DyslexiaDyslexie REMEDNCT05514457
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
A study testing visual stimulation with I pad and visual stimulation with lamp in people with Dyslexia, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- visual stimulation with I pad and visual stimulation with lamp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- other neurodevelopmental problem
- strabismus, amblyopia
- For the glasses (group 2) : epileptic child are excluded
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Neurosciences de Lyon
Bron, Auvergne-Rhône-Alpes, 69500
About this study
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.
- Conditions
- Dyslexia
- Being tested
- visual stimulation with I pad, visual stimulation with lamp
- Keywords
- Dyslexia, Remediation, Visual attention span, Visual search
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual stimulation with I padBehavioural
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 lampBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| remediation group 1 | Experimental | dyslexic children Receives: Behavioral: visual stimulation with I pad |
| remediation group 2 | Experimental | dyslexic children Receives: Behavioral: visual stimulation with lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
reading performance
change in reading time
Measured: 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
reading performance
change in number of errors
Measured: 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 outcomes (4)
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
Measured: one time at baseline
visual attention span
number of letters identified in a single ocular fixation (200 ms)
Measured: one time at baseline
Visual search time
average visual search time of symbols versus colored objects
Measured: one time at baseline
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
Measured: one time at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start17 Nov 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514457
- Sponsor's protocol ID
- 69HCL21_0736
- Acronym
- Dyslexie REMED
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
- ClinicalTrials.gov ID
- NCT05514457
- Acronym / sponsor ID
- Dyslexie REMED / 69HCL21_0736
- Conditions
- Dyslexia
- Keywords
- Dyslexia, Remediation, Visual attention span, Visual search
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remediation group 1 | Experimental | Behavioral: visual stimulation with I paddyslexic children |
| remediation group 2 | Experimental | Behavioral: visual stimulation with lampdyslexic children |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- other neurodevelopmental problem
- strabismus, amblyopia
- For the glasses (group 2) : epileptic child are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual stimulation with I padAt 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. | Behavioural | remediation group 1 |
| visual stimulation with lampAt 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). | Behavioural | remediation group 2 |
Primary outcome
reading performance
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
change in reading time
reading performance
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
change in number of errors
4 secondary outcomes
score of Elementary Visuo-Spatial Perception test
Time frame: one time at baseline
visual attention span
Time frame: one time at baseline
Visual search time
Time frame: one time at baseline
performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)
Time frame: one time at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Dyslexia
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual stimulation with I pad and visual stimulation with lamp in people with Dyslexia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reading performance (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.