Clinical trial NCT04028310: Developmental Dyslexia and Remediation Methods
Official title: Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia, Developmental
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 145
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: reading skills effectiveness
timeFrame: 26 weeks to baseline
Secondary outcomes:
measure: reading skills effectiveness 8 weeks
timeFrame: 8 weeks to baseline
measure: reading skills effectiveness 18 weeks
timeFrame: 18 weeks to baseline
measure: orthographic skills effectiveness
timeFrame: 26 weeks to baseline
measure: reading comprehension skills effectiveness
timeFrame: 26 weeks to baseline
measure: perception of the evolution of the reading disorder
timeFrame: 26 weeks to baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL
name: HARRAR-ESKINAZI KARINE
role: PRINCIPAL_INVESTIGATOR
References: