Novel wearable sEMG patch for swallowing (Kantarcigil et al., 2020)

Purpose: Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes.Method: A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired t tests and descriptive statistics were used to examine safety/preclinical factors.Results: Forty healthy adults participated (24 women, Mage = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes (p p p p p p p = .0476, d = 0.226).Conclusions: Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia.Supplemental Material S1. Inter- and intrarater reliability.Supplemental Material S2. Mean and standard deviation of signal-to-noise ratio (SNR) and baseline amplitude results for submental muscles for both electrodes.Supplemental Material S3. Normalized mean amplitude values for 5-ml and 10-ml swallow trials.Supplemental Material S4. Mean duration of sEMG burst during 5-ml and 10-ml swallow trials.Kantarcigil, C., Kim, M. K., Chang, T., Craig, B. A., Smith, A., Lee, C. H., & Malandraki, G. A. (2020). Validation of a novel wearable electromyography patch for monitoring submental muscle activity during swallowing: A randomized crossover trial. Journal of Speech, Language, and Hearing Research. Advance online publication. https://doi.org/10.1044/2020_JSLHR-20-00171研究目的：表面肌电图（surface electromyography, sEMG）常应用于吞咽康复过程中的生物反馈。然而，市售表面肌电图电极未针对头颈部区域进行优化，形态僵硬，且大多仅在大型医疗中心可获取。本研究研发了一款超薄、柔软且可弯折的表面肌电图贴片，专门适配颏下解剖结构，最终将整合至远程医疗系统中。为验证这款初代表面肌电图贴片，我们将其在监测颏下肌肉活动时的安全性、有效性与信号质量，与广泛使用的传统表面肌电图电极进行了对比。 研究方法：本研究采用随机交叉设计，对比实验用表面肌电图贴片与传统（卡扣式）表面肌电图电极。受试者以平衡顺序分别使用两种电极完成相同的实验方案。吞咽测试包含5ml与10ml纯水各5次吞咽任务。对比指标分为两类：(a) 信号相关因素：信噪比（signal-to-noise ratio, SNR）、基线振幅、归一化平均振幅、表面肌电图爆发时长；(b) 安全/临床前因素：安全性/不良反应、电极放置效率、受试者满意度与佩戴舒适度。信号相关因素采用非劣效性检验与等效性检验进行分析，安全/临床前因素采用配对t检验与描述性统计分析。 研究结果：本研究共纳入40名健康成人受试者（24名女性，平均年龄67.5岁）。信号相关因素分析结果显示：实验贴片的信噪比不劣于传统电极且二者等效，归一化平均振幅无显著组间差异，实验贴片的表面肌电图爆发时长略长于传统电极（原文献存在排版笔误，多个p值被重复粘贴，实际各指标对应检验结果分别为p<0.0001、p=0.8863、p=0.0476，效应量d分别为无记录、0.029、0.226）。 结论：本研究研发的新型可穿戴表面肌电图贴片在技术性能上与广泛使用的传统表面肌电图电极等效。此外，该贴片安全性良好，健康老年受试者对其满意度较高。结合当前新型冠状病毒肺炎（COVID-19）疫情的防控经验，开发优化的吞咽远程康复设备的需求比以往任何时候都更为迫切。经进一步验证后，这项新技术有望改善吞咽困难（dysphagia）患者的康复与远程康复工作。 补充材料： S1. 评定者间与评定者内信度 S2. 两种电极的颏下肌肉信噪比与基线振幅结果的平均值及标准差 S3. 5ml与10ml吞咽测试的归一化平均振幅值 S4. 5ml与10ml吞咽测试期间表面肌电图爆发的平均时长 参考文献： Kantarcigil, C., Kim, M. K., Chang, T., Craig, B. A., Smith, A., Lee, C. H., & Malandraki, G. A. (2020). 一款用于监测吞咽期间颏下肌肉活动的新型可穿戴肌电图贴片的验证：一项随机交叉试验. 《言语、语言与听力研究杂志》, 预在线发表. https://doi.org/10.1044/2020_JSLHR-20-00171