An interventional study of Poppins Clinical 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 2026-02-05.
Sponsored by Poppins · Not applicable, Interventional, and Treatment
Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing skills of pediatric participants with a specific learning disability with reading and/or written expression deficit.
Participants will be assigned randomly either to an experimental group that will use the medical device in combination with reduced speech and reading therapy sessions (1 session each 2 weeks) or to the control group receiving conventional standard of care, i.e. 1 speech and reading therapy sessions per week.
The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills.
Poppins Clinical is a software as a medical device (saMD) that combines a musical and cognitive training program and a written language training program. It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders (SLD) with reading deficit. Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game.
The POPPINS-02 study thus proposes to include two patient arms:
A randomization list will be generated, directing patients to the experimental or control arm, and informing parents, the patient, and the speech and reading therapist after the first pre-test. The investigator and his team will be blinded to the patient allocation group. It is therefore a single-blind study since parents, patients, and speech and reading therapists will be aware of the randomization.
In the experimental group, patients will have access to training with Poppins Clinical for 5 sessions per week, each session lasting approximately 20 minutes.
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 71 across 106 interventional 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 →
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 cognitive training program and written language training program.
Evaluate the 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 EVALEO 2-minute word reading test (EVAL2M) and measuring the number of correctly read words.
Time frame: 12 weeks
Secondary safety objective
any adverse events will be collected from participants. Evaluation of adverse events reported by participants
Time frame: 12 weeks
Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of read words.
Time frame: 12 weeks
Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)
This endpoint evaluates the 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).
Time frame: 12 weeks
Secondary objective 3: description and evaluation of the coast associated to children's treatment
This endpoint evaluates the coasts related to the medical care between the two groups, based on the number of treatment sessions, cost per session, cost of the medical device and travel cost, using a custom-made questionnaire
Time frame: 12 weeks
Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)
This endpoint examines the impact of adding Poppins Clinical on parents' stress levels, measured using the parenting stress index short form
Time frame: 12 weeks
Secondary objective 5: Description and comparison of the effect of adding Poppins Clinical on the parents' quality of life between the two groups (EXPE/CONT) (non-inferiority)
This endpoint examines the impact of adding Poppins Clinical on parents' quality of life, measured using the EQ-5D-5L quality of life questionnaire
Time frame: 12 weeks
Secondary outcome 6: evaluate the effect of adding Poppins Clinical on meta-phonological skills between the two groups (EXPE/CONT) (non-inferiority)
This endpoint evaluates the effect of adding Poppins Clinical on meta-phonological skills as assessed by the BALE phoneme suppression test (correct answers score)
Time frame: 12 weeks
Secondary objective 7: Evaluate the effect of adding Poppins Clinical on text comprehension (non-inferiority)
This endpoint evaluates at the effect of adding Poppins Clinical on text comprehension assessed using the computerized adaptable test battery (BMT-i)
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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