一项使用可穿戴传感器客观评估电针治疗帕金森病患者步态疗效的临床试验
A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors.
作者信息
Lei Hong, Toosizadeh Nima, Schwenk Michael, Sherman Scott, Karp Stephan, Sternberg Esther, Najafi Bijan
机构信息
Department of Neurology, College of Medicine, University of Arizona, Tucson, Arizona, United States of America.
Interdisciplinary Consortium on Advanced Motion Performance (iCAMP) and Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, College of Medicine, University of Arizona, Tucson, Arizona, United States of America.
出版信息
PLoS One. 2016 May 26;11(5):e0155613. doi: 10.1371/journal.pone.0155613. eCollection 2016.
BACKGROUND
Gait disorder, a key contributor to fall and poor quality of life, represents a major therapeutic challenge in Parkinson's disease (PD). The efficacy of acupuncture for PD remains unclear, largely due to methodological flaws and lack of studies using objective outcome measures.
OBJECTIVE
To objectively assess the efficacy of electroacupuncture (EA) for gait disorders using body-worn sensor technology in patients with PD.
METHODS
In this randomized pilot study, both the patients and assessors were masked. Fifteen PD patients were randomly assigned to an experimental group (n = 10) or to a control group (n = 5). Outcomes were assessed at baseline and after completion of three weekly EA treatments. Measurements included gait analysis during single-task habitual walking (STHW), dual-task habitual walking (DTHW), single-task fast walking (STFW), dual-task fast walking (DTFW). In addition, Unified Parkinson's Disease Rating Scale (UPDRS), SF-12 health survey, short Falls Efficacy Scale-International (FES-I), and visual analog scale (VAS) for pain were utilized.
RESULTS
All gait parameters were improved in the experimental group in response to EA treatment. After adjustment by age and BMI, the improvement achieved statistical significant level for gait speed under STHW, STFW, and DTFW (9%-19%, p<0.05) as well as stride length during DTFW (9%, p = 0.037) and midswing speed during STFW (6%, p = 0.033). No significant changes were observed in the control group (p>0.110). The highest correlation between gait parameters and UPRDS scores at baseline was observed between gait speed during STFW and UPDRS II (r = -0.888, p = 0.004). The change in this gait parameter in response to active intervention was positively correlated with baseline UPDRS (r = 0.595, p = 0.057). Finally, comparison of responses to treatment between groups showed significant improvement, prominently in gait speed (effect size 0.32-1.16, p = 0.001).
CONCLUSIONS
This study provides the objective proof of concept for potential benefits of non-pharmaceutical based EA therapy on enhancing gait in patients with PD.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02556164.
背景
步态障碍是导致跌倒和生活质量下降的关键因素，是帕金森病（PD）治疗中的一项重大挑战。针刺治疗帕金森病的疗效尚不清楚，这主要是由于方法上的缺陷以及缺乏使用客观结局指标的研究。
目的
运用可穿戴传感器技术客观评估电针（EA）治疗帕金森病患者步态障碍的疗效。
方法
在这项随机对照试验研究中，患者和评估者均处于盲态。15例帕金森病患者被随机分为实验组（n = 10）和对照组（n = 5）。在基线期以及完成每周1次，共3次的电针治疗后进行疗效评估。测量指标包括单任务习惯步行（STHW）、双任务习惯步行（DTHW）、单任务快速步行（STFW）、双任务快速步行（DTFW）期间的步态分析。此外，还使用了统一帕金森病评定量表（UPDRS）、SF-12健康调查、国际简短跌倒效能量表（FES-I）以及疼痛视觉模拟量表（VAS）。
结果
实验组患者经电针治疗后，所有步态参数均得到改善。经年龄和体重指数校正后，在STHW、STFW和DTFW状态下，实验组患者的步态速度改善具有统计学意义（9%-19%，p<0.05）；在DTFW状态下的步幅（9%，p = 0.037）以及STFW状态下的摆动中期速度（6%，p = 0.033）也有改善。对照组未观察到显著变化（p>0.110）。基线期时，步态参数与UPRDS评分之间的最高相关性出现在STFW状态下的步态速度与UPDRS II之间（r = -0.888，p = 0.004）。主动干预后该步态参数的变化与基线期UPDRS呈正相关（r = 0.595，p = 0.057）。最后，两组间治疗反应的比较显示出显著改善，主要体现在步态速度方面（效应量0.32-1.16，p = 0.001）。
结论
本研究为基于非药物的电针疗法对改善帕金森病患者步态的潜在益处提供了客观的概念验证。
试验注册
ClinicalTrials.gov NCT02556164。
Zotero 插件