PurposeSurface 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.MethodA 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. Pairedttests and descriptive statistics were used to examine safety/preclinical factors.ResultsForty 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< .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes (p< .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml:p< .025; 10 ml:p< .0012), and sEMG burst duration was also equivalent (5 ml:p< .0001; 10 ml:p< .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch (p= .0476,d= 0.226).ConclusionsOur 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 Materialhttps://doi.org/10.23641/asha.12915509

中文翻译：

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用于监测吞咽过程中颏下肌肉活动的新型可穿戴肌电图贴片的验证：随机交叉试验

目的表面肌电图（sEMG）通常用于吞咽康复期间的生物反馈。然而，市售的表面肌电图电极并未针对头部和颈部区域进行优化，形状僵硬，并且大多在大型医疗中心提供。我们开发了一种超薄、柔软且灵活的表面肌电贴片，专门设计用于符合颏下解剖结构，最终将被纳入远程医疗系统。为了验证第一代 sEMG 贴片，我们将其监测颏下肌肉活动的安全性、效率和信号质量与广泛使用的传统 sEMG 电极进行了比较。方法使用随机交叉设计将实验 sEMG 贴片与传统（卡扣式）sEMG 电极进行比较。参与者以平衡顺序使用两个电极完成了相同的实验方案。吞咽试验包括 5 次 5 毫升和 10 毫升水的试验。比较了 (a) 信号相关因素：信噪比 (SNR)、基线幅度、归一化平均幅度和 sEMG 突发持续时间，以及 (b) 安全性/临床前因素：安全性/不良反应、电极效率放置和满意度/舒适度。非劣效性和等效性检验用于检查信号相关因素。配对t使用测试和描述性统计来检查安全性/临床前因素。结果四十名健康成年人参加（24 名女性，中号年龄= 67.5 年）。信号相关因素：实验贴片的信噪比不低于传统电极的信噪比（p< .0056)。同样，使用实验贴片获得的基线幅度并不逊色于使用传统电极获得的基线幅度（p< .0001)。最后，归一化振幅值在吞咽过程中是等效的（5 毫升：p< .025；10 毫升：p< .0012），并且 sEMG 突发持续时间也相同（5 毫升：p< .0001；10 毫升：p< .0001)。安全性/临床前因素：实验贴片导致较少的轻微不良反应。实验补丁的参与者满意度更高（p= .0476,d= 0.226）。结论我们的新型可穿戴表面肌电贴片在技术性能方面与广泛使用的传统表面肌电电极相当。此外，我们的贴片是安全的，健康的老年人对此感到满意。吸取当前 COVID-19 大流行的教训，开发最佳吞咽远程康复设备比以往任何时候都更加紧迫。经过进一步验证，这项新技术有潜力改善吞咽困难患者的康复和远程康复工作。补充材料https://doi.org/10.23641/asha.12915509