Visual Attention Span Mobilisation for Dyslexia

February 26, 2024 updated by: Humans Matter

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

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ajaccio, France, 20000
        • MARTINELLI Karen
      • Albertville, France, 73200
        • BERARD Marine
      • Albertville, France, 73200
        • CARCEY-CADET Elise
      • Albi, France, 81000
        • KOUASSI-PUJOL Marie
      • Antibes, France, 06600
        • CLAVIER-MARCOUX Laetitia
      • Argences-en-Aubrac, France, 12420
        • BOCCOGNANI Jordane
      • Arles, France, 13200
        • CHAUVET Clémence
      • Bagnères-de-Bigorre, France, 65200
        • CHABERT Claire
      • Biganos, France, 33380
        • SCHMITT Véronique
      • Billère, France, 64140
        • CRABÉ Marion
      • Bordes, France, 64510
        • BIRAN Sandrine
      • Brest, France, 29200
        • VALLERY Théoline
      • Brive-la-Gaillarde, France, 19100
        • LADOUL Marine
      • Cabasse, France, 83340
        • COURANT Sabrina
      • Champagne-au-Mont-d'Or, France, 69410
        • CONTESTI Véronique
      • Chateau-gontier, France, 53200
        • MINIAC-FOURNIER Stéphanie
      • Digoin, France, 71160
        • CASTERES Catherine
      • Fay de Bretagne, France, 44130
        • PASQUIER Amélie
      • Fontenay-sous-Bois, France, 94120
        • LEGENDRE Laure
      • Garches, France, 92380
        • FORTIER Anne
      • Givors, France, 69700
        • BLANC Emilie
      • Guichainville, France, 27930
        • KRAYEM Mona
      • Guichainville, France, 27930
        • RIZK Joumana
      • Irigny, France, 69100
        • SHAW PERRIN Anne-Sophie
      • Lamballe, France, 22400
        • DE MUYNCK Solène
      • Lanmeur, France, 29620
        • CADALEN Hélène
      • Le Chesnay, France, 78150
        • VOLUET FROMENT Adeline
      • Le Havre, France, 76000
        • BERNARD-DENIS Fabienne
      • Le Touquet-Paris-Plage, France, 62520
        • TERRASSON Cécile
      • Liancourt, France, 60140
        • CALAIS Cécile
      • Lux, France, 71100
        • Britt
      • Machecoul, France, 44270
        • GOBÉ Valérie
      • Marignier, France, 74970
        • JORDANIS Mélanie
      • Meuilley, France, 21700
        • VERLOT-MORY Ludivine
      • Miribel, France, 01700
        • MAZERAN Anne-Cécile
      • Montigny-le-Bretonneux, France, 78180
        • KIS Nathalie
      • Nantes, France, 44000
        • EMERIAU Mathilde
      • Neufchateau, France, 88300
        • LHUILLIER Françoise
      • Paimpol, France, 22500
        • LEJOSNE Julie
      • Plaisir, France, 78370
        • BRESSON Raphaëlle
      • Plerin, France, 22190
        • BERTHELOT Florence
      • Ploudalmézeau, France, 29830
        • BERTHOLOM Anne-Marine
      • Remoulins, France, 30210
        • ZIMMERMAN Amélie
      • Reze, France, 44400
        • CAMUS-BRUNEAU Anne
      • Saint Germain En Laye, France, 78100
        • KOCHEL Jeanne-Marie
      • Saint Lô, France, 50 000
        • LECLERC LE COADOU Rozenn
      • Saint Quentin, France, 02100
        • DESCENDRE Myriam
      • Saint-Nom-la-Bretêche, France, 78860
        • NADAUD Stéphanie
      • Saint-leu, France, 97416
        • VIERLING Pauline
      • Saint-peray, France, 07130
        • REVERSE Christelle
      • Sainte-anne, France, 97180
        • RAYNAUD LEGROS Caroline
      • Sartrouville, France, 78500
        • AÏT LEMKADEM Mimouna
      • Schiltigheim, France, 67300
        • FRITSCH Colombine
      • Tourrettes, France, 83440
        • CARRIQUE Pascale
      • Vendenheim, France, 67550
        • KALCK Christine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAEVAD - DeCaLigne
The experimental group will first receive MAEVAD then the control therapy
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.
Placebo Comparator: DeCaLigne - MAEVAD
The control group will first receive the control therapy then MAEVAD
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading speed
Time Frame: 10 weeks to baseline
Measure of reding time from texts of 122 to 152 words
10 weeks to baseline
Reading speed
Time Frame: 18 weeks to baseline
Measure of reding time from texts of 122 to 152 words
18 weeks to baseline
Reading speed
Time Frame: 26 weeks to baseline
Measure of reding time from texts of 122 to 152 words
26 weeks to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading skills
Time Frame: 10 weeks to baseline
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
10 weeks to baseline
Reading skills
Time Frame: 18 weeks to baseline
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
18 weeks to baseline
Reading skills
Time Frame: 26 weeks to baseline
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
26 weeks to baseline
Orthographic skills
Time Frame: 10 weeks to baseline
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
10 weeks to baseline
Orthographic skills
Time Frame: 18 weeks to baseline
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
18 weeks to baseline
Orthographic skills
Time Frame: 26 weeks to baseline
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
26 weeks to baseline
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.
10 weeks to baseline
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.
18 weeks to baseline
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.
26 weeks to baseline
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.

10 weeks to baseline
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.

18 weeks to baseline
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.

26 weeks to baseline
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.
10 weeks to baseline
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.
18 weeks to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Mélodie FOUILLEN, PhD, Humans Matter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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