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Study for fall assessment and early warning system in elderly population
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注册号:

Registration number:

ChiCTR1900022685 

最近更新日期:

Date of Last Refreshed on:

2019-04-21 

注册时间:

Date of Registration:

2019-04-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

老年人群跌倒评估和预警系统的研究 

Public title:

Study for fall assessment and early warning system in elderly population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

老年人群跌倒评估和预警系统的研究 

Scientific title:

Study for fall assessment and early warning system in elderly population 

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:

张玉梅 

研究负责人:

张玉梅 

Applicant:

Zhang Yumei 

Study leader:

Zhang Yumei 

申请注册联系人电话:

Applicant telephone:

+86 13983655689 

研究负责人电话:

Study leader's telephone:

+86 13983655689 

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:

zhangyumei19693@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyumei19693@sina.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:

重庆市沙坪坝区新桥正街183号 

研究负责人通讯地址:

重庆市沙坪坝区新桥正街183号 

Applicant address:

183 Xinqiao Main Street, Shapingba District, Chongqing  

Study leader's address:

183 Xinqiao Main Street, Shapingba District, Chongqing  

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:

第三军医大学新桥医院骨科 

Applicant's institution:

Orthopedic department of TMMU  

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:

第三军医大学新桥医院骨科 

Primary sponsor:

Orthopedic department of TMMU  

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥正街183号 

Primary sponsor's address:

183 Xinqiao Main Street, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学附属第二医院

具体地址:

重庆市沙坪坝区新桥正街

Institution
hospital:

Orthopedic department of TMMU

Address:

183 Xinqiao Main Street, Chongqing, China

经费或物资来源:

课题经费 

Source(s) of funding:

Project funding 

研究疾病:

跌倒风险 

Target disease:

the risk of falls 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.研发与智能鞋垫(项目合作单位已做出样品)配套的数据传输和处理软件系统。此系统能够传送和接受基于NB-IoT窄带物联网技术的无线数据,并对数据进行实时处理(延时<1分钟),建立并提供数据图表曲线供医用分析数据库。 2.获得重庆地区老年人跌倒预警阈值。智能鞋垫对于老年人群跌倒有较好的评估预测能力,且其预测能力不低于TUGT。将研究结果运用于预警系统,且可与数据库随时完成数据的传输和更新。 

Objectives of Study:

1.To develop the transmission system and processing software concerning intelligent shoe-pad (model already made) . the system which transmits and receives the data based on the internet wireless technology of NB-loT narrow-band can process the real-time data (latency < 1 minute) and establish dynamic graphs for medical analysis. 2.To obtain the warning threshold of the fallen elderly in Chongqing. The date from shoe-pals can well predict the possibility of the fallen elderly which is not lower than TUGT. The results applied to the warning system integrate dynamic date and updated . 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.年龄≥60岁;2.听力和意识基本正常;3.有基本的沟通和理解能力;4.知情同意。 

Inclusion criteria

1. aged more than 60 years; 2. hearing and consciousness are basically normal; 3. have the capacity to communication and understanding; 4. sign informed consent.  

排除标准:

1.患有严重影响活动、行走的骨关节或其它疾病;2.患有影响正常穿戴智能鞋垫或参数收集的足部疾病如足弓、足趾畸形;3.患有精神疾病或精神疾病家族史;4.患有痴呆和认知功能障碍;5.患有其它严重疾病(或疾病急性或加重阶段)如心衰、COPD急性加重期、肝肾功能不全、脑血管疾病等。 

Exclusion criteria:

1. Patients have dysfunctionaljoints and other diseases severely affecting moving and walking and other daily activities; 2. Patients who have foot diseases such as arch and toe deformity which disrupts the pad to date collecting, should be excluded; 3. Patients have mental illness or related family history; 4. Patients have dementia and cognitive impairment; 5. Patients have any other severe diseases with acute or progressive stages,like heart failure, acute exacerbation of COPD, hepatic and renal insufficiency, cerebrovascular diseases, etc.  

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

900

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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:

 

单位(医院):

第三军医大学新桥医院骨科 

单位级别:

三级甲等 

Institution
hospital:

Orthopedic department of TMMU  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

计时起立行走测试完成时间

指标类型:

主要指标 

Outcome:

TUGT completion time

Type:

Primary indicator 

测量时间点:

测量方法:

受测者坐在有扶手的靠背椅子上(椅高约46 cm)。在离座椅3m远的地面上放置标志杆。当测试者发出“开始”的指令后,受测者从靠背椅上站起,以正常步态,向前走至标志杆处,然后再走回到椅子前并转身坐下,身体靠到椅背上。测试者记录受测者背部离开椅背到再次坐下(臀部触到椅面)所用的时间,以s为单位。测试进行3次,测试间隔体息1min,本研究以3次测试时间的平均值作为测试结果。

Measure time point of outcome:

Measure method:

指标中文名:

足底压力参数

指标类型:

主要指标 

Outcome:

Plantar pressure parameters

Type:

Primary indicator 

测量时间点:

测量方法:

智能鞋垫内置的感应元件将记录相应部位压力,并计算区域峰值压力值(Fmax)、足底压力曲线、区域峰值压强值(Pmax)、足底测定区域压强—时间积分值(Pt)、人体向地面施加压力的作用点轨迹(Cop轨迹)

Measure time point of outcome:

Measure method:

指标中文名:

跌倒记录

指标类型:

主要指标 

Outcome:

Fall record

Type:

Primary indicator 

测量时间点:

2年内

测量方法:

有无跌倒发生、跌倒次数以及发生跌倒时间与环境

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

公众在2021年起即可以通过科室电话、博客及微信链接方式查询其相关数据

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

The public can click the link of data through blog and WeChat, or call us since Jan 1, 2021.

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:

使用EpiData进行数据创建、保存及管理。

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

We use the Epidata to manage the data of this project.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-21
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