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前庭功能的步态评估及数字化技术
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注册号：

Registration number：

 ChiCTR1900024353 

最近更新日期：

Date of Last Refreshed on：

 2019-07-06 21:56:55 

注册时间：

Date of Registration：

 2019-07-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

前庭功能的步态评估及数字化技术

Public title：

Gait Assessment and Digitization of Vestibular Function

注册题目简写：

English Acronym：

研究课题的正式科学名称：

前庭功能的步态评估及数字化技术

Scientific title：

Gait Assessment and Digitization of Vestibular Function

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：

于倩茹 

研究负责人：

于淑东 

Applicant：

Yu Qianru 

Study leader：

Yu Shudong 

申请注册联系人电话：

Applicant telephone：

 +86 15953145725

研究负责人电话：

Study leader's
telephone：

+86 13969159389

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：

 15953145725@163.com

研究负责人电子邮件：

Study leader's E-mail：

 yushudong@126.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：

山东省济南市经五纬七路324号

研究负责人通讯地址：

山东省济南市经五纬七路324号

Applicant address：

324 Jing-Wu Wei-Qi Road, Ji'nan, Shandong, China

Study leader's address：

324 Jing-Wu Wei-Qi Road, Ji'nan, Shandong, 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：

山东省立医院

Applicant's institution：

Shandong Provincial Hospital

研究负责人所在单位：

山东省立医院

Affiliation of the Leader：

Shandong Provincial 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：

 LCYJ:NO.2019-110

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：

山东省立医院医学伦理委员会

Name of the ethic committee：

Shandong Provincial Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-05 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

山东省济南市经五纬七路324号

Contact Address of the ethic committee：

324 Jing-Wu Wei-Qi Road, Ji'nan, Shandong, China

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：

山东省立医院

Primary sponsor：

Shandong Provincial Hospital

研究实施负责（组长）单位地址：

山东省济南市经五纬七路324号

Primary sponsor's address：

324 Jing-Wu Wei-Qi Road, Ji'nan, Shandong, 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)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东省立医院

具体地址：

山东省济南市经五纬七路324号

Institution
hospital：

Shandong Provincial Hospital

Address：

324 Jing-Wu Wei-Qi Road, Ji'nan, Shandong, China

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

前庭功能  

Target disease：

Vestibular Function

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

1、建立修改版本动态步态指数（DGI）的测试 - 再测试和评估者之间可靠性以及并发结构有效性，作为前庭功能障碍患者动态平衡的一种指标。 2、初步研究在完成步态任务的过程中，前庭三维传感器在前庭功能障碍患者中的临床应用。  

Objectives of Study：

1. Establish a modified version of the Dynamic Gait Index (DGI) test - Reliability between retest and evaluator and concurrent structural validity as an indicator of dynamic balance in patients with vestibular dysfunction; 2. Preliminary study of the clinical application of vestibular three-dimensional sensors in patients with vestibular dysfunction during the completion of gait tasks.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

既往有已知的神经或肌肉骨骼疾病的诊断史，有可以解释的导致不平衡的一些疾病，例如脑血管意外，帕金森病，心脏病，短暂性脑缺血发作或下肢关节置换等疾病。

Exclusion criteria：

There has been no history of diagnosis of neurological, musculoskeletal or vestibular disorders, and there are no identifiable diseases that cause imbalances, such as cerebrovascular accidents (CVA), Parkinsons Disease (PD), transient ischemic attack (TIA) or lower extremity joint replacement.



(1) 45 subjects with well-diagnosed vestibular dysfunction met the following inclusion criteria:
1) does not have the ability to follow three-step instructions;
2) The ability to provide informed consent;
3) The ability to walk 6 meters (20 feet) without manual assistance;
4) All gait tasks cannot be tolerated and may cause significant discomfort such as excessive fatigue or dizziness.
5) Except those who take drugs with dizziness or vertigo side effects and subjects with cognitive impairment.
(2) 30 healthy volunteers meet the following inclusion criteria:
There have been known history of the diagnosis of neurological or musculoskeletal diseases, and there are some diseases that can explain the imbalance, such as cerebrovascular accidents, Parkinson's disease, heart disease, transient ischemic attack or lower limb joint replacement.






(1) 45 subjects with well-diagnosed vestibular dysfunction met the following inclusion criteria:
1) does not have the ability to follow three-step instructions;
2) The ability to provide informed consent;
3) The ability to walk 6 meters (20 feet) without manual assistance;
4) All gait tasks cannot be tolerated and may cause significant discomfort such as excessive fatigue or dizziness.
5) Except those who take drugs with dizziness or vertigo side effects and subjects with cognitive impairment.
(2) 30 healthy volunteers meet the following inclusion criteria:
There have been known history of the diagnosis of neurological or musculoskeletal diseases, and there are some diseases that can explain the imbalance, such as cerebrovascular accidents, Parkinson's disease, heart disease, transient ischemic attack or lower limb joint replacement.





(1) 45 subjects with well-diagnosed vestibular dysfunction met the following inclusion criteria:
1) does not have the ability to follow three-step instructions;
2) The ability to provide informed consent;
3) The ability to walk 6 meters (20 feet) without manual assistance;
4) All gait tasks cannot be tolerated and may cause significant discomfort such as excessive fatigue or dizziness.
5) Except those who take drugs with dizziness or vertigo side effects and subjects with cognitive impairment.
(2) 30 healthy volunteers meet the following inclusion criteria:
There have been known history of the diagnosis of neurological or musculoskeletal diseases, and there are some diseases that can explain the imbalance, such as cerebrovascular accidents, Parkinson's disease, heart disease, transient ischemic attack or lower limb joint replacement.




There have been known history of the diagnosis of neurological or musculoskeletal diseases, and there are some diseases that can explain the imbalance, such as cerebrovascular accidents, Parkinson's disease, heart disease, transient ischemic attack or lower limb joint replacement







There have been known history of the diagnosis of neurological or musculoskeletal diseases, and there are some diseases that can explain the imbalance, such as cerebrovascular accidents, Parkinson's disease, heart disease, transient ischemic attack or lower limb joint replacement

研究实施时间：

Study execute time：

从 From 2018-06-01 00:00:00至 To 2020-06-06 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-11-01 00:00:00 至 To 2019-06-01 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

修改版本动态步态指数（DGI）

Index test:

modified version of the Dynamic Gait Index (DGI) test

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

前庭功能障碍患者

例数:

Sample size:

45

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

patients with vestibular dysfunction

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

例数:

Sample size:

30

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东省立医院 

单位级别：

 三甲等医院 

Institution
hospital：

Shandong Provincial Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

修改版本动态步态指数

指标类型：

主要指标

Outcome：

Dizziness Handicap Inventory

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

眩晕障碍量表

指标类型：

主要指标

Outcome：

Dizziness Handicap Inventory

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

定时起立和行走试验

指标类型：

主要指标

Outcome：

TheTimed Up & Go Test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SEN, SPE, ACC, AUC of ROC

指标类型：

次要指标

Outcome：

SEN, SPE, ACC, AUC of ROC

Type：

Secondary 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 岁 years
最大 Max age 80 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

通过ResMan提供原始数据查询

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：

采用Excel保存数据；SPSS软件分析数据

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

The data will be managed by Excel and analyzed by the software SPSS.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2019-07-06 21:56:55
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