search
Back to results

Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement

Primary Purpose

Developmental Dyslexia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RRT rhythm only
RRT rhythm + visual cue
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dyslexia

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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 HeartRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

RRT rhythm only

RRT rhythm + visual cue

No intervention

Arm Description

10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer

10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer

5 weeks no intervention period

Outcomes

Primary Outcome Measures

Word reading speed - DDE-2
Word reading speed in syllable / second
Word reading accuracy - DDE-2
Word reading accuracy in n. of errors
Word reading speed - DDE-2
Word reading speed in syllable / second
Word reading accuracy - DDE-2
Word reading accuracy in n. of errors
Pseudo-word reading speed - DDE-2
Pseudo-word reading speed in syllable / second
Pseudo-word reading accuracy - DDE-2
Pseudo-word reading accuracy in n. of errors
Pseudo-word reading speed - DDE-2
Pseudo-word reading speed in syllable / second
Pseudo-word reading accuracy - DDE-2
Pseudo-word reading accuracy in n. of errors
Text reading speed - MT-3-Clinica Battery
Text reading speed in syllable / second
Text reading accuracy - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Text reading speed - MT-3-Clinica Battery
Text reading speed in syllable / second
Text reading accuracy - 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 in phonemic elision
Phonemic awareness task (Judica et al., in press)
N. of errors in phonemic blending + n. of errors in 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
Selective Auditory attention task - NEPSY-II
N. of errors
Selective Auditory attention task - NEPSY-II
N. of errors
Rhythm reproduction task
n. of correctly reproduced rhythmic patterns
Rhythm reproduction task
n. of correctly reproduced rhythmic patterns

Full Information

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, ASST Fatebenefratelli Sacco, Associazione La Nostra Famiglia, Como, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT04995991
Brief Title
Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement
Official Title
Rhythmic Reading Training (RRT): Comparing the Rhythmic and Visual Contributions to Reading Improvement in Developmental Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
June 27, 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, ASST Fatebenefratelli Sacco, Associazione La Nostra Famiglia, Como, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RRT rhythm only
Arm Type
Experimental
Arm Description
10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer
Arm Title
RRT rhythm + visual cue
Arm Type
Experimental
Arm Description
10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
5 weeks no intervention period
Intervention Type
Behavioral
Intervention Name(s)
RRT rhythm only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RRT rhythm + visual cue
Intervention Description
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).
Primary Outcome Measure Information:
Title
Word reading speed - DDE-2
Description
Word reading speed in syllable / second
Time Frame
5 weeks
Title
Word reading accuracy - DDE-2
Description
Word reading accuracy in n. of errors
Time Frame
5 weeks
Title
Word reading speed - DDE-2
Description
Word reading speed in syllable / second
Time Frame
3 months
Title
Word reading accuracy - DDE-2
Description
Word reading accuracy in n. of errors
Time Frame
3 months
Title
Pseudo-word reading speed - DDE-2
Description
Pseudo-word reading speed in syllable / second
Time Frame
5 weeks
Title
Pseudo-word reading accuracy - DDE-2
Description
Pseudo-word reading accuracy in n. of errors
Time Frame
5 weeks
Title
Pseudo-word reading speed - DDE-2
Description
Pseudo-word reading speed in syllable / second
Time Frame
3 months
Title
Pseudo-word reading accuracy - DDE-2
Description
Pseudo-word reading accuracy in n. of errors
Time Frame
3 months
Title
Text reading speed - MT-3-Clinica Battery
Description
Text reading speed in syllable / second
Time Frame
5 weeks
Title
Text reading accuracy - MT-3-Clinica Battery
Description
Text reading accuracy in n. of errors
Time Frame
5 weeks
Title
Text reading speed - MT-3-Clinica Battery
Description
Text reading speed in syllable / second
Time Frame
3 months
Title
Text reading accuracy - 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 in 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 in 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
Selective Auditory attention task - NEPSY-II
Description
N. of errors
Time Frame
5 weeks
Title
Selective Auditory attention task - NEPSY-II
Description
N. of errors
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Cancer, PhD
Phone
0272342282
Email
alice.cancer@unicatt.it
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Milan
ZIP/Postal Code
20123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Cancer, MD
Email
alice.cancer@unicatt.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement

We'll reach out to this number within 24 hrs