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

Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders: a Multiple Baseline Online SCED Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858566
Acronym
KALIGO+
Enrollment
15
Registered
2025-03-05
Start date
2025-03-21
Completion date
2027-02-24
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Writing Disorder

Keywords

learning to write, writing disorders, SCED study, Children

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.

Interventions

OTHERKaligo + score

The Kaligo + Score will be taken twice a week during baseline and intervention and once a week during follow-up.

Sponsors

Fondation Ildys
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Single Case Experimental Design - SCED

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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 interventionaStatic 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

MeasureTime frameDescription
Assessing the ecological impact and its generalisationThis 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.Movement Assessment Battery for Children \| Second Edition (M-ABC-II). Questionnaire to assess motor skills in everyday situations, comprising 3 parts: part A movement in a static and/or predictable environment, part B movement in a dynamic and/or non-static environment, part C non-motor factors that can affect movement. A raw score is obtained for each of these parts, as well as a total motricity score (A + B).
- Evaluate the maintenance of performance over time after the end of the interventionThis 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 interventionThis 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 interventionEvolution 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 familyduring the last visit, 1 month after interventionThe CSQ 8 is a short customer satisfaction questionnaire. The CSQ8 is the benchmark questionnaire for assessing satisfaction among parents, children and teenagers.
Assessing the acceptability and usability of the solution for families and professionalsduring the last visit, 1 month after interventionMobile Application Rating Scale (MARS). This validated questionnaire makes it possible to assess the quality of mobile healthcare applications in a way that is transparent for healthcare professionals and patients alike.

Countries

France

Contacts

Primary ContactManon LE GOFF
manon.legoff@ildys.org0298028308
Backup ContactMatthieu PICHELIN
matthieu.pichelin@ildys.org0298293915

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026