今天是:2019-06-18 星期二

梁俊杰医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 下肢正压技术对脑卒中后下肢运动功能重建的影响及动态生物力学机制探讨
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注册号:

Registration number:

ChiCTR1900023800 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

梁俊杰医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 下肢正压技术对脑卒中后下肢运动功能重建的影响及动态生物力学机制探讨 

Public title:

Effect of lower-body positive pressure treadmills on rebuilding and dynamic biomechanical mechanism of lower limbs motor function after stroke  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

下肢正压技术对脑卒中后下肢运动功能重建的影响及动态生物力学机制探讨 

Scientific title:

Effect of lower-body positive pressure treadmills on rebuilding and dynamic biomechanical mechanism of lower limbs motor function after stroke  

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:

梁俊杰 

研究负责人:

梁俊杰 

Applicant:

Liang Junjie 

Study leader:

Liang Junjie 

申请注册联系人电话:

Applicant telephone:

+86 13828405123 

研究负责人电话:

Study leader's telephone:

+86 13828405123 

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:

Ljj88961@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ljj88961@qq.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:

中国广东省广州市黄埔区港湾路621号 

研究负责人通讯地址:

中国广东省广州市黄埔区港湾路621号 

Applicant address:

621 Harbour Road, Huangpu District, Guangzhou, Guangdong, China  

Study leader's address:

621 Harbour Road, Huangpu District, Guangzhou, Guangdong, 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:

广州医科大学附属第五医院 

Applicant's institution:

the Fifth Affiliated Hospital of Guangzhou Medical University  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

广州医科大学附属第五医院 

Primary sponsor:

the Fifth Affiliated Hospital of Guangzhou Medical University  

研究实施负责(组长)单位地址:

中国广东省广州市黄埔区港湾路621号 

Primary sponsor's address:

621 Harbour Road, Huangpu District, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第五医院

具体地址:

黄埔区港湾路621号

Institution
hospital:

the Fifth Affiliated Hospital of Guangzhou Medical University

Address:

621 Harbour Road, Huangpu District

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

脑卒中 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本项研究拟通过不同步态分析方法对下肢正压跑台干预卒中后偏瘫进行机制探究,国内外首次使用动态足底压力分析研究脑卒中患者下肢运动功能重建机制,并多角度评估下肢正压跑台的作用靶点,研究结果对于多角度步态分析的推广应用、筛选临床功能评测终点指标及指导个体化及精准化的新型下肢运动康复治疗尤为重要。 

Objectives of Study:

The study intends to research the effect of AlterG anti-gravity treadmill training in stroke patients, and compare to the traditional gait training group for studying the related efficacy and mechanism.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①符合全国第四次脑血管病学术会议自制订的脑卒中诊断标准;②经颅脑CT或MRI证实为脑卒中;③脑卒中导致一侧下肢功能障碍,且使用/不使用助行器下可步行;④Brunnstrom分期3-5期;⑤MMSE≥24分;⑥自愿签署知情同意书。 

Inclusion criteria

1. According to the national stroke diagnostic criteria established by the 4th Cerebrovascular Diseases Conference; 2. Confirmed by CT or MRI as stroke; 3. Lower limb dysfunction caused by stroke, and have a capacity of walk or stand with /without stick; 4. Voluntarily signing up informed consent.  

排除标准:

①无法配合完成实验,存在严重认知功能障碍或失语;②病情不稳定或实验期间出现病情变化,影响实验结果;③合并严重心、肺、肝肾等重要脏器疾病而不能完成实验者;④患有严重精神障碍疾病。 

Exclusion criteria:

1. unable to finish the experiment with serious cognitive impairment or aphasia; 2. The condition of disease is unstable or changes during the experiment and affects the experimental results; 3. Combined with serious heart, lung, liver and kidney and other important organ diseases and unable to finish the experiment; 4. Patients with severe mental disorders.  

研究实施时间:

Study execute time:

From2019-06-10To 2022-12-31 

干预措施:

Interventions:

组别:

LBPP组

样本量:

20

Group:

lower-body positive pressure treadmills group

Sample size:

干预措施:

LBPP跑台

干预措施代码:

1

Intervention:

lower-body positive pressure treadmills

Intervention code:

组别:

传统组

样本量:

20

Group:

Traditional group

Sample size:

干预措施:

传统步态治疗

干预措施代码:

2

Intervention:

Traditional gait intervention

Intervention code:

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):

广州医科大学附属第五医院 

单位级别:

三甲医院 

Institution
hospital:

the Fifth Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

三维运动分析

指标类型:

主要指标 

Outcome:

kinematics analysis

Type:

Primary indicator 

测量时间点:

治疗前,治疗结束后,4周后随访

测量方法:

BTS SMART DX动作捕捉分析系统

Measure time point of outcome:

pre- treatment, post- treatment, follow-up on 4 weeks

Measure method:

BTS SMART DX Motion Capture Analysis System

指标中文名:

起立-行走计时测试

指标类型:

次要指标 

Outcome:

Time up and go test

Type:

Secondary indicator 

测量时间点:

治疗前,治疗结束后,4周后随访

测量方法:

临床功能评估

Measure time point of outcome:

pre- treatment, post- treatment, follow-up on 4 weeks

Measure method:

Clinical function assessment

指标中文名:

肌电分析

指标类型:

主要指标 

Outcome:

electromyogram analysis

Type:

Primary indicator 

测量时间点:

治疗前,治疗结束后,4周后随访

测量方法:

表面肌电刺激

Measure time point of outcome:

pre- treatment, post- treatment, follow-up on 4 weeks

Measure method:

BTS free EMG

指标中文名:

10米步行测试

指标类型:

次要指标 

Outcome:

the 10 meter walk test

Type:

Secondary indicator 

测量时间点:

治疗前,治疗结束后,4周后随访

测量方法:

临床功能评估

Measure time point of outcome:

pre- treatment, post- treatment, follow-up on 4 weeks

Measure method:

Clinical function assessment

指标中文名:

Fugl-Meyer

指标类型:

次要指标 

Outcome:

Fugl-Meyer

Type:

Secondary indicator 

测量时间点:

治疗前,治疗结束后,4周后随访

测量方法:

临床功能评估

Measure time point of outcome:

pre- treatment, post- treatment, follow-up on 4 weeks

Measure method:

Clinical function assessment

指标中文名:

足底压力

指标类型:

主要指标 

Outcome:

Plantar Pressure

Type:

Primary indicator 

测量时间点:

第0、3、6、9、12、15天和4周后随访

测量方法:

Sensor Medica FM16040

Measure time point of outcome:

day0, day3, day6, day9, day12, day15 and follow-up on 4 weeks

Measure method:

Sensor Medica FM16040

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No sample

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 70 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):

计算机软件

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

Computer Software generated

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

2023年6月 请说明共享方式

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

June, 2023 请说明共享方式

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-12
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