RecruitingNCT06902610

Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Bi-monthly Speech and Reading Therapy on Reading Writing Abilities of Pediatric Patients With SLD Reading VS Control Group

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)


Sponsor

Poppins

Enrollment

306 participants

Start Date

Jun 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Poppins-02-b is an observational follow-up study examining the medium-term effect on non-inferiority of the previous training with the digital medical device (DMN) Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing abilities of pediatrics patients with specific learning disorders involving reading and/or writing deficits compared to a control group that received weekly speech and reading therapy sessions. Poppins-02-b is an ancillary study to Poppins-02 and consists of monitoring patients who participated in Poppins-02 study.


Eligibility

Min Age: 7 YearsMax Age: 11 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

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Interventions

DEVICEPoppins Clinical

Poppins Clinical is a software as a medical device that combines a musical and combines a musical and cognitive training program and written language training program.


Locations(2)

Hôpital Pitié-Salpêtrière

Paris, France

Hôpital Henri Laborit

Poitiers, France

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NCT06902610


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