跳至主要内容
临床试验/NCT05383937
NCT05383937Unknown不适用

Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Reading fluency to the Alouette test.

研究概览

简要总结

Dyslexia is characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. However, no clinical trial of a standardized rehabilitation has shown an impact on reading fluency. In the era of intensive rehabilitation, a new protocol based on the current data from the medical literature has been designed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from 8 to 12 years old,
  • Living in and around 50 kilometers from Besançon.
  • Diagnosis of dyslexia according to the DSM-V or CIM-10 requirements.
  • Consent form signed by the parental authority and the child,
  • Affiliation to a social security system.

排除标准

  • Mother's medical history of pregnancy or delivery complications,
  • Patients's medical history of neurological infectious, vascular or tumoral events,
  • Patient's medical history of intellectual deficiency,
  • Patients's medical history of visual or hearing disorders,
  • Patient's medical history of psychiatric disorders (especially diagnosis of Attention Deficit / Hyperactivity Disorders (AD/HD)),
  • legal incapacity,
  • limited cooperation suspected by the investigator.

结局指标

主要结局

Reading fluency to the Alouette test.

时间窗: Six month.

Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.

次要结局

  • Visual pattern.(Six month.)
  • Phonological processing tests.(Six month.)
  • Rehabilitation adhesion.(6 month)
  • Speech langage rehabilitation cost.(6 month.)
  • Life Quality.(6 month.)
  • Family and school evaluation.(6 month.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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