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

Not Applicable

Completed

• Conditions: Learning Disorders, Specific; Learning Disabilities; Specific Learning Disorder, With Impairment in Reading; Dyslexia
• Interventions: Device: Poppins Clinical

• Registration Number: NCT06596980
• Lead Sponsor: Poppins

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Poppins Clinical	Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions)

Primary Outcome Measures

Name	Time	Method
Effect of Poppins Clinical on reading abilities (accuracy)	8 weeks	Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of reading accuracy) of participants using a word reading task and measuring the number of correctly read words.

Secondary Outcome Measures

Name	Time	Method
Reported adverse events	8 weeks	To evaluate safety, reported adverse events during the 8 weeks follow-up phase will be evaluated.
Effect of Poppins Clinical on reading abilities (speed)	8 weeks	Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of speed) of participants using a word reading task and measuring the number of read words.
Effect of Poppins Clinical on phonological skills	8 weeks	Evaluate the effect of 8 weeks of training with Poppins Clinical on phonological skills of participants using the BALE test.
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)	8 weeks	Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading accuracy) using a word reading task and measuring the number of correctly read words.
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)	8 weeks	Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading speed) using a word reading task and measuring the number of read words.

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France