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Completed

NCT Number: NCT06944613

Augmented Reality Training for Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Infantile Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Julia HAMONET-TORNY

Limoges, 87025, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented reality-based programme/Microsoft Hololens version 2

Device

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

Primary outcomes

  1. System Usability Scale

    Time frame: Immediately after the intervention

    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

Secondary outcomes

  1. Semantic user experience

    Time frame: Immediately after the intervention

    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.

  2. Emotionnal user experience

    Time frame: Immediately after the intervention

    The user experience of the device will also be assessed using the emotions dimension of the "meCUE" UX scale. Children will rate 8 statements using a 7-point Likert scale with anchor points at either end ("Strongly disagree" or "Strongly agree").

  3. Acceptance

    Time frame: Before and Immediately after the intervention

    Acceptance of the AR device before and after use will be assessed using four dimensions of the Technology Acceptance Model (TAM): perceived usefulness, perceived ease of use, perceived pleasure and behavioural intention to use. Acceptance before use is measured following a short presentation of the device and its purpose (video). The children rated 3 statements per dimension (12 in total) using a 7-point Likert scale with anchor points at either end ("Strongly disagree" or "Strongly agree"). The score for each dimension was then analysed separately.

  4. Motivation

    Time frame: Immediately after the intervention

    Motivation for the session will be measured by the modified "Intrinsic Motivation Inventory" questionnaire. Of the 7 dimensions of this questionnaire, we have chosen 4 (23 items in total) that are of interest to our subject: Interest/Pleasure, Perceived Competence, Effort/Importance, Pressure/Tension. For each item in the 4 dimensions, the children were asked to indicate their agreement using a 7-point Likert scale with anchor points at either end ("Strongly disagree" or "Strongly agree"). The score for each dimension is then analysed separately.

  5. Fatigue

    Time frame: Pre-intervention

    Fatigue (physical and mental) will be measured using the RPE-C "Rating scale of Perceived Exertion for Children", before and after the session. The ratings range from 6 (no fatigue) to 20 (extreme fatigue), accompanied by images of Gaston Lagaffe, representative of the state of fatigue.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Registry information

Official study title

Study of the Usability of an Augmented Reality Exercise for the Cognitive-motor Rehabilitation of Cerebral Palsy (CP) or Acquired Brain Injury (ABI)

Acronym: TERAPACE

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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