Multicentric Randomized Non-inferiority Study Examining the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Addition to Reduced Conventional Standard of Care 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 Conventional Standard of Care.
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 reduced conventional standard of care 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.
Single Arm Study Assessing the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Pediatric Participants with a Specific Learning Disability with Deficits in Reading
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.
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