Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)

Developmental Dyslexia Clinical Trial

Official title:

Comparing the Effectiveness of Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders, Using a Rhythm-based Intervention for Reading (Rhythmic Reading Training, RRT)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04995471
• Other study ID #: RRT vs. RRTT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2020
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 2021
• Est. primary completion date: February 22, 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

Related Conditions & MeSH terms

• Developmental Dyslexia
• Dyslexia

Intervention

Behavioral:
• In presence RRT - prototype software
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
• In presence RRT - online platform
RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.
• Tele-RRT - prototype software
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
• Tele-RRT - online platform
RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Word reading - DDE-2	Word reading speed in syllable / seconds	5 weeks
Primary	Word reading - DDE-2	Word reading accuracy in n. of errors	5 weeks
Primary	Word reading - DDE-2	Word reading speed in syllable / seconds	3 months
Primary	Word reading - DDE-2	Word reading accuracy in n. of errors	3 months
Primary	Pseudo-word reading - DDE-2	Pseudo-word reading speed in syllable / seconds	5 weeks
Primary	Pseudo-word reading - DDE-2	Pseudo-word reading accuracy in n. of errors	5 weeks
Primary	Pseudo-word reading - DDE-2	Pseudo-word reading speed in syllable / seconds	3 months
Primary	Pseudo-word reading - DDE-2	Pseudo-word reading accuracy in n. of errors	3 months
Primary	Text reading - MT-3-Clinica Battery	Text reading speed in syllable / seconds	5 weeks
Primary	Text reading - MT-3-Clinica Battery	Text reading accuracy in n. of errors	5 weeks
Primary	Text reading - MT-3-Clinica Battery	Text reading speed in syllable / seconds	3 months
Primary	Text reading - 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 phonemic elision	5 weeks
Secondary	Phonemic awareness task (Judica et al., in press)	N. of errors in phonemic blending + N. of errors 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	Rhythm reproduction task	N. of correctly reproduced rhythmic patterns	5 weeks
Secondary	Rhythm reproduction task	N. of correctly reproduced rhythmic patterns	3 months