An observational study in Learning Disorder, Specific, Learning Disability and Specific Learning Disorder, With Impairment in Reading, sponsored by Poppins. Completed at 2 sites in France. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Poppins · Observational
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.
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:
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.
127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.
This study's enrollment of 306 is above the median of 90 across 20 observational studies indexed under Dyslexia.
Browse Dyslexia studies →Poppins is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Dyslexia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Specific Learning Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical
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.
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
Time frame: 12 weeks
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.
Time frame: 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.
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).
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
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Ran from Jun 2025 to primary completion in Apr 2026, 9 months.
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