Assessing the Noninferiority of a Rhythm and Language Training Serious Game Combined With Speech Therapy Versus Speech Therapy Care for Children With Dyslexia: Protocol for an Investigator-Blinded Randomized Controlled Trial.

Background: Specific learning disorder (SLD) of reading skills impacts approximately 7% of children. Speech and reading therapy is currently the gold-standard intervention for improving children's reading abilities. However, intensive interventions are difficult to implement. Recently, numerous studies have investigated the interest of game- and home-based training approaches to enhance children's motivation and facilitate intensive learning activities in home settings. The serious game Poppins Clinical integrates rhythm and specific written language exercises to improve reading skills in children with SLD.

Objective: This study aimed to assess the noninferiority of Poppins Clinical combined with a reading specialist session once every 2 weeks versus a reading specialist session every week, on the reading skills of children with SLD.

Methods: A total of 306 children with dyslexia will be recruited for this study and randomly assigned to either the experimental or control group. Children in the experimental group will use the serious game Poppins Clinical at home for 20 minutes, 5 days a week, and attend 1 reading therapy session every 2 weeks. The control group will participate in one reading therapy session per week. Poppins Clinical combines rhythm and language exercises integrated into an engaging game designed to maintain user motivation. We will use a noninferiority paradigm to assess the clinical impact of both interventions in terms of reading accuracy, reading speed, and reading comprehension. We will also investigate the evolution of phonological and visual-attentional skills. However, we will explore the impact of the protocol on parental stress and children's perception of their difficulties. Finally, we will also assess the cost of medical care and the impact of introducing the serious game Poppins Clinical on reading therapy. To facilitate recruitment and ensure the representativeness of our sample, the evaluation of the children will be conducted via videoconference using standardized tests that have been adapted for videoconference administration.

Results: Patient recruitment is expected to start in December 2024, with study completion by the end of August 2025.

Conclusions: This study should allow us to assess the interest in using the serious game Poppins Clinical in addition to reading therapy to improve reading abilities in children with SLD.

Trial Registration: ClinicalTrials.gov NCT06592911; https://clinicaltrials.gov/study/NCT06592911.

International Registered Report Identifier (irrid): DERR1-10.2196/71326.