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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Poppins Clinical.
- Who it may be relevant to
- Registry conditions: Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia. Basic parameters: 7 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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 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)
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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 [Time frame: 12 weeks]
Secondary outcome measures (6)
- Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority). [Time frame: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority). [Time frame: 12 weeks]
- Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority). [Time frame: 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). [Time frame: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority). [Time frame: 12 weeks]
- Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority). [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 2 centers
- Hôpital Pitié-Salpêtrière — Paris
- Hôpital Henri Laborit — Poitiers
Identifiers
NCT: NCT06902610 · POPPINS-02-b