Developmental DyslexiaNCT03199092
Rhythmic Reading Training Compared to 'Abilmente' Method
A study testing RRT+sat and Abilmente in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial 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'. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- RRT+sat and Abilmente
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Jun 2017to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Catholic University of the Sacred Heart
Milan, 20123
Studio Abilmente
Milan
About this study
Official title: Effectiveness of Intervention for Developmental Dyslexia: Rhythmic Reading Training Compared to 'Abilmente' Method
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.
- Conditions
- Developmental Dyslexia
- Being tested
- RRT+sat, Abilmente
- Keywords
- Reading, Developmental Dyslexia, Music, Rhythm, Intervention
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRT+satBehavioural
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.
AbilmenteBehavioural
'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features.
| Study group | Role | What they receive |
|---|---|---|
| RRT+sat | Experimental | RRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions). Receives: Behavioral: RRT+sat |
| Abilmente | Experimental | Abilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions). Receives: Behavioral: Abilmente |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 1 month
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).
Measured: 1 month
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).
Measured: 1 month
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).
Measured: 1 month
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).
Measured: 1 month
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.
Measured: 2.5 months
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.
Measured: 2.5 months
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).
Measured: 2.5 months
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).
Measured: 2.5 months
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).
Measured: 2.5 months
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).
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start26 Jun 2017
- Primary completion12 Oct 2017
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
- Investigators
- Alessandro Antonietti, PhD, Study director, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199092
- Sponsor's protocol ID
- RRT-Abilmente
- Status last verified
- Jan 2018
- First submitted
- 20 Jun 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intervention for Developmental Dyslexia: Rhythmic Reading Training Compared to 'Abilmente' Method
- ClinicalTrials.gov ID
- NCT03199092
- Acronym / sponsor ID
- RRT-Abilmente
- Conditions
- Developmental Dyslexia
- Keywords
- Reading, Developmental Dyslexia, Music, Rhythm, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RRT+sat | Experimental | Behavioral: RRT+satRRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions). |
| Abilmente | Experimental | Behavioral: AbilmenteAbilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions). |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRT+satRRT 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. | Behavioural | RRT+sat |
| Abilmente'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features. | Behavioural | Abilmente |
Primary outcome
Text reading accuracy expressed in number of errors change
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 1 month
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
Time frame: 2.5 months
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
Time frame: 2.5 months
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
Time frame: 2.5 months
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
Time frame: 2.5 months
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
Time frame: 2.5 months
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
Time frame: 2.5 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Antonietti, PhD study director
Catholic University of the Sacred Heart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRT+sat and Abilmente in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text reading accuracy expressed in number of errors change (time frame: 1 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.