Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 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
- 否
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.
研究组 & 干预措施
intensive arm
The children included in this arm will receive two weeks of daily care during which two daily speech therapy sessions of one hour each will be performed. This will be done between M2 and M4 of inclusion in order to avoid potential measurement bias. These sessions will be carried out by a state-qualified speech therapist employed at the CRRF of Bregille. They will guide the intensive rehabilitation of dyslexic children by focusing the exercises on their main difficulties.
干预措施: Speech Therapy INTENS-DYS (Other)
classic arm or gold standard
The speech therapy session will be provided only by private practitioners, with a weekly consultation of 30 minutes. The private speech therapist who initially referred the patient for inclusion in the research protocol will be responsible for his or her "classic" rehabilitation. The therapy will continue during the 6 months of research.
干预措施: Speech Therapy INTENS-DYS (Other)
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.)