Children With a Need of Rehabilitation for HandwritingRVALIGONCT07040722
Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties ( RVALIGO )
A study testing Baseline and Intervention in people with Children With a Need of Rehabilitation for Handwriting, run by Fondation Ildys at 5 sites in France.
Trial summary
Difficulties in learning to write affect a large number of children and can have a significant impact on their personal and professional future. To facilitate this learning process, develop fun, motivating and effective devices for the different skills involved in writing (motor skills, postural control, visual… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Children With a Need of Rehabilitation for Handwriting
- What is being tested?
- Baseline and Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Oct 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age : 6-13 years
- BHK: degradation score ≥ 1 standard deviation. The BHK will be administered at the time of the inclusion visit (V1) and/or child with writing difficulties in in daily activities.
- Children benefiting or to benefit from rehabilitation care to improve handwriting skills.
- Be able to understand instructions and complete all assessments.
Who cannot join
- Contraindications to using a virtual reality HMD
- Severe visual impairment
- Facial injury
- Epilepsy
- Lack of parental and/or child consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Cabinet Ker ergo
Brest, Finistère, 29200
- Recruiting
Fondation ILDYS
Brest, Finistère, 29200
VALLEE, 0298293939
- Not yet recruiting
Fondation ILDYS
Brest, France, 29218
Manon LE GOFF, 0298028303 ext. +33, manon.legoff@ildys.org
Matthieu PICHELIN, 0298293915 ext. +33, matthieu.pichelin@ildys.org
- Recruiting
Cabinet d'ergothérapie - Maison des Korrigans
Lesneven, Finistère, 29260
- Recruiting
Cabinet d'ergothérapie Scol'Ergo
Pont-de-l'Arche, Eure, 27340
About this study
Official title: Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties : a Randomized Multiple Baseline Single-case Experimental Design (SCED)
Difficulties in learning to write affect a large number of children and can have a significant impact on their personal and professional future. To facilitate this learning process, develop fun, motivating and effective devices for the different skills involved in writing (motor skills, postural control, visual attention, letter recognition) is needing. Virtual Reality (VR) seems to be a promising tool for this purpose.
The SCED (Single Case Experimental Design) methodology is adapted to this study to evaluate the impact of VR on learning to write, as it allows a high level of evidence and is applicable to a heterogeneous population such as that affected by difficulties in learning to write. The study will include an original study of 3 children and 3 replications of 3 children each. In total, 12 children will be included in four different settings. This study will determine whether VR training can facilitate learning to write.
The main objective of this study is to evaluate the impact of immersive virtual reality training on handwriting using the Evaligo tool to assess static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting difficulties according to a SCED methodology.
Read the detailed description
5% to 30% of children in mainstream education experience difficulties with writing acquisition. This prevalence increases among children with motor disabilities such as cerebral palsy, coordination disorders, or attention-deficit/hyperactivity disorder. Writing difficulties can significantly impact other core learning areas, as well as children's development and future (e.g., increased risk of academic failure, reduced access to higher education, lower self-esteem).
These writing difficulties are multifactorial and require individualized intervention. Fine motor skills, postural control, and visual attention-key abilities in the learning of writing-are often impaired in children with writing difficulties.
Virtual reality (VR) can be defined as the digital simulation of a virtual environment with which users can interact through their own movements. In immersive VR, users wear a head mounted display (HMD) that allows them to be fully immersed in the virtual environment.
VR has been shown to improve upper limb function and postural control in pediatric rehabilitation. It integrates several features that support motor learning, including task repetition, sensory feedback, and enhanced motivation during exercises.
Using VR training to target skills associated with writing thus appears to be relevant. Furthermore, proposing writing training through gross motor activities in VR may facilitate the consolidation of motor programs necessary for letter formation.
This engaging system could increase the amount of training, introduce variability between virtual and real-world practice, and promote the child's autonomy-all key elements for effective learning and, consequently, improved writing skills.
The following hypotheses are proposing:
- Immersive VR training will facilitate the learning of writing.
