Back to resultsRhythmic Reading Training Compared to 'Abilmente' Method
Primary Purpose
Developmental Dyslexia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RRT+sat
Abilmente
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Dyslexia focused on measuring Reading, Developmental Dyslexia, Music, Rhythm, Intervention
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 (whereas comorbidity with other learning disabilities were allowed)
- exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).
Sites / Locations
- Catholic University of the Sacred Heart
- Studio Abilmente
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RRT+sat
Abilmente
Arm Description
RRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions).
Abilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions).
Outcomes
Primary Outcome Measures
Text reading accuracy expressed in number of errors change
Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Text reading speed expressed in syllables per seconds change
The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Word reading speed expressed in syllables per seconds change
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Word reading accuracy expressed in number of errors change
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Pseudo-word reading speed expressed in syllables per seconds change
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Pseudo-word reading accuracy expressed in number of errors change
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Text reading accuracy expressed in number of errors change
Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Text reading speed expressed in syllables per seconds change
The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Word reading speed expressed in syllables per seconds change
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Word reading accuracy expressed in number of errors change
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Pseudo-word reading speed expressed in syllables per seconds change
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Pseudo-word reading accuracy expressed in number of errors change
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Secondary Outcome Measures
Full Information
NCT ID
NCT03199092
First Posted
June 20, 2017
Last Updated
January 23, 2018
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT03199092
Brief Title
Rhythmic Reading Training Compared to 'Abilmente' Method
Official Title
Effectiveness of Intervention for Developmental Dyslexia: Rhythmic Reading Training Compared to 'Abilmente' Method
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
October 12, 2017 (Actual)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
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 purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of a multimodal intervention comprising different methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5 months, in 60 minutes biweekly sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dyslexia
Keywords
Reading, Developmental Dyslexia, Music, Rhythm, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RRT+sat
Arm Type
Experimental
Arm Description
RRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions).
Arm Title
Abilmente
Arm Type
Experimental
Arm Description
Abilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions).
Intervention Type
Behavioral
Intervention Name(s)
RRT+sat
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. For this study, RRT was delivered in combination with a specific auditory training involving several music games specifically designed for improving auditory processing abilities typically compromised in children with DD.
Intervention Type
Behavioral
Intervention Name(s)
Abilmente
Intervention Description
'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features.
Primary Outcome Measure Information:
Title
Text reading accuracy expressed in number of errors change
Description
Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
1 month
Title
Text reading speed expressed in syllables per seconds change
Description
The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
1 month
Title
Word reading speed expressed in syllables per seconds change
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
1 month
Title
Word reading accuracy expressed in number of errors change
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
1 month
Title
Pseudo-word reading speed expressed in syllables per seconds change
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
1 month
Title
Pseudo-word reading accuracy expressed in number of errors change
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
1 month
Title
Text reading accuracy expressed in number of errors change
Description
Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
2.5 months
Title
Text reading speed expressed in syllables per seconds change
Description
The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts.
Time Frame
2.5 months
Title
Word reading speed expressed in syllables per seconds change
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
2.5 months
Title
Word reading accuracy expressed in number of errors change
Description
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Time Frame
2.5 months
Title
Pseudo-word reading speed expressed in syllables per seconds change
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
2.5 months
Title
Pseudo-word reading accuracy expressed in number of errors change
Description
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Time Frame
2.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 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 (whereas comorbidity with other learning disabilities were allowed)
exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Antonietti, PhD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Study Director
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Studio Abilmente
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Rhythmic Reading Training Compared to 'Abilmente' Method
We'll reach out to this number within 24 hrs