Evaluating the effects of cognitive and musical training on reading and writing in children with learning disorders
Observational Follow-up Study Examining the Medium-term Effect on Non-inferiority of the Previous Training With the Digital Medical Device (DMD) Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Abilities of Pediatric Patients With Specific Learning Disorders Involving Reading and/or Writing Deficits (SLD Reading) Compared to a Control Group Receiving Weekly Speech and Reading Therapy Sessions (POPPINS-02-b, Ancillary Study to POPPINS-02)
Poppins · NCT06902610
This study is testing whether combining cognitive and musical training can improve reading and writing skills in children with learning disorders compared to just regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 306 (estimated) |
| Ages | 7 Years to 11 Years |
| Sex | All |
| Sponsor | Poppins (industry) |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06902610 on ClinicalTrials.gov |
What this trial studies
This observational follow-up study examines the medium-term effects of cognitive and musical training using the Poppins Clinical digital medical device on the reading and writing abilities of pediatric patients with specific learning disorders. It compares outcomes between patients who received this training alongside reduced conventional care and those who received only standard care. The study involves monitoring patients who participated in a previous trial, with evaluations conducted at the start, end, and after a follow-up period. The aim is to assess the non-inferiority of the new approach compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients who have previously participated in the Poppins-02 study and have specific learning disorders affecting reading and/or writing.
Not a fit: Patients with other pathologies that may interfere with participation or those involved in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance reading and writing skills in children with learning disorders, providing a novel therapeutic option.
How similar studies have performed: Other studies have shown promise in using digital medical devices for cognitive training, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria: * Patient who has been enrolled in the POPPINS-02 study. * Participation agreement from the patient as well as from the legal guardians, and commitment to follow the protocol. Exclusion Criteria: * Any pathology that, at the discretion of the investigator, may prevent the patient from participating in the study. * Patient participating in an interventional study that could affect the results.
Where this trial is running
Paris and 1 other locations
- Hôpital Pitié-Salpêtrière — Paris, France (RECRUITING)
- Hôpital Henri Laborit — Poitiers, France (RECRUITING)
Study contacts
- Study coordinator: François Vonthron
- Email: francois@poppins.io
- Phone: 0669515961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia