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

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

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)

Study Overview

• Status: Enrolling by invitation
• 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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20123
    • Catholic University of the Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In presence RRT - prototype software; 10 biweekly in presence sessions of 45 minutes supervised by a trainer	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.
Experimental: In presence RRT - online platform; 10 biweekly in presence sessions of 45 minutes supervised by a trainer	Behavioral: 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.
Experimental: Tele-RRT - prototype software; 10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer	Behavioral: 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.
Experimental: Tele-RRT - online platform; 10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer	Behavioral: 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.
No Intervention: No intervention; 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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

General Publications

• Cancer A, Sarti D, De Salvatore M, Granocchio E, Chieffo DPR, Antonietti A. Dyslexia Telerehabilitation during the COVID-19 Pandemic: Results of a Rhythm-Based Intervention for Reading. Children (Basel). 2021 Nov 5;8(11). pii: 1011. doi: 10.3390/children8111011.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): February 22, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: RRT vs. RRTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No