Efficacy of Digital Speech Therapy for Poststroke Dysarthria: Randomized Noninferiority Trial.

Background: Poststroke dysarthria, a common speech impairment, affects up to half of all stroke survivors, often reducing their ability to communicate, and adversely affecting their quality of life. Although conventional speech therapy for poststroke dysarthria is effective, access is often limited by time and geographical constraints. Here, digital speech therapy may serve as a remotely deliverable alternative for selected patients. However, few trials have assessed its efficacy, safety, and usability. Objective: This study aimed to evaluate whether a smartphone-based speech therapy app is noninferior to conventional workbook-based therapy in improving speech intelligibility among individuals with poststroke dysarthria. Methods: This single-blind, randomized controlled, noninferiority trial was performed at 3 hospitals in South Korea. Adults (≥19 y) with poststroke dysarthria who were cognitively intact, without aphasia, and able to use a smartphone were eligible. Participants were enrolled between July 20, 2023, and April 15, 2024. Participants were randomly assigned (1:1), stratified by stroke phase, using a block randomization method, to receive either a smartphone-based digital therapy app or a conventional workbook-based therapy for 4 weeks. The primary outcome was speech intelligibility (0-100 perceptual rating) after the intervention. Primary analysis was intention-to-treat using analysis of covariance. A noninferiority margin of 19 points was pre-defined. Results: A total of 73 participants were enrolled (median age 62.00 years). Among them, 38 were assigned to the digital speech therapy group and 35 to the control group. Intelligibility scores improved from 80.48 (SD 18.92) to 92.08 (SD 12.38) in the intervention group, and from 80.94 (SD 16.74) to 88.11 (SD 18.06) in the control group. The adjusted between-group difference was 4.49 (95% CI 0.61-8.37), and the lower bound of the 95% CI was above the prespecified noninferiority margin (-19), which supported noninferiority. No significant between-group differences were observed in the secondary outcomes related to speech function or psychological status. The system usability score was 89.6, and adherence in the digital speech therapy group was 64.6% based on app logs, with no treatment-related adverse events. Conclusions: Digital speech therapy was noninferior to conventional workbook-based therapy in improving speech intelligibility and was feasible across acute to early subacute and chronic stroke phases in cognitively intact stroke survivors with predominantly mild-to-moderate dysarthria. However, feasibility and efficacy in older stroke survivors with cognitive deficits or co-occurring aphasia, or in those unable to use smartphones, remain to be established.