Zhan Zhuang Qigong 干预对帕金森病 Pisa 综合征的疗效和长期影响:一项随机对照试验的研究方案。

Efficacy and long-term effects of the intervention of Zhan Zhuang Qigong on Pisa syndrome in Parkinson's disease: the study protocol for a randomised control trial.

机构信息

Nantong Fourth People's Hospital Affiliated to Kangda College of Nanjing Medical University, Nantong, Jiangsu, China.

Universidad de Barcelona, Barcelona, Catalunya, Spain.

出版信息

BMJ Open. 2024 Nov 1;14(10):e084418. doi: 10.1136/bmjopen-2024-084418.

Abstract

INTRODUCTION

Pisa syndrome (PS) is a postural abnormality that frequently manifests in various neurological disorders. In recent years, the dangers associated with Parkinson's disease (PD) and PS have been increasingly acknowledged, leading to heightened research efforts directed toward the treatment of PS. Nevertheless, the underlying causes of PS remain complex, and no clinically effective treatments have been established. While several studies have demonstrated the significant effects of Qigong in treating PD, there is currently no evidence to support the efficacy of Qigong in the treatment of PS.

OBJECTIVE

To assess the immediate and long-term effects of Zhan Zhuang Qigong on PS in participants with PD using a rigorous randomised, parallel-control design with assignment concealment and evaluator-blinding methodologies.

METHODS

60 PD participants meeting the inclusion criteria will be recruited and randomly assigned to one of two groups: conventional treatment (n=30) or Zhan Zhuang Qigong (n=30). The conventional treatment group will receive standard medications and physical therapy. The Zhan Zhuang Qigong group will receive conventional medicine plus 30 min of Zhan Zhuang Qigong practiced five times per week. The long-term effects of Qigong on PS will be evaluated after 6 months and 1 year of follow-up. Assessment tools will include the NeuroPostureApp, the B-PHY(A model of a balance testing system) balance check training system, the Unified Parkinson's Disease Rating Scale and the Parkinson's Disease Quality of Life Questionnaire, which will measure total camptocormia, upper hump degree, Pisa angles, plantar pressure distribution, motor function and quality of life in participants with PD.

ETHICS AND DISSEMINATION

The local ethics committee approved this study (approval number: 2023-K068). The committee will oversee the study throughout its duration and will be notified of any protocol modifications. The results of the study will be disseminated through publication in an international journal or presentation at a conference.

TRIAL REGISTRATION NUMBER

ChiCTR2400079696.

摘要

简介

Pisa 综合征(PS)是一种姿势异常,常出现在各种神经疾病中。近年来,帕金森病(PD)和 PS 相关的危险已被日益认识到,导致对 PS 治疗的研究工作增加。然而,PS 的根本原因仍然复杂,没有建立起临床上有效的治疗方法。虽然有几项研究表明气功在治疗 PD 方面有显著效果,但目前没有证据支持气功在治疗 PS 方面的疗效。

目的

采用严格的随机、平行对照设计,采用分配隐藏和评估者盲法方法,评估站桩气功对 PD 患者 PS 的即刻和长期影响。

方法

将招募符合纳入标准的 60 名 PD 参与者,并随机分为两组:常规治疗组(n=30)或站桩气功组(n=30)。常规治疗组将接受标准药物治疗和物理治疗。站桩气功组将接受常规药物治疗加每周 5 次,每次 30 分钟的站桩气功。6 个月和 1 年后将评估气功对 PS 的长期影响。评估工具将包括 NeuroPostureApp、B-PHY(平衡测试系统模型)平衡检查训练系统、统一帕金森病评定量表和帕金森病生活质量问卷,用于测量 PD 患者的总驼背程度、上驼背程度、比萨角度、足底压力分布、运动功能和生活质量。

伦理和传播

当地伦理委员会批准了这项研究(批准号:2023-K068)。委员会将监督研究的整个过程,并将收到任何方案修改的通知。研究结果将通过在国际期刊上发表或在会议上展示来传播。

试验注册号

ChiCTR2400079696。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4654/11529775/0b94334e0508/bmjopen-14-10-g001.jpg

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