Cerebral Palsy InfantileTERAPACENCT06944613
Augmented Reality Training for Cerebral Palsy
A study testing Augmented reality-based programme/Microsoft Hololens version 2 in people with Cerebral Palsy Infantile and Acquired Brain Injury, run by Centre Hospitalier Esquirol at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Cerebral Palsy Infantile, Acquired Brain Injury
- What is being tested?
- Augmented reality-based programme/Microsoft Hololens version 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2023to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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 :
- 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
- Being tested
- Augmented reality-based programme/Microsoft Hololens version 2
- Keywords
- Cognitive rehabilitation, Augmented reality-based programme, Double tasks, Users experiences
- Medical subject headings
- Cerebral Palsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality-based programme/Microsoft Hololens version 2Device
Participants play two exergames, the aim of this process is to engage cognitive double tasks
| Study group | Role | What they receive |
|---|---|---|
| exergames | Other | There are two exergames: corsi and zoo games Receives: Device: Augmented reality-based programme/Microsoft Hololens version 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the intervention
Secondary outcomes (5)
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.
Measured: Immediately after the intervention
Emotionnal user experience
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").
Measured: Immediately after the intervention
Acceptance
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.
Measured: Before and Immediately after the intervention
Motivation
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.
Measured: Immediately after the intervention
Fatigue
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.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start22 Nov 2023
- Primary completion29 Nov 2023
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia HAMONET-TORNY, Centre Hospitalier Esquirol
- Investigators
- Julia HAMONEt-TORNY, MD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944613
- Sponsor's protocol ID
- 2023-A00904-41
- Acronym
- TERAPACE
- Status last verified
- Apr 2025
- First submitted
- 23 Oct 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06944613
- Acronym / sponsor ID
- TERAPACE / 2023-A00904-41
- Conditions
- Cerebral Palsy Infantile, Acquired Brain Injury
- Keywords
- Cognitive rehabilitation, Augmented reality-based programme, Double tasks, Users experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional pilot study
| Arm | Type | Receives |
|---|---|---|
| exergames | Other | Device: Augmented reality-based programme/Microsoft Hololens version 2There are two exergames: corsi and zoo games |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality-based programme/Microsoft Hololens version 2Participants play two exergames, the aim of this process is to engage cognitive double tasks | Device | exergames |
Primary outcome
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
5 secondary outcomes
Semantic user experience
Time frame: Immediately after the intervention
Emotionnal user experience
Time frame: Immediately after the intervention
Acceptance
Time frame: Before and Immediately after the intervention
Motivation
Time frame: Immediately after the intervention
Fatigue
Time frame: Pre-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia HAMONEt-TORNY, MD principal investigator
Centre Hospitalier Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality-based programme/Microsoft Hololens version 2 in people with Cerebral Palsy Infantile and Acquired Brain Injury, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.