- Skills associated with writing (visual attention, fine motor skills, gross motor skills, postural control, and letter recognition) will be improved through immersive VR training.
- Motivation will be maintained throughout the intervention due to the use of VR.
A multicentre, multiple baseline SCED, following the SCRIBE recommendations will be conducting. This is a prospective design allowing intensive study of one or a few individuals with the aim of measuring their state (baseline) and the state engendered by a therapeutic intervention. It is the demonstration of 3 effects that allows us to conclude that the intervention is effective (for example: measurement of 3 effects in 3 different patients, effects corresponding to the introduction of the therapeutic intervention). This design is suitable because i/ each subject is his or her own control, which makes it possible to avoid matching difficulties (complex in our case, given the varied expected profiles of children with writing disorders) and to respect the individualised nature of the treatment, ii/ it allows the inclusion of a small number of subjects, which is well suited to a pilot study, iii/ the repeated measurements of the main outcome make it possible to ensure that the changes observed are indeed linked to the intervention. This design is adapted to the specificities of rehabilitation treatment, with an effect that lasts over time.
In this study, baseline will be randomised for each child. It will last from 2 to 6 weeks (6 to 14 sessions of repeated measurements of the primary endpoint), starting at visit 1. From this phase onwards, the children will benefit from an intervention ('control', i.e. the usual care of the child by the usual therapist) aimed at training writing (paper/pencil).
The therapeutic intervention (introduction of the VR HMD) will last 8 weeks (16 sessions of repeated measures of the primary endpoint). It will include 2 intervention sessions with the child's usual care therapist per week (during which the repeated measures of the primary endpoint will be performed by the child's therapist).
Inclusion visits (V1), visits at the start of the intervention (V2), and visits at the end of the intervention (V5) will be used to assess the skills associated with writing. V3 and V4 will evaluate the sense of presence of children just after the use of the HMD.
- Being tested
- Baseline, Intervention
- Keywords
- Handwriting difficulties, Virtual reality, SCED, Children, Pediatric rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
During the baseline, children will carry out their standard paper-and-pencil exercises for writing difficulties (that their perform during usual rehabilitation).
InterventionOther
During the intervention, they will carry out usual exercises and they will use VR 15 minutes during each session
| Study group | Role | What they receive |
|---|---|---|
| Children with handwriting difficulties | Experimental | Children included in the study will carry out the baseline (i.e. a 'control' phase) as well as the intervention (corresponding to the introduction of the VR) Receives: Other: Baseline; Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of immersive virtual reality training on learning using the Evaligo score.
The Evaligo score assesses static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting learning difficulties, using a SCED methodology.
This assessment has several advantages in this study design: its validity has been verified, it can be repeated a large number of times without test-retest effect, it is sensitive to change and is quick to set up (around 5 minutes), which reduces the burden of assessments for the participating children and therapists.
- This score is obtained on the basis of a brief evaluation of around 5 minutes (and repeated, according to the SCED methodology) of trained items (during the intervention), throughout participation in the research (baseline, intervention).
The minimum score is 0 (worst), the maximum score is 1 (best).
Measured: This score will be assessed twice a week during the baseline and intervention periods (10 to 14 weeks depending on the baseline).
Secondary outcomes (13)
Assess fine and gross motor skills
Evolution of the score of the Bruininks-Oseretsky Test of Motor Proficiency Brief Form. This test has been validated in a population aged 4 to 21 years. It assesses gross and fine motor skills. The strength subtest will be our control measure in this SCED. The control measure will make it possible to assess an untrained parameter (in this case strength), which is supposed to remain stable during the intervention.
The maximum score for fine motor skills part is 60, the minimum score is 0. A high score means high performance in fine motor skills.
The maximum score for gross motor skills part is 65, the minimum score is 0. A high score means high performance in gross motor skills.
Measured: This criterion will be measured (during the first week of the baseline), during the first week of intervention (V2), and the visit at the 8th of the inetervention (V5)
Assess visual attention
Evolution of the score of the sky search and geographic map subtests of the Test of Everyday Attention for Children (TEA-CH). It assesses visual attention. This test has been validated in a population aged 6 to 16 years. Two subtest will be used: "Map Mission" and "Sky Search" in this study.
