Abstract
BACKGROUND: Specific learning disorder in reading (SLD reading), commonly named dyslexia, is a neurodevelopmental condition affecting reading. Current best practice recommendations for SLD reading emphasize the necessity of including graphophonological interventions. The serious game Mila-Learn, which is based on rhythm training, showed promising results in a prior randomized trial. However, it lacked a component of graphophonological training. OBJECTIVE: This study aimed to evaluate the effectiveness of Poppins, a new digital medical device that combines rhythm-based and graphophonological training for improving reading and phonological skills in children with SLD reading. We also explored its performance against Mila-Learn, the earlier version based on rhythm training only. METHODS: A single-arm study without an active control group was conducted with 38 children (aged 7-11 years) diagnosed with SLD reading. The participants completed an 8-week training program with Poppins (five 20-minute sessions per week). Pre- and posttraining assessments measured reading accuracy and speed, phoneme deletion, and phonological discrimination. Statistical analysis included pre- and postcomparisons (primary analysis) and comparisons with children's improvement from a previous randomized controlled trial of Mila-Learn, an earlier version of the device (exploratory analysis). RESULTS: The participants demonstrated significant improvements in reading accuracy (+11.46 words correctly read; P<.001), reading speed (+10.26 words read; P<.001), and phoneme deletion (+2.87 points; P<.001). No significant change was observed in reading comprehension for younger participants (grades 2-3; P=.09), although improvements were noted in older children (grades 4-5, P=.03). Exploratory analysis comparing children's improvements with Mila-Learn and Poppins revealed similar gains in reading accuracy and speed but revealed superior improvement in phonological skills for the Poppins group, with a moderate effect size according to the benchmarks by Cohen (Cohen d=0.48, P=.02). CONCLUSIONS: Poppins is an effective and safe tool for enhancing reading and phonological skills in children with SLD reading. By integrating rhythm-based and graphophonological exercises, the device aligns with best practice recommendations for curative intervention. Future research should explore its long-term effects and medicoeconomic impact and compare outcomes with those of conventional therapy, as serious games provide an engaging, scalable method for delivering such interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT06596980; https://clinicaltrials.gov/study/NCT06596980.