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 (POPPINS-02-B)

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-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.

Study Overview

• Status: Recruiting
• Conditions: Dyslexia; Learning Disability; Learning Disorder, Specific; Specific Learning Disorder, With Impairment in Reading
• Intervention / Treatment: Device: Poppins Clinical

Detailed Description

The POPPINS-02-b follow-up study consists in following up patients who took part in the POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group designed to assess the effect of adding the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions on the skills of patients with reading disorders. Patients included in the original POPPINS-02 study were randomized into one of two groups:

1. Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions.
2. Control group (CONT group): will receive weekly speech and reading therapy sessions.

In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a preliminary evaluation (T1) and a final evaluation (T2) after this period.

All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will return to their usual speech therapy management with the frequency planned before their participation in POPPINS-02. During this follow-up phase, patients in both groups will not have access to the Poppins Clinical application. At the end of the 12-week follow-up period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and exploratory endpoints.

A questionnaire will also be submitted to parents and speech therapists caring for the children during T3 in order to collect information on the dates of speech therapy sessions during this follow-up period, and to benefit from their perspective on the medium-term effect of the study protocol on speech therapy follow-up.

Access to the Poppins Clinical digital medical device will be offered to children in the two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study at the end of the experiment.

The investigator and his team will remain blind as to which groups will be assigned to the POPPINS-02 study.

• Study Type: Observational
• Enrollment (Estimated): 306

Contacts and Locations

• Study Contact: Name: Mélanie Descamps; Email: melanie@poppins.io
• Study Contact Backup: Name: François Vonthron; Phone Number: +33 0669515961; Email: francois@poppins.io

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital Pitié-Salpétrière
    • Contact: David Cohen; Phone Number: 0142162351; Email: david.cohen@aphp.fr
  • Poitiers, France, 86000
    • Recruiting
    • Hôpital Henri Laborit
    • Contact: Jean Xavier; Phone Number: 0549445759; Email: jean.xavier@ch-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

According to the DSM-5-TR or ICD-11 Specific Learning Disability (SLD) or Developmental Learning Disability (DLD) is one of the most common neurodevelopmental disorders. It affects between 5% and 15% of schoolchildren. In particular, SLD is one of the most common neurodevelopmental disorders. It affects between 6% and 8% of schoolchildren. It is characterized by significant and persistent difficulties in the acquisition of academic skills, which may include reading, writing or arithmetic, although dyslexia is by far the most common type, accounting for 80% of SLD. SLD first manifests itself during the teaching of academic or occupational functioning. Children with SLD do not have associated intellectual retardation, overt brain damage or degenerative disorders. They are therefore likely to benefit most from remediation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No intervention: CONTROL; 1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical
Experimental; Reduced speech and reading therapy sessions (1 session every 2 weeks) and use of the medical device Poppins Clinical	Device: Poppins 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the medium term non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy	This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the 2-minutes word reading rest form EVALEO (EVAL2M), assessing the number of words correctly read, 12 weeks after the last evaluation of the POPPINS-02 study	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).	This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the 2-minute word reading test from EVALEO (EVAL2M), assessing the number of words read, 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).	This endpoint evaluates the mid-term effect of the addition of Poppins Clinical on word reading skills in terms of speed and accuracy as assessed by a text reading test (Alouette) (speed and accuracy scores), 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).	This endpoint evaluates the mid-term effect of adding Poppins Clinical on meta-phonological skills as assessed by the BALE phoneme suppression test (correct answers score), 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks
Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).	This endpoint examines the mid-term impact of adding Poppins Clinical on parents' stress levels, measured using the parenting stress index short form, 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks
Description and comparison of the medium-term effect of adding Poppins Clinical on the quality of life of parents between the two groups (EXP/CONT) (non-inferiority).	This endpoint examines the mid-term impact of adding Poppins Clinical on parents' quality of life, measured using the EQ-5D-5L quality of life questionnaire, 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority).	This endpoint evaluates at the mid-term effect of adding Poppins Clinical on text comprehension assessed using the computerized adaptable test battery (BMT-i) (evaluated scores: correct answers to text comprehension questions score, reading precision and speed), 12 weeks after the last evaluation of the POPPINS-02 study.	12 weeks

Collaborators and Investigators

• Sponsor: Poppins
• Collaborators: Lindus Health

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Language Disorders; Specific Learning Disorder; Learning Disabilities; Dyslexia
• Other Study ID Numbers: POPPINS-02-b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No