Rhythm training improves word-reading in children with dyslexia.

Specific learning disorder with reading deficit (SLD-reading), or dyslexia, is one of the most common neurodevelopmental disorders. Intensive training with reading specialists is recommended, but delayed access to care is common. In this study, we tested an innovative user-friendly and accessible intervention, the medical device Mila-Learn, which is a video game based on cognitive and rhythmic training to improve phonological and reading ability. This randomized placebo-controlled trial (ClinicalTrials.gov NCT05154721) included children aged 7 to 11 y/o with SLD-reading. The children were in 2nd to 5th grade and had been in school for more than 3 years. The exclusion criteria were reading or writing remediation during the past 12 months, previous use of Mila-Learn, and severe chronic illness. The patients, who were all native French speakers, were recruited from throughout France and were randomly assigned to Mila-Learn or a matched-placebo game for an 8-week training. The primary variable was nonword decoding. The secondary variables included phonological skills, 2-min word-reading accuracy and speed, grapheme-to-phoneme conversion skills, and self-esteem. Between September 2021 and April 2023, 151 children were assigned to Mila-Learn (n = 75; male = 36; female = 39) or the placebo (n = 76; male = 42; female = 34). We registered 39 adverse events; only one was due to the protocol and was in the placebo group. We found no differences between the groups in nonword decoding in the intention-to-treat (N = 151; p = 0.39) or per-protocol analysis (N = 93; p = 0.21). However, the per-protocol analysis revealed the superiority of Mila-Learn over the placebo by 5.05 score points (95% CI 0.21; 10.3, p < 0.05) for 2-minute word-reading accuracy and by 5.44 score points (95% CI 0.57; 10.99, p < 0.05) for 2-min word-reading speed. We found no other significant effects. Mila-Learn is safe for children with SLD-reading who might benefit from this medical device.Study registration: ClinicalTrials.gov NCT05154721-13/12/2021.