NCT06592911

Examining the Effect of a Digital MD for Cognitive and Musical Training + Reduced Conventional SOC on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit vs a Control Group Receiving Conventional SOC.

Multicentric Randomized Non-inferiority Study Examining the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit Compared With a Control Group Receiving Weekly Speech and Reading Therapy Sessions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Poppins · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing skills of pediatric participants with a specific learning disability with reading and/or written expression deficit. Participants will be assigned randomly either to an experimental group that will use the medical device in combination with reduced speech and reading therapy sessions (1 session each 2 weeks) or to the control group receiving conventional standard of care, i.e. 1 speech and reading therapy sessions per week.

Detailed description

The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills. Poppins Clinical is a software as a medical device (saMD) that combines a musical and cognitive training program and a written language training program. It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders (SLD) with reading deficit. Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game. The POPPINS-02 study thus proposes to include two patient arms: * The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy (1 session each 2 weeks), * The control arm having only conventional speech and reading therapy (1 session per week) during 12 weeks. A randomization list will be generated, directing patients to the experimental or control arm, and informing parents, the patient, and the speech and reading therapist after the first pre-test. The investigator and his team will be blinded to the patient allocation group. It is therefore a single-blind study since parents, patients, and speech and reading therapists will be aware of the randomization. In the experimental group, patients will have access to training with Poppins Clinical for 5 sessions per week, each session lasting approximately 20 minutes.

Conditions

• Learning Disorder, Specific
• Learning Disability
• Specific Learning Disorder, With Impairment in Reading
• Dyslexia

Interventions

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

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2024-09-19
• Last updated: 2026-02-05

Locations

2 sites across 1 country: France