Remotely Controlled Intervention for Developmental Reading and Spelling Disorders Through the Tachidino Platform

Study Overview
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Brief Summary
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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.

Detailed Description
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The system for the improvement of reading and writing skills (Tachidino software) is based on two principles of proven effectiveness: 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.); 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 As per current clinical practice, intervention in e-health mode is divided into one or more rehabilitation modules through the use of the Tachidino platform, with systematic monitoring and motivational reinforcement by professionals with experience in e-health approaches. In order to be included in the training, the child must have already obtained a diagnosis of dyslexia, according to the current diagnostic standards. The structure of the intervention modules, as currently implemented, is as follows: 1 initial meeting to get to know the child, pre-test assessment - reading and writing tests of words, non-words and sentences, metaphonological tests (phonemic elision and synthesis) and text reading tests (reading accuracy and speed) in order to define dyslexia subtypes; intervention planning - demonstration of Tachidino use and programming of first activities telephone support to monitor and motivate correct use of the software, during active intervention 1 final assessment meeting (with repetition of the tests used at pre-test and compilation of satisfaction questionnaires). 1 follow-up meeting 6 months after discharge with repetition of reading tests (this meeting is relevant in order to assess stabilization of obtained improvements) Participants' characteristics: Children aged between 7 and 14 years with a diagnosis of Specific Reading Disorder or Specific Spelling Disorder, not treated before. The improvements obtained in one month treatment will be compared with those obtained with outpatient intervention programmes of the same duration and intensity, combining treatment based on the two component parts: Visual Hemisphere-Specific Stimulation (V-HSS) and Visual-Attentional Training with Action Video Games.

Official Title
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Remotely Controlled Intervention for Developmental Reading and Spelling Disorders

Conditions
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Developmental Dyslexia, Developmental Spelling Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Intellectual disability Neurological disorders Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from pre-test to post-test in reading ability | 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) | 4 weeks | 
| change from pre-test to post-test in spelling ability | 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)) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from pre-test to post-test in metaphonological ability | Difference in treatment-related changes (post-test minus pre-test) observed in metaphonological tests (phonemic elision and phoneme blending) - average of the number of errors in the two tests | 4 weeks | 
| persistence of improvement at follow-up (6 months) | no significant difference between post-test scores and follow-up scores (follow-up 6 months after discharge and in the absence of further intervention) in text, word and nonword reading (MT tests, DDE-2) | 7 months (1 month intervention and 6 months follow-up) | 
| satisfaction with remote intervention experience | scores expressed by parents and patients at post-test, on a questionnaire concerning satisfaction with the delivery of remote intervention and its effects | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Developmental Dyslexia, Intervention, Hemisphere-specific stimulation, Visual-attentional training, E-health, telerehabilitation, web-based platform, Developmental Spelling Disorder