Martin Daniel, Patriciu Andrei, Schulz Anne-Kathrin, Schackert Gabriele
Department of Neurosurgery, Technische Universität Dresden, Dresden, Germany.
nstim Services GmbH Vienna, Vienna, Austria.
Innov Surg Sci. 2021 Jan 6;6(1):20191003. doi: 10.1515/iss-2019-1003. eCollection 2021 Jan.
Direct electrical stimulation of the peroneal nerve, using the implantable ActiGait® system, enables a therapy of the centrally caused drop foot, to improve the gait of the patients. In this paper, we present long-term results at 36-month follow-up post implantation.
A total of 33 patients, 27 stroke and six multiple sclerosis (MS) patients, suffering from spastic drop foot were implanted in our center and assessed in terms of gait endurance, speed, risk of fall, and life quality at baseline and 36 months following implantation.
The six min gait endurance test increased significantly from 202 ± 41 m without walking aids to 380 ± 30 m (p=0.038), while using the implant. Moreover, the time in the gait speed measured over 20 m decreased from 31.8 ± 10.2 s without to 18.5 ± 4.6 s by using the ActiGait® system (p=0.039). Similarly, gait steadiness, measured by the Timed Up and Go (TUG) test improved by 36.6%, with patients demonstrating a reduced time from 18.6 ± 5.5 to 11.2 ± 3.8 s (p=0.041) upon implant activation. Most importantly, 31 of 33 patients reported remarkable improvements of their quality of life following direct electrical nerve stimulation.
Our findings confirm previously published efficacy data at 12 months after implantation and underline the long-lasting effect of the ActiGait® system.
使用可植入式ActiGait®系统直接电刺激腓总神经,能够对中枢性足下垂进行治疗,改善患者步态。在本文中,我们展示了植入后36个月的长期随访结果。
本中心共纳入33例患有痉挛性足下垂的患者,其中27例为中风患者,6例为多发性硬化(MS)患者,并在基线期及植入后36个月对其步态耐力、速度、跌倒风险和生活质量进行评估。
在使用该植入装置时,6分钟步态耐力测试结果从无辅助行走时的202±41米显著提高至380±30米(p = 0.038)。此外,使用ActiGait®系统时,20米步态速度测试时间从无辅助时的31.8±10.2秒降至18.5±4.6秒(p = 0.039)。同样,通过计时起立行走测试(TUG)测量的步态稳定性提高了36.6%。激活植入装置后,患者完成测试的时间从18.6±5.5秒减少至11.2±3.8秒(p = 0.041)。最重要的是,33例患者中有31例报告在直接电神经刺激后生活质量有显著改善。
我们的研究结果证实了先前发表的植入后12个月疗效数据,并强调了ActiGait®系统的长期效果。