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Efficacy of Baduanjin exercise on balance and gait in patients with cervical dystonia study protocol for a randomised controlled trial

注册号：

Registration number：

ITMCTR2024000240

最近更新日期：

Date of Last Refreshed on：

2025-04-21

注册时间：

Date of Registration：

2024-08-15

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

八段锦改善痉挛性斜颈患者下肢平衡功能及步态：随机对照试验

Public title：

Efficacy of Baduanjin exercise on balance and gait in patients with cervical dystonia study protocol for a randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

八段锦改善痉挛性斜颈患者下肢平衡功能及步态：随机对照试验

Scientific title：

Efficacy of Baduanjin exercise on balance and gait in patients with cervical dystonia study protocol for a randomised controlled trial

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

范顺

研究负责人：

李华南

Applicant：

Shun Fan

Study leader：

Huanan Li

申请注册联系人电话：

Applicant telephone：

17695600322

研究负责人电话：

Study leader's telephone：

15122129317

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

l_ldashun@163.com

研究负责人电子邮件：

Study leader's E-mail：

lihuanan1984@126.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

天津市西青区昌凌路88号

研究负责人通讯地址：

天津市西青区昌凌路88号

Applicant address：

No. 88 Changling Road Xiqing District Tianjin City

Study leader's address：

No. 88 Changling Road Xiqing District Tianjin City

申请注册联系人邮政编码：

Applicant postcode：

300381

研究负责人邮政编码：

Study leader's postcode：

300381

申请人所在单位：

天津中医药大学第一附属医院

Applicant's institution：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

TYLL2024[Z]字042

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

天津中医药大学第一附属医院医学伦理委员会

Name of the ethic committee：

IRB of The First Teaching Hospital of Tianjin University of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/5 0:00:00

伦理委员会联系人：

郑子琦

Contact Name of the ethic committee：

Ziqi Zheng

伦理委员会联系地址：

天津市西青区昌凌路88号

Contact Address of the ethic committee：

NO.88 Changling Road, Xiqing District, Tianjin, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

022-27986258

伦理委员会联系人邮箱：

Contact email of the ethic committee：

b1s1z1@sina.com

研究实施负责（组长）单位：

天津中医药大学第一附属医院

Primary sponsor：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

天津市西青区昌凌路88号

Primary sponsor's address：

NO.88 Changling Road, Xiqing District, Tianjin, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津市

市(区县)：

西青区

Country：

China

Province：

Tianjin

City：

Xiqing District

单位(医院)：

天津中医药大学第一附属医院

具体地址：

天津市西青区昌凌路88号

Institution
hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address：

NO.88 Changling Road, Xiqing District, Tianjin, China

经费或物资来源：

自筹

Source(s) of funding：

self - raise funds

研究疾病：

痉挛性斜颈

研究疾病代码：

8A02(ICD11)

Target disease：

Cervical Dystonia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过八段锦联合常规治疗对比常规治疗的临床设计，改善痉挛性斜颈患者下肢平衡功能及异常步态，探究其临床疗效，以期后续用于CD患者回归社区后的慢病管理疗法，为功法改善CD平衡功能提供高质量临床证据，推进中医传统功法的传承创新发展。

Objectives of Study：

Through the clinical design of comparing Baduanjin combined with conventional treatment with conventional treatment alone improve the lower - limb balance function and abnormal gait of patients with spasmodic torticollis explore its clinical efficacy with the hope of using it as a chronic disease management therapy for CD patients after they return to the community provide high - quality clinical evidence for the improvement of CD balance function by traditional Chinese exercises and promote the inheritance innovation and development of traditional Chinese martial arts.

