ABSTRACT
BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027849. Registered on 30 November 2019, http://www.chictr.org.cn/showproj.aspx?proj=46316.
Subject(s)
Acupuncture Therapy , Cognitive Dysfunction , Stroke Rehabilitation , Stroke , Cognitive Dysfunction/diagnosis , Cognitive Dysfunction/etiology , Cognitive Dysfunction/therapy , Humans , Multicenter Studies as Topic , Prospective Studies , Randomized Controlled Trials as Topic , Stroke/complications , Stroke/diagnosis , Stroke/therapy , Treatment OutcomeABSTRACT
BACKGROUND: Mild cognitive impairment (MCI) in the elderly is a health problem worldwide. Several clinical trials indicated that traditional Chinese medicine (TCM) exercise therapies can effectively improve MCI, such as Tai Ji, Baduan jin exercise, Liuzi jue, and finger exercise. However, there is still controversy over which therapy is the best for elderly MCI patients. In this study, we aimed to systematically evaluate and compare the effectiveness and safety of these 4 TCM exercise therapies in elderly patients with MCI. METHODS: The Web of Science, PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Clinical Trials, China National Knowledge Infrastructure, Wangfang database, and Chinese Biomedical Medicine will be comprehensively searched to collect all randomized controlled trials which included elderly participants with MCI receiving TCM exercise therapies through July 2020. Two reviewers will independently screen and evaluate each included study and extract the outcome indexes. ADDIS 1.16.8 software will be used for the network meta-analysis and STATA 14 software will be used for drawing network evidence plots and funnel plots. RESULTS: We will use the Bayesian statistical model to conduct a network meta-analysis to rank the effectiveness and safety of these 4 interventions, and use the GRADE approach to interpret the results. CONCLUSION: This network meta-analysis will find out the optimal treatment plan for MCI and provide evidence-based bias for clinical treatments decision-making. PROTOCOL REGISTRATION NUMBER: INPLASY202070006.