DyslexiaINTENS-DYSNCT05383937
Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
A study testing Speech Therapy INTENS-DYS in people with Dyslexia and Speech Therapy, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Dyslexia is characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dyslexia, Speech Therapy, Children, Only
- What is being tested?
- Speech Therapy INTENS-DYS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 15 Apr 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
- Children from 8 to 12 years old,
- Living in and around 50 kilometers from Besançon.
- Diagnosis of dyslexia according to the DSM-V or CIM-10 requirements.
- Consent form signed by the parental authority and the child,
- Affiliation to a social security system.
Who cannot join
- Mother's medical history of pregnancy or delivery complications,
- Patients's medical history of neurological infectious, vascular or tumoral events,
- Patient's medical history of intellectual deficiency,
- Patients's medical history of visual or hearing disorders,
- Patient's medical history of psychiatric disorders (especially diagnosis of Attention Deficit / Hyperactivity Disorders (AD/HD)),
- legal incapacity,
- limited cooperation suspected by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Dyslexia is characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. However, no clinical trial of a standardized rehabilitation has shown an impact on reading fluency. In the era of intensive rehabilitation, a new protocol based on the current data from the medical literature has been designed.
- Conditions
- Dyslexia, Speech Therapy, Children, Only
- Being tested
- Speech Therapy INTENS-DYS
- Keywords
- Dyslexia, Speech Therapy, Children, Intensive rehabilitation
- Medical subject headings
- Dyslexia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Therapy INTENS-DYSOther
During the six research month, children included in the intensive arm will benefit of two daily hours speech therapy during two weeks. Those one will be carried out between the second and the fourth month.
| Study group | Role | What they receive |
|---|---|---|
| intensive arm | Experimental | The children included in this arm will receive two weeks of daily care during which two daily speech therapy sessions of one hour each will be performed. This will be done between M2 and M4 of inclusion in order to avoid potential measurement bias. These sessions will be carried out by a state-qualified speech therapist employed at the CRRF of Bregille. They will guide the intensive rehabilitation of dyslexic children by focusing the exercises on their main difficulties. Receives: Other: Speech Therapy INTENS-DYS |
| classic arm or gold standard | Active comparator | The speech therapy session will be provided only by private practitioners, with a weekly consultation of 30 minutes. The private speech therapist who initially referred the patient for inclusion in the research protocol will be responsible for his or her "classic" rehabilitation. The therapy will continue during the 6 months of research. Receives: Other: Speech Therapy INTENS-DYS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading fluency to the Alouette test.
Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.
Measured: Six month.
Secondary outcomes (6)
Phonological processing tests.
Difference in the number of errors in logatom repetition, which means phonological rules of a language corresponding of meaningless words, in the intensive and the conventional arm.
Measured: Six month.
Visual pattern.
Difference in the number of errors to five visual pattern from the BALE and the EVALEO, in the intensive and the conventional arm.
Measured: Six month.
Life Quality.
Difference on the AUQUEI self questionnary, in the intensive and the conventional arm.
Measured: 6 month.
Rehabilitation adhesion.
Number of speech therapy session performed by patient in each arms.
Measured: 6 month
Speech langage rehabilitation cost.
Differential cost/progress relation of intensive and classical rehabilitation.
Measured: 6 month.
Family and school evaluation.
Difference to Visual Analog Scale (VAS) regarding the benefit of speech therapy rehabilitation, assessed by the family and the school teachers, in each arms.
Measured: 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start10 Oct 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Why it stopped: recruitement diffculties
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 Centre Hospitalier Universitaire de BesanconThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BEVALOT, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383937
- Sponsor's protocol ID
- 2022/692
- Acronym
- INTENS-DYS
- Status last verified
- Sep 2024
- First submitted
- 17 May 2022
- Last updated
- 19 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
- ClinicalTrials.gov ID
- NCT05383937
- Acronym / sponsor ID
- INTENS-DYS / 2022/692
- Conditions
- Dyslexia, Speech Therapy, Children, Only
- Keywords
- Dyslexia, Speech Therapy, Children, Intensive rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement diffculties
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 20 May 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 characterized by difficulties with accurate and/or fluent word recognition and by poor spelling and decoding abilities. In France, dyslexia is a public health disorder. Dyslexia is a real public health problem in France, affecting 6% of the general population. However, no clinical trial of a standardized rehabilitation has shown an impact on reading fluency. In the era of intensive rehabilitation, a new protocol based on the current data from the medical literature has been designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive arm | Experimental | Other: Speech Therapy INTENS-DYSThe children included in this arm will receive two weeks of daily care during which two daily speech therapy sessions of one hour each will be performed. This will be done between M2 and M4 of inclusion in order to avoid potential measurement bias. These sessions will be carried out by a state-qualified speech therapist employed at the CRRF of Bregille. They will guide the intensive rehabilitation of dyslexic children by focusing the exercises on their main difficulties. |
| classic arm or gold standard | Active comparator | Other: Speech Therapy INTENS-DYSThe speech therapy session will be provided only by private practitioners, with a weekly consultation of 30 minutes. The private speech therapist who initially referred the patient for inclusion in the research protocol will be responsible for his or her "classic" rehabilitation. The therapy will continue during the 6 months of research. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children from 8 to 12 years old,
- Living in and around 50 kilometers from Besançon.
- Diagnosis of dyslexia according to the DSM-V or CIM-10 requirements.
- Consent form signed by the parental authority and the child,
- Affiliation to a social security system.
Key exclusion criteria (7 listed)
- Mother's medical history of pregnancy or delivery complications,
- Patients's medical history of neurological infectious, vascular or tumoral events,
- Patient's medical history of intellectual deficiency,
- Patients's medical history of visual or hearing disorders,
- Patient's medical history of psychiatric disorders (especially diagnosis of Attention Deficit / Hyperactivity Disorders (AD/HD)),
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 |
|---|---|---|
| Speech Therapy INTENS-DYSDuring the six research month, children included in the intensive arm will benefit of two daily hours speech therapy during two weeks. Those one will be carried out between the second and the fourth month. | Other | classic arm or gold standard, intensive arm |
Primary outcome
Reading fluency to the Alouette test.
Time frame: Six month.
Difference in the number of words read correctly in three minutes in the intensive and the conventional arm.
6 secondary outcomes
Phonological processing tests.
Time frame: Six month.
Visual pattern.
Time frame: Six month.
Life Quality.
Time frame: 6 month.
Rehabilitation adhesion.
Time frame: 6 month
Speech langage rehabilitation cost.
Time frame: 6 month.
Family and school evaluation.
Time frame: 6 month.
Results and safety
The study was stopped early (reason given: recruitement diffculties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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
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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.
Julien BEVALOT principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Therapy INTENS-DYS in people with Dyslexia and Speech Therapy, run by Centre Hospitalier Universitaire de Besancon 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 7 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: stopped early, as of the sponsor's last update on 19 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 was stopped early (reason given: recruitement diffculties). Results are not available in the source record.
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 fluency to the Alouette test. (time frame: Six month.). 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 19 Sep 2024.