ChiCTR2100047113 版本V1.4 版本创建时间2022/01/23 19:47:10 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100047113 

最近更新日期：

Date of Last Refreshed on：

2022-01-23 19:26:13 

注册时间：

Date of Registration：

2021-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Exploring Mechanism of Falls and Fall-prevention Strategies in Older Fallers and Older Non-Fallers with Neuromuscular, Sonographic and Biomechanical Analysis.

Public title：

Exploring Mechanism of Falls and Fall-prevention Strategies in Older Fallers and Older Non-Fallers with Neuromuscular, Sonographic and Biomechanical Analysis.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: a randomized controlled trial

Scientific title：

Exploring Mechanism of Falls and Fall-prevention Strategies in Older Fallers and Older Non-Fallers with Neuromuscular, Sonographic and Biomechanical Analysis.

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：

ZHU Tanglong 

研究负责人：

MA Zonghao 

Applicant：

ZHU Tanglong 

Study leader：

MA Zonghao 

申请注册联系人电话：

Applicant telephone：

+852 95117947

研究负责人电话：

Study leader's telephone：

+852 27667671

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：

20031257r@connect.polyu.hk

研究负责人电子邮件：

Study leader's E-mail：

czh.ma@polyu.edu.hk

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：

中國香港九龍紅磡育才道11號

研究负责人通讯地址：

中國香港九龍紅磡育才道11號

Applicant address：

11 Yu Choi Road, Hung Hom, Kowloon, Hong Kong, China

Study leader's address：

11 Yu Choi Road, Hung Hom, Kowloon, Hong Kong, 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：

香港理工大學

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大學

Affiliation of the Leader：

The Hong Kong Polytechnic University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HSEARS20210122001

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：

Human Subjects Ethics Sub-committee (HSESC) of The Hong Kong Polytechnic University

Name of the ethic committee：

Human Subjects Ethics Sub-committee (HSESC) of The Hong Kong Polytechnic University

伦理委员会批准日期：

Date of approved by ethic committee：

2021-02-25 00:00:00

伦理委员会联系人：

Research Office of The Hong Kong Polytechnic University

Contact Name of the ethic committee：

Research Office of The Hong Kong Polytechnic University

伦理委员会联系地址：

香港九龍紅磡育才道11號

Contact Address of the ethic committee：

11 Yu Choi Road, Hung Hom, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 27665111

伦理委员会联系人邮箱：

Contact email of the ethic committee：

polyu@polyu.edu.hk

研究实施负责（组长）单位：

香港理工大學

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

香港九龍紅磡育才道11號

Primary sponsor's address：

11 Yu Choi Road, Hung Hom, Kowloon, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

九龍

Country：

China

Province：

Hong Kong SAR

City：

Kowloon

单位(医院)：

Department of Biomedical Engineering

具体地址：

11 Yu Choi Road, Hung Hom, Kowloon

Institution
hospital：

Department of Biomedical Engineering

Address：

11 Yu Choi Road, Hung Hom, Kowloon

经费或物资来源：

The Hong Kong Polytechnic University

Source(s) of funding：

The Hong Kong Polytechnic University

Target disease：

Falls in elderly people

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：

0

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

This project in the long run aims to identify the more rooted fall-risk factors in elderly people, thus guiding a more effective fall-prevention program for future implementation. Specifically, the objectives of study are: 1. To determine whether the muscular characteristics measured by mechanomyography (MMG) could differentiate the older community-dwelling fallers from non-fallers; 2. To identify the neural and contractile attribution to the older fallers static reactive balance response, by detecting whether the differences of neuromuscular onset-time delays existed between the community-dwelling elders with and without history of falls; 3. To find out to what extent the maximal neuromuscular and kinetic capacity is utilized in response to unexpected perturbations in older community-dwelling people with different previous histories of falls.  

Objectives of Study：

This project in the long run aims to identify the more rooted fall-risk factors in elderly people, thus guiding a more effective fall-prevention program for future implementation. Specifically, the objectives of study are: 1. To determine whether the muscular characteristics measured by mechanomyography (MMG) could differentiate the older community-dwelling fallers from non-fallers; 2. To identify the neural and contractile attribution to the older fallers static reactive balance response, by detecting whether the differences of neuromuscular onset-time delays existed between the community-dwelling elders with and without history of falls; 3. To find out to what extent the maximal neuromuscular and kinetic capacity is utilized in response to unexpected perturbations in older community-dwelling people with different previous histories of falls.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Aged > 65 years;
2. Independent living and able to walk >400 meters without assistive tools;
3. willing to participate in this study and sign the written informed consent form.

Inclusion criteria

1. Aged > 65 years;
2. Independent living and able to walk >400 meters without assistive tools;
3. Willing to participate in this study and sign the written informed consent form.

排除标准：

1. Living in hospitals or other institutional residences for >6 months in the past one year;
2. Having experienced falling due to the traffic or occupational accident(s);
3. Cognitive impairment manifested by the score of Mini-Mental State Exam <24;
4. Any significant impairments (e.g. neuromuscular, orthopedic or cardiopulmonary disorders) that limit physical activities;
5. Having participated in any structured vigorous exercise or strengthening regimen in the past one year.

Exclusion criteria：

1. Living in hospitals or other institutional residences for > 6 months in the past one year;
2. Having experienced falling due to the traffic or occupational accident(s);
3. Cognitive impairment manifested by the score of Mini-Mental State Exam < 24;
4. Any significant impairments (e.g. neuromuscular, orthopedic or cardiopulmonary disorders) that limit physical activities;
5. Having participated in any structured vigorous exercise or strengthening regimen in the past one year.

研究实施时间：

Study execute time：

从 From 2020-09-01 00:00:00至 To 2022-08-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-06-20 00:00:00 至 To 2022-08-30 00:00:00  

干预措施：

Interventions：

组别：

Older fallers (i.e., older people with falling history)

样本量：

69

Group：

Older fallers (i.e., older people with falling history)

Sample size：

干预措施：

Laboratory-induced balance perturbation

干预措施代码：

Intervention：

Laboratory-induced balance perturbation

Intervention code：

组别：

Older non-fallers (i.e., older people without falling history)

样本量：

69

Group：

Older non-fallers (i.e., older people without falling history)

Sample size：

干预措施：

Laboratory-induced balance perturbation

干预措施代码：

Intervention：

Laboratory-induced balance perturbation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

Department of Biomedical Engineering 

单位级别：

大学 

Institution
hospital：

Department of Biomedical Engineering

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Muscle Architecture data of lower limb

指标类型：

主要指标

Outcome：

Muscle Architecture data of lower limb

Type：

Primary indicator

测量时间点：

Real-time recording during the balance perturbation trial

测量方法：

Sonomyography (i.e., Muscular ultrasound imaging)

Measure time point of outcome：

Real-time recording during the balance perturbation trial

Measure method：

Sonomyography (i.e., Muscular ultrasound imaging)

指标中文名：

Neuromuscular data of lower limb

指标类型：

主要指标

Outcome：

Neuromuscular data of lower limb

Type：

Primary indicator

测量时间点：

Real-time recording during the balance perturbation trial

测量方法：

EMG and Mechanomyography (MMG)

Measure time point of outcome：

Real-time recording during the balance perturbation trial

Measure method：

EMG and Mechanomyography (MMG)

指标中文名：

Kinematic and Kinetic data

指标类型：

主要指标

Outcome：

Kinematic and Kinetic data

Type：

Primary indicator

测量时间点：

Real-time recording during the balance perturbation trial

测量方法：

3D Motion Capture and Analysis System

Measure time point of outcome：

Real-time recording during the balance perturbation trial

Measure method：

3D Motion Capture and Analysis System

指标中文名：

Level of physical activity

指标类型：

次要指标

Outcome：

Level of physical activity

Type：

Secondary indicator

测量时间点：

Before perturbation trials

测量方法：

Physical Activity Scale for the Elderly (PASE)

Measure time point of outcome：

Before perturbation trials

Measure method：

Physical Activity Scale for the Elderly (PASE)

指标中文名：

Score (Fear of Falling)

指标类型：

次要指标

Outcome：

Score (Fear of Falling)

Type：

Secondary indicator

测量时间点：

Before perturbation trials

测量方法：

The Falls Efficacy Scale International (FES-I)

Measure time point of outcome：

Before perturbation trials

Measure method：

The Falls Efficacy Scale International (FES-I)

指标中文名：

Score (Balance capability)

指标类型：

次要指标

Outcome：

Score (Balance capability)

Type：

Secondary indicator

测量时间点：

Before perturbation trials

测量方法：

The Berg Balance Scale (BBS)

Measure time point of outcome：

Before perturbation trials

Measure method：

The Berg Balance Scale (BBS)

指标中文名：

Clinical demographic assessment (weight, height etc.)

指标类型：

次要指标

Outcome：

Clinical demographic assessment (weight, height etc.)

Type：

Secondary indicator

测量时间点：

Before perturbation trials

测量方法：

Weight scale, tape, caliper, etc.

Measure time point of outcome：

Before perturbation trials

Measure method：

Weight scale, tape, caliper, etc.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

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 65 岁 years
最大 Max age 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）：

1. For each subject, the sequence of three perturbation trials of different magnitudes will be determined by random number generation. 2. For each magnitude of trial, the directions and time intervals of twelve pulls will be randomized.

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

1. For each subject, the sequence of three perturbation trials of different magnitudes will be determined by random number generation. 2. For each magnitude of trial, the directions and time intervals of twelve pulls will be randomized.

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：

One tester will evaluate the participant's fall status and code the participant so that other testers who conduct MVIC trials and waist-pull trials will be blinded to the participant's fall status.

Blinding：

One tester will evaluate the participant's fall status and code the participant so that other testers who conduct MVIC trials and waist-pull trials will be blinded to the participant's fall status.

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

Yes

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）：

IPD will be uploaded to this Clinical Trial Registry platform within six months after completion.

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

IPD will be uploaded to this Clinical Trial Registry platform within six months after completion.

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：

Data will be collected through fundamental demographic assessment and real-time objective detection. Data will be kept by the research personnel of this study.

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

Data will be collected through fundamental demographic assessment and real-time objective detection. Data will be kept by the research personnel of this study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-06-08 02:21:53