Home rehabilitation supported by a wearable soft-robotic device for improving hand function in older adults: A pilot randomized controlled trial

BackgroundNew developments, based on the concept of wearable soft-robotic devices, make it possible to support impaired hand function during the performance of daily activities and intensive task-specific training. The wearable soft-robotic ironHand glove is such a system that supports grip strength during the performance of daily activities and hand training exercises at home.DesignThis pilot randomized controlled clinical study explored the effect of prolonged use of the assistive ironHand glove during daily activities at home, in comparison to its use as a trainings tool at home, on functional performance of the hand.MethodsIn total, 91 older adults with self-perceived decline of hand function participated in this study. They were randomly assigned to a 4-weeks intervention of either assistive or therapeutic ironHand use, or control group (received no additional exercise or treatment). All participants performed a maximal pinch grip test, Box and Blocks test (BBT), Jebsen-Taylor Hand Function Test (JTHFT) at baseline and after 4-weeks of intervention. Only participants of the assistive and therapeutic group completed the System Usability Scale (SUS) after the intervention period.ResultsParticipants of the assistive and therapeutic group reported high scores on the SUS (mean = 73, SEM = 2). The therapeutic group showed improvements in unsupported handgrip strength (mean Δ = 3) and pinch strength (mean Δ = 0.5) after 4 weeks of ironHand use (p≤0.039). Scores on the BBT and JTHFT improved not only after 4 weeks of ironHand use (assistive and therapeutic), but also in the control group. Only handgrip strength improved more in the therapeutic group compared to the assistive and control group. No significant correlations were found between changes in performance and assistive or therapeutic ironHand use (p≥0.062).ConclusionThis study showed that support of the wearable soft-robotic ironHand system either as assistive device or as training tool may be a promising way to counter functional hand function decline associated with ageing.

背景 基于穿戴式软体机器人设备理念开发的新型技术，可在日常活动执行与针对性高强度任务训练期间，辅助受损的手部功能。本次研究涉及的穿戴式软体机器人ironHand手套（ironHand glove），正是一类可在日常活动中辅助握力、并支持居家手部训练的系统。
设计 本先导性随机对照临床研究，旨在对比两种居家使用场景下的ironHand手套应用方案——即长期作为日常活动辅助器具使用，与作为居家训练工具使用——对手部功能表现的影响。
方法 本研究共纳入91名自我感知手部功能减退的老年人。所有受试者被随机分配至4周干预期的三组：辅助使用组、治疗使用组，以及对照组（仅接受常规护理，无额外训练或治疗）。所有受试者在干预前基线与干预4周后，均完成最大捏握力测试、箱块测验（Box and Blocks Test, BBT）、捷辛-泰勒手部功能测试（Jebsen-Taylor Hand Function Test, JTHFT）。仅辅助使用组与治疗使用组的受试者在干预结束后完成了系统可用性量表（System Usability Scale, SUS）评定。
结果 辅助使用组与治疗使用组的受试者在系统可用性量表上得分较高（均值为73，标准误为2）。治疗使用组在使用ironHand手套4周后，无辅助握力（均值变化量Δ=3）与捏握力（均值变化量Δ=0.5）均得到显著改善（p≤0.039）。箱块测验与捷辛-泰勒手部功能测试的得分，不仅在使用ironHand手套的辅助、治疗两组中得到提升，对照组同样出现得分改善。相较于辅助使用组与对照组，仅治疗使用组的握力提升幅度更为显著。受试者手部功能表现的变化量与ironHand手套的辅助或治疗性使用之间，未发现显著相关性（p≥0.062）。
结论 本研究表明，穿戴式软体机器人ironHand系统无论是作为日常辅助器具，还是居家训练工具，均有望成为对抗衰老相关手部功能衰退的有效手段。