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Recruiting NCT06858566

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

No phase Interventional Writing Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kaligo + score.
Who it may be relevant to
Registry conditions: Writing Disorder. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

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

Primary outcome measures

  • Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo + [Time frame: 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 outcome measures (12)
  • Assessing the ecological impact and its generalisation [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
  • - Evaluate the maintenance of performance over time after the end of the intervention [Time frame: This assessment will be carried out at the end of the intervention and every week for a month.]
  • Assessing the specific nature of the intervention [Time frame: 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 satisfaction with the intervention for the child and his or her family [Time frame: during the last visit, 1 month after intervention]
  • Assessing satisfaction with the intervention for the child and his or her family [Time frame: during the last visit, 1 month after intervention]
  • Assessing the acceptability and usability of the solution for families and professionals [Time frame: during the last visit, 1 month after intervention]
  • Assessing the acceptability and usability of the solution for families and professionals [Time frame: during the last visit, 1 month after intervention]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Fondation ILDYS — Brest

Identifiers

NCT: NCT06858566 · RI2022_008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