Tablet-Assisted Speech and Language Therapy for Acute Post-Stroke Aphasia: A Randomized Clinical Trial (LEXI Study).

BACKGROUND: Aphasia after acute stroke is a frequent and disabling condition, impairing communication and quality of life. We investigated whether tablet-assisted Speech and Language Therapy (SLT) using the Neolexon application is superior to standard SLT in acute stroke patients. METHODS: In this prospective, open-label, randomized, controlled clinical trial, patients with acute post-stroke aphasia were recruited from one stroke center and two neurorehabilitation clinics in Germany. Participants were stratified by aphasia severity and randomized to tablet-assisted SLT (n = 53) or standard SLT (n = 51), initiated during inpatient care and continued in rehabilitation (30 min/Day). The primary outcome was the change in the Bielefelder Aphasia Screening (BIAS) percentile rank from baseline to 90 days. Secondary outcomes included frequency and duration of self-training. RESULTS: From 07/2021 to 09/2024, 4097 patients were screened and 104 randomized (mean age 74.4 ± 11.2 years; 51.9% female). No significant difference in BIAS change was found at 90 days (18 vs. 14). The trial was stopped early for futility. The intervention group engaged in self-directed training more frequently (37.7% vs. 21.6%) and trained longer (10 vs. 4 h). Subgroup analyses showed benefits of tablet-assisted SLT in patients with mild (β = 15.51; 95% CI -1.67 to 32.69) and moderate aphasia (β = 23.58; 95% CI -4.48 to 51.65), and those with a National Institutes of Health Stroke Scale of less than 5 (β = 21.69; 95% CI 5.54-37.84). CONCLUSIONS: Although underpowered to demonstrate overall superiority, tablet-assisted SLT showed potential benefits in patients with mild to moderate aphasia and less severe strokes in the acute setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04080817.