药物成份或治疗方案详述：

试验组在常规治疗的基础上，在病房进行为期2周（每周5天）的有监督的八段锦训练。研究人员会为患者提供八段锦运动指导，并在试验后分发八段锦使用说明书和视频演示。聘请了具有5年以上教学经验的合格八段锦运动教练在医院现场指导训练，并纠正患者的动作。采用国家体育总局2003年颁布的健身气功八段锦锻炼的相关内容，八段锦共 8 段。第一段：双手托天理三焦；第二段：左右开弓似射雕；第三段：调理脾胃臂单举；第四段：五劳七伤往后瞧；第五段：摇头摆尾去心火；第六段：双手攀足固肾腰；第七段：攒拳怒目增气力；第八段：背后七颠百病消。八段锦的练习，应由专业人员对患者进行八段锦的教授与练习指导。康复治疗师首先要进行八段锦动作的分解与演示，让患者逐渐掌握各个动作的动作要领，然后再进行系统练习。八段锦的练习过程中，要让患者领悟松静自然、准确灵活、练养相兼、循序渐进的习练要领。所有八段锦培训均由同一名八段锦专业人员教学并带练。每环节大约50分钟，包括10分钟的热身练习，30分钟的八段锦练习和10分钟的拉伸。八段锦项目包括8个动作练习。2周疗程出院后，患者在每周3天的情况下于家中进行同样的练习，持续18周。

Description for medicine or protocol of treatment in detail：

On the basis of conventional treatment the experimental group received supervised Baduanjin training in the ward for 2 weeks (5 days a week).The researchers will provide patients with guidance on Baduanjin exercises and distribute instruction manuals and video demonstrations of Baduanjin after the experiment.A qualified Baduanjin coach with more than 5 years of teaching experience was hired to provide on - site training guidance in the hospital and correct the patients movements.The relevant content of the Baduanjin exercise in the fitness qigong promulgated by the General Administration of Sport of China in 2003 was adopted. Baduanjin consists of 8 sections.The first section: Hold hands up to regulate the three - energizer;The second section: Draw the bow left and right like shooting an eagle;The third section: Regulate the spleen and stomach by raising one arm;The fourth section: Look backward to relieve five - overstrain and seven - impairment;The fifth section: Shake the head and swing the tail to remove heart - fire;The sixth section: Reach for the feet with both hands to strengthen the kidneys and waist;The seventh section: Clench fists and glare to increase strength;The eighth section: Bounce on the heels seven times behind the back to eliminate all diseases.For the practice of Baduanjin professional personnel should teach patients Baduanjin and guide them in the practice.The rehabilitation therapist should first decompose and demonstrate the Baduanjin movements so that patients can gradually master the essentials of each movement and then conduct systematic practice.During the practice of Baduanjin patients should be made to understand the practice essentials of relaxation tranquility naturalness accuracy flexibility combining practice and cultivation and gradual progress.All Baduanjin training was taught and led by the same Baduanjin professional.Each session lasted about 50 minutes including 10 minutes of warm - up exercises 30 minutes of Baduanjin practice and 10 minutes of stretching.The Baduanjin program includes 8 action exercises.After being discharged from the hospital after a 2 - week course of treatment patients continued to practice the same exercises at home 3 days a week for 18 weeks.

纳入标准：

（1）符合原发性颈部肌张力障碍的诊断； （2）Berg平衡量表＜54分； （3）年龄≥18岁且≤65岁，性别不限； （4）头颅MRI检查无结构性损伤或异常； （5）入组前3个月内未接受肉毒杆菌毒素注射或运动训练； （6）签订知情同意书。

Inclusion criteria

(1) Complies with the diagnosis of primary cervical dystonia; (2) Berg Balance Scale<54 points; (3) Age ≥ 18 years old and ≤ 65 years old gender not limited; (4) Head MRI examination shows no structural damage or abnormalities; (5) Not receiving botulinum toxin injections or exercise training within the first 3 months of enrollment; (6) Sign the informed consent form.

排除标准：

（1）使用过脑深部电刺激术（DBS）、改良Foerster-Dandy术、痉挛肌肉选择性切除术等治疗； （2）怀孕或哺乳妇女； （3）不适合八段锦的情况，如患有严重心脏、大脑、肺部和其他关键器官疾病的人； （4）帕金森病或痴呆症等疾病引起的认知功能障碍； （5）影响平衡的疾病，如脑梗死或舞蹈病； （6）影响步态的疾病，如腰椎间盘突出症或膝骨性关节炎。

Exclusion criteria：

(1) Has undergone treatments such as deep brain stimulation (DBS) modified Foerster Dandy procedure and selective excision of spastic muscles; (2) Pregnant or lactating women; (3) Not suitable for baduanjin sports such as those with severe heart brain lung and other critical organ diseases; (4) Cognitive impairment caused by diseases such as Parkinson's disease or dementia; (5) Diseases that affect balance such as cerebral infarction or chorea; (6) Diseases that affect gait such as lumbar disc herniation or knee osteoarthritis.

