Tufft Abbey, Neilens Helen, Marsden Jonathan, Creanor Siobhan, Ali Ayesha, Donovan-Hall Margaret, Aspinall Paigan, Lord Amber, Jones Ben, Taylor Paul
Peninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK
Peninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
BMJ Open. 2025 Sep 5;15(9):e097010. doi: 10.1136/bmjopen-2024-097010.
Difficulty with walking can lead to reduced quality of life for people with Parkinson's disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD.
STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES.
This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access.
ISRCTN13120555.
行走困难会导致帕金森病患者（pwPD）的生活质量下降；改善行走能力被视为治疗的优先事项。药物疗法可以控制帕金森病症状；然而，pwPD患者通常仍会出现行动不便的问题。功能性电刺激（FES）通过外部电刺激诱导弱肌运动。FES用于中风和多发性硬化症患者，通过刺激腓总神经来纠正足下垂，并与生活质量和行动能力的改善相关。在这项确定性研究之前的随机可行性研究表明，每日FES可使pwPD患者的步行速度产生具有临床意义的改善；在停止FES治疗4周后，这种改善仍持续存在。STEPS II是第一项具有盲法结局评估的确定性随机对照试验，旨在确定FES对pwPD的疗效。
STEPS II是一项两组平行、评估者盲法、优效性随机对照试验，设有内部预试验，旨在比较FES加常规护理与单纯常规护理。234名参与者将在英国的八个地点进行随机分组。通过电话预筛查和面对面筛查确定入选资格。干预组将参加四次非盲法FES访视，以接收设备并评估有无FES时的行走情况。所有参与者在基线以及第2、6、18和第22周进行盲法评估。主要目标是通过10米步行速度的变化，比较基线后18周时的全身运动迟缓情况。次要目标将评估FES对帕金森步态和生活质量的更广泛影响。一个嵌入式定性部分将探索FES的更广泛体验。
本研究获得了约克郡和亨伯-谢菲尔德研究伦理委员会的伦理批准（参考编号23/YH/0193）。数据监测委员会和试验指导委员会将提供独立监督。传播将通过出版物、会议和社交媒体进行。FES干预和培训材料将开放获取。
ISRCTN13120555。
