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

Study Overview
=================
Brief 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)

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)

Conditions
-----------------
Developmental Dyslexia

Intervention / Treatment
-----------------
* Behavioral: In presence RRT - prototype software
* Behavioral: In presence RRT - online platform
* Behavioral: Tele-RRT - prototype software
* Behavioral: Tele-RRT - online platform


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In presence RRT - prototype software<br>10 biweekly in presence sessions of 45 minutes supervised by a trainer | Behavioral: In presence RRT - prototype software<br>* Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.<br>|
| Experimental: In presence RRT - online platform<br>10 biweekly in presence sessions of 45 minutes supervised by a trainer | Behavioral: In presence RRT - online platform<br>* 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.<br>|
| Experimental: Tele-RRT - prototype software<br>10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer | Behavioral: Tele-RRT - prototype software<br>* Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.<br>|
| Experimental: Tele-RRT - online platform<br>10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer | Behavioral: Tele-RRT - online platform<br>* 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.<br>|
| No Intervention: No intervention<br>5 weeks no intervention period | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word reading - DDE-2 | Word reading speed in syllable / seconds | 5 weeks | 
| Word reading - DDE-2 | Word reading accuracy in n. of errors | 5 weeks | 
| Word reading - DDE-2 | Word reading speed in syllable / seconds | 3 months | 
| Word reading - DDE-2 | Word reading accuracy in n. of errors | 3 months | 
| Pseudo-word reading - DDE-2 | Pseudo-word reading speed in syllable / seconds | 5 weeks | 
| Pseudo-word reading - DDE-2 | Pseudo-word reading accuracy in n. of errors | 5 weeks | 
| Pseudo-word reading - DDE-2 | Pseudo-word reading speed in syllable / seconds | 3 months | 
| Pseudo-word reading - DDE-2 | Pseudo-word reading accuracy in n. of errors | 3 months | 
| Text reading - MT-3-Clinica Battery | Text reading speed in syllable / seconds | 5 weeks | 
| Text reading - MT-3-Clinica Battery | Text reading accuracy in n. of errors | 5 weeks | 
| Text reading - MT-3-Clinica Battery | Text reading speed in syllable / seconds | 3 months | 
| Text reading - MT-3-Clinica Battery | Text reading accuracy in n. of errors | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phonemic awareness task (Judica et al., in press) | N. of errors in phonemic blending + N. of errors phonemic elision | 5 weeks | 
| Phonemic awareness task (Judica et al., in press) | N. of errors in phonemic blending + N. of errors phonemic elision | 3 months | 
| Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) | Forward and backward digit span | 5 weeks | 
| Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV) | Forward and backward digit span | 3 months | 
| Rapid Automatized naming task - RAN (De Luca et al., 2005) | RAN Speed in seconds | 5 weeks | 
| Rapid Automatized naming task - RAN (De Luca et al., 2005) | RAN Speed in seconds | 3 months | 
| Rhythm reproduction task | N. of correctly reproduced rhythmic patterns | 5 weeks | 
| Rhythm reproduction task | N. of correctly reproduced rhythmic patterns | 3 months |