Developmental DyslexiaNCT04995991
Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement
A study testing RRT rhythm only and RRT rhythm + visual cue in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- RRT rhythm only and RRT rhythm + visual cue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2018to Aug 2021
- 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 8 to 15 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
- having been involved in previous reading intervention programs in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of the Sacred Heart
Milan, 20123
Alice Cancer, MD, alice.cancer@unicatt.it
About this study
Official title: 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.
- Conditions
- Developmental Dyslexia
- Being tested
- RRT rhythm only, RRT rhythm + visual cue
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRT rhythm onlyBehavioural
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.
RRT rhythm + visual cueBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| RRT rhythm only | Experimental | 10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer Receives: Behavioral: RRT rhythm only |
| RRT rhythm + visual cue | Experimental | 10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer Receives: Behavioral: RRT rhythm + visual cue |
| No intervention | No intervention | 5 weeks no intervention period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word reading speed - DDE-2
Word reading speed in syllable / second
Measured: 5 weeks
Word reading accuracy - DDE-2
Word reading accuracy in n. of errors
Measured: 5 weeks
Word reading speed - DDE-2
Word reading speed in syllable / second
Measured: 3 months
Word reading accuracy - DDE-2
Word reading accuracy in n. of errors
Measured: 3 months
Pseudo-word reading speed - DDE-2
Pseudo-word reading speed in syllable / second
Measured: 5 weeks
Pseudo-word reading accuracy - DDE-2
Pseudo-word reading accuracy in n. of errors
Measured: 5 weeks
Pseudo-word reading speed - DDE-2
Pseudo-word reading speed in syllable / second
Measured: 3 months
Pseudo-word reading accuracy - DDE-2
Pseudo-word reading accuracy in n. of errors
Measured: 3 months
Text reading speed - MT-3-Clinica Battery
Text reading speed in syllable / second
Measured: 5 weeks
Text reading accuracy - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Measured: 5 weeks
Text reading speed - MT-3-Clinica Battery
Text reading speed in syllable / second
Measured: 3 months
Text reading accuracy - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Measured: 3 months
Secondary outcomes (10)
Phonemic awareness task (Judica et al., in press)
- of errors in phonemic blending + n. of errors in phonemic elision
Measured: 5 weeks
Phonemic awareness task (Judica et al., in press)
- of errors in phonemic blending + n. of errors in phonemic elision
Measured: 3 months
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Forward and backward digit span
Measured: 5 weeks
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Forward and backward digit span
Measured: 3 months
Rapid Automatized naming task - RAN (De Luca et al., 2005)
RAN speed in seconds
Measured: 5 weeks
Rapid Automatized naming task - RAN (De Luca et al., 2005)
RAN speed in seconds
Measured: 3 months
Selective Auditory attention task - NEPSY-II
- of errors
Measured: 5 weeks
Selective Auditory attention task - NEPSY-II
- of errors
Measured: 3 months
Rhythm reproduction task
- of correctly reproduced rhythmic patterns
Measured: 5 weeks
Rhythm reproduction task
- of correctly reproduced rhythmic patterns
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start9 Jul 2018
- Primary completion27 Jun 2021
- Study completionAug 2021 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, ASST Fatebenefratelli Sacco, Associazione La Nostra Famiglia, Como, Italy
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995991
- Sponsor's protocol ID
- RRT-VISUALCUE
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Reading Training (RRT): Comparing the Rhythmic and Visual Contributions to Reading Improvement in Developmental Dyslexia
- ClinicalTrials.gov ID
- NCT04995991
- Acronym / sponsor ID
- RRT-VISUALCUE
- Conditions
- Developmental Dyslexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, ASST Fatebenefratelli Sacco, Associazione La Nostra Famiglia, Como, Italy
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 Aug 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RRT rhythm only | Experimental | Behavioral: RRT rhythm only10 RRT rhythm only sessions of 60 minutes, twice a week under the supervision of a trainer |
| RRT rhythm + visual cue | Experimental | Behavioral: RRT rhythm + visual cue10 RRT rhythm + visual cue sessions of 60 minutes, twice a week under the supervision of a trainer |
| No intervention | No intervention | –5 weeks no intervention period |
Who may qualify
- Ages
- 8 to 15 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
- having been involved in previous reading intervention programs in the previous 3 months
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 rhythm onlyRRT 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. | Behavioural | RRT rhythm only |
| RRT rhythm + visual cueRRT 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). | Behavioural | RRT rhythm + visual cue |
Primary outcome
Word reading speed - DDE-2
Time frame: 5 weeks
Word reading speed in syllable / second
Word reading accuracy - DDE-2
Time frame: 5 weeks
Word reading accuracy in n. of errors
Word reading speed - DDE-2
Time frame: 3 months
Word reading speed in syllable / second
Word reading accuracy - DDE-2
Time frame: 3 months
Word reading accuracy in n. of errors
Pseudo-word reading speed - DDE-2
Time frame: 5 weeks
Pseudo-word reading speed in syllable / second
Pseudo-word reading accuracy - DDE-2
Time frame: 5 weeks
Pseudo-word reading accuracy in n. of errors
Pseudo-word reading speed - DDE-2
Time frame: 3 months
Pseudo-word reading speed in syllable / second
Pseudo-word reading accuracy - DDE-2
Time frame: 3 months
Pseudo-word reading accuracy in n. of errors
Text reading speed - MT-3-Clinica Battery
Time frame: 5 weeks
Text reading speed in syllable / second
Text reading accuracy - MT-3-Clinica Battery
Time frame: 5 weeks
Text reading accuracy in n. of errors
Text reading speed - MT-3-Clinica Battery
Time frame: 3 months
Text reading speed in syllable / second
Text reading accuracy - MT-3-Clinica Battery
Time frame: 3 months
Text reading accuracy in n. of errors
10 secondary outcomes
Phonemic awareness task (Judica et al., in press)
Time frame: 5 weeks
Phonemic awareness task (Judica et al., in press)
Time frame: 3 months
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Time frame: 5 weeks
Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
Time frame: 3 months
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Time frame: 5 weeks
Rapid Automatized naming task - RAN (De Luca et al., 2005)
Time frame: 3 months
Selective Auditory attention task - NEPSY-II
Time frame: 5 weeks
Selective Auditory attention task - NEPSY-II
Time frame: 3 months
Rhythm reproduction task
Time frame: 5 weeks
Rhythm reproduction task
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRT rhythm only and RRT rhythm + visual cue in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 1 site 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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Alice Cancer, PhD (0272342282, alice.cancer@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word reading speed - DDE-2 (time frame: 5 weeks). 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 9 Aug 2021.