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Completed

NCT Number: NCT05201235

Visual Attention Span Mobilisation for Dyslexia

The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MARTINELLI Karen, Ajaccio, France

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About this study

MAEVAD is a digital therapy specifically designed to improve the visual attention (VA) span of children with dyslexia. Dyslexia is characterized by a specific and significant impairment in reading and/or writing production and spelling. Some profiles of children with dyslexia show a deficit in VA span, characterized by a decrease in the number of distinct visual elements that can be processed simultaneously. VA span plays a critical role in the acquisition of reading skills and specific knowledge of word spelling. Brain regions involved in visual-attentional skills are under-activated in dyslexic children with VA deficits and can be reactivated following specific and intensive VA span training.

In this study 150 children with dyslexia will be randomized in tow groups. On the first group children will be trained first with MAEVAD then with a control training that does not stimulate the VA span. On contrary, on the second group children will first perform the control training and then MAEVAD.

For each intervention the sessions will lasts 15 minutes. 5 sessions are planned per weeks for 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • School children from CE2 to CM2, aged 8 to 11 years
  • Dyslexic children with a VA span deficit (composite visual-attention span below the fifteenth percentile and a letter threshold above or equal to the twentieth percentile with the - - - Evadys(c) battery)
  • Established diagnosis of Dyslexia
  • Children whose parents/legal guardians have signed informed consent and agree to participate in the study
  • Children whose first language is French or who have been educated in French since kindergarten
  • Raven's Progressive Matrices score above the 20th percentile or a WISC IV or V Verbal Comprehension Index or WISC IV or V Perceptual/Fluid Reasoning Index above 85 or documented/objectifiable absence of intellectual deficit
  • Child with access to a computer
  • Normal or corrected vision and audition

Exclusion criteria

  • Attention deficit hyperactivity disorder,dysphasia, dyspraxia, Autism Spectrum Disorder
  • Neurological disorders
  • Children who have missed 3 months or more of school in the current or previous year (excluding lockdown)
  • Children not affiliated to a social security scheme

Treatment and study plan

MAEVAD

Device

MAEVAD is a training device which aims to improve VA span as a prerequisite for learning to read. By increasing the number of distinct visual elements that can be processed simultaneously during fixation, MAEVAD is intended to improve the reading (accuracy and fluency) and spelling (lexical) performance of dyslexics who have a VA span deficit. MAEVAD is designed to be used in total autonomy by dyslexic children with a VA span disorder. The therapy takes place over 6 weeks with 5 sessions of 15 minutes per week. In order to improve compliance, the therapy has been integrated into "le Royaume d'Adelia", a serious game where the child will be able to collect materials at the end of each session that will allow him to create objects to customise a character.

DeCaLigne

Device

DéCaLigne is an intervention programme for the discovery of calculation with the number line. The objectives are to improve numerical representations in the form of a number line and to improve addition and subtraction skills. The overall principle is to move numbers or calculation results on a number line. This training does not stimulate VA span or the phonological dimensions involved in reading. This therapy is being adapted to be used in total autonomy at home and to correspond to the MAEVAD therapy in duration (5 sessions of 15 minutes per week for 6 weeks). It has also been integrated into the "royaume d'Adelia" in order to control the motivational effect of the serious game.

Primary outcomes

  1. Reading speed

    Time frame: 10 weeks to baseline

    Measure of reding time from texts of 122 to 152 words

  2. Reading speed

    Time frame: 18 weeks to baseline

    Measure of reding time from texts of 122 to 152 words

  3. Reading speed

    Time frame: 26 weeks to baseline

    Measure of reding time from texts of 122 to 152 words

Secondary outcomes

  1. Reading skills

    Time frame: 10 weeks to baseline

    Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)

  2. Reading skills

    Time frame: 18 weeks to baseline

    Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)

  3. Reading skills

    Time frame: 26 weeks to baseline

    Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)

  4. Orthographic skills

    Time frame: 10 weeks to baseline

    Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)

  5. Orthographic skills

    Time frame: 18 weeks to baseline

    Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)

  6. Orthographic skills

    Time frame: 26 weeks to baseline

    Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)

  7. VA Span

    Time frame: 10 weeks to baseline

    Evadys test : EVADYS(c) provides a reliable diagnosis of visual-attention span disorder. The software includes three versions of the global and partial report tests, each adapted to a given age group.

  8. VA Span

    Time frame: 18 weeks to baseline

    Evadys test : EVADYS(c) provides a reliable diagnosis of visual-attention span disorder. The software includes three versions of the global and partial report tests, each adapted to a given age group.

  9. VA Span

    Time frame: 26 weeks to baseline

    Evadys test : EVADYS(c) provides a reliable diagnosis of visual-attention span disorder. The software includes three versions of the global and partial report tests, each adapted to a given age group.

  10. Phonologic skills

    Time frame: 10 weeks to baseline

    Evalec(c) test : The child will have to delete, orally, the first phoneme of the pseudowords presented on the screen.

    12 pseudowords with a consonant-vowel-consonant structure and 12 with a consonant-consonant-vowel structure are presented one by one on the screen.

  11. Phonologic skills

    Time frame: 18 weeks to baseline

    Evalec(c) test : The child will have to delete, orally, the first phoneme of the pseudowords presented on the screen.

    12 pseudowords with a consonant-vowel-consonant structure and 12 with a consonant-consonant-vowel structure are presented one by one on the screen.

  12. Phonologic skills

    Time frame: 26 weeks to baseline

    Evalec(c) test : The child will have to delete, orally, the first phoneme of the pseudowords presented on the screen.

    12 pseudowords with a consonant-vowel-consonant structure and 12 with a consonant-consonant-vowel structure are presented one by one on the screen.

  13. Mathematical skills

    Time frame: 10 weeks to baseline

    DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.

  14. Mathematical skills

    Time frame: 18 weeks to baseline

    DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.

Sponsors and collaborators

Lead sponsor

Humans Matter

Industry

Registry information

Official study title

Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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