Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 110
- 主要终点
- Reading speed
研究概览
简要总结
The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.
详细描述
MAEVAD is a digital therapy specifically designed to improve the visual attention (VA) span of children with dyslexia. Dyslexia is characterized by a specific and significant impairment in reading and/or writing production and spelling. Some profiles of children with dyslexia show a deficit in VA span, characterized by a decrease in the number of distinct visual elements that can be processed simultaneously. VA span plays a critical role in the acquisition of reading skills and specific knowledge of word spelling. Brain regions involved in visual-attentional skills are under-activated in dyslexic children with VA deficits and can be reactivated following specific and intensive VA span training.
In this study 150 children with dyslexia will be randomized in tow groups. On the first group children will be trained first with MAEVAD then with a control training that does not stimulate the VA span. On contrary, on the second group children will first perform the control training and then MAEVAD.
For each intervention the sessions will lasts 15 minutes. 5 sessions are planned per weeks for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The training will be performed at home. The investigators/evaluators will send a download link of the therapy to the patient's parents without knowing which therapy it corresponds to.
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •School children from CE2 to CM2, aged 8 to 11 years
- •Dyslexic children with a VA span deficit (composite visual-attention span below the fifteenth percentile and a letter threshold above or equal to the twentieth percentile with the - - - Evadys(c) battery)
- •Established diagnosis of Dyslexia
- •Children whose parents/legal guardians have signed informed consent and agree to participate in the study
- •Children whose first language is French or who have been educated in French since kindergarten
- •Raven's Progressive Matrices score above the 20th percentile or a WISC IV or V Verbal Comprehension Index or WISC IV or V Perceptual/Fluid Reasoning Index above 85 or documented/objectifiable absence of intellectual deficit
- •Child with access to a computer
- •Normal or corrected vision and audition
排除标准
- •Attention deficit hyperactivity disorder,dysphasia, dyspraxia, Autism Spectrum Disorder
- •Neurological disorders
- •Children who have missed 3 months or more of school in the current or previous year (excluding lockdown)
- •Children not affiliated to a social security scheme
研究组 & 干预措施
MAEVAD - DeCaLigne
The experimental group will first receive MAEVAD then the control therapy
干预措施: MAEVAD (Device)
DeCaLigne - MAEVAD
The control group will first receive the control therapy then MAEVAD
干预措施: DeCaLigne (Device)
结局指标
主要结局
Reading speed
时间窗: 26 weeks to baseline
Measure of reding time from texts of 122 to 152 words
次要结局
- Orthographic skills(26 weeks to baseline)
- Reading skills(26 weeks to baseline)
- VA Span(26 weeks to baseline)
- Phonologic skills(26 weeks to baseline)
- Mathematical skills(18 weeks to baseline)