Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)
Primary Purpose
Developmental Dyslexia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
In presence RRT - prototype software
In presence RRT - online platform
Tele-RRT - prototype software
Tele-RRT - online platform
Sponsored by

About this trial
This is an interventional treatment trial for Developmental Dyslexia
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
Sites / Locations
- Catholic University of the Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
In presence RRT - prototype software
In presence RRT - online platform
Tele-RRT - prototype software
Tele-RRT - online platform
No intervention
Arm Description
10 biweekly in presence sessions of 45 minutes supervised by a trainer
10 biweekly in presence sessions of 45 minutes supervised by a trainer
10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer
10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer
5 weeks no intervention period
Outcomes
Primary Outcome Measures
Word reading - DDE-2
Word reading speed in syllable / seconds
Word reading - DDE-2
Word reading accuracy in n. of errors
Word reading - DDE-2
Word reading speed in syllable / seconds
Word reading - DDE-2
Word reading accuracy in n. of errors
Pseudo-word reading - DDE-2
Pseudo-word reading speed in syllable / seconds
Pseudo-word reading - DDE-2
Pseudo-word reading accuracy in n. of errors
Pseudo-word reading - DDE-2
Pseudo-word reading speed in syllable / seconds
Pseudo-word reading - DDE-2
Pseudo-word reading accuracy in n. of errors
Text reading - MT-3-Clinica Battery
Text reading speed in syllable / seconds
Text reading - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Text reading - MT-3-Clinica Battery
Text reading speed in syllable / seconds
Text reading - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Secondary Outcome Measures
Phonemic awareness task (Judica et al., in press)
N. of errors in phonemic blending + N. of errors phonemic elision
Phonemic awareness task (Judica et al., in press)
N. of errors in phonemic blending + N. of errors phonemic elision
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Forward and backward digit span
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Forward and backward digit span
Rapid Automatized naming task - RAN (De Luca et al., 2005)
RAN Speed in seconds
Rapid Automatized naming task - RAN (De Luca et al., 2005)
RAN Speed in seconds
Rhythm reproduction task
N. of correctly reproduced rhythmic patterns
Rhythm reproduction task
N. of correctly reproduced rhythmic patterns
Full Information
NCT ID
NCT04995471
First Posted
July 16, 2021
Last Updated
July 30, 2021
Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04995471
Brief Title
Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In presence RRT - prototype software
Arm Type
Experimental
Arm Description
10 biweekly in presence sessions of 45 minutes supervised by a trainer
Arm Title
In presence RRT - online platform
Arm Type
Experimental
Arm Description
10 biweekly in presence sessions of 45 minutes supervised by a trainer
Arm Title
Tele-RRT - prototype software
Arm Type
Experimental
Arm Description
10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer
Arm Title
Tele-RRT - online platform
Arm Type
Experimental
Arm Description
10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
5 weeks no intervention period
Intervention Type
Behavioral
Intervention Name(s)
In presence RRT - prototype software
Intervention Description
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
Intervention Type
Behavioral
Intervention Name(s)
In presence RRT - online platform
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-RRT - prototype software
Intervention Description
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
Intervention Type
Behavioral
Intervention Name(s)
Tele-RRT - online platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Word reading - DDE-2
Description
Word reading speed in syllable / seconds
Time Frame
5 weeks
Title
Word reading - DDE-2
Description
Word reading accuracy in n. of errors
Time Frame
5 weeks
Title
Word reading - DDE-2
Description
Word reading speed in syllable / seconds
Time Frame
3 months
Title
Word reading - DDE-2
Description
Word reading accuracy in n. of errors
Time Frame
3 months
Title
Pseudo-word reading - DDE-2
Description
Pseudo-word reading speed in syllable / seconds
Time Frame
5 weeks
Title
Pseudo-word reading - DDE-2
Description
Pseudo-word reading accuracy in n. of errors
Time Frame
5 weeks
Title
Pseudo-word reading - DDE-2
Description
Pseudo-word reading speed in syllable / seconds
Time Frame
3 months
Title
Pseudo-word reading - DDE-2
Description
Pseudo-word reading accuracy in n. of errors
Time Frame
3 months
Title
Text reading - MT-3-Clinica Battery
Description
Text reading speed in syllable / seconds
Time Frame
5 weeks
Title
Text reading - MT-3-Clinica Battery
Description
Text reading accuracy in n. of errors
Time Frame
5 weeks
Title
Text reading - MT-3-Clinica Battery
Description
Text reading speed in syllable / seconds
Time Frame
3 months
Title
Text reading - MT-3-Clinica Battery
Description
Text reading accuracy in n. of errors
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Phonemic awareness task (Judica et al., in press)
Description
N. of errors in phonemic blending + N. of errors phonemic elision
Time Frame
5 weeks
Title
Phonemic awareness task (Judica et al., in press)
Description
N. of errors in phonemic blending + N. of errors phonemic elision
Time Frame
3 months
Title
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Description
Forward and backward digit span
Time Frame
5 weeks
Title
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Description
Forward and backward digit span
Time Frame
3 months
Title
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Description
RAN Speed in seconds
Time Frame
5 weeks
Title
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Description
RAN Speed in seconds
Time Frame
3 months
Title
Rhythm reproduction task
Description
N. of correctly reproduced rhythmic patterns
Time Frame
5 weeks
Title
Rhythm reproduction task
Description
N. of correctly reproduced rhythmic patterns
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Milan
ZIP/Postal Code
20123
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34828724
Citation
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):1011. doi: 10.3390/children8111011.
Results Reference
derived
Learn more about this trial
Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)
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