穴位注射联合肌电生物反馈治疗脑瘫患儿疗效评价

注册号:

Registration number:

AMCTR-IOR-19000248 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 19:05:54 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

穴位注射联合肌电生物反馈治疗脑瘫患儿疗效评价 

Public title:

Efficacy Evaluation of Acupoint Injection Combined with Electromyographic Biofeedback for Children with Cerebral Palsy 

研究课题的正式科学名称:

穴位注射联合肌电生物反馈治疗脑瘫患儿疗效评价 

Scientific title:

Efficacy Evaluation of Acupoint Injection Combined with Electromyographic Biofeedback for Children with Cerebral Palsy 

研究课题代号(代码):

Study subject ID:

2018020991 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈大帅 

研究负责人:

陈大帅 

Applicant:

Chen Dashuai 

Study leader:

Chen Dashuai 

申请注册联系人电话:

Applicant telephone:

15937740978 

研究负责人电话:

Study leader's telephone:

15937740978 

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:

chendashuai@live.com 

研究负责人电子邮件:

Study leader's E-mail:

chendashuai@live.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:

河南省南阳市宛城区光武中路25号 

研究负责人通讯地址:

河南省南阳市宛城区光武中路25号 

Applicant address:

25 Guangwu Mid Road, Wancheng Area, Nanyang City, Henan, China 

Study leader's address:

25 Guangwu Mid Road, Wancheng Area, Nanyang City, Henan, 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:

南阳市第二人民医院 

Applicant's institution:

Nanyang Second General Hospital 

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:

2019010 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南阳市第二人民医院伦理委员会 

Name of the ethic committee:

Nanyang Second General Hospital ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-03 

研究实施负责(组长)单位:

南阳市第二人民医院 

Primary sponsor:

Nanyang Second General Hospital 

研究实施负责(组长)单位地址:

河南省南阳市宛城区建设东路66号 

Primary sponsor's address:

66 Jianshe East Road, Wancheng Area, Nanyang City, Henan, 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):

河南

市(区县):

南阳市

Country:

China

Province:

Henan

City:

Nanyang

单位(医院):

南阳市第二人民医院

具体地址:

河南省南阳市宛城区建设东路66号

Institution
hospital:

Nanyang Second General Hospital

Address:

66 Jianshe East Road, Wancheng Area, Nanyang City, Henan, China

经费或物资来源:

南阳市第二人民医院 

Source(s) of funding:

Nanyang Second General Hospital 

研究疾病:

脑性瘫痪 

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:

通过穴位注射联合肌电生物反馈对脑瘫患儿康复疗效临床研究,建立起完善的脑瘫儿童临床疗效评价体系,评价穴位注射联合肌电生物反馈治疗脑瘫患儿的临床疗效。 

Objectives of Study:

Through clinical observation on rehabilitation effect of acupoint injection combined with electromyographic biofeedback for children with cerebral palsy, a complete clinical efficacy evaluation system for children with cerebral palsy was established,and evaluate the clinical effect of acupoint injection combined with electromyographic biofeedback for treatment of children with cerebral palsy. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

符合下述诊断标准的患儿,年龄在1岁~6岁 ; ①引起脑瘫的脑损伤为非进行性; ②引起运动障碍的病变部位在脑部; ③症状在婴儿期出现; ④有时合并智力障碍、癫痫、感知觉障碍及其他异常; ⑤除外进行性疾病所致的中枢性运动障碍及正常小儿暂时性的运动发育迟缓。 

Inclusion criteria

Meet the following diagnostic criteria for children, aged 1 to 7 years old: 1. brain damage caused by cerebral palsy is non-progressive; 2. cause movement disorders of the lesion in the brain; 3. symptoms appear in infancy; 4. sometimes combined with mental retardation, epilepsy, sensory disturbance and other abnormalities; 5. except for progressive disease caused by central movement disorders and normal children with temporary developmental delay. 

排除标准:

①排除严重心、肝、肾等全身器质性病变及内分泌和代谢性障碍疾患; ②排除精神病及严重癫痫者; ③排除脑白质营养不良症、婴儿型脊髓性肌萎缩、脊髓一小脑共济失调综合征、遗传代谢性疾病如苯丙酮尿症以及先天性克汀病、先天性脑积水等现代医学通过病因治疗、手术治疗可获显效的病人; ④不配合治疗观察者。 

Exclusion criteria:

1.exclude serious heart, liver, kidney and other systemic organic disease and endocrine and metabolic disorders; 2. exclusion of mental illness and severe epilepsy; 3. exclusion of white matter malnutrition, infantile spinal muscular atrophy, spinal cord cerebellar ataxia syndrome, genetic metabolic diseases such as phenylketonuria and congenital cretinism, congenital hydrocephalus and other modern medicine through the cause Treatment, surgical treatment can be effective patients; 4. not with the treatment of observers. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

观察组

样本量:

36

Group:

Observation Group

Sample size:

干预措施:

穴位注射联合肌电生物反馈

干预措施代码:

Intervention:

Acupoint Injection Combined with Electromyographic Biofeedback

Intervention code:

组别:

对照组

样本量:

36

Group:

Control Group

Sample size:

干预措施:

肌电生物反馈

干预措施代码:

Intervention:

Electromyographic Biofeedback

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

南阳 

Country:

China 

Province:

Henan 

City:

Nanyang 

单位(医院):

南阳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Nanyang Second General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

表面肌电评价

指标类型:

主要指标 

Outcome:

iEMG

Type:

Primary indicator 

指标中文名:

改良Ashworth肌张力分级

指标类型:

次要指标 

Outcome:

The modified Ashworth Scale

Type:

Secondary indicator 

指标中文名:

粗大运动功能评价量表

指标类型:

次要指标 

Outcome:

Gross Motor Function Measure

Type:

Secondary indicator 

指标中文名:

儿童日常生活活动能力量表

指标类型:

次要指标 

Outcome:

Children's Activities of Daily Living Scale

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

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:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 6 years

随机方法(请说明由何人用什么方法产生随机序列):

使用计算机软件进行随机对照分组

性别:

男女均可

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

Randomized controlled grouping was performed by computer software

Gender:

Both

盲法:

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):

课题组于本临床试验所获原始数据将于本试验结束后6个月内在中国针灸试验注册中心进行

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

The original data collected in this study will be shared in 6 months after the end of this study at the Acupuncture-Moxibustion Clinical Trials Registry

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):

数据采集使用病例记录表

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

Case Record Form, CRF

创建人:

Creater Name:

 2019-01-18
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