Effects of Kaiyin Xuanfei Manipulation Treatment on Patients with Dysarthria after Stroke: Study Protocol for a Randomized Controlled Trial

Abstract

Background Dysarthria is one of the most common stroke complications. It seriously affects the patient’s ability to communicate with one another and their overall recovery. The priority therapeutic methods in treating dysarthria after stroke (DAS) are speech training, physical therapy, and traditional Chinese rehabilitation, but the overall outcomes are not optimal. This study combines proprioceptive neuromuscular facilitation (PNF) and traditional chinese medicine (TCM) theory to design a kaiyin xuanfei manipulation (KYXF), which may improve the physiological function of vocal organs and improve speech intelligibility. However, there is still a lack of high-quality, large-sample clinical studies. The objective of this study is to conduct a randomized controlled trial to evaluate KYXF's efficacy in the treatment of DAS. Methods Patients (N = 60) who meet the trial's inclusion criteria will be randomly divided into 2 groups in this prospective, single-blind, randomized controlled trial: speech training and speech training plus KYXF, with each group consisting of 30 patients. Both groups will undergo routine medical therapy, rehabilitation, and speech training. For 8 weeks, all treatments will be delivered 5 times per week. The Frenchay functional score will be used to evaluate all outcomes at baseline, week 4, week 8, and follow-up. Discussion This study will be the first prospective randomized controlled trial to evaluate the safety and preliminary efficacy of KYXF in patients with DAS. Furthermore, this trial is also expected to standardize and expand the clinical treatment of DAS using a combination of traditional chinese and western medicine. Trial Registration Chinese Clinical Trial Registry, identifier: ChiCTR2100050343. Registered on 26 August 2021.