多模态MRI联合动态脑电图分析补肾健脑针法对脑瘫患儿脑功能的影响

注册号:

Registration number:

AMCTR-IOR-19000280 

注册号获得时间:

Date of releasing the registration number:

2019/7/15 23:38:28 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

多模态MRI联合动态脑电图分析补肾健脑针法对脑瘫患儿脑功能的影响 

Public title:

Effect of Tonifying Kidney and Invigorating Brain Acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram 

研究课题的正式科学名称:

多模态MRI联合动态脑电图分析补肾健脑针法对脑瘫患儿脑功能的影响 

Scientific title:

Effect of Tonifying Kidney and Invigorating Brain Acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram 

研究课题代号(代码):

Study subject ID:

BE2017769 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

鲍超 

研究负责人:

鲍超 

Applicant:

Bao Chao 

Study leader:

Bao Chao 

申请注册联系人电话:

Applicant telephone:

+86 13951933623 

研究负责人电话:

Study leader's telephone:

+86 13951933623 

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:

drbaochao@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drbaochao@163.com 

申请单位网址(自愿提供):

Applicant 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:

江苏省南京市秦淮区汉中路155号 

研究负责人通讯地址:

江苏省南京市秦淮区汉中路155号 

Applicant address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, 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:

南京中医药大学附属医院 

Applicant's institution:

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017NL-115-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京中医药大学附属医院(江苏省中医院)伦理委员会 

Name of the ethic committee:

the ethic committee of Affiliated Hospital of Nanjing University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-26 

研究实施负责(组长)单位:

南京中医药大学附属医院 

Primary sponsor:

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号 

Primary sponsor's address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, 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):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京中医药大学附属医院

具体地址:

江苏省南京市秦淮区汉中路155号

Institution
hospital:

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Address:

155 Hanzhong Road, Qinhuai District, Nanjing, Jiangsu, China

经费或物资来源:

江苏省科技厅 

Source(s) of funding:

Science and Technology Department of JiangSu Province 

研究疾病:

脑瘫 

Target disease:

Cerebral palsy 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

1.完善针灸干预痉挛型脑瘫患儿的有效康复模式; 2.评价多模态MRI联合动态脑电图研究痉挛型脑瘫儿童脑功能的可行性及有效性,建立针灸干预痉挛型脑瘫疗效评价的功能影像学方法。 

Objectives of Study:

1. Improve the effective rehabilitation mode of acupuncture and moxibustion for children with spastic cerebral palsy; 2. Evaluate the feasibility and effectiveness of multimodal MRI combined with dynamic electroencephalography in the study of brain function in children with spastic cerebral palsy, and establish a functional imaging method for evaluating the efficacy of acupuncture in the treatment of spastic cerebral palsy. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 符合脑瘫的诊断标准;分型属痉挛型; 2. 年龄大于6个月,不超过7周岁; 3. 自愿作为受试对象,并由患儿监护人签署知情同意书。 

Inclusion criteria

1. Meet the diagnostic criteria of cerebral palsy; the classification is sputum type; 2. The age is greater than 6 months and not more than 7 years old; 3. Volunteer as the subject, and the informed consent form is signed by the guardian of the child. 

排除标准:

1.病情分级为极重度脑瘫痉挛型; 2.合并有严重的器质性疾病(先天性心脏病、脑水肿、颅压高、肝肾功能不全、精神病)或同时患有慢性传染性疾病 

Exclusion criteria:

1.extremely severe sputum type of cerebral palsy; 2.Complicated with serious organic diseases (congenital heart disease, cerebral edema, high intracranial pressure, liver and kidney dysfunction, mental illness) or chronic infectious diseases. 

研究实施时间:

Study execute time:

From2017-07-01To 2020-06-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

36

Group:

Experimental group

Sample size:

干预措施:

补肾健脑针法结合常规康复训练

干预措施代码:

Intervention:

Tonifying Kidney and Invigorating Brain Acupuncture combined with routine rehabilitation training

Intervention code:

组别:

对照组

样本量:

36

Group:

control group

Sample size:

干预措施:

常规康复训练

干预措施代码:

Intervention:

routine rehabilitation training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京市 

Country:

China 

Province:

 

City:

 

单位(医院):

南京中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

多模态MR联合动态脑电图

指标类型:

主要指标 

Outcome:

multi-modality MRI combined with dynamic electroencephalogram

Type:

Primary indicator 

指标中文名:

格赛尔发育诊断量表

指标类型:

主要指标 

Outcome:

GESELL

Type:

Primary indicator 

指标中文名:

粗大运动功能分级系统

指标类型:

次要指标 

Outcome:

GMFCS

Type:

Secondary indicator 

指标中文名:

粗大功能评定量表

指标类型:

次要指标 

Outcome:

GMFM

Type:

Secondary indicator 

指标中文名:

儿童功能独立性评估量表

指标类型:

次要指标 

Outcome:

WeeFIM

Type:

Secondary indicator 

指标中文名:

改良Ashworth量表

指标类型:

次要指标 

Outcome:

MAS

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 7 years

随机方法(请说明由何人用什么方法产生随机序列):

南京中医药大学附属医院数据数据中心王晓骁采用R 3.0.3软件设计随机程序,由R随机程序产生的“处理组随机数字”。

性别:

男女均可

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

Wang Xiaoxiao,a member of Data Center of Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, used R 3.0.3 software to design a random program, “random number of processing group” generated by R random program.

Gender:

Both

盲法:

未说明

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2021年; ResMan;网址:http://www.medresman.org/uc/project/projectlistauthor.aspx

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

2021; ResMan;http://www.medresman.org/uc/project/projectlistauthor.aspx

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

电子采集和管理系统

The repository and management of the data(Please specify what repository will be used for management of the metadata):

(Electronic Data Capture,EDC)

创建人:

Creater Name:

 2019-07-15
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