Status:
COMPLETED
Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities
Lead Sponsor:
Poppins
Conditions:
Learning Disorders, Specific
Learning Disabilities
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to assess the effect on reading skills of the digital medical device Poppins Clinical for cognitive and musical training in pediatric participants (ages 7-11) with a...
Eligibility Criteria
Inclusion
- Diagnosis of SLD with reading deficit, based on a speech-language assessment. SLD with reading deficit is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, 2022) and the International Classification of Diseases (ICD-11, 2022). The speech-language assessment should consist of at least three reading and/or transcription tests with a SD (standard deviation) of at least - 1.4 or a result below the 20th percentile or two reading and/or transcription tests with a SD of at least - 2 SD or a results below the 10th percentile;
- Subject aged between 7 and 11, enrolled from CE1 to CM2;
- French mother tongue or French bilingualism at home and more than 3 years schooling in France;
- Tablet or smartphone available at home;
- Subject affiliated to the French National Insurance (Securite Sociale)
- Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.
Exclusion
- Subject has previously used Poppins Clinical or Mila-Learn;
- Uncontrolled chronic illness (at investigator's discretion);
- Previous epileptic seizures;
- Participant actively participating in an interventional study that may affect results.
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06596980
Start Date
June 28 2024
End Date
February 11 2025
Last Update
March 18 2025
Active Locations (1)
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1
Hôpital Pitié-Salpêtrière
Paris, France, 75013