The maximum score for Map Mission subtest is 80, the minimum score is 1. A high score means high performance in visual attention. The maximum raw score for Sky Search is 20, the minimum score is 1. A high score means high performance in visual attention.
Measured: The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).
Assess postural control
Evolution of the Pediatric Reach Test (PRT) score, validated in children aged 5 to 15 with or without motor disorders. This test assesses postural control. The score is the difference, in cm, between the starting position and the finishing position.
Measured: The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).
Determine whether a generalization of learning to write takes place on the paper/pencil writing activity.
Evolution of the BHK score, the benchmark test for assessing handwriting. In the BHK (Brave Handwriting Kindergarten), the child is asked to copy a text for 5 minutes. Blind double scoring is used (the scorer does not know when the child has copied the text). A degradation score is calculated: the higher the score, the more "degraded" the quality of the child's handwriting. The standardized score is taken into account for inclusion (to situate the child's performance in relation to his class), while the raw score is taken into account over the course of the intervention (allowing comparison of the subject with himself).
The maximum score for the handwriting quality is 65. A high score means low performance in handwriting.
Measured: The BHK will be taken at the first week of the baseline and at the 8th week of the intervention (V5).
Check that the child's motivation is maintained during training.
Visual analogue scale score at each end of session, during baseline and intervention. The maximum score is 10, the minimum score is 0. A high score means a high motivation during session.
Measured: Analog scale score at the end of each session, during baseline and intervention (10 to 14 weeks depending on the baseline).
Assess satisfaction with the intervention : CSQ-8
The CSQ-8 is a questionnaire used to assess customer satisfaction. The families of the children who took part in the study will be invited to complete this questionnaire during the V5 visit. This questionnaire has been adapted for different populations (families).
Scores range from 8 to 32, higher values indicates higher satisfaction.
Measured: Assessment carried out at the 8th week of the intervention.
Assess satisfaction with the intervention
A visual analogue scale (VAS) will be implemented during the V5 visit to determine children's and professionals' satisfaction with the use of the immersive VR headset. The maximum score is 10, the minimum score is 0. A high score means a high global satisfaction during the study.
Measured: Evaluation carried out at 8th week of the intervention.
Evaluate the usability of the solution
SUS (System Usability Scale) questionnaire to be completed by children and professionals.
This questionnaire is currently the most widely used in the scientific community for measuring user satisfaction with a product, interactive system or service.
Scores range from 0 to 100, higher values indicates higher satisfaction.
Measured: Evaluation carried out at 8th week of the intervention
Assess the child's sense of presence in the virtual environment
Spatial Presence for Immersive Environments questionnaire (SP-IE), to be completed by the children to assess their sense of presence in the virtual environment. The SP-IE comprises 20 items.
Each item is assessed on a 5-point Likert Scale, ranging from 1 (strongly disagree) to 5 (strongly agree)
Measured: Evaluation carried out at the first session of the intervention phase (Session 1 of the intervention phase), and at the last session pf the intervention phase (Session 16 of the intervention phase).
Assessing language levels : letter recognition
Evolve assessments of language skills into assessments that are used as references in teaching with letter recognition. For the subtest letter recognition, the maximum score is 6 and the minimum score is 0.
Measured: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : knowledge of letter names
Evolve assessments of language skills into assessments that are used as references in teaching with knowledge of letter names. For the subtest knowledge of letters names, the maximum score is 12, and the minimum score is 0.
Measured: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : writing a letter
Evolve assessments of language skills into assessments that are used as references in teaching with writing a letter. For the subtest writing a letter, the maximum score is 12 and the minimum score is 0.
Measured: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : recognition of allographs
Evolve assessments of language skills into assessments that are used as references in teaching with recognition of allographs. For the subtest recognition of allographs, the maximum score is 6 and the minimum score is 0.
