Sheffield Institute of Translational Neurosciences, University of Sheffield, Sheffield, UK.
Combined Community and Acute Care Group, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
BMC Neurol. 2024 Nov 9;24(1):437. doi: 10.1186/s12883-024-03635-x.
Post stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES.
Overall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation.
The results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261).
脑卒中后肘痉挛（PSES）影响超过三分之一的脑卒中患者，对功能恢复、舒适度和生活质量产生负面影响。药物治疗的疗效有限且存在不良反应，肉毒毒素虽然有效，但价格昂贵，传统的电刺激疗法长期受到习惯化的限制。我们旨在研究谢菲尔德自适应模式电刺激（SHAPES）的疗效，该刺激通过时空变化的电刺激模式，与经皮电刺激（TENS）和标准护理相比，降低 PSES 的效果。
总体而言，将 297 名 PSES 患者随机分为 3 组（1:1:1）：标准护理（无电刺激）、TENS（常规模式电刺激）或 SHAPES（自适应模式电刺激）。SHAPES 和 TENS 均使用专门设计的电刺激袖套，每天使用 60 分钟，持续 6 周。在基线、治疗结束时（6 周）以及治疗结束后 6 周、12 周和 24 周进行结局测量。疗效将根据接受治疗的患者中，7 天数字评分量表（NRS-S）中 PSES 有意义改善（18%）的比例来确定，与干预组和标准护理组进行比较，以及两组干预组之间进行比较。还将测量手臂运动功能（行动研究手臂测试、MRC 量表）和生活质量（SQoL-6D、EQ-5D），并进行平行的健康经济评估。
SHAPES 试验的结果将为脑卒中后肘痉挛的治疗提供信息。SHAPES 干预措施是一种低成本、自我管理的痉挛治疗方法，可以重复使用，如果发现比 TENS 或对照组更有效，有可能在英国国民保健制度医疗保健环境中广泛实施。此外，尽管 TENS 在痉挛治疗中的应用广泛，但这项研究将提供关于其疗效的急需证据。该试验已在 ISRCTN 注册中心（ISRCTN26060261）注册。
