Augmented Reality Training for Cerebral Palsy | NCT06944613

Studies
Augmented Reality Training for Cerebral Palsy

NCT06944613

Sponsor

Centre Hospitalier Esquirol

Status

Completed

Last Update Posted

Apr 25, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cerebral Palsy Infantile
Acquired Brain Injury

Interventions

Augmented reality-based programme/Microsoft Hololens version 2

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2023Actual

Primary Completion Date

Nov 29, 2023Actual

Completion Date

Nov 6, 2024Actual

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Apr 17, 2025

First Posted Date

Apr 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julia HAMONET-TORNY, Doctor, Centre Hospitalier EsquirolPrincipal Investigator

Lead Sponsor

Centre Hospitalier EsquirolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exergames	Other	There are two exergames: corsi and zoo games	Device: Augmented reality-based programme/Microsoft Hololens version 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Semantic user experience	This criteria is evaluated with "AttrakDiff" questionnaire. The children will score the 28 items of the questionnaire are in the form of semantic diﬀerentiators (pair of contrasting words) in 7 points (from -3 to 3). The score for each dimension is then analysed. Scores close to the mean (area between -1 and 1) are standard. Scores between 1 and 3 are considered as positive points and between -1 and -3 as negative points of the system.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia HAMONEt-TORNY, MD	Centre Hospitalier Esquirol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Julia HAMONET-TORNY		Limoges		87025	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided