The Feasibility of a Smartphone-based Digital Therapeutics for Dysarthria after Stroke (DiDaS): Protocol for a pilot randomized controlled trial

Background Dysarthria is a motor speech disorder occurring from neurological conditions such as stroke. It leads to serious problems in the intelligibility of patients’ speech, affecting their ability to communicate, quality of life, and emotional well-being. While digital therapeutic approaches for rehabilitation of dysarthria are increasing, clinical evidence of the effectiveness of digital therapeutics has been lacking. A mobile application, D-ST01, has the potential to enhance intensive and repetitive speech rehabilitation due to its high treatment accessibility and its incorporation of gamification, tailored feedback, and interactive functions. Methods In our trial, 60 stroke patients with dysarthria within 30 days following the occurrence of stroke will be recruited. In a 1:1 ratio, participants will be randomly assigned to either the intervention group (using D-ST01 for 60 minutes/day, five days/week along with usual stroke care) or the control group (usual stroke care only). This will be a single-blind study in which researchers will evaluate outcome measurements while masked to treatment allocation. After four weeks of treatment intervention, we will compare speech and psychological changes between the two groups. Conclusions Our study will evaluate the feasibility of the speech treatment application D-ST01 for patients with post-stroke dysarthria. In addition, it will collect evidence for investigating the future efficacy of a large-scale randomized controlled trial. Trial registration number [ClinicalTrial.gov][1] #[NCT05146765][2] ### Competing Interest Statement JK is a founder of HAII Corp, the makers of D-ST01. Other authors have declared that no competing interests exist. ### Clinical Trial NCT05146765 ### Clinical Protocols ### Funding Statement This work was supported by the Technology Development Program (S3301230) funded by the Ministry of SMEs and Startups (MSS, Korea). https://www.mss.go.kr/site/eng/main.do The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Ewha Womans University Seoul Hospital Institutional Review Board (SEUMC 2021-12-011). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Not Applicable Data cannot be shared publicly because of confidentiality. Data are available from the Institutional Data Access or Ethics Committee of Ewha Womans University Seoul Hospital (contact via knstar@ewha.ac.kr) for researchers who meet the criteria for access to confidential data. [1]: http://ClinicalTrial.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05146765&atom=%2Fmedrxiv%2Fearly%2F2022%2F08%2F17%2F2022.08.16.22278857.atom