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Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION (Dyslexie REMED)

Primary Purpose

Dyslexia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
visual stimulation with I pad
visual stimulation with lamp
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslexia focused on measuring Dyslexia, Remediation, Visual attention span, Visual search

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • Aged 8 to 12
  • Diagnosed dyslexics
  • Normal or corrected to normal vision
  • Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate.

Exclusion Criteria:

  • other neurodevelopmental problem
  • strabismus, amblyopia

For the glasses (group 2) : epileptic child are excluded

Sites / Locations

  • Centre de Recherche en Neurosciences de LyonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

remediation group 1

remediation group 2

Arm Description

dyslexic children

dyslexic children

Outcomes

Primary Outcome Measures

reading performance
change in reading time
reading performance
change in number of errors

Secondary Outcome Measures

score of Elementary Visuo-Spatial Perception test
comparisons of score of (lengths, sizes, angles and relative positions within and between objects). Minimum score = 36 and maximum (better) score = 72
visual attention span
number of letters identified in a single ocular fixation (200 ms)
Visual search time
average visual search time of symbols versus colored objects
performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)
metaphonology = removal of phonemes. Minimum score = 0 and maximum (better) score = 20

Full Information

First Posted
August 5, 2022
Last Updated
January 30, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05514457
Brief Title
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
Acronym
Dyslexie REMED
Official Title
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
February 17, 2025 (Anticipated)
Study Completion Date
February 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia
Keywords
Dyslexia, Remediation, Visual attention span, Visual search

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remediation group 1
Arm Type
Experimental
Arm Description
dyslexic children
Arm Title
remediation group 2
Arm Type
Experimental
Arm Description
dyslexic children
Intervention Type
Behavioral
Intervention Name(s)
visual stimulation with I pad
Intervention Description
At the beginning of the study, for baseline condition, children will do 4 tests (visuo-spatial perception test, visual attention span, visual research, phonology tests). In the first group of the study, the children will do visual research exercises on I pad 10 minutes per day during one month = remediation. They will also do 4 reading aloud tests, once a month, for 3 months. The remediation exercises will be realized during the first, second or third month.
Intervention Type
Behavioral
Intervention Name(s)
visual stimulation with lamp
Intervention Description
At the beginning of the study, for baseline condition, children will do the 4 tests like group 1. In the second group of the study, the children will do reading aloud tests, with lamp adjusted with different parameters = remediation (passive visual stimulation of a specific frequency believed to promote visual processing of written symbols).
Primary Outcome Measure Information:
Title
reading performance
Description
change in reading time
Time Frame
for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes
Title
reading performance
Description
change in number of errors
Time Frame
for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes
Secondary Outcome Measure Information:
Title
score of Elementary Visuo-Spatial Perception test
Description
comparisons of score of (lengths, sizes, angles and relative positions within and between objects). Minimum score = 36 and maximum (better) score = 72
Time Frame
one time at baseline
Title
visual attention span
Description
number of letters identified in a single ocular fixation (200 ms)
Time Frame
one time at baseline
Title
Visual search time
Description
average visual search time of symbols versus colored objects
Time Frame
one time at baseline
Title
performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)
Description
metaphonology = removal of phonemes. Minimum score = 0 and maximum (better) score = 20
Time Frame
one time at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Aged 8 to 12 Diagnosed dyslexics Normal or corrected to normal vision Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate. Exclusion Criteria: other neurodevelopmental problem strabismus, amblyopia For the glasses (group 2) : epileptic child are excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure PISELLA, Dr
Phone
04 72 91 34 12
Ext
+33
Email
laure.pisella@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey VIALATTE, Dr
Phone
04 72 91 34 12
Ext
+33
Email
audrey.vialatte@inserm.fr
Facility Information:
Facility Name
Centre de Recherche en Neurosciences de Lyon
City
Bron
State/Province
Rhone Alpes
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure PISELLA, Dr
Phone
04 72 91 34 12
Ext
+33
Email
laure.pisella@inserm.fr
First Name & Middle Initial & Last Name & Degree
Audrey VIALATTE, Dr
Phone
04 72 91 34 12
Ext
+33
Email
audrey.vialatte@inserm.fr
First Name & Middle Initial & Last Name & Degree
Laure PISELLA, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION

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