Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties ( RVALIGO )
NCT ID: NCT07040722
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2025-10-01
2027-09-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Children with handwriting difficulties
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)
Baseline
During the baseline, children will carry out their standard paper-and-pencil exercises for writing difficulties (that their perform during usual rehabilitation).
Intervention
During the intervention, they will carry out usual exercises and they will use VR 15 minutes during each session
Interventions
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Baseline
During the baseline, children will carry out their standard paper-and-pencil exercises for writing difficulties (that their perform during usual rehabilitation).
Intervention
During the intervention, they will carry out usual exercises and they will use VR 15 minutes during each session
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Severe visual impairment
* Facial injury
* Epilepsy
* Lack of parental and/or child consent
6 Years
13 Years
ALL
No
Sponsors
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LP3C, University of Brest
UNKNOWN
LaTim Laboratory
UNKNOWN
Fondation Ildys
OTHER
Responsible Party
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Principal Investigators
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Jéromine HERVO, Coordinator Investigator
Role: PRINCIPAL_INVESTIGATOR
Fondation Ildys
Locations
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Cabinet d'ergothérapie Scol'Ergo
Pont-de-l'Arche, Eure, France
Cabinet Ker ergo
Brest, Finistère, France
Fondation ILDYS
Brest, Finistère, France
Cabinet d'ergothérapie - Maison des Korrigans
Lesneven, Finistère, France
Fondation ILDYS
Brest, France, France
Countries
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Central Contacts
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Facility Contacts
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VALLEE
Role: primary
Manon LE GOFF
Role: primary
Matthieu PICHELIN
Role: backup
References
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Overvelde 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.
Bonneton-Botte N, Miramand L, Bailly R, Pons C. Teaching and Rehabilitation of Handwriting for Children in the Digital Age: Issues and Challenges. Children (Basel). 2023 Jun 22;10(7):1096. doi: 10.3390/children10071096.
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.
Bartlett 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.
Manly 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.
Krasny-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.
Tate 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.
Bara 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.
Tatla 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.
Warnier 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.
Burin-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.
Monge 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.
Adamovich 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.
Lopez 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.
Bumin 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.
Biotteau 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.
Other Identifiers
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RI2024_020
Identifier Type: -
Identifier Source: org_study_id