Study design and participants
dysphagia
DYSPHAGIA
This was a post-hoc analysis of a multicenter, prospective, double-blind, randomized controlled clinical trial on the clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia. The detailed trial design and study results have been published previouslyFor this post-hoc analysis, we included a subset of participants who’s initial and follow-up VFSS data could be kinematically identified and analyzed (Fig. Flowchart of this study.Patients were assigned in a 1:1 ratio to receive the 4-channel NMES or 2-channel NMES. All participants received 2- or 4-channel NMES for 2–3 weeks (minimal session: 7 times, treatment duration: 300–800 min). The interventions started within 1 week after the initial clinical and VFSS evaluations, and follow-up evaluations were performed within 1 week after the last intervention. The maximal duration between the initial and follow-up evaluations was 4 weeks. The reporting of this study conforms to all CONSORT 2010 guidelines. The study protocol was approved by the institutional review board of each hospital (IRB Nos.: E-1806/475-002, 2018-07-012, JEJUNUH 2018-07-010, J-1810-064-979, DFH19DPOS033, respectively), approved by the Ministry of Food and Drug Safety in the Republic of Korea, and registered at clinicaltrial.gov (registration number: NCT03670498, initial release: 13/09/2018, first registration date: 01/10/2018, actual study completion date: 04/08/2019, last release: 23/07/2020). Written informed consent was obtained from all participants.