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.
NCT06592911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306
Last updated 2026-02-05
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.
Conditions
- Learning Disorder, Specific
- Learning Disability
- Specific Learning Disorder, With Impairment in Reading
- Dyslexia
Interventions
- 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.
Sponsors & Collaborators
-
Lindus Health
collaborator INDUSTRY -
Poppins
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-20
- Primary Completion
- 2026-01-29
- Completion
- 2026-01-29
Countries
- France
Study Locations
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