Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION

Dyslexia Clinical Trial

— Dyslexie REMED  

Official title:

Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514457
• Other study ID #: 69HCL21_0736
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: February 17, 2025

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Laure PISELLA, Dr
• Phone: 04 72 91 34 12
• Email: laure.pisella[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: February 17, 2025
• Est. primary completion date: February 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslexia

Intervention

Behavioral:
• visual stimulation with I pad
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.
• visual stimulation with lamp
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).

Locations

Country	Name	City	State
France	Centre de Recherche en Neurosciences de Lyon	Bron	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reading performance	change in reading time	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
Primary	reading performance	change in number of errors	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	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	one time at baseline
Secondary	visual attention span	number of letters identified in a single ocular fixation (200 ms)	one time at baseline
Secondary	Visual search time	average visual search time of symbols versus colored objects	one time at baseline
Secondary	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	one time at baseline