NCT05201235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

55 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

January 7, 2022

Last Update Submit

February 26, 2024

Conditions

Keywords

MAEVADMAEVAReadingRemediationVisual attention span

Outcome Measures

Primary Outcomes (3)

  • Reading speed

    Measure of reding time from texts of 122 to 152 words

    10 weeks to baseline

  • Reading speed

    Measure of reding time from texts of 122 to 152 words

    18 weeks to baseline

  • Reading speed

    Measure of reding time from texts of 122 to 152 words

    26 weeks to baseline

Secondary Outcomes (14)

  • Reading skills

    10 weeks to baseline

  • Reading skills

    18 weeks to baseline

  • Reading skills

    26 weeks to baseline

  • Orthographic skills

    10 weeks to baseline

  • Orthographic skills

    18 weeks to baseline

  • +9 more secondary outcomes

Study Arms (2)

MAEVAD - DeCaLigne

EXPERIMENTAL

The experimental group will first receive MAEVAD then the control therapy

Device: MAEVAD

DeCaLigne - MAEVAD

PLACEBO COMPARATOR

The control group will first receive the control therapy then MAEVAD

Device: DeCaLigne

Interventions

MAEVADDEVICE

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.

MAEVAD - DeCaLigne
DeCaLigneDEVICE

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.

DeCaLigne - MAEVAD

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (55)

MARTINELLI Karen

Ajaccio, 20000, France

Location

BERARD Marine

Albertville, 73200, France

Location

CARCEY-CADET Elise

Albertville, 73200, France

Location

KOUASSI-PUJOL Marie

Albi, 81000, France

Location

CLAVIER-MARCOUX Laetitia

Antibes, 06600, France

Location

BOCCOGNANI Jordane

Argences en Aubrac, 12420, France

Location

CHAUVET Clémence

Arles, 13200, France

Location

CHABERT Claire

Bagnères-de-Bigorre, 65200, France

Location

SCHMITT Véronique

Biganos, 33380, France

Location

CRABÉ Marion

Billère, 64140, France

Location

BIRAN Sandrine

Bordes, 64510, France

Location

VALLERY Théoline

Brest, 29200, France

Location

LADOUL Marine

Brive-la-Gaillarde, 19100, France

Location

COURANT Sabrina

Cabasse, 83340, France

Location

CONTESTI Véronique

Champagne-au-Mont-d'Or, 69410, France

Location

MINIAC-FOURNIER Stéphanie

Château-Gontier, 53200, France

Location

CASTERES Catherine

Digoin, 71160, France

Location

PASQUIER Amélie

Fay-de-Bretagne, 44130, France

Location

LEGENDRE Laure

Fontenay-sous-Bois, 94120, France

Location

FORTIER Anne

Garches, 92380, France

Location

BLANC Emilie

Givors, 69700, France

Location

KRAYEM Mona

Guichainville, 27930, France

Location

RIZK Joumana

Guichainville, 27930, France

Location

SHAW PERRIN Anne-Sophie

Irigny, 69100, France

Location

DE MUYNCK Solène

Lamballe, 22400, France

Location

CADALEN Hélène

Lanmeur, 29620, France

Location

VOLUET FROMENT Adeline

Le Chesnay, 78150, France

Location

BERNARD-DENIS Fabienne

Le Havre, 76000, France

Location

TERRASSON Cécile

Le Touquet-Paris-Plage, 62520, France

Location

CALAIS Cécile

Liancourt, 60140, France

Location

Britt

Lux, 71100, France

Location

GOBÉ Valérie

Machecoul, 44270, France

Location

JORDANIS Mélanie

Marignier, 74970, France

Location

VERLOT-MORY Ludivine

Meuilley, 21700, France

Location

MAZERAN Anne-Cécile

Miribel, 01700, France

Location

KIS Nathalie

Montigny-le-Bretonneux, 78180, France

Location

EMERIAU Mathilde

Nantes, 44000, France

Location

LHUILLIER Françoise

Neufchâteau, 88300, France

Location

LEJOSNE Julie

Paimpol, 22500, France

Location

BRESSON Raphaëlle

Plaisir, 78370, France

Location

BERTHELOT Florence

Plérin, 22190, France

Location

BERTHOLOM Anne-Marine

Ploudalmézeau, 29830, France

Location

ZIMMERMAN Amélie

Remoulins, 30210, France

Location

CAMUS-BRUNEAU Anne

Rezé, 44400, France

Location

KOCHEL Jeanne-Marie

Saint-Germain-en-Laye, 78100, France

Location

VIERLING Pauline

Saint-Leu, 97416, France

Location

LECLERC LE COADOU Rozenn

Saint-Lô, 50 000, France

Location

NADAUD Stéphanie

Saint-Nom-la-Bretêche, 78860, France

Location

REVERSE Christelle

Saint-Péray, 07130, France

Location

DESCENDRE Myriam

Saint-Quentin, 02100, France

Location

RAYNAUD LEGROS Caroline

Sainte-Anne, 97180, France

Location

AÏT LEMKADEM Mimouna

Sartrouville, 78500, France

Location

FRITSCH Colombine

Schiltigheim, 67300, France

Location

CARRIQUE Pascale

Tourrettes, 83440, France

Location

KALCK Christine

Vendenheim, 67550, France

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mélodie FOUILLEN, PhD

    Humans Matter

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 21, 2022

Study Start

January 17, 2022

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations