Today is 2020-07-05

Effectiveness of radial extracorporeal shockwave therapy dosages on chronic stroke patients with upper limb spasticity
download

注册号:

Registration number:

ChiCTR2000030496 

最近更新日期:

Date of Last Refreshed on:

2020-03-05 

注册时间:

Date of Registration:

2020-03-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

发散状体外冲击波治疗伴有上肢痉挛的慢性脑卒中病人的疗效:随机对照试验 

Public title:

Effectiveness of radial extracorporeal shockwave therapy dosages on chronic stroke patients with upper limb spasticity 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

发散状体外冲击波治疗伴有上肢痉挛的慢性脑卒中病人的疗效:随机对照试验 

Scientific title:

Effectiveness of radial extracorporeal shockwave therapy dosages on chronic stroke patients with upper limb spasticity, a randomized control trial 

研究课题代号(代码):

Study subject ID:

2016ZDXM009 

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:

Jinga Ana Maria Ramona 

研究负责人:

虞乐华 

Applicant:

Jinga Ana Maria Ramona 

Study leader:

Yu Le-Hua 

申请注册联系人电话:

Applicant telephone:

+86 18623565195 

研究负责人电话:

Study leader's telephone:

+86 13896179179 

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:

AnA_MiCkYe54@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

300895@hospital.cqmu.edu.cm 

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:

中国重庆市渝中区临江路76号 

研究负责人通讯地址:

中国重庆市渝中区临江路76号 

Applicant address:

76 Linjiang Road, Yuzhong District, Chongqing, China 

Study leader's address:

76 Linjiang Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属第二医院 

Applicant's institution:

Second Affiliated Hospital of Chongqing Medical University 

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:

(2019)342 

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:

重庆医科大学附属第二医院医学伦理委员会 

Name of the ethic committee:

The ethics committee of Second Affiliated Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-25 

伦理委员会联系人:

重庆医科大学附属第二医院医学伦理委员会 

Contact Name of the ethic committee:

The ethics committee of Second Affiliated Hospital of Chongqing Medical University 

伦理委员会联系地址:

重庆医科大学附属第二医院 

Contact Address of the ethic committee:

Second Affiliated Hospital of Chongqing Medical University 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 63693662 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

重庆医科大学附属第二医院 

Primary sponsor:

Second Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

中国重庆市渝中区临江路76号 

Primary sponsor's address:

76 Linjing Road, Yuzhong District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

重庆市卫生健康委员会 

Source(s) of funding:

Chongqing Municipal Health Committee 

研究疾病:

卒中 

Target disease:

Stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

The purpose of this study is to determine the optimal dosage of rESW sessions and also to investigate the effects and long-term effects of radial ESW on upper limb muscles affected by spasticity in patients with chronic stroke. 

Objectives of Study:

The purpose of this study is to determine the optimal dosage of rESW sessions and also to investigate the effects and long-term effects of radial ESW on upper limb muscles affected by spasticity in patients with chronic stroke. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机抽样 

Study design:

Randomly Sampling 

纳入标准:

(1) Inpatient stroke rehabilitation center, who gave their written informed consent; (2) Aged between 18 and 80 years; (3) Patients who has at least Modified Ashworth Scale (MAS) +1; (4) Stroke patients whose duration of disease has been more than 6 months; (5) Patients who had not had BTX-A injections before 2 months; (6) Patients with stable spasticity (no variability 2 months before recruitment); (7) Patients with first episode of unilateral stroke with hemiparesis; (8) Patients with ability to understand instructions and medically stable. 

Inclusion criteria

(1) Inpatient stroke rehabilitation center, who gave their written informed consent; (2) Aged between 18 and 80 years; (3) Patients who has at least Modified Ashworth Scale (MAS) +1; (4) Stroke patients whose duration of disease has been more than 6 months; (5) Patients who had not had BTX-A injections before 2 months; (6) Patients with stable spasticity (no variability 2 months before recruitment); (7) Patients with first episode of unilateral stroke with hemiparesis; (8) Patients with ability to understand instructions and medically stable. 

排除标准:

(1) Participation in other trials; (2) Patients with fixed contractures; (3) Patients with presence of contraindications for rESW stimulation (pregnancy, cancer, local tumors, coagulation disorders, acute and recurent inflamatory states or pacemakers and other electronic implants); (4) Other disorders or clinical conditions (strong aphasia, serious problems with comunication and episodes of hyperesthesia); (5) A condition other than stroke etiology of spasticity (traumatic brain injury, multiple sclerosis or cerebral palsy). 

Exclusion criteria:

(1) Participation in other trials; (2) Patients with fixed contractures; (3) Patients with presence of contraindications for rESW stimulation (pregnancy, cancer, local tumors, coagulation disorders, acute and recurent inflamatory states or pacemakers and other electronic implants); (4) Other disorders or clinical conditions (strong aphasia, serious problems with comunication and episodes of hyperesthesia); (5) A condition other than stroke etiology of spasticity (traumatic brain injury, multiple sclerosis or cerebral palsy). 

研究实施时间:

Study execute time:

From2019-01-15To 2019-07-10 

干预措施:

Interventions:

组别:

Group A

样本量:

20

Group:

Group A

Sample size:

干预措施:

Radial Extracorporeal Shockwave

干预措施代码:

Intervention:

Radial Extracorporeal Shockwave

Intervention code:

组别:

Group B

样本量:

20

Group:

Group B

Sample size:

干预措施:

Radial Extracorporeal Shockwave

干预措施代码:

Intervention:

Radial Extracorporeal Shockwave

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Modified Ashworth Scale

指标类型:

主要指标 

Outcome:

Modified Ashworth Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Fugl-Meyer Assessment

指标类型:

主要指标 

Outcome:

Fugl-Meyer Assessment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

The Barthel Index

指标类型:

主要指标 

Outcome:

The Barthel Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

surface EMG

指标类型:

主要指标 

Outcome:

surface EMG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Computarized random generator software

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

Computarized random generator software

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

ResMan临床试验公共管理平台

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

IPD will be public accessable via ResMan

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:

No

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

No

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-05
return list