头针带针训练治疗卒中恢复期吞咽障碍的临床研究

注册号:

Registration number:

ITMCTR2023000037

最近更新日期:

Date of Last Refreshed on:

2023-08-29

注册时间:

Date of Registration:

2023-08-29

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

头针带针训练治疗卒中恢复期吞咽障碍的临床研究

Public title:

Heading needle training intervenes dysphagia in apoplexy decubation

注册题目简写:

English Acronym:

研究课题的正式科学名称:

头针针刺运动疗法干预卒中恢复期吞咽障碍的临床疗效评价:随机对照临床试验

Scientific title:

Heading needle training intervenes dysphagia in apoplexy decubation:A randomized 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:

郭万林

研究负责人:

贾超

Applicant:

Guo Wanlin

Study leader:

Jia Chao

申请注册联系人电话:

Applicant telephone:

17760624355

研究负责人电话:

Study leader's telephone:

13535307000

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:

942155806@qq.com

研究负责人电子邮件:

Study leader's E-mail:

doctorjiachao@163.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:

广东省广州市白云区机场路16号,广州中医药大学三元里校区

研究负责人通讯地址:

广东省广州市白云区机场路16号,广州中医药大学三元里校区

Applicant address:

Guangzhou University of Chinese Medicine, Sanyuanli Campus, Guangzhou, China

Study leader's address:

Guangzhou University of Chinese Medicine, Sanyuanli Campus, Guangzhou, China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

广州中医药大学

Applicant's institution:

Guangzhou University of 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:

JY2023-036

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

广州中医药大学第一附属医院伦理委员会教研分会

Name of the ethic committee:

The Teaching and Research Branch of the Ethics Committee in The First Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/5/8 0:00:00

伦理委员会联系人:

黄纯美

Contact Name of the ethic committee:

Huang Chunmei

伦理委员会联系地址:

广东省广州市白云区机场路16号,广州中医药大学三元里校区综教楼919

Contact Address of the ethic committee:

Comprehensive education building 919, Guangzhou University of Chinese Medicine, Sanyuanli Campus, Guangzhou,

伦理委员会联系人电话:

Contact phone of the ethic committee:

+862036585411

伦理委员会联系人邮箱:

Contact email of the ethic committee:

630000739@qq.com

研究实施负责(组长)单位:

广州中医药大学

Primary sponsor:

Guangzhou University of Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市白云区机场路12号,广州中医药大学第一附属医院

Primary sponsor's address:

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, No.12 Airport Road, Baiyun District, Guangzhou City, Guangdong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

广东省广州市白云区机场路16号,广州中医药大学三元里校区

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, No.12 Airport Road, Baiyun District, Guangzhou City, Guangdong Province

经费或物资来源:

研究生经费

Source(s) of funding:

research Funding Grants

研究疾病:

脑卒中

研究疾病代码:

Target disease:

apoplexy

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:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

1 主要目的:明确“带针训练”与“非带针训练”治疗卒中恢复期吞咽障碍,何者疗效更为显著。 2 次要目的:为带针训练、针刺结合康复训练能有效治疗卒中后吞咽障碍提供临床证据支持;为后期针刺运动疗法治疗更多卒中后遗症提供文献依据。

Objectives of Study:

1 Main purpose: To clarify the "training with needle" and "non-training with needle" to treat swallowing disorders in the recovery period of stroke, which effect is more significant. 2 Secondary objective: To provide clinical evidence for the effective treatment of post-stroke swallowing disorders with needle training and acupuncture combined with rehabilitation training; and to provide literature basis for the treatment of more stroke sequelae.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)“脑卒中”符合《中国各类主要脑血管病诊断要点2019》、《卒中病情监测中国多学科专家共识》中的诊断标准;“吞咽障碍”符合《中国吞咽障碍评估与治疗专家共识(2017年版)》中的诊断标准;“中风”符合《中风的诊断依据、证候分类、疗效评定——中华人民共和国中医药行业标准《中医内科病证诊断疗效标准》》中的诊断标准。其中吞咽困难因脑卒中导致; (2)处于脑卒中恢复期,发病在1个月后至半年以内; (3)洼田饮水试验在3-5级; (4)生命体征平稳,没有严重智能障碍或感觉性失语等影响理解指令者,能理解并配合治疗人员的简单指令,简易精神状态评价量表评估为“无认知功能缺陷”; (5)依从性好,患者及家属均愿意配合本研究治疗方案及随访; (6)研究对象及家属充分了解治疗的风险及受益情况,自愿参与试验,签署知情同意书。

