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Rhythm and Music to Rehabilitate Reading Disorders (ReMus)

Primary Purpose

Reading Disability

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music training
Visual arts
Sponsored by
Aix Marseille Université
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Disability focused on measuring music training, rhythm

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Music training

    Visual arts

    Arm Description

    twice a week one hour for 30 weeks, music training

    twice a week one hour for 30 weeks, visual arts training

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    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.
    Word reading
    The ability to read aloud single words and pseudowords is measured on a standardized list of 102 Italian words

    Full Information

    First Posted
    December 9, 2014
    Last Updated
    December 11, 2014
    Sponsor
    Aix Marseille Université
    Collaborators
    WHO Collaborating Centre for Maternal and Child Health, Trieste, University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02316873
    Brief Title
    Rhythm and Music to Rehabilitate Reading Disorders
    Acronym
    ReMus
    Official Title
    Rhythm and Music to Rehabilitate Reading Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aix Marseille Université
    Collaborators
    WHO Collaborating Centre for Maternal and Child Health, Trieste, University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reading Disability
    Keywords
    music training, rhythm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Music training
    Arm Type
    Experimental
    Arm Description
    twice a week one hour for 30 weeks, music training
    Arm Title
    Visual arts
    Arm Type
    Active Comparator
    Arm Description
    twice a week one hour for 30 weeks, visual arts training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Music training
    Intervention Description
    This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Visual arts
    Intervention Description
    This program emphasized visual-spatial and hand skills as well as creativity.
    Primary Outcome Measure Information:
    Title
    Pseudoword reading test
    Description
    The primary outcome variable was the performance in the pseudoword reading test measured in terms of accuracy (percentile of number of errors).
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Reading text
    Description
    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).
    Time Frame
    six months
    Title
    Phonological awareness
    Description
    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.
    Time Frame
    six months
    Title
    Word reading
    Description
    The ability to read aloud single words and pseudowords is measured on a standardized list of 102 Italian words
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26407242
    Citation
    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.
    Results Reference
    derived

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    Rhythm and Music to Rehabilitate Reading Disorders

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