Visual Attention Span Mobilisation for Dyslexia

Sponsor

Humans Matter (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05201235

Collaborator

(none)

150

Enrollment

Locations

Arms

7.5

Anticipated Duration (Months)

2.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyslexia Visual Attention Span Deficit	Device: MAEVAD Device: DeCaLigne	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The training will be performed at home. The investigators/evaluators will send a download link of the therapy to the patient's parents without knowing which therapy it corresponds to.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 17, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: MAEVAD - DeCaLigne

The experimental group will first receive MAEVAD then the control therapy

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.

Placebo Comparator: DeCaLigne - MAEVAD

The control group will first receive the control therapy then MAEVAD

Device: 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.

Outcome Measures

Primary Outcome Measures

Reading speed [10 weeks to baseline]
Measure of reding time from texts of 122 to 152 words
Reading speed [18 weeks to baseline]
Measure of reding time from texts of 122 to 152 words
Reading speed [26 weeks to baseline]
Measure of reding time from texts of 122 to 152 words

Secondary Outcome Measures

Reading skills [10 weeks to baseline]
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Reading skills [18 weeks to baseline]
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Reading skills [26 weeks to baseline]
Word and pseudoword reading tests (reding time and accuracy) Text reading (reading time and accuracy)
Orthographic skills [10 weeks to baseline]
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Orthographic skills [18 weeks to baseline]
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
Orthographic skills [26 weeks to baseline]
Lexical-spelling judgment (Accuracy and time) Words and pseudowords dictation (Accuracy)
VA Span [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.
VA Span [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.
VA Span [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.
Phonologic skills [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.
Phonologic skills [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.
Phonologic skills [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.
Mathematical skills [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.
Mathematical skills [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	MARTINELLI Karen	Ajaccio	France	20000
2	BERARD Marine	Albertville	France	73200
3	CARCEY-CADET Elise	Albertville	France	73200
4	DELOUS Thomas	Albi	France	81000
5	KOUASSI-PUJOL Marie	Albi	France	81000
6	BLONDE Manon	Amiens	France	80000
7	CLAVIER-MARCOUX Laetitia	Antibes	France	06600
8	BOCCOGNANI Jordane	Argences-en-Aubrac	France	12420
9	CHAUVET Clémence	Arles	France	13200
10	CHABERT Claire	Bagnères-de-Bigorre	France	65200
11	DE VALENCE Cécile	Belleville	France	69220
12	SCHMITT Véronique	Biganos	France	33380
13	BIRAN Sandrine	Bordes	France	64510
14	GUILLERMOND Sandra	Bourg-de-péage	France	26300
15	LADOUL Marine	Brive-la-Gaillarde	France	19100
16	COURANT Sabrina	Cabasse	France	83340
17	JOIRE Isabelle	Chateau La Vallière	France	37330
18	MINIAC-FOURNIER Stéphanie	Chateau-gontier	France	53200
19	RUBINI Diane	Clamart	France	92140
20	PELLATON Aurélie	Coarraze	France	64800
21	HOLLINGSHAUSEN Sophie	Colomiers	France	31770
22	CASTERES Catherine	Digoin	France	71160
23	PASQUIER Amélie	Fay de Bretagne	France	44130
24	LEGENDRE Laure	Fontenay-sous-Bois	France	94120
25	BLANC Emilie	Givors	France	69700
26	LE BOURHIS Aurélie	Labastidette	France	31600
27	DE MUYNCK Solène	Lamballe	France	22400
28	BERNARD-DENIS Fabienne	Le Havre	France	76000
29	TERRASSON Cécile	Le Touquet-Paris-Plage	France	62520
30	BOIS PARRIAUD Françoise	Levallois-Perret	France	92300
31	GOBÉ Valérie	Machecoul	France	44270
32	PREVOST Adeline	Maromme	France	76150
33	VERLOT-MORY Ludivine	Meuilley	France	21700
34	MAZERAN Anne-Cécile	Miribel	France	01700
35	LEFÈVRE Hélène	Morsain	France	02290
36	LHUILLIER Françoise	Neufchateau	France	88300
37	LEJOSNE Julie	Paimpol	France	22500
38	CAILLY Gautier	Pelissanne	France	13330
39	BRESSON Raphaëlle	Plaisir	France	78370
40	BERTHELOT Florence	Plerin	France	22190
41	ZIMMERMAN Amélie	Remoulins	France	30210
42	CAMUS-BRUNEAU Anne	Reze	France	44400
43	KOCHEL Jeanne-Marie	Saint Germain En Laye	France	78100
44	BOUJU Céline	Saint Laurent D'aigouze	France	30220
45	LECLERC LE COADOU Rozenn	Saint Lô	France	50 000
46	RAFFIN LETHULLIER Virginie	Saint Malo	France	35400
47	DESCENDRE Myriam	Saint Quentin	France	02100
48	VIERLING Pauline	Saint-leu	France	97416
49	REVERSE Christelle	Saint-peray	France	07130
50	RAYNAUD LEGROS Caroline	Sainte-anne	France	97180
51	RICARD Pauline	Thouars	France	79100
52	CARRIQUE Pascale	Tourrettes	France	83440
53	FLAMMANT Anne-Sophie	Vaugrigneuse	France	91640
54	KALCK Christine	Vendenheim	France	67550