Inclusion criteria

(1)According to the "Key Points of Diagnosis of Major Cerebrovascular Diseases in China 2019" and the "Chinese Expert Consensus of Monitoring Stroke," the symptoms of "stroke" meet the diagnostic criteria. Similarly, the "Expert Consensus of Assessment and Treatment of Swallowing Disorders in China (2017 edition)" confirms that "swallowing disorder" meets the diagnostic criteria."Stroke" meets the diagnostic criteria in the TCM Industry standard of China's "Diagnosis Basis, Syndrome Classification and Efficacy Evaluation of Stroke" and the "Certificate Diagnosis and Efficacy Standards for Internal Medicine of Traditional Chinese Medicine." Additionally, dysphagia is commonly caused by a stroke. (2)In the recovery phase of stroke, onset occurred between 1 month and six months ago. (3)Water Swallow Test (WST) at levels 3 to 5. (4)Stable vital signs, absence of severe cognitive impairments or receptive aphasia affecting command comprehension, and a "No Cognitive Impairment" assessment on the Mini-Mental State Examination (MMSE). (5)Good compliance willingness of both patients and family members to cooperate with the research treatment plan and follow-up. (6)Comprehensive understanding of the risks and benefits of treatment by research subjects and their families, voluntary participation in the trial, and signing informed consent forms.

排除标准:

(1)合并有影响吞咽功能的其他疾病,如食管肿瘤、格林-巴利综合征、头颈部肿瘤等疾病;或合并有其他影响吞咽功能的情况,如行气管切开术、因病情需要禁食水等; (2)合并严重的心、肺、肝、肾、肿瘤等其他系统疾病;或合并凝血功能异常、血液系统疾病或极度消瘦的恶病质患者; (3)脑卒中的次数≥2次; (4)预期生存时间小于3个月者; (5)现存或可疑吸入性肺炎患者; (6)妊娠或哺乳期妇女; (7)正在参加其他临床试验或已接受其它有关针刺治疗可能影响本研究者。

Exclusion criteria:

(1) Combined with other conditions affecting swallowing function, such as esophageal tumors, Guillain-Barré syndrome, head and neck tumors, etc.; or concurrent with situations impacting swallowing function, such as undergoing tracheostomy or water restriction due to medical reasons. (2) Accompanied by severe systemic diseases like cardiovascular, pulmonary, hepatic, renal disorders, malignancies, or with abnormal coagulation function, hematologic disorders, or cachexia. (3) History of two or more strokes. (4) Anticipated survival of less than 3 months. (5) Existing or suspected cases of aspirational pneumonia. (6) Pregnant or lactating women. (7) Currently participating in other clinical trials or having received other acupuncture treatments that could affect the present study.

研究实施时间:

Study execute time:

From 2023-05-10

To      2024-03-01

征募观察对象时间:

Recruiting time:

From 2023-05-10

To      2024-02-01

干预措施:

Interventions:

组别:

非带针训练组

样本量:

53

Group:

Needling and Training group

Sample size:

干预措施:

针灸+吞吐康复训练

干预措施代码:

2

Intervention:

Training with needles synchronously

Intervention code:

组别:

带针训练组

样本量:

53

Group:

Needling Training group

Sample size:

干预措施:

带针同时进行吞咽训练

干预措施代码:

1

Intervention:

Conduct the swallowing training simultaneously with the needle.

