Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities (POPPINS-CE)

Poppins

Status

Completed

Conditions

Learning Disabilities

Learning Disorders, Specific

Specific Learning Disorder, With Impairment in Reading

Dyslexia

Treatments

Device: Poppins Clinical

Study type

Interventional

Funder types

Industry

Identifiers

NCT06596980

POPPINS-CE

2024-A00432-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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.