- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316873
Rhythm and Music to Rehabilitate Reading Disorders (ReMus)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music training
twice a week one hour for 30 weeks, music training
|
This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.
|
Active Comparator: Visual arts
twice a week one hour for 30 weeks, visual arts training
|
This program emphasized visual-spatial and hand skills as well as creativity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading text
Time Frame: six months
|
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).
|
six months
|
Phonological awareness
Time Frame: six months
|
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.
|
six months
|
Word reading
Time Frame: six months
|
The ability to read aloud single words and pseudowords is measured on a standardized list of 102 Italian words
|
six months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ReMus R-11-85
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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