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