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CompletedNCT04028310DDMRUpdated Sep 29, 2023

Developmental Dyslexia and Remediation Methods

An interventional study of Phonological and Visual-attention in Dyslexia, Developmental, sponsored by Fondation Lenval. Completed at 1 site in France. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Fondation Lenval · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Dyslexia, Developmental

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03

In context

Dyslexia

124 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 145 is above the median of 76 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

Fondation Lenval is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Phonological group

    Other: Phonological

  • Experimental
    visual-attention group

    Other: Visual-attention

Interventions

  • OtherPhonological

    * Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) * Phase 2: intervention with targeted daily training * Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) * Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) * Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) * Phase 3: stopping training sessions for 8 weeks

  • OtherVisual-attention

    * Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks) * Phase 2: intervention with targeted daily training * Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks) * Phonological training (15 minutes/ day, 5 days/week, for 8 weeks) * Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks) * Phase 3: stopping training sessions for 8 weeks

06

What researchers measure

Primary outcomes

  1. reading skills effectiveness

    measure of reading level (reading age) : accuracy (number of errors) and reading time (in seconds) in raw scores and standard deviation

    Time frame: 26 weeks to baseline

Secondary outcomes

  1. reading skills effectiveness 8 weeks

    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

    Time frame: 8 weeks to baseline

  2. reading skills effectiveness 18 weeks

    Measure of reading level : accuracy (error rates) and reading time (in milliseconds) in raw scores and standard deviations

    Time frame: 18 weeks to baseline

  3. orthographic skills effectiveness

    count of orthographic (number of errors) in raw scores and standard deviation

    Time frame: 26 weeks to baseline

  4. reading comprehension skills effectiveness

    measure of reading comprehension level (error rates) in raw scores and standard deviation

    Time frame: 26 weeks to baseline

  5. perception of the evolution of the reading disorder

    measure the perception of the evolution of the reading disorder by Likert scales : Number of items: 13 * Score from 5 to 1 * For example, "I like to read" a lot = 5, a lot = 4, normal" = 3, a little = 2, not at all = 1 Another example "it's easy to read", really very easy = 5, I do well = 4, normal = 3, a little difficult = 4, very difficult = 1 * The maximum value 5 means that reading and learning are perceived very positively * The minimum value 1 means that reading and learning are perceived very negatively * Results: An increase in scores measured before and after the three training sessions means an improvement

    Time frame: 26 weeks to baseline

07

Study locations

1 site
  • Hôpitaux Pédiatriques de Nice CHU-Lenval
    Nice, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04028310
Lead sponsor
Fondation Lenval
Responsible party
Sponsor
First posted
Jul 22, 2019
Start date
Oct 25, 2019
Primary completion
Dec 12, 2022
Completion
Dec 12, 2022
Last update
Sep 29, 2023

Study contacts

HARRAR-ESKINAZI KARINE
principal investigator · CERTA Fondation Lenval, Children Hospital of Nice CHU-LENVAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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