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临床试验/NCT04028310
NCT04028310已完成不适用

Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.

Fondation Lenval1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
145
试验地点
1
主要终点
reading skills effectiveness

研究概览

简要总结

At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation

详细描述

Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus.

Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills.

In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation.

The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 8 years old and ≤ at 13 years old;
  • Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.
  • Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.
  • Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.
  • Home equipped with a connected computer system for daily training.
  • Signing of informed consent by the parents
  • The child must be affiliated to a social security scheme

排除标准

  • Intellectual retardation, neurological disorders, pervasive developmental disorder;
  • Primary sensory deficit;
  • Educational deficiencies;
  • attention deficit hyperactivity disorder, dysphasia;
  • Previous daily phonological or visual-attentional training.

结局指标

主要结局

reading skills effectiveness

时间窗: 26 weeks to baseline

measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation

次要结局

  • reading comprehension skills effectiveness(26 weeks to baseline)
  • reading skills effectiveness 8 weeks(8 weeks to baseline)
  • reading skills effectiveness 18 weeks(18 weeks to baseline)
  • orthographic skills effectiveness(26 weeks to baseline)
  • perception of the evolution of the reading disorder(26 weeks to baseline)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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