- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995991
Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement
July 30, 2021 updated by: Alice Cancer, Catholic University of the Sacred Heart
Rhythmic Reading Training (RRT): Comparing the Rhythmic and Visual Contributions to Reading Improvement in Developmental Dyslexia
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alice Cancer, PhD
- Phone Number: 0272342282
- Email: alice.cancer@unicatt.it
Study Locations
-
-
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Milan, Italy, 20123
- Recruiting
- Catholic University of the Sacred Heart
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention
5 weeks no intervention period
|
|
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Experimental: RRT rhythm only
10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer
|
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.
|
|
Experimental: RRT rhythm + visual cue
10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Word reading speed - DDE-2
Time Frame: 5 weeks
|
Word reading speed in syllable / second
|
5 weeks
|
|
Word reading accuracy - DDE-2
Time Frame: 5 weeks
|
Word reading accuracy in n. of errors
|
5 weeks
|
|
Word reading speed - DDE-2
Time Frame: 3 months
|
Word reading speed in syllable / second
|
3 months
|
|
Word reading accuracy - DDE-2
Time Frame: 3 months
|
Word reading accuracy in n. of errors
|
3 months
|
|
Pseudo-word reading speed - DDE-2
Time Frame: 5 weeks
|
Pseudo-word reading speed in syllable / second
|
5 weeks
|
|
Pseudo-word reading accuracy - DDE-2
Time Frame: 5 weeks
|
Pseudo-word reading accuracy in n. of errors
|
5 weeks
|
|
Pseudo-word reading speed - DDE-2
Time Frame: 3 months
|
Pseudo-word reading speed in syllable / second
|
3 months
|
|
Pseudo-word reading accuracy - DDE-2
Time Frame: 3 months
|
Pseudo-word reading accuracy in n. of errors
|
3 months
|
|
Text reading speed - MT-3-Clinica Battery
Time Frame: 5 weeks
|
Text reading speed in syllable / second
|
5 weeks
|
|
Text reading accuracy - MT-3-Clinica Battery
Time Frame: 5 weeks
|
Text reading accuracy in n. of errors
|
5 weeks
|
|
Text reading speed - MT-3-Clinica Battery
Time Frame: 3 months
|
Text reading speed in syllable / second
|
3 months
|
|
Text reading accuracy - MT-3-Clinica Battery
Time Frame: 3 months
|
Text reading accuracy in n. of errors
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Time Frame: 5 weeks
|
Forward and backward digit span
|
5 weeks
|
|
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Time Frame: 3 months
|
Forward and backward digit span
|
3 months
|
|
Phonemic awareness task (Judica et al., in press)
Time Frame: 5 weeks
|
N. of errors in phonemic blending + n. of errors in phonemic elision
|
5 weeks
|
|
Phonemic awareness task (Judica et al., in press)
Time Frame: 3 months
|
N. of errors in phonemic blending + n. of errors in phonemic elision
|
3 months
|
|
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Time Frame: 5 weeks
|
RAN speed in seconds
|
5 weeks
|
|
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Time Frame: 3 months
|
RAN speed in seconds
|
3 months
|
|
Selective Auditory attention task - NEPSY-II
Time Frame: 5 weeks
|
N. of errors
|
5 weeks
|
|
Selective Auditory attention task - NEPSY-II
Time Frame: 3 months
|
N. of errors
|
3 months
|
|
Rhythm reproduction task
Time Frame: 5 weeks
|
n. of correctly reproduced rhythmic patterns
|
5 weeks
|
|
Rhythm reproduction task
Time Frame: 3 months
|
n. of correctly reproduced rhythmic patterns
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 9, 2018
Primary Completion (Actual)
June 27, 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
Other Study ID Numbers
- RRT-VISUALCUE
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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