Measured: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Children With a Need of Rehabilitation for HandwritingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- LP3C, University of Brest, LaTim Laboratory
- Responsible party
- Sponsor
- Investigators
- Jéromine HERVO, Coordinator Investigator, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040722
- Sponsor's protocol ID
- RI2024_020
- Acronym
- RVALIGO
- Status last verified
- Jun 2025
- First submitted
- 6 May 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapp C, Perlini T, Baggio S, Stephan P, Urrego AR, Rengade CE, Macias M, Hainard N, Halfon O. [Psychometric properties of the Consumer Satisfaction Questionnaire (CSQ-8) and the Helping Alliance Questionnaire (HAQ)]. Sante Publique. 2014 May-Jun;26(3):337-44. French.
PubMed 25291882Bartlett D, Birmingham T. Validity and reliability of a pediatric reach test. Pediatr Phys Ther. 2003 Summer;15(2):84-92. doi: 10.1097/01.PEP.0000067885.63909.5C.
PubMed 17057438Manly T, Anderson V, Nimmo-Smith I, Turner A, Watson P, Robertson IH. The differential assessment of children's attention: the Test of Everyday Attention for Children (TEA-Ch), normative sample and ADHD performance. J Child Psychol Psychiatry. 2001 Nov;42(8):1065-81. doi: 10.1111/1469-7610.00806.
PubMed 11806689Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Phys Ther. 2016 Jul;96(7):e1-e10. doi: 10.2522/ptj.2016.96.7.e1.
PubMed 27371692Bara F, Bonneton-Botte N. Learning Letters With the Whole Body: Visuomotor Versus Visual Teaching in Kindergarten. Percept Mot Skills. 2018 Feb;125(1):190-207. doi: 10.1177/0031512517742284. Epub 2017 Nov 21.
PubMed 29161949Tatla SK, Sauve K, Virji-Babul N, Holsti L, Butler C, Van Der Loos HF. Evidence for outcomes of motivational rehabilitation interventions for children and adolescents with cerebral palsy: an American Academy for Cerebral Palsy and Developmental Medicine systematic review. Dev Med Child Neurol. 2013 Jul;55(7):593-601. doi: 10.1111/dmcn.12147. Epub 2013 Mar 29.
PubMed 23550896Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
PubMed 31674852Burin-Chu S, Baillet H, Leconte P, Lejeune L, Thouvarecq R, Benguigui N. Effectiveness of virtual reality interventions of the upper limb in children and young adults with cerebral palsy: A systematic review with meta-analysis. Clin Rehabil. 2024 Jan;38(1):15-33. doi: 10.1177/02692155231187858. Epub 2023 Jul 27.
PubMed 37499213Monge Pereira E, Molina Rueda F, Alguacil Diego IM, Cano de la Cuerda R, de Mauro A, Miangolarra Page JC; CONSOLIDER-Ingenio 2010. Use of virtual reality systems as proprioception method in cerebral palsy: clinical practice guideline. Neurologia. 2014 Nov-Dec;29(9):550-9. doi: 10.1016/j.nrl.2011.12.004. Epub 2012 Feb 17. English, Spanish.
PubMed 22341675Adamovich SV, Fluet GG, Tunik E, Merians AS. Sensorimotor training in virtual reality: a review. NeuroRehabilitation. 2009;25(1):29-44. doi: 10.3233/NRE-2009-0497.
PubMed 19713617Lopez C, Vaivre-Douret L. Influence of visual control on the quality of graphic gesture in children with handwriting disorders. Sci Rep. 2021 Dec 7;11(1):23537. doi: 10.1038/s41598-021-02969-7.
PubMed 34876643Bumin G, Kavak ST. An investigation of the factors affecting handwriting skill in children with hemiplegic cerebral palsy. Disabil Rehabil. 2010;32(8):692-703. doi: 10.3109/09638281003654789.
