Developmental DyslexiaNCT04995471
Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)
A study testing In presence RRT - prototype software, In presence RRT - online platform and Tele-RRT - prototype software in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training) 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?
- In presence RRT - prototype software, In presence RRT - online platform and Tele-RRT - prototype software
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2020to 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.
About this study
Official title: Comparing the Effectiveness of Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders, Using a Rhythm-based Intervention for Reading (Rhythmic Reading Training, RRT)
The aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training)
- Conditions
- Developmental Dyslexia
- Being tested
- In presence RRT - prototype software, In presence RRT - online platform, Tele-RRT - prototype software, Tele-RRT - online platform
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In presence RRT - prototype softwareBehavioural
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
In presence RRT - online platformBehavioural
RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.
Tele-RRT - prototype softwareBehavioural
Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
Tele-RRT - online platformBehavioural
RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.
| Study group | Role | What they receive |
|---|---|---|
| In presence RRT - prototype software | Experimental | 10 biweekly in presence sessions of 45 minutes supervised by a trainer Receives: Behavioral: In presence RRT - prototype software |
| In presence RRT - online platform | Experimental | 10 biweekly in presence sessions of 45 minutes supervised by a trainer Receives: Behavioral: In presence RRT - online platform |
| Tele-RRT - prototype software | Experimental | 10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer Receives: Behavioral: Tele-RRT - prototype software |
| Tele-RRT - online platform | Experimental | 10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer Receives: Behavioral: Tele-RRT - online platform |
| 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 - DDE-2
Word reading speed in syllable / seconds
Measured: 5 weeks
Word reading - DDE-2
Word reading accuracy in n. of errors
Measured: 5 weeks
Word reading - DDE-2
Word reading speed in syllable / seconds
Measured: 3 months
Word reading - DDE-2
Word reading accuracy in n. of errors
Measured: 3 months
Pseudo-word reading - DDE-2
Pseudo-word reading speed in syllable / seconds
Measured: 5 weeks
Pseudo-word reading - DDE-2
Pseudo-word reading accuracy in n. of errors
Measured: 5 weeks
Pseudo-word reading - DDE-2
Pseudo-word reading speed in syllable / seconds
Measured: 3 months
Pseudo-word reading - DDE-2
Pseudo-word reading accuracy in n. of errors
Measured: 3 months
Text reading - MT-3-Clinica Battery
Text reading speed in syllable / seconds
Measured: 5 weeks
Text reading - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Measured: 5 weeks
Text reading - MT-3-Clinica Battery
Text reading speed in syllable / seconds
Measured: 3 months
Text reading - MT-3-Clinica Battery
Text reading accuracy in n. of errors
Measured: 3 months
Secondary outcomes (8)
Phonemic awareness task (Judica et al., in press)
- of errors in phonemic blending + N. of errors phonemic elision
Measured: 5 weeks
Phonemic awareness task (Judica et al., in press)
- of errors in phonemic blending + N. of errors 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
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 start15 Apr 2020
- Primary completion22 Feb 2021
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 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, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995471
- Sponsor's protocol ID
- RRT vs. RRTT
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cancer A, Sarti D, De Salvatore M, Granocchio E, Chieffo DPR, Antonietti A. Dyslexia Telerehabilitation during the COVID-19 Pandemic: Results of a Rhythm-Based Intervention for Reading. Children (Basel). 2021 Nov 5;8(11):1011. doi: 10.3390/children8111011.
PubMed 34828724
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
- Comparing the Effectiveness of Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders, Using a Rhythm-based Intervention for Reading (Rhythmic Reading Training, RRT)
- ClinicalTrials.gov ID
- NCT04995471
- Acronym / sponsor ID
- RRT vs. RRTT
- Conditions
- Developmental Dyslexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 22 Feb 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 aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| In presence RRT - prototype software | Experimental | Behavioral: In presence RRT - prototype software10 biweekly in presence sessions of 45 minutes supervised by a trainer |
| In presence RRT - online platform | Experimental | Behavioral: In presence RRT - online platform10 biweekly in presence sessions of 45 minutes supervised by a trainer |
| Tele-RRT - prototype software | Experimental | Behavioral: Tele-RRT - prototype software10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer |
| Tele-RRT - online platform | Experimental | Behavioral: Tele-RRT - online platform10 biweekly telerehabilitation sessions of 45 minutes supervised by 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 |
|---|---|---|
| In presence RRT - prototype softwareRhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed. | Behavioural | In presence RRT - prototype software |
| In presence RRT - online platformRRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available. | Behavioural | In presence RRT - online platform |
| Tele-RRT - prototype softwareRhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed. | Behavioural | Tele-RRT - prototype software |
| Tele-RRT - online platformRRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available. | Behavioural | Tele-RRT - online platform |
Primary outcome
Word reading - DDE-2
Time frame: 5 weeks
Word reading speed in syllable / seconds
Word reading - DDE-2
Time frame: 5 weeks
Word reading accuracy in n. of errors
Word reading - DDE-2
Time frame: 3 months
Word reading speed in syllable / seconds
Word reading - DDE-2
Time frame: 3 months
Word reading accuracy in n. of errors
Pseudo-word reading - DDE-2
Time frame: 5 weeks
Pseudo-word reading speed in syllable / seconds
Pseudo-word reading - DDE-2
Time frame: 5 weeks
Pseudo-word reading accuracy in n. of errors
Pseudo-word reading - DDE-2
Time frame: 3 months
Pseudo-word reading speed in syllable / seconds
Pseudo-word reading - DDE-2
Time frame: 3 months
Pseudo-word reading accuracy in n. of errors
Text reading - MT-3-Clinica Battery
Time frame: 5 weeks
Text reading speed in syllable / seconds
Text reading - MT-3-Clinica Battery
Time frame: 5 weeks
Text reading accuracy in n. of errors
Text reading - MT-3-Clinica Battery
Time frame: 3 months
Text reading speed in syllable / seconds
Text reading - MT-3-Clinica Battery
Time frame: 3 months
Text reading accuracy in n. of errors
8 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
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.
- Derived from this study: PubMed 34828724Cancer A, Sarti D, De Salvatore M, Granocchio E, Chieffo DPR, Antonietti A. Dyslexia Telerehabilitation during the COVID-19 Pandemic: Results of a Rhythm-Based Intervention for Reading. Children (Basel). 2021 Nov 5;8(11):1011. doi: 10.3390/children8111011.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In presence RRT - prototype software, In presence RRT - online platform and Tele-RRT - prototype software 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?
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?
Word reading - 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?
On the ClinicalTrials.gov record for NCT04995471, which also lists 1 linked publication.
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.