Clinical trial NCT06858566: Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders : KALIGO+
Official title: Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders: a Multiple Baseline Online SCED Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Writing Disorder
Keywords: learning to write
writing disorders
SCED study
Children
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design - SCED
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +
timeFrame: 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
Secondary outcomes:
measure: Assessing the ecological impact and its generalisation
timeFrame: 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.
measure: Assessing the ecological impact and its generalisation
timeFrame: 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
measure: Assessing the ecological impact and its generalisation
timeFrame: 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.
measure: Assessing the ecological impact and its generalisation
timeFrame: 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.
measure: Assessing the ecological impact and its generalisation
timeFrame: 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.
measure: Assessing the ecological impact and its generalisation
timeFrame: 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.
measure: - Evaluate the maintenance of performance over time after the end of the intervention
timeFrame: This assessment will be carried out at the end of the intervention and every week for a month.
measure: Assessing the specific nature of the intervention
timeFrame: 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
measure: Assessing satisfaction with the intervention for the child and his or her family
timeFrame: during the last visit, 1 month after intervention
measure: Assessing satisfaction with the intervention for the child and his or her family
timeFrame: during the last visit, 1 month after intervention
measure: Assessing the acceptability and usability of the solution for families and professionals
timeFrame: during the last visit, 1 month after intervention
measure: Assessing the acceptability and usability of the solution for families and professionals
timeFrame: during the last visit, 1 month after intervention
measure: Assessing the acceptability and usability of the solution for families and professionals
timeFrame: during the last visit, , 1 month after intervention
Other outcomes:
Locations:
city: Brest cedex 2
country: France
facility: Fondation ILDYS
Study officials:
affiliation: Fondation Ildys
name: Christelle PONS BECMEUR, MP/PhD
role: PRINCIPAL_INVESTIGATOR
References: