Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic … (NCT05383937) | Clinical Trial Compass
TerminatedNot Applicable
Comparative Impact of Protocolized Management, Intensive Rehabilitation Versus Long-term Classic Rehabilitation of Dyslexic Children.
Stopped: recruitement diffculties
France3 participantsStarted 2022-10-10
Plain-language 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. 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.
Who can participate
Age range
8 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reading fluency to the Alouette test.
Timeframe: Six month.
Trial details
NCT IDNCT05383937
SponsorCentre Hospitalier Universitaire de Besancon