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

NCT04382482 | Completed

• 1 other identifier: 08/17oss
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Developmental Dyslexia; Developmental Spelling Disorder

Keywords

Developmental Dyslexia; Intervention; Hemisphere-specific stimulation; Visual-attentional training; E-health; telerehabilitation; web-based platform; Developmental Spelling Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• change from pre-test to post-test in metaphonological ability

  4 weeks

• 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

Other Outcomes (1)

• comparison with existing data about inpatient treatment effectiveness

  4 weeks

Study Arms (1)

Tachidino

This group is being treated through the web platform Tachidino for remote rehabilitation of reading and spelling disorders

Device: Tachidino

Interventions

Tachidino DEVICE

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).

Tachidino

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, LC, 23842, Italy

Location

Related Publications (8)

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

  PMID: 1583415 BACKGROUND

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

  PMID: 16352500 BACKGROUND

• 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.

  PMID: 16565034 BACKGROUND

• 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.

  PMID: 23453956 BACKGROUND

• 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.

  PMID: 21383106 BACKGROUND

• 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.

  PMID: 35053699 RESULT

• 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.

  PMID: 38269376 RESULT

• 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.

  PMID: 38224428 RESULT

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria L Lorusso, Ph.D.

  IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: January 20, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 30, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (1)