Actively Recruiting
Observational Follow-up Study on Medium-term Effects of Poppins Clinical Device and Speech Therapy in Pediatric Specific Learning Disorders Involving Reading and Writing
Led by Poppins · Updated on 2025-07-02
306
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Poppins
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
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 and/or 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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who has been enrolled in the POPPINS-02 study
- Participation agreement from the patient and legal guardians
- Commitment to follow the study protocol
You will not qualify if you...
- Any medical condition that may prevent participation, as decided by the investigator
- Participation in another interventional study that could affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 12 weeks
Participants who completed the initial POPPINS-02 study are followed for 12 weeks while returning to their usual speech therapy management without access to the Poppins Clinical device. Assessments will be conducted at the end of this period.
1 follow-up visit at the end of 12 weeks
Trial Site Locations
Total: 2 locations
1
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
2
Hôpital Henri Laborit
Poitiers, France, 86000
Actively Recruiting
Research Team
F
François Vonthron
M
Mélanie Descamps
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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