跳至主要内容
临床试验/NCT06858566
NCT06858566招募中不适用

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

Fondation Ildys2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年3月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 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).

次要结局

  • - 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.)
  • Assessing satisfaction with the intervention for the child and his or her family(during the last visit, 1 month after intervention)
  • 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)
  • Assessing the acceptability and usability of the solution for families and professionals(during the last visit, , 1 month after 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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