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

NCT ID: NCT06596980

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2025-02-11

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 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.

Conditions

Learning Disorders, Specific; Learning Disabilities; Specific Learning Disorder, With Impairment in Reading; Dyslexia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional arm

Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions)

Group Type: EXPERIMENTAL

Poppins Clinical

Intervention Type: DEVICE

Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.

Interventions

Poppins Clinical

Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 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 affect results.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poppins

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Cohen

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié-Salpêtrière, Paris, France

Locations

Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

References

Grossard C, Descamps M, Pellerin H, Vonthron F, Cohen D. Children's Improvement After Language and Rhythm Training With the Digital Medical Device Poppins for Dyslexia: Single-Arm Intervention Study. JMIR Serious Games. 2025 Aug 1;13:e76435. doi: 10.2196/76435.

Reference Type: DERIVED

PMID: 40750096 (View on PubMed)

Other Identifiers

2024-A00432-45

Identifier Type: OTHER

Identifier Source: secondary_id

POPPINS-CE

Identifier Type: -

Identifier Source: org_study_id