Intervention code:

样本总量 Total sample size : 106

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

单位级别:

三甲医院

Institution/hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution:

Grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

洼田饮水试验

指标类型:

次要指标

Outcome:

water swallowing test, WST

Type:

Secondary indicator

测量时间点:

干预前、干预第2周、结束后第2周、第4周

测量方法:

填写量表

Measure time point of outcome:

Before the intervention, week 2, week 2 and week 4 after the intervention

Measure method:

Fill-out the scale

指标中文名:

标准吞咽功能评价量表

指标类型:

主要指标

Outcome:

standardized swallowing assessment,SSA

Type:

Primary indicator

测量时间点:

干预前、干预第2周、结束后第2周、第4周

测量方法:

填写量表

Measure time point of outcome:

Before the intervention, week 2, week 2 and week 4 after the intervention

Measure method:

Fill-out the scale

指标中文名:

舌骨位移幅度

指标类型:

次要指标

Outcome:

The amplitude of the exhumation of the tongue bone

Type:

Secondary indicator

测量时间点:

干预前、干预第2周

测量方法:

超声定位

Measure time point of outcome:

Before the intervention, week 2

Measure method:

ultrasound localization

指标中文名:

简明健康状况调查表

指标类型:

次要指标

Outcome:

the Short-Form Health Survey,SF-36

Type:

Secondary indicator

测量时间点:

干预前、干预第2周、结束后第2周、第4周

测量方法:

填写量表

Measure time point of outcome:

Before the intervention, week 2, week 2 and week 4 after the intervention

Measure method:

Fill-out the scale

指标中文名:

血氧饱和度变化情况

指标类型:

次要指标

Outcome:

oxygen saturation of blood

Type:

Secondary indicator

测量时间点:

干预前、干预第2周、结束后第2周、第4周受试者完成洼田饮水试验时、完成2min后

测量方法:

指脉氧仪器测量

Measure time point of outcome:

Before the intervention, week 2, week 2 and week 4 after the intervention

Measure method:

Measurement of the finger pulse oxygen instrument

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 100
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):

研究者Qin Qi利用SPSS26软件生成106个随机数字(种子数字为:20230117)

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

Investigator Qin Qi used SPSS26 software to generate 106 random numbers (seed number: 20230117)

盲法:

基于带针训练干预措施的特殊性,无法实现针刺者、患者、康复训练师的盲法,因此我们采用评估者盲法。在分组、对患者进行试验涉及的量表评估、数据统计分析环节由除研究者和患者之外的第三方,且与研究无直接利益关联的专业人员来评定,以减少因主观因素所导致的偏倚,增加试验分组的可信度和重复性。在数据分析环节进行初步揭盲,分析完成后全部揭盲。

Blinding:

Due to the unique nature of acupuncture-based intervention, achieving blinding for acupuncturists, patients, and rehabilitation trainers is unattainable. Therefore, we employed assessor blinding. Group allocation, scale assessments involving patient trials, and data statistical analyses were conducted by a third-party professional unrelated to the study and having no direct vested interest, apart from the researchers and patients. This approach was adopted to mitigate biases stemming from subjective factors, enhancing the credibility and reproducibility of the trial's grouping. Preliminary unblinding was conducted during the data analysis phase, with complete unblinding occurring after the analysis was finalized.

是否共享原始数据:

IPD sharing:

No

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):

使用用临床试验公共管理平台ResMan完成数据管理与公开,公开时间在完成试验1年以内(2023031)。

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

Data management and disclosure were completed using the clinical trial public management platform ResMan, within 1 year of the completion of the trial (2023031).

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:

使用用临床试验公共管理平台ResMan完成数据管理

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

Data management was completed using ResMan, a common clinical trial management platform

数据管理委员会:

Data Managemen Committee:

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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