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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02316873
Other study ID # ReMus R-11-85
Secondary ID
Status Completed
Phase N/A
First received December 9, 2014
Last updated December 11, 2014
Start date September 2011
Est. completion date December 2013

Study information

Verified date December 2014
Source Aix Marseille Université
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether music training is an effective treatment of reading disorders


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


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 11 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Music training
This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.
Visual arts
This program emphasized visual-spatial and hand skills as well as creativity.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Aix Marseille Université University of Roma La Sapienza, WHO Collaborating Centre for Maternal and Child Health, Trieste

Outcome

Type Measure Description Time frame Safety issue
Primary 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). six months No
Secondary 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). six months No
Secondary 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. six months No
Secondary Word reading The ability to read aloud single words and pseudowords is measured on a standardized list of 102 Italian words six months No
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