Visual Attention Span Mobilisation for Dyslexia

Dyslexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201235
• Other study ID #: 2021-A01457-34
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: February 2024
• Source: Humans Matter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslexia

Intervention

Device:
• MAEVAD
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
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.

Locations

Country	Name	City	State
France	MARTINELLI Karen	Ajaccio
France	BERARD Marine	Albertville
France	CARCEY-CADET Elise	Albertville
France	KOUASSI-PUJOL Marie	Albi
France	CLAVIER-MARCOUX Laetitia	Antibes
France	BOCCOGNANI Jordane	Argences-en-Aubrac
France	CHAUVET Clémence	Arles
France	CHABERT Claire	Bagnères-de-Bigorre
France	SCHMITT Véronique	Biganos
France	CRABÉ Marion	Billère
France	BIRAN Sandrine	Bordes
France	VALLERY Théoline	Brest
France	LADOUL Marine	Brive-la-Gaillarde
France	COURANT Sabrina	Cabasse
France	CONTESTI Véronique	Champagne-au-Mont-d'Or
France	MINIAC-FOURNIER Stéphanie	Chateau-gontier
France	CASTERES Catherine	Digoin
France	PASQUIER Amélie	Fay de Bretagne
France	LEGENDRE Laure	Fontenay-sous-Bois
France	FORTIER Anne	Garches
France	BLANC Emilie	Givors
France	KRAYEM Mona	Guichainville
France	RIZK Joumana	Guichainville
France	SHAW PERRIN Anne-Sophie	Irigny
France	DE MUYNCK Solène	Lamballe
France	CADALEN Hélène	Lanmeur
France	VOLUET FROMENT Adeline	Le Chesnay
France	BERNARD-DENIS Fabienne	Le Havre
France	TERRASSON Cécile	Le Touquet-Paris-Plage
France	CALAIS Cécile	Liancourt
France	Britt	Lux
France	GOBÉ Valérie	Machecoul
France	JORDANIS Mélanie	Marignier
France	VERLOT-MORY Ludivine	Meuilley
France	MAZERAN Anne-Cécile	Miribel
France	KIS Nathalie	Montigny-le-Bretonneux
France	EMERIAU Mathilde	Nantes
France	LHUILLIER Françoise	Neufchateau
France	LEJOSNE Julie	Paimpol
France	BRESSON Raphaëlle	Plaisir
France	BERTHELOT Florence	Plerin
France	BERTHOLOM Anne-Marine	Ploudalmézeau
France	ZIMMERMAN Amélie	Remoulins
France	CAMUS-BRUNEAU Anne	Reze
France	KOCHEL Jeanne-Marie	Saint Germain En Laye
France	LECLERC LE COADOU Rozenn	Saint Lô
France	DESCENDRE Myriam	Saint Quentin
France	VIERLING Pauline	Saint-leu
France	NADAUD Stéphanie	Saint-Nom-la-Bretêche
France	REVERSE Christelle	Saint-peray
France	RAYNAUD LEGROS Caroline	Sainte-anne
France	AÏT LEMKADEM Mimouna	Sartrouville
France	FRITSCH Colombine	Schiltigheim
France	CARRIQUE Pascale	Tourrettes
France	KALCK Christine	Vendenheim

Sponsors (1)

Lead Sponsor	Collaborator
Humans Matter

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading speed	Measure of reding time from texts of 122 to 152 words	10 weeks to baseline
Primary	Reading speed	Measure of reding time from texts of 122 to 152 words	18 weeks to baseline
Primary	Reading speed	Measure of reding time from texts of 122 to 152 words	26 weeks to baseline
Secondary	Reading skills	Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)	10 weeks to baseline
Secondary	Reading skills	Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)	18 weeks to baseline
Secondary	Reading skills	Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)	26 weeks to baseline
Secondary	Orthographic skills	Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)	10 weeks to baseline
Secondary	Orthographic skills	Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)	18 weeks to baseline
Secondary	Orthographic skills	Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)	26 weeks to baseline
Secondary	VA Span	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
Secondary	VA Span	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
Secondary	VA Span	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
Secondary	Phonologic skills	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
Secondary	Phonologic skills	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
Secondary	Phonologic skills	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
Secondary	Mathematical skills	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
Secondary	Mathematical skills	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