BACKGROUND People with Amyotrophic Lateral Sclerosis (PwALS) in the advanced phase are critically affected by an almost total loss of mobility and severe communication problems. Scanning access based on the patient's interaction with a sensor (or switch) that intercepts even a weak body movement is a valid communication aid. However, its use becomes limited with the progressive decline of residual movements. To overcome this problem, we designed a new sensor, the Lever Magnetic-spring Mechanical Switch (LeMMS), allowing repeated activation/release cycles requiring a very small activation force. METHODS The LeMMS was applied and validated in a group of 20 PwALS in an advanced stage of disease. All subjects were regular users of communication aids employing other sensors, but which they could no longer operate their sensors (different from LeMMS). Patients were assessed at baseline (t0) and after one (t1), 6 (t2) and 12 (t3) months. Assessment at t0 included administration of standardized clinical scales, the Click-Test-30 counting the maximum number of LeMMS activations in 30 s, and thumb/fingers strength assessment with the Kendall scale. The QUEST 2.0-Dev questionnaire was administered at t1. Some use-related information and the Click-Test-30 were collected at t1, t2 and t3. RESULTS After one training session, all patients could operate the LeMMS with minimal residual movement of one finger. At t1, they used it on average 5.45 h/day. The mean score of the QUEST 2.0-Dev was 4.63, suggesting strong satisfaction with the LeMMS. Regarding Click-Test-30 scores, no significant difference was found between t0 and t1, but performance at t2 and t3 declined significantly (p < 0.005 vs. t0). At t3, 9/20 patients were still able to use their communication aid. CONCLUSIONS This new switch sensor can enable PwALS to use their communication aids for a prolonged time even in the advanced phase of disease. It is easy to use, reliable and cheap, thus representing an intermediate alternative to more sophisticated and costly devices.

中文翻译：

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开发一种新的高灵敏度机械开关，用于肌萎缩性侧索硬化症患者的增广和替代性交流。

背景技术患有晚期的肌萎缩性侧索硬化症（PwALS）的人受到几乎完全丧失活动能力和严重的沟通问题的严重影响。基于患者与传感器（或开关）的交互进行扫描访问（即使身体动作微弱也可以拦截）是一种有效的通讯工具。但是，随着残余运动的逐渐下降，其使用受到限制。为了克服这个问题，我们设计了一种新的传感器，杠杆电磁弹簧机械开关（LeMMS），允许重复的激活/释放循环，所需的激活力非常小。方法LeMMS在一组20例疾病晚期的PwALS中进行了应用和验证。所有受试者都是使用其他传感器的通讯辅助设备的常规用户，但他们无法再操作其传感器（与LeMMS不同）。在基线（t0）以及1个月（t1），6个月（t2）和12个月（t3）之后对患者进行评估。在t0时的评估包括标准化临床量表的管理，Click-Test-30计数30 s内LeMMS激活的最大次数以及用Kendall量表进行拇指/手指力量评估。QUEST 2.0-Dev问卷在t1时进行管理。在t1，t2和t3收集了一些与使用有关的信息和Click-Test-30。结果在一次培训之后，所有患者都可以用一个手指的最小残留运动来操作LeMMS。在t1，他们平均每天使用5.45小时。QUEST 2.0-Dev的平均得分为4.63，表明对LeMMS的满意度很高。关于Click-Test-30得分，t0和t1之间没有发现显着差异，但是在t2和t3时的性能显着下降（与t0相比，p <0.005）。在t3时，仍有9/20的患者能够使用他们的通讯帮助。结论这种新的开关传感器可以使PwALS即使在疾病的晚期也可以长时间使用其通信辅助工具。它易于使用，可靠且便宜，因此代表了更复杂，更昂贵的设备的中间替代方案。