Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders : KALIGO+

Not Applicable

Recruiting

• Conditions: Writing Disorder

• Registration Number: NCT06858566
• Lead Sponsor: Fondation Ildys

Brief Summary

Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Initial studies into the use of new technologies (tablets, virtual reality headsets) have shown that they can help children learn to write. Attractive to children, these interfaces make it possible to apply new paradigms (e.g. enrichment of feedback \[sonification\], variation of writing media) that have proved effective, mainly with children with 'typical' development. The Kaligo+ solution is based on the latest scientific advances to offer an innovative approach to learning to write, particularly for children with significant difficulties in this area. This study proposes to test the benefits of the Kaligo+ solution on 15 children with writing difficulties.

The main objective of this pilot study is to demonstrate improved writing performance following use of the Kaligo+ solution in children aged 6 to 11 with writing difficulties, using a Single Case Experimental Design (SCED) methodology.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-27
• Study Start: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2027-02-24
• Study Completion: 2027-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Children with writing difficulties (who may or may not be receiving care in this area)
• Age: 6 - 11 years
• Score > 1 standard deviation on the BHK deterioration score

Exclusion Criteria

• Contraindication to the use of the tablet or virtual reality
• Moderate, severe or profound intellectual disability (Total Intelligence Quotient below 55 on an intellectual efficiency scale such as WISC-V or K-ABC-II).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +	This assessment will be carried out twice a week up to 19 weeks during the baseline and intervention and once a week up to 1 month after the interventiona	Static parameters: density, height, width and length Kinematic parameters: Time (in air and on paper), speed, number of speed inversion, median frequency of the speed, jerk and acceleration.; Pressure: Median, 60th percentile, median frequency of the pressure change. The score is normalized between 0 (worst) and 1 (best).

Secondary Outcome Measures

Name	Time	Method
Assessing the ecological impact and its generalisation	This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.	Written Language Analytical Battery (BALE). In the BALE \[Batterie Analytique du Langage Ecrit, Analytic test of the written language\], the child is asked to write (under dictation) simple, complex and frequent irregular words from the French language, and to read regular and frequent irregular words. For the purposes of this study, only raw scores will be taken into account, in order to compare the subject with himself.
- Evaluate the maintenance of performance over time after the end of the intervention	This assessment will be carried out at the end of the intervention and every week for a month.	Evolution of the Kaligo + score. Kaligo + Score: This composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure).
Assessing the specific nature of the intervention	This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention	Evolution of performance on an untrained task. It will be demonstrated by the absence of as great an improvement in the control variable (face recognition task) compared with the improvement recorded in the primary endpoint
Assessing satisfaction with the intervention for the child and his or her family	during the last visit, 1 month after intervention	10-point visual analogue scale to be completed by the child.
Assessing the acceptability and usability of the solution for families and professionals	during the last visit, , 1 month after intervention	Carrying out qualitative interviews with families and professionals

Trial Locations

Locations (1)

Fondation ILDYS; 🇫🇷 Brest cedex 2, France