研究实施时间：

Study execute time：

从From 2024-09-01

至To      2026-05-31

征募观察对象时间：

Recruiting time：

从From 2025-04-30

至To      2026-04-30

干预措施：

Interventions：

组别：

对照组

样本量：

35

Group：

Control group

Sample size：

干预措施：

常规治疗

干预措施代码：

Intervention：

conventional therapy

Intervention code：

组别：

试验组

样本量：

35

Group：

Experimental group

Sample size：

干预措施：

常规治疗联合八段锦

干预措施代码：

Intervention：

conventional therapy plus baduanjin

Intervention code：

样本总量 Total sample size ： 70

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

天津市

市(区县)：

西青区

Country：

China

Province：

Tianjin

City：

Xiqing Distric

单位(医院)：

天津中医药大学第一附属医院

单位级别：

公立三甲医院

Institution/hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Public tertiary hospital

测量指标：

Outcomes：

指标中文名：

伯格平衡量表

指标类型：

主要指标

Outcome：

Berg Balance Scale

Type：

Primary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

量表分析

Measure time point of outcome：

Before treatment, at the 2nd week of intervention, 6th week of intervention, 12th week of intervention, and 20th week of intervention

Measure method：

Questionnaire analysis

指标中文名：

TUG测试

指标类型：

次要指标

Outcome：

Timed Up and Go Test

Type：

Secondary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

数据分析

Measure time point of outcome：

Before treatment at the 2nd week of intervention 6th week of intervention 12th week of intervention and 20th week of intervention

Measure method：

data analysis

指标中文名：

西多伦多痉挛性斜颈评分量表

指标类型：

次要指标

Outcome：

Toronto Western Spasmodic Torticollis Rating Scale，TWSTRS

Type：

Secondary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

量表分析

Measure time point of outcome：

Before treatment, at the 2nd week of intervention, 6th week of intervention, 12th week of intervention, and 20th week of intervention

Measure method：

Questionnaire analysis

指标中文名：

站姿静态平衡能力

指标类型：

次要指标

Outcome：

standing static balance ability

Type：

Secondary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

数据分析

Measure time point of outcome：

Before treatment at the 2nd week of intervention 6th week of intervention 12th week of intervention and 20th week of intervention

Measure method：

data analysis

指标中文名：

三维步态分析仪

指标类型：

主要指标

Outcome：

3D gait analyzer

Type：

Primary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

数据分析

Measure time point of outcome：

Before treatment, at the 2nd week of intervention, 6th week of intervention, 12th week of intervention, and 20th week of intervention

Measure method：

Data analysis

指标中文名：

不良事件发生率

指标类型：

次要指标

Outcome：

Adverse event rate

Type：

Secondary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

填写不良事件记录表并计算不良事件发生率

Measure time point of outcome：

Before treatment at the 2nd week of intervention 6th week of intervention 12th week of intervention and 20th week of intervention

Measure method：

Fill out the adverse event record form and calculate the incidence rate of adverse events

指标中文名：

汉密尔顿焦虑量表

指标类型：

主要指标

Outcome：

Hamilton Anxiety Scale

Type：

Primary indicator

测量时间点：

治疗前、入组干预第2周、干预第6周、干预第12周、干预第20周

测量方法：

量表分析

Measure time point of outcome：

Before treatment, at the 2nd week of intervention, 6th week of intervention, 12th week of intervention, and 20th week of intervention

Measure method：

Questionnaire analysis

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机化操作者独立操作，采用R软件（4.4.0，RStudio-2024.04.1-748）中R包（randomizr）进行简单随机，分配比例为1：1（即35例分配到试验组，35例分配到对照组），设置种子方便后续复现随机结果。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization operator operates independently using the R package (randomizr) in R software (4.4.0 RStudio - 2024.04.1 - 748) for simple randomization. The allocation ratio is 1:1 (that is 35 cases are allocated to the experimental group and 35 cases are allocated to the control group). A seed is set to facilitate the subsequent reproduction of the random results.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

中国临床试验注册中心的ResMan原始数据共享平台(IPD共享平台)

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

IPD Sharing Platformhttp://www.medresman.org.cn/login.aspx

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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