Clinical trial NCT06902610: 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
Official title: 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 Reduced Conventional Care 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 That Received Conventional Standard Care (POPPINS-02-b, Ancillary Study to POPPINS-02)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Learning Disorder, Specific
Learning Disability
Specific Learning Disorder, With Impairment in Reading
Dyslexia
Lead sponsor: Poppins
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2025-03-30
Enrollment: 302
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).
timeFrame: 12 weeks
measure: Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).
timeFrame: 12 weeks
measure: Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).
timeFrame: 12 weeks
measure: Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).
timeFrame: 12 weeks
measure: 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).
timeFrame: 12 weeks
measure: Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Poitiers
country: France
facility: Hôpital Henri Laborit
Study officials:
References: