- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201235
Visual Attention Span Mobilisation for Dyslexia
Maevad - Mobilisation Active de l'Empan Visuo-Attentionel Pour la Dyslexie
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mélodie FOUILLEN, PhD
- Phone Number: +33629713936
- Email: m.fouillen@humansmatter.co
Study Locations
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Ajaccio, France, 20000
- MARTINELLI Karen
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Albertville, France, 73200
- BERARD Marine
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Albertville, France, 73200
- CARCEY-CADET Elise
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Albi, France, 81000
- KOUASSI-PUJOL Marie
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Antibes, France, 06600
- CLAVIER-MARCOUX Laetitia
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Argences-en-Aubrac, France, 12420
- BOCCOGNANI Jordane
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Arles, France, 13200
- CHAUVET Clémence
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Bagnères-de-Bigorre, France, 65200
- CHABERT Claire
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Biganos, France, 33380
- SCHMITT Véronique
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Billère, France, 64140
- CRABÉ Marion
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Bordes, France, 64510
- BIRAN Sandrine
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Brest, France, 29200
- VALLERY Théoline
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Brive-la-Gaillarde, France, 19100
- LADOUL Marine
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Cabasse, France, 83340
- COURANT Sabrina
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Champagne-au-Mont-d'Or, France, 69410
- CONTESTI Véronique
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Chateau-gontier, France, 53200
- MINIAC-FOURNIER Stéphanie
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Digoin, France, 71160
- CASTERES Catherine
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Fay de Bretagne, France, 44130
- PASQUIER Amélie
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Fontenay-sous-Bois, France, 94120
- LEGENDRE Laure
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Garches, France, 92380
- FORTIER Anne
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Givors, France, 69700
- BLANC Emilie
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Guichainville, France, 27930
- KRAYEM Mona
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Guichainville, France, 27930
- RIZK Joumana
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Irigny, France, 69100
- SHAW PERRIN Anne-Sophie
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Lamballe, France, 22400
- DE MUYNCK Solène
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Lanmeur, France, 29620
- CADALEN Hélène
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Le Chesnay, France, 78150
- VOLUET FROMENT Adeline
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Le Havre, France, 76000
- BERNARD-DENIS Fabienne
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Le Touquet-Paris-Plage, France, 62520
- TERRASSON Cécile
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Liancourt, France, 60140
- CALAIS Cécile
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Lux, France, 71100
- Britt
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Machecoul, France, 44270
- GOBÉ Valérie
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Marignier, France, 74970
- JORDANIS Mélanie
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Meuilley, France, 21700
- VERLOT-MORY Ludivine
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Miribel, France, 01700
- MAZERAN Anne-Cécile
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Montigny-le-Bretonneux, France, 78180
- KIS Nathalie
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Nantes, France, 44000
- EMERIAU Mathilde
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Neufchateau, France, 88300
- LHUILLIER Françoise
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Paimpol, France, 22500
- LEJOSNE Julie
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Plaisir, France, 78370
- BRESSON Raphaëlle
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Plerin, France, 22190
- BERTHELOT Florence
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Ploudalmézeau, France, 29830
- BERTHOLOM Anne-Marine
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Remoulins, France, 30210
- ZIMMERMAN Amélie
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Reze, France, 44400
- CAMUS-BRUNEAU Anne
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Saint Germain En Laye, France, 78100
- KOCHEL Jeanne-Marie
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Saint Lô, France, 50 000
- LECLERC LE COADOU Rozenn
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Saint Quentin, France, 02100
- DESCENDRE Myriam
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Saint-Nom-la-Bretêche, France, 78860
- NADAUD Stéphanie
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Saint-leu, France, 97416
- VIERLING Pauline
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Saint-peray, France, 07130
- REVERSE Christelle
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Sainte-anne, France, 97180
- RAYNAUD LEGROS Caroline
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Sartrouville, France, 78500
- AÏT LEMKADEM Mimouna
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Schiltigheim, France, 67300
- FRITSCH Colombine
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Tourrettes, France, 83440
- CARRIQUE Pascale
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Vendenheim, France, 67550
- KALCK Christine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
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Experimental: MAEVAD - DeCaLigne
The experimental group will first receive MAEVAD then the control therapy
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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.
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Placebo Comparator: DeCaLigne - MAEVAD
The control group will first receive the control therapy then MAEVAD
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading speed
Time Frame: 10 weeks to baseline
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Measure of reding time from texts of 122 to 152 words
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10 weeks to baseline
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Reading speed
Time Frame: 18 weeks to baseline
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Measure of reding time from texts of 122 to 152 words
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18 weeks to baseline
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Reading speed
Time Frame: 26 weeks to baseline
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Measure of reding time from texts of 122 to 152 words
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26 weeks to baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading skills
Time Frame: 10 weeks to baseline
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Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
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10 weeks to baseline
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Reading skills
Time Frame: 18 weeks to baseline
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Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
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18 weeks to baseline
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Reading skills
Time Frame: 26 weeks to baseline
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Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
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26 weeks to baseline
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Orthographic skills
Time Frame: 10 weeks to baseline
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Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
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10 weeks to baseline
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Orthographic skills
Time Frame: 18 weeks to baseline
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Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
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18 weeks to baseline
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Orthographic skills
Time Frame: 26 weeks to baseline
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Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
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26 weeks to baseline
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VA Span
Time Frame: 10 weeks to baseline
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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.
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10 weeks to baseline
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VA Span
Time Frame: 18 weeks to baseline
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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.
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18 weeks to baseline
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VA Span
Time Frame: 26 weeks to baseline
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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.
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26 weeks to baseline
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Phonologic skills
Time Frame: 10 weeks to baseline
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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
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Phonologic skills
Time Frame: 18 weeks to baseline
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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
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Phonologic skills
Time Frame: 26 weeks to baseline
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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
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Mathematical skills
Time Frame: 10 weeks to baseline
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DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.
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10 weeks to baseline
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Mathematical skills
Time Frame: 18 weeks to baseline
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DeCaLigne(c) and Examath(c): The child will have to find the position of a number on a numerical line and answer mental calculation.
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18 weeks to baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mélodie FOUILLEN, PhD, Humans Matter
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01457-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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