PubMed 20205584Biotteau M, Danna J, Baudou E, Puyjarinet F, Velay JL, Albaret JM, Chaix Y. Developmental coordination disorder and dysgraphia: signs and symptoms, diagnosis, and rehabilitation. Neuropsychiatr Dis Treat. 2019 Jul 8;15:1873-1885. doi: 10.2147/NDT.S120514. eCollection 2019.
PubMed 31371960Overvelde A, Hulstijn W. Handwriting development in grade 2 and grade 3 primary school children with normal, at risk, or dysgraphic characteristics. Res Dev Disabil. 2011 Mar-Apr;32(2):540-8. doi: 10.1016/j.ridd.2010.12.027. Epub 2011 Jan 26.
PubMed 21269805
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties : a Randomized Multiple Baseline Single-case Experimental Design (SCED)
- ClinicalTrials.gov ID
- NCT07040722
- Acronym / sponsor ID
- RVALIGO / RI2024_020
- Keywords
- Handwriting difficulties, Virtual reality, SCED, Children, Pediatric rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- LP3C, University of Brest, LaTim Laboratory
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Jun 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.
Difficulties in learning to write affect a large number of children and can have a significant impact on their personal and professional future. To facilitate this learning process, develop fun, motivating and effective devices for the different skills involved in writing (motor skills, postural control, visual attention, letter recognition) is needing. Virtual Reality (VR) seems to be a promising tool for this purpose.
The SCED (Single Case Experimental Design) methodology is adapted to this study to evaluate the impact of VR on learning to write, as it allows a high level of evidence and is applicable to a heterogeneous population such as that affected by difficulties in learning to write. The study will include an original study of 3 children and 3 replications of 3 children each. In total, 12 children will be included in four different settings. This study will determine whether VR training can facilitate learning to write.
The main objective of this study is to evaluate the impact of immersive virtual reality training on handwriting using the Evaligo tool to assess static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting difficulties according to a SCED methodology.
Detailed description
5% to 30% of children in mainstream education experience difficulties with writing acquisition. This prevalence increases among children with motor disabilities such as cerebral palsy, coordination disorders, or attention-deficit/hyperactivity disorder. Writing difficulties can significantly impact other core learning areas, as well as children's development and future (e.g., increased risk of academic failure, reduced access to higher education, lower self-esteem).
These writing difficulties are multifactorial and require individualized intervention. Fine motor skills, postural control, and visual attention-key abilities in the learning of writing-are often impaired in children with writing difficulties.
Virtual reality (VR) can be defined as the digital simulation of a virtual environment with which users can interact through their own movements. In immersive VR, users wear a head mounted display (HMD) that allows them to be fully immersed in the virtual environment.
VR has been shown to improve upper limb function and postural control in pediatric rehabilitation. It integrates several features that support motor learning, including task repetition, sensory feedback, and enhanced motivation during exercises.
Using VR training to target skills associated with writing thus appears to be relevant. Furthermore, proposing writing training through gross motor activities in VR may facilitate the consolidation of motor programs necessary for letter formation.
This engaging system could increase the amount of training, introduce variability between virtual and real-world practice, and promote the child's autonomy-all key elements for effective learning and, consequently, improved writing skills.
The following hypotheses are proposing:
- Immersive VR training will facilitate the learning of writing.
- Skills associated with writing (visual attention, fine motor skills, gross motor skills, postural control, and letter recognition) will be improved through immersive VR training.
- Motivation will be maintained throughout the intervention due to the use of VR.
A multicentre, multiple baseline SCED, following the SCRIBE recommendations will be conducting. This is a prospective design allowing intensive study of one or a few individuals with the aim of measuring their state (baseline) and the state engendered by a therapeutic intervention. It is the demonstration of 3 effects that allows us to conclude that the intervention is effective (for example: measurement of 3 effects in 3 different patients, effects corresponding to the introduction of the therapeutic intervention). This design is suitable because i/ each subject is his or her own control, which makes it possible to avoid matching difficulties (complex in our case, given the varied expected profiles of children with writing disorders) and to respect the individualised nature of the treatment, ii/ it allows the inclusion of a small number of subjects, which is well suited to a pilot study, iii/ the repeated measurements of the main outcome make it possible to ensure that the changes observed are indeed linked to the intervention. This design is adapted to the specificities of rehabilitation treatment, with an effect that lasts over time.
