Follow-up Study on the Medium-term Effects of Poppins Clinical Device and Speech Therapy on Reading and Writing Skills in Children With Specific Learning Disorders Aged 7 to 11

What this Trial Is About

Researchers are examining the medium-term effects of a previous training involving the Poppins Clinical digital medical device alongside bi-monthly speech and reading therapy sessions for children aged 7 to 11 with specific learning disorders affecting reading andor writing. This observational follow-up study compares these results to a control group that received weekly speech and reading therapy sessions. The study aims to assess whether the digital medical device combined with less frequent therapy is not inferior to the traditional weekly therapy approach. Participants were originally part of the POPPINS-02 clinical trial where they were randomized into two groups one received the Poppins Clinical device plus bi-monthly therapy, and the other received weekly therapy without the device. The original treatment phase lasted 12 weeks with evaluations before and after. In this follow-up, lasting an additional 12 weeks, all patients return to their usual speech therapy schedule as before the original study, without access to the Poppins Clinical device. During the follow-up phase, participants will be assessed at the end of 12 weeks to evaluate reading, writing, metaphonological skills, text comprehension, and parental stress and quality of life. Questionnaires will be given to parents and speech therapists to gather information on therapy sessions and perspectives on the lasting effects of the initial training. Access to the Poppins Clinical device will be offered after the study to interested participants. The research team remains unaware of the participants original group assignments during this follow-up.

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