- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028310
Developmental Dyslexia and Remediation Methods (DDMR)
Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Developmental dyslexia is defined as a specific and lasting reading learning disorder. This neurodevelopmental disorder has a severe impact on overall academic learning and behavior, compromises professional and social development and affects 10% of school-age children. As a public health problem, its diagnosis and management are still highly controversial, and the lack of scientific consensus leads to great heterogeneity in clinical practices and post-treatment outcomes. Three therapeutic axes guide research for developmental dyslexia. The first axis is based on phonological deficits. According to the phonological representation hypothesis, a specific deficit in the processing of phonological representations that support the identification of sounds is the cause of the reading disorder. The second axis focuses on attention-related cognitive deficits. According to the visuo-attention deficit hypothesis, a lack of the visuo-attention processing can be viewed as one of the explanatory causes of a dysfunction in letter identification and reading procedures. The third axis aims to achieve automatized processing for letter/sound association. According to the axis, a lack of cross-modal integration in word decoding is altered by a lack of simultaneous association between of a visual and an auditory stimulus.
Many studies attempted to exclusively validate selective remediation according to causal hypotheses that are mainly cross-modal, phonological or visuo-attentional. However, the evaluation of these underlying processing in dyslexic children shows great clinical heterogeneity since most of children simultaneously have the three deficits. Furthermore, no study evaluates the benefits of combining these different trainings on reading skills.
In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation.
The secondary objectives will be 1°) to compare the effectiveness on reading skills of a phonological training, versus a visuo-attentional training, 2°) to compare the effectiveness on reading skills from in the order of phonological and visuo-attentional training, 3°) to compare the evolution of performance in comprehension and written production at the end of the three training sessions and 4°) to evaluate child and parents' perception for the outcome of the reading disorder at the end of the training sessions using Likert scales, by means of a questionnaire. The analysis of the results will make possible to evaluate a remedial approach to dyslexia in a clinical context and to better understanding and management of written language disorders.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nice, France
- Hôpitaux Pédiatriques de Nice CHU-Lenval
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 8 years old and ≤ at 13 years old;
- Diagnosis of dyslexia validated by performances ≤ at -1.5 standard deviations from the mean on leximetric tests.
- Diagnosis of mixed dyslexia validated by performances ≤ at -1.5 standard deviations from the mean for reading irregular words and pseudo-words in the Evalec© test.
- Performance ≤ at -1.5 standard deviations from the mean for phonological (Evalec©) and visual-attentional tasks in the Evadys© and Sigl© tests.
- Home equipped with a connected computer system for daily training.
- Signing of informed consent by the parents
- The child must be affiliated to a social security scheme
Exclusion Criteria:
- Intellectual retardation, neurological disorders, pervasive developmental disorder;
- Primary sensory deficit;
- Educational deficiencies;
- attention deficit hyperactivity disorder, dysphasia;
- Previous daily phonological or visual-attentional training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phonological group
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Experimental: visual-attention group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reading skills effectiveness
Time Frame: 26 weeks to baseline
|
measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation
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26 weeks to baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reading skills effectiveness 8 weeks
Time Frame: 8 weeks to baseline
|
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
|
8 weeks to baseline
|
reading skills effectiveness 18 weeks
Time Frame: 18 weeks to baseline
|
Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations
|
18 weeks to baseline
|
orthographic skills effectiveness
Time Frame: 26 weeks to baseline
|
count of orthographic (number of errors) in raw scores and standard deviation
|
26 weeks to baseline
|
reading comprehension skills effectiveness
Time Frame: 26 weeks to baseline
|
measure of reading comprehension level (error rates) in raw scores and standard deviation
|
26 weeks to baseline
|
perception of the evolution of the reading disorder
Time Frame: 26 weeks to baseline
|
measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13
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26 weeks to baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HARRAR-ESKINAZI KARINE, CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-HPNCL-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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