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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04995991
Other study ID # RRT-VISUALCUE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 9, 2018
Est. completion date August 2021

Study information

Verified date July 2021
Source Catholic University of the Sacred Heart
Contact Alice Cancer, PhD
Phone 0272342282
Email alice.cancer@unicatt.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the study is to evaluate the specific effect of the sub-components of the reading training program Rhythmic Reading Training (RRT) on reading speed and accuracy in a sample of Italian students with developmental dyslexia (DD). More precisely, in order to better understand the neuropsychological mechanisms involved in reading improvements following RRT, the specific contribution of the visual component of the training (presence of a visual cue) will be investigated in a study with between-groups design.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2021
Est. primary completion date June 27, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years to 15 Years
Eligibility Inclusion Criteria: - having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice Exclusion Criteria: - presence of comorbidity with other neuropsychiatric or psychopathological conditions - having been involved in previous reading intervention programs in the previous 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
RRT rhythm only
RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the RRT activities comprise only a rhythm accompaniment and no visual cue.
RRT rhythm + visual cue
RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the rhythmic accompaniment is synchronize with a visual cue (the verbal stimuli are highlighted using a red font in synchrony with the rhythm).

Locations

Country Name City State
Italy Catholic University of the Sacred Heart Milan

Sponsors (4)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart Associazione La Nostra Famiglia, Como, Italy, ASST Fatebenefratelli Sacco, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Word reading speed - DDE-2 Word reading speed in syllable / second 5 weeks
Primary Word reading accuracy - DDE-2 Word reading accuracy in n. of errors 5 weeks
Primary Word reading speed - DDE-2 Word reading speed in syllable / second 3 months
Primary Word reading accuracy - DDE-2 Word reading accuracy in n. of errors 3 months
Primary Pseudo-word reading speed - DDE-2 Pseudo-word reading speed in syllable / second 5 weeks
Primary Pseudo-word reading accuracy - DDE-2 Pseudo-word reading accuracy in n. of errors 5 weeks
Primary Pseudo-word reading speed - DDE-2 Pseudo-word reading speed in syllable / second 3 months
Primary Pseudo-word reading accuracy - DDE-2 Pseudo-word reading accuracy in n. of errors 3 months
Primary Text reading speed - MT-3-Clinica Battery Text reading speed in syllable / second 5 weeks
Primary Text reading accuracy - MT-3-Clinica Battery Text reading accuracy in n. of errors 5 weeks
Primary Text reading speed - MT-3-Clinica Battery Text reading speed in syllable / second 3 months
Primary Text reading accuracy - MT-3-Clinica Battery Text reading accuracy in n. of errors 3 months
Secondary Phonemic awareness task (Judica et al., in press) N. of errors in phonemic blending + n. of errors in phonemic elision 5 weeks
Secondary Phonemic awareness task (Judica et al., in press) N. of errors in phonemic blending + n. of errors in phonemic elision 3 months
Secondary Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) Forward and backward digit span 5 weeks
Secondary Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) Forward and backward digit span 3 months
Secondary Rapid Automatized naming task - RAN (De Luca et al., 2005) RAN speed in seconds 5 weeks
Secondary Rapid Automatized naming task - RAN (De Luca et al., 2005) RAN speed in seconds 3 months
Secondary Selective Auditory attention task - NEPSY-II N. of errors 5 weeks
Secondary Selective Auditory attention task - NEPSY-II N. of errors 3 months
Secondary Rhythm reproduction task n. of correctly reproduced rhythmic patterns 5 weeks
Secondary Rhythm reproduction task n. of correctly reproduced rhythmic patterns 3 months
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