Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties ( RVALIGO )

NCT07040722 | Recruiting

• 1 other identifier: RI2024_020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Children With a Need of Rehabilitation for Handwriting

Keywords

Handwriting difficulties; Virtual reality; SCED; Children; Pediatric rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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.

  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.

  Analog scale score at the end of each session, during baseline and intervention (10 to 14 weeks depending on the baseline).

Study Arms (1)

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)

Other: Baseline; Other: Intervention

Interventions

Baseline OTHER

During the baseline, children will carry out their standard paper-and-pencil exercises for writing difficulties (that their perform during usual rehabilitation).

Children with handwriting difficulties

Intervention OTHER

During the intervention, they will carry out usual exercises and they will use VR 15 minutes during each session

Children with handwriting difficulties

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age : 6-13 years
• Children benefiting or to benefit from rehabilitation care to improve handwriting skills.
• Be able to understand instructions and complete all assessments.

You may not qualify if:

• Contraindications to using a virtual reality HMD
• Severe visual impairment
• Facial injury
• Epilepsy
• Lack of parental and/or child consent

Sponsors & Collaborators

• Fondation Ildys: lead
• LP3C, University of Brest: collaborator
• LaTim Laboratory: collaborator

Study Sites (5)

Cabinet d'ergothérapie Scol'Ergo

Pont-de-l'Arche, Eure, 27340, France

RECRUITING

Cabinet Ker ergo

Brest, Finistère, 29200, France

RECRUITING

Fondation ILDYS

Brest, Finistère, 29200, France

RECRUITING

Cabinet d'ergothérapie - Maison des Korrigans

Lesneven, Finistère, 29260, France

RECRUITING

Fondation ILDYS

Brest, France, 29218, France

NOT YET RECRUITING

Related Publications (16)

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MeSH Terms

Interventions

BaseLine dental cement; Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jéromine HERVO, Coordinator Investigator

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon LE GOFF

CONTACT

0298028308; manon.legoff@ildys.org

Matthieu PICHELIN

CONTACT

0298293915; matthieu.pichelin@ildys.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 27, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)