In this study, baseline will be randomised for each child. It will last from 2 to 6 weeks (6 to 14 sessions of repeated measurements of the primary endpoint), starting at visit 1. From this phase onwards, the children will benefit from an intervention ('control', i.e. the usual care of the child by the usual therapist) aimed at training writing (paper/pencil).
The therapeutic intervention (introduction of the VR HMD) will last 8 weeks (16 sessions of repeated measures of the primary endpoint). It will include 2 intervention sessions with the child's usual care therapist per week (during which the repeated measures of the primary endpoint will be performed by the child's therapist).
Inclusion visits (V1), visits at the start of the intervention (V2), and visits at the end of the intervention (V5) will be used to assess the skills associated with writing. V3 and V4 will evaluate the sense of presence of children just after the use of the HMD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with handwriting difficulties | Experimental | Other: Baseline, Other: InterventionChildren included in the study will carry out the baseline (i.e. a 'control' phase) as well as the intervention (corresponding to the introduction of the VR) |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age : 6-13 years
- BHK: degradation score ≥ 1 standard deviation. The BHK will be administered at the time of the inclusion visit (V1) and/or child with writing difficulties in in daily activities.
- Children benefiting or to benefit from rehabilitation care to improve handwriting skills.
- Be able to understand instructions and complete all assessments.
Key exclusion criteria (5 listed)
- Contraindications to using a virtual reality HMD
- Severe visual impairment
- Facial injury
- Epilepsy
- Lack of parental and/or child consent
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 |
|---|---|---|
| BaselineDuring the baseline, children will carry out their standard paper-and-pencil exercises for writing difficulties (that their perform during usual rehabilitation). | Other | Children with handwriting difficulties |
| InterventionDuring the intervention, they will carry out usual exercises and they will use VR 15 minutes during each session | Other | Children with handwriting difficulties |
Primary outcome
Evaluation of the impact of immersive virtual reality training on learning using the Evaligo score.
Time frame: This score will be assessed twice a week during the baseline and intervention periods (10 to 14 weeks depending on the baseline).
The Evaligo score assesses static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting learning difficulties, using a SCED methodology. This assessment has several advantages in this study design: its validity has been verified, it can be repeated a large number of times without test-retest effect, it is sensitive to change and is quick to set up (around 5 minutes), which reduces the burden of assessments for the participating children and therapists. • This score is obtained on the basis of a brief evaluation of around 5 minutes (and repeated, according to the SCED methodology) of trained items (during the intervention), throughout participation in the research (baseline, intervention). The minimum score is 0 (worst), the maximum score is 1 (best).
13 secondary outcomes
Assess fine and gross motor skills
Time frame: This criterion will be measured (during the first week of the baseline), during the first week of intervention (V2), and the visit at the 8th of the inetervention (V5)
Assess visual attention
Time frame: The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).
Assess postural control
Time frame: The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).
Determine whether a generalization of learning to write takes place on the paper/pencil writing activity.
Time frame: The BHK will be taken at the first week of the baseline and at the 8th week of the intervention (V5).
Check that the child's motivation is maintained during training.
Time frame: Analog scale score at the end of each session, during baseline and intervention (10 to 14 weeks depending on the baseline).
Assess satisfaction with the intervention : CSQ-8
Time frame: Assessment carried out at the 8th week of the intervention.
Assess satisfaction with the intervention
Time frame: Evaluation carried out at 8th week of the intervention.
Evaluate the usability of the solution
Time frame: Evaluation carried out at 8th week of the intervention
Assess the child's sense of presence in the virtual environment
Time frame: Evaluation carried out at the first session of the intervention phase (Session 1 of the intervention phase), and at the last session pf the intervention phase (Session 16 of the intervention phase).
