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Developmental DyslexiaNCT04382482

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

An observational study of Developmental Dyslexia and Developmental Spelling Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 16 years
What is being tested?
Tachidino
Type of treatment
Medical device
How many people
80 participants
Where
1 siteItaly
Study dates
20 Jan 2018to 30 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children will be recruited among those referred to IRCCS Medea because of learning and school-achievement problems. All children who were offered treatment through the web-based platform "Tachidino" and who met inclusion/exclusion criteria were enrolled in the study after their parents had accepted and signed informed consent.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Scientific Institute IRCCS E. Medea

    Bosisio Parini, LC, 23842

Other trials in Italy

About this study

Official title: Remotely Controlled Intervention for Developmental Reading and Spelling Disorders

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.

Read the detailed description

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.

All visual stimuli are presented at tachistoscopic speed to a visual hemifield in order to stimulate the contralateral hemisphere to a greater degree, or they may also be flashed in the center of the computer screen, involving both hemispheres simultaneously.

The visual hemisphere-specific stimulation is based on a revisit of Bakker's 'Balance model'. Each child was classified as a P-, L-, or M-type dyslexic reader based on the persistent over-reliance on specific reading strategies as shown by reading and spelling errors, and on reading speed.

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.

Being tested
Tachidino
Keywords
Developmental Dyslexia, Intervention, Hemisphere-specific stimulation, Visual-attentional training, E-health, telerehabilitation, web-based platform, Developmental Spelling Disorder
Medical subject headings
Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TachidinoDevice

    Web-platform delivering remote treatment of reading and spelling disorders through the (visual or auditory) presentation of words and sentences to be either decoded or corrected (reordering wrong letter sequences).

Study groups in NCT04382482
Study groupRoleWhat they receive
TachidinoThis group is being treated through the web platform Tachidino for remote rehabilitation of reading and spelling disorders
Receives: Device: Tachidino

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4 weeks

  2. 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))

    Measured: 4 weeks

Secondary outcomes (3)
  1. 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

    Measured: 4 weeks

  2. 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")

    Measured: 7 months (1 month intervention and 6 months follow-up)

  3. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start20 Jan 2018
  3. Primary completion1 Dec 2020
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382482
Sponsor's protocol ID
08/17oss
Status last verified
Mar 2024
First submitted
6 May 2020
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bakker DJ. Neuropsychological classification and treatment of dyslexia. J Learn Disabil. 1992 Feb;25(2):102-9. doi: 10.1177/002221949202500203.

    PubMed 1583415
  • Bakker DJ. Treatment of developmental dyslexia: a review. Pediatr Rehabil. 2006 Jan-Mar;9(1):3-13. doi: 10.1080/13638490500065392.

    PubMed 16352500
  • Lorusso ML, Facoetti A, Paganoni P, Pezzani M, Molteni M. Effects of visual hemisphere-specific stimulation versus reading-focused training in dyslexic children. Neuropsychol Rehabil. 2006 Apr;16(2):194-212. doi: 10.1080/09602010500145620.

    PubMed 16565034
  • Franceschini S, Gori S, Ruffino M, Viola S, Molteni M, Facoetti A. Action video games make dyslexic children read better. Curr Biol. 2013 Mar 18;23(6):462-6. doi: 10.1016/j.cub.2013.01.044. Epub 2013 Feb 28.

    PubMed 23453956
  • Lorusso ML, Facoetti A, Bakker DJ. Neuropsychological treatment of dyslexia: does type of treatment matter? J Learn Disabil. 2011 Mar-Apr;44(2):136-49. doi: 10.1177/0022219410391186.

    PubMed 21383106
  • Lorusso ML, Borasio F, Molteni M. Remote Neuropsychological Intervention for Developmental Dyslexia with the Tachidino Platform: No Reduction in Effectiveness for Older Nor for More Severely Impaired Children. Children (Basel). 2022 Jan 5;9(1):71. doi: 10.3390/children9010071.

    PubMed 35053699
  • Lorusso ML, Borasio F, Misto P, Salandi A, Travellini S, Lotito M, Molteni M. Remote treatment of developmental dyslexia: how ADHD comorbidity, clinical history and treatment repetition may affect its efficacy. Front Public Health. 2024 Jan 10;11:1135465. doi: 10.3389/fpubh.2023.1135465. eCollection 2023.

    PubMed 38269376
  • Lorusso ML, Borasio F, Molteni M. The challenge of remote treatment in neuropsychological intervention for reading and spelling in dyslexia: A prospective observational cohort study. Dyslexia. 2024 Feb;30(1):e1758. doi: 10.1002/dys.1758. Epub 2024 Jan 15.

    PubMed 38224428

Questions about this trial

What is this clinical trial studying?

An observational study of Developmental Dyslexia and Developmental Spelling Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from pre-test to post-test in reading ability (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04382482, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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