Kim Jaeuk U, Kim Jae Kyoun, Shin Jae-Young, Ku Boncho, Bae Jang-Han, Yeom Seungryong, Lee Sangkwan
KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon Clinical Trial Center, Wonkwang University Gwangju Hospital, Gwangju Department of Global Public Health and Korean Medicine Management, Graduate School, Kyung Hee University, Seoul Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.
Medicine (Baltimore). 2018 Mar;97(13):e0204. doi: 10.1097/MD.0000000000010204.
About 55% to 75% of stroke survivors have motor disorders and problems that affect their quality of life. The prevention of secondary neurological damages through relapse prevention and the rehabilitation of stroke patients suffering from morbidities are crucial to improve the prognosis of patients with stroke. Pulse examinations can be used to determine the stroke progression. This study will investigate the differences and changes in radial artery pressure-pulse waves during the treatment of hemiplegia caused by stroke.
METHODS/DESIGN: This study protocol is for a prospective matched case-control study. A total of 84 participants will be recruited, 56 patients with hemiplia caused by stroke, and 28 control patients matched by age, gender, and body mass index. The primary outcome of this study will be the differences and changes in the radial augmentation index.
The results of the study will help to determine the differences and changes in radial artery pressure-pulse waves during the treatment of hemiplegia caused by stroke. The findings will provide information about the physiological and hemodynamic mechanisms.
This will be the first study to analyze the pulse wave of the radial artery (PWRA) on the affected side and on the normal side in stroke patients with hemiplegia. This study will clarify whether the radial artery pressure pulse wave can be used to evaluate the result of stroke treatment objectively. The results of the study will be available in February 2019. The version of the protocol is v1.6 written in March 7, 2016.
Written informed consent will be obtained from all participants. This study has been approved by the Institutional Review Board (IRB) of Wonkwang University Gwangju Hospital, Gwangju, Republic of Korea (WKIRB-2016/8). The study findings will be published in peer-reviewed journals and presented at national and international conferences.
This trial was registered with the Clinical Research Information Service (CRIS) of the Korea National Institute of Health (NIH), Republic of Korea (KCT0002147).
约55%至75%的中风幸存者存在运动障碍及影响生活质量的问题。通过预防复发及对患有并发症的中风患者进行康复治疗来预防继发性神经损伤，对于改善中风患者的预后至关重要。脉搏检查可用于确定中风进展情况。本研究将调查中风所致偏瘫治疗过程中桡动脉压力脉搏波的差异和变化。
方法/设计：本研究方案为前瞻性匹配病例对照研究。共招募84名参与者，其中56名中风所致偏瘫患者，28名年龄、性别和体重指数匹配的对照患者。本研究的主要结局将是桡动脉增强指数的差异和变化。
研究结果将有助于确定中风所致偏瘫治疗过程中桡动脉压力脉搏波的差异和变化。这些发现将提供有关生理和血流动力学机制的信息。
这将是第一项分析偏瘫中风患者患侧和正常侧桡动脉脉搏波（PWRA）的研究。本研究将阐明桡动脉压力脉搏波是否可用于客观评估中风治疗效果。研究结果将于2019年2月公布。该方案版本为2016年3月7日编写的v1.6。
将从所有参与者处获得书面知情同意书。本研究已获得韩国光州圆光大学医院机构审查委员会（IRB）的批准（WKIRB - 2016/8）。研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。
本试验已在韩国国立卫生研究院（NIH）的临床研究信息服务（CRIS）注册（KCT0002147）。
