Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Reduced Conventional Care on the Reading and Writing Abilities of Pediatric Patients With SLD Reading VS Control Group Receiving Conventional SOC

Recruiting

• Conditions: Learning Disorder, Specific; Learning Disability; Specific Learning Disorder, With Impairment in Reading; Dyslexia

• Registration Number: NCT06902610
• Lead Sponsor: Poppins

Brief 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 reduced conventional care 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 conventional standard care.

Poppins-02-b is an ancillary study to Poppins-02 and consists of monitoring patients who participated in Poppins-02 study.

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 to reduced conventional care (one speech therapy session every two weeks) 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 reduced conventional treatment (one speech therapy session every two weeks).

2. Control group (CONT group): will receive conventional treatment only (one speech therapy session per week).

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 Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Status Verified: 2025-04
• Study Start: 2025-04-15
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-04-15
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 302

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).	12 weeks	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.
Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).	12 weeks	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.
Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).	12 weeks	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.
Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).	12 weeks	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.
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).	12 weeks	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.
Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority).	12 weeks	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.

Trial Locations

Locations (2)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Henri Laborit; 🇫🇷 Poitiers, France