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Effects of different acupuncture treatment methods on post-stroke cognitive impairment: study protocol for a multicenter randomized controlled trial

机译:不同针灸治疗方法对冲程后认知障碍的影响:多中心随机对照试验的研究方案

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摘要

Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive function, but its curative effect is limited. Acupuncture is a core component of traditional Chinese medicine (TCM), and some previous clinical studies have shown that it might be effective in treating post-stroke cognitive impairment (PSCI), but further evidence from large-sample studies is needed. The overall objective of this trial is to obtain further data to develop an optimized acupuncture treatment for PSCI by comparing the effects of different acupuncture treatment methods on cognitive function in PSCI patients. In this multicenter, prospective, randomized controlled trial, 206 eligible stroke inpatients who meet the trial criteria will be randomly assigned to 2 groups: an electroacupuncture (EA) plus needle retention (NR) group and an EA group. Both groups of patients will undergo the same routine cognitive rehabilitation treatments. All treatments will be given 5 times per week for 8?weeks. The primary outcomes will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment scale (MOCA). The secondary outcome will be measured by the Barthel Index (BI). All outcomes will be evaluated at baseline, week 4, week 8, and the third and sixth month after the end of treatment. Our aim is to evaluate the effects of two different acupuncture treatment methods for treating PSCI patients. This study is expected to provide data to be used in developing an optimized acupuncture treatment method for PSCI treatment.
机译:认知障碍是严重影响患者整体回收的血小犬后常见功能障碍。认知康复训练目前是改善认知功能的主要治疗方法,但其疗效有限。针灸是中药(中医)的核心成分,并有一些以前的临床研究表明,它可能有效地治疗卒中后认知障碍(PSCI),但需要来自大型样本研究的进一步证据。该试验的总体目的是通过比较不同针灸治疗方法对PSCI患者的认知功能的影响来获得进一步的数据以对PSCI进行优化的针灸治疗。在这种多中心,预期,随机对照试验中,符合试验标准的206名符合条件的中风住院患者将随机分配给2组:电针(EA)加上针保留(NR)组和EA组。两组患者将经历同样的常规认知康复治疗方法。所有治疗均每周将给予5次8?周。主要结果将使用迷你精神状态检查(MMSE)和蒙特利尔认知评估规模(MOCA)进行评估。二次结果将通过Barthel指数(BI)测量。所有结果将在待遇结束后的基线,第4周,第8周和第三个月和第六个月进行评估。我们的目标是评估两种不同针灸治疗方法治疗PSCI患者的影响。该研究预计将提供用于开发PSCI治疗的优化针灸治疗方法的数据。

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