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 (POPPINS-02-B)

Poppins

Status

Enrolling

Conditions

Specific Learning Disorder, With Impairment in Reading

Dyslexia

Learning Disability

Learning Disorder, Specific

Treatments

Device: Poppins Clinical

Study type

Observational

Funder types

Industry

Identifiers

NCT06902610

POPPINS-02-b

Details and patient eligibility

About

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.

Full 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:

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).
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.

Enrollment

302 estimated patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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.