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

NCT06858566 | Recruiting

• 1 other identifier: RI2022_008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Writing Disorder

Keywords

learning to write; writing disorders; SCED study; Children

Outcome Measures

Primary Outcomes (1)

• Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +

  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).

  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 (13)

• 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.

• 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

• 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.

• 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.

• 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.

Study Arms (1)

Children with handwriting difficulties

EXPERIMENTAL

Other: Kaligo + score

Interventions

Kaligo + score OTHER

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

Children with handwriting difficulties

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondation Ildys: lead

Study Sites (1)

Fondation ILDYS

Brest, 29218, France

RECRUITING

Study Officials

• Christelle PONS BECMEUR, MP/PhD

  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

Model Details: Single Case Experimental Design - SCED

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 5, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): February 24, 2027
• Study Completion (Estimated): February 24, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)