intervention

• Motivation

  Immediately after the intervention

• Fatigue

  Pre-intervention

Study Arms (1)

exergames

OTHER

There are two exergames: corsi and zoo games

Device: Augmented reality-based programme/Microsoft Hololens version 2

Interventions

Augmented reality-based programme/Microsoft Hololens version 2 DEVICE

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

exergames

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Julia HAMONET-TORNY

Limoges, 87025, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Julia HAMONEt-TORNY, MD

  Centre Hospitalier Esquirol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Cross-sectional pilot study

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: April 25, 2025
• Study Start: November 22, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 6, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)