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临床试验/NCT04382482
NCT04382482已完成不适用

Remotely Controlled Intervention for Developmental Reading and Spelling Disorders

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月20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
80
试验地点
1
主要终点
change from pre-test to post-test in reading ability

研究概览

简要总结

The study aims to document the effects of the intervention system for specific reading and spelling disorders, currently in use at Scientific Institute (IRCCS) Medea as an innovative intervention model in e-health mode. The model constitutes the application of research data collected in more than fifteen years research on the causes of dyslexia and rehabilitation techniques, combined with the most advanced technologies for remotely-controlled clinical management and therapy monitoring through adaptive, self-updating algorithms.

A single group of about 80 children will be observed and their performance on reading, spelling and metaphonological tests at pre-test, post-test and follow-up (after 6 months) will be recorded in order to assess improvement (and, consequently, treatment effectiveness) and its stability. The improvements obtained in four weeks treatment will subsequently be compared with those obtained with outpatient intervention programmes of the same duration and intensity.

详细描述

The system for the improvement of reading and writing skills ("Tachidino" software) is based on two principles of proven effectiveness:

  1. The selective stimulation of a cerebral hemisphere and specific reading strategies. Taking up some of the principles already set out in the Balance Model of Dyslexia, the aim is to retrace the different stages of reading acquisition by focusing on those stages and processes which have proved more problematic or less efficiently activated. Such stages may require greater involvement of the right hemisphere, carrying out an accurate visual analysis of the material to be read, or of the left hemisphere, anticipating the words to be read by exploiting linguistic skills (knowledge of words, relationships between meanings, relationships between sounds, grammatical agreement and syntactic rules, etc.);
  2. the training of selective visuospatial attention, as well as the perception of rapid movement and the analysis of the visual characteristics of words. A further mechanism involved in the training is the so-called visual crowding, an automatic effect of our perceptual system producing a sort of "blurring" of the visual areas surrounding the object to be analyzed, to make its vision clearer. A malfunction of this mechanism and an insufficient ability to concentrate visual attention in a restricted area of the visual field, or to move it quickly and precisely from one point to another would be among the causes of reading disorders, as suggested by the Magnocellular theory of dyslexia.

Studies carried out by researchers at IRCCS Medea have shown excellent results for the two types of treatment (Hemisphere-specific stimulation according to the Balance Model, and Visual-attentional training with Action Video- Games or Wii games, but above all they showed how these effects are strongly enhanced by the association in a single intervention.

Clinical and assessment procedures

In the Tachidino program, the child (sitting in fron of the computer screen) is required to recognize the target candy (a spiral candy) among various candies (distractors) and press the space bar at the exact moment the target candy is crossing a circle target (fixation point). The word to be decoded/encoded is presented, visually or auditory, only if the child clicks at the right moment, thus ensuring that fixation was in correspondence with the fixation point in the center of the visual field. If the bar is pressed in the target timeframe and in correspondence of the target candy, the word to be decoded/encoded is immediately presented and the child is asked to either write the word on the keyboard or re-order a sequence containing all the correct graphemes in random order.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A formal diagnosis of Developmental Dyslexia, Specific Reading Disorders, Specific Spelling Disorders or Mixed Learning Disorders
  • Age between 7 and 16
  • Attending at least the third class of primary school
  • Monolingual speakers of Italian or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
  • Intelligence Quotient (IQ) >= 80
  • At least one z-score below -2 Standard Deviations from age mean in at least one of the following tests: text reading, word reading, nonword reading, word writing to dictation, nonword writing to dictation ("DDE-2" battery, "MT" tests)
  • Not having received any specific rehabilitation treatment for dyslexia before

排除标准

  • Intellectual disability
  • Neurological disorders
  • Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.

结局指标

主要结局

change from pre-test to post-test in reading ability

时间窗: 4 weeks

Difference in treatment-related changes (post-test minus pre-test) observed in reading measures (speed and accuracy in word, nonword and text reading standardized tests: Memory Training (MT) group reading test and "Developmental Dyslexia and Dysgraphia (DDE-2); average of the scores expressed as z-scores with respect to age norms)

change from pre-test to post-test in spelling ability

时间窗: 4 weeks

Difference in treatment-related changes (post-test minus pre-test) observed in spelling tests (writing to dictation of words, nonwords and sentences) - average of the scores expressed as z-scores with respect to age norms in standardized tests ("DDE-2", "Diagnosis of Dysgraphic Disorders" (DDO-2))

次要结局

  • persistence of improvement at follow-up (6 months)(7 months (1 month intervention and 6 months follow-up))
  • satisfaction with remote intervention experience(4 weeks)
  • change from pre-test to post-test in metaphonological ability(4 weeks)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

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