Reading DisabilityReMusNCT02316873
Rhythm and Music to Rehabilitate Reading Disorders
A study testing Music training and Visual arts in people with Reading Disability, run by Aix Marseille Université.
Trial summary
The purpose of this study is to determine whether music training is an effective treatment of reading disorders Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Reading Disability
- What is being tested?
- Music training and Visual arts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2013
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Italian native language
- Reading performance (accuracy and/or speed) failed on at least two of three school grade standardized Italian tests: text, words, pseudowords (cut-offs: z-score <-1.8 standard deviations from the mean for speed scores, a score <5th percentile in the accuracy scores).
- Hearing and neurological examination within normal range
- Normal or corrected-to-normal visual acuity
- General IQ >85 at Wechsler Intelligence Scale for Children III.
Who cannot join
- Presence of comorbidity involving Attentional Deficit Disorders with Hyperactivity (ADHD)
- Presence of comorbidity involving Specific Language Impairment (SLI)
- Presence of comorbidity involving Oppositional Defiant Disorder (ODD)
- Severe emotional-relational impairments
- Previous formal musical or painting education for more than one year, other on-going treatment.
- Presence of other diseases (i.e. diabetes , cystic fibrosis, asthma...) that could influence the performance in cognitive and executive functions.
About this study
The purpose of this study is to determine whether music training is an effective treatment of reading disorders
Read the detailed description
Introduction: Children with dyslexia show deficits in temporal processing, both in language and in music. Musical activity increases phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development, a compelling evidence for a role of music training in fostering brain plasticity. Within this theoretical framework, we investigate the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia.
Methods: The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test
- Conditions
- Reading Disability
- Being tested
- Music training, Visual arts
- Keywords
- music training, rhythm
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music trainingBehavioural
This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.
Visual artsBehavioural
This program emphasized visual-spatial and hand skills as well as creativity.
| Study group | Role | What they receive |
|---|---|---|
| Music training | Experimental | twice a week one hour for 30 weeks, music training Receives: Behavioral: Music training |
| Visual arts | Active comparator | twice a week one hour for 30 weeks, visual arts training Receives: Behavioral: Visual arts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pseudoword reading test
The primary outcome variable was the performance in the pseudoword reading test measured in terms of accuracy (percentile of number of errors).
Measured: six months
Secondary outcomes (3)
Reading text
Reading a short standardized text, measured in terms of accuracy (percentile of number of errors) and speed (z score of reading syll/sec or time).
Measured: six months
Phonological awareness
Phonemic blending task. Children have to blend sounds into words (e.g. hearing [c]-[a]-[t] and produce [cat]). The number of correct items is the dependent variable.
Measured: six months
Word reading
The ability to read aloud single words and pseudowords is measured on a standardized list of 102 Italian words
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionDec 2013
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 Reading DisabilityStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aix Marseille Université
- Sponsor type
- University, hospital or other
- Collaborators
- WHO Collaborating Centre for Maternal and Child Health, Trieste, University of Roma La Sapienza
- Responsible party
- Principal investigator, Daniele Schon, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316873
- Sponsor's protocol ID
- ReMus R-11-85
- Acronym
- ReMus
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Flaugnacco E, Lopez L, Terribili C, Montico M, Zoia S, Schon D. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial. PLoS One. 2015 Sep 25;10(9):e0138715. doi: 10.1371/journal.pone.0138715. eCollection 2015.
PubMed 26407242
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm and Music to Rehabilitate Reading Disorders
- ClinicalTrials.gov ID
- NCT02316873
- Acronym / sponsor ID
- ReMus / ReMus R-11-85
- Conditions
- Reading Disability
- Keywords
- music training, rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aix Marseille UniversitéUniversity, hospital or other
- Collaborators
- WHO Collaborating Centre for Maternal and Child Health, Trieste, University of Roma La Sapienza
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Dec 2014 (estimated)
- 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 this study is to determine whether music training is an effective treatment of reading disorders
Detailed description
Introduction: Children with dyslexia show deficits in temporal processing, both in language and in music. Musical activity increases phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development, a compelling evidence for a role of music training in fostering brain plasticity. Within this theoretical framework, we investigate the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia.
Methods: The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music training | Experimental | Behavioral: Music trainingtwice a week one hour for 30 weeks, music training |
| Visual arts | Active comparator | Behavioral: Visual artstwice a week one hour for 30 weeks, visual arts training |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Italian native language
- Reading performance (accuracy and/or speed) failed on at least two of three school grade standardized Italian tests: text, words, pseudowords (cut-offs: z-score <-1.8 standard deviations from the mean for speed scores, a score <5th percentile in the accuracy scores).
- Hearing and neurological examination within normal range
- Normal or corrected-to-normal visual acuity
- General IQ >85 at Wechsler Intelligence Scale for Children III.
Key exclusion criteria (6 listed)
- Presence of comorbidity involving Attentional Deficit Disorders with Hyperactivity (ADHD)
- Presence of comorbidity involving Specific Language Impairment (SLI)
- Presence of comorbidity involving Oppositional Defiant Disorder (ODD)
- Severe emotional-relational impairments
- Previous formal musical or painting education for more than one year, other on-going treatment.
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 |
|---|---|---|
| Music trainingThis program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing. | Behavioural | Music training |
| Visual artsThis program emphasized visual-spatial and hand skills as well as creativity. | Behavioural | Visual arts |
Primary outcome
Pseudoword reading test
Time frame: six months
The primary outcome variable was the performance in the pseudoword reading test measured in terms of accuracy (percentile of number of errors).
3 secondary outcomes
Reading text
Time frame: six months
Phonological awareness
Time frame: six months
Word reading
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Derived from this study: PubMed 26407242Flaugnacco E, Lopez L, Terribili C, Montico M, Zoia S, Schon D. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial. PLoS One. 2015 Sep 25;10(9):e0138715. doi: 10.1371/journal.pone.0138715. eCollection 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Music training and Visual arts in people with Reading Disability, run by Aix Marseille Université.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pseudoword reading test (time frame: six months). 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 NCT02316873, 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 15 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.