Assessing language levels : letter recognition
Time frame: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : knowledge of letter names
Time frame: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : writing a letter
Time frame: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Assessing language levels : recognition of allographs
Time frame: The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 25291882Kapp C, Perlini T, Baggio S, Stephan P, Urrego AR, Rengade CE, Macias M, Hainard N, Halfon O. [Psychometric properties of the Consumer Satisfaction Questionnaire (CSQ-8) and the Helping Alliance Questionnaire (HAQ)]. Sante Publique. 2014 May-Jun;26(3):337-44. French.
- Background: PubMed 17057438Bartlett D, Birmingham T. Validity and reliability of a pediatric reach test. Pediatr Phys Ther. 2003 Summer;15(2):84-92. doi: 10.1097/01.PEP.0000067885.63909.5C.
- Background: PubMed 11806689Manly T, Anderson V, Nimmo-Smith I, Turner A, Watson P, Robertson IH. The differential assessment of children's attention: the Test of Everyday Attention for Children (TEA-Ch), normative sample and ADHD performance. J Child Psychol Psychiatry. 2001 Nov;42(8):1065-81. doi: 10.1111/1469-7610.00806.
- Background: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Background: PubMed 27371692Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Phys Ther. 2016 Jul;96(7):e1-e10. doi: 10.2522/ptj.2016.96.7.e1.
- Background: PubMed 29161949Bara F, Bonneton-Botte N. Learning Letters With the Whole Body: Visuomotor Versus Visual Teaching in Kindergarten. Percept Mot Skills. 2018 Feb;125(1):190-207. doi: 10.1177/0031512517742284. Epub 2017 Nov 21.
- Background: PubMed 23550896Tatla SK, Sauve K, Virji-Babul N, Holsti L, Butler C, Van Der Loos HF. Evidence for outcomes of motivational rehabilitation interventions for children and adolescents with cerebral palsy: an American Academy for Cerebral Palsy and Developmental Medicine systematic review. Dev Med Child Neurol. 2013 Jul;55(7):593-601. doi: 10.1111/dmcn.12147. Epub 2013 Mar 29.
- Background: PubMed 31674852Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
- Background: PubMed 37499213Burin-Chu S, Baillet H, Leconte P, Lejeune L, Thouvarecq R, Benguigui N. Effectiveness of virtual reality interventions of the upper limb in children and young adults with cerebral palsy: A systematic review with meta-analysis. Clin Rehabil. 2024 Jan;38(1):15-33. doi: 10.1177/02692155231187858. Epub 2023 Jul 27.
- Background: PubMed 22341675Monge Pereira E, Molina Rueda F, Alguacil Diego IM, Cano de la Cuerda R, de Mauro A, Miangolarra Page JC; CONSOLIDER-Ingenio 2010. Use of virtual reality systems as proprioception method in cerebral palsy: clinical practice guideline. Neurologia. 2014 Nov-Dec;29(9):550-9. doi: 10.1016/j.nrl.2011.12.004. Epub 2012 Feb 17. English, Spanish.
- Background: PubMed 19713617Adamovich SV, Fluet GG, Tunik E, Merians AS. Sensorimotor training in virtual reality: a review. NeuroRehabilitation. 2009;25(1):29-44. doi: 10.3233/NRE-2009-0497.
- Background: PubMed 34876643Lopez C, Vaivre-Douret L. Influence of visual control on the quality of graphic gesture in children with handwriting disorders. Sci Rep. 2021 Dec 7;11(1):23537. doi: 10.1038/s41598-021-02969-7.
- Individual participant dataSharing planned: No
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.
Jéromine HERVO, Coordinator Investigator principal investigator
Fondation Ildys
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline and Intervention in people with Children With a Need of Rehabilitation for Handwriting, run by Fondation Ildys at 5 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon LE GOFF (0298028308 ext. +33, manon.legoff@ildys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of immersive virtual reality training on learning using the Evaligo score. (time frame: This score will be assessed twice a week during the baseline and intervention periods (10 to 14 weeks depending on the baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040722, which also lists 16 linked publications.
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 24 Dec 2025.