Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities

Last updated: March 17, 2025
Sponsor: Poppins
Overall Status: Completed

Phase

N/A

Condition

Williams Syndrome

Dyslexia

Learning Disorders

Treatment

Poppins Clinical

Clinical Study ID

NCT06596980
POPPINS-CE
2024-A00432-45
  • Ages 7-11
  • All Genders

Study 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 specific learning disability with reading deficit. The main objective of the study is to assess the evolution in reading skills through a word reading task before and after the intervention.

Participants will be asked to train with the digital medical device Poppins Clinical 5 times per week for 8 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of SLD with reading deficit, based on a speech-language assessment. SLDwith reading deficit is defined in the Diagnostic and Statistical Manual of MentalDisorders (DSM-5-TR, 2022) and the International Classification of Diseases (ICD-11, 2022). The speech-language assessment should consist of at least three readingand/or transcription tests with a SD (standard deviation) of at least - 1.4 or aresult below the 20th percentile or two reading and/or transcription tests with a SDof 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 schoolingin 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 tofollow the protocol.

Exclusion

Exclusion Criteria:

  • 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 affectresults.

Study Design

Total Participants: 38
Treatment Group(s): 1
Primary Treatment: Poppins Clinical
Phase:
Study Start date:
June 28, 2024
Estimated Completion Date:
February 11, 2025

Connect with a study center

  • Hôpital Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

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