ChiCTR2500099547 版本V1.0 版本创建时间2025/03/25 16:07:20 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：

 ChiCTR2500099547 

最近更新日期：

Date of Last Refreshed on：

 2025-03-25 16:07:13 

注册时间：

Date of Registration：

 2025-03-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

Public title：

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

Scientific title：

Smart digitalized intervention for fall prevention of older adults in residential care facilities: a feasibility study and pilot randomized controlled trial (RCT)

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：

Li Kejing 

研究负责人：

Ma Zonghao 

Applicant：

Li Kejing 

Study leader：

Ma Zonghao 

申请注册联系人电话：

Applicant telephone：

 +852 6573 5385

研究负责人电话：

Study leader's
telephone：

+852 2766 7671

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：

 21039876r@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：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

研究负责人通讯地址：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

Applicant address：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

Study leader's address：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

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：

Department of Biomedical Engineering, The Hong Kong Polytechnic University

Applicant's institution：

Department of Biomedical Engineering, The Hong Kong Polytechnic University

研究负责人所在单位：

Department of Biomedical Engineering, The Hong Kong Polytechnic University

Affiliation of the Leader：

Department of Biomedical Engineering, The Hong Kong Polytechnic 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：

 HSEARS20240819003

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：

The PolyU Institutional Review Board

Name of the ethic committee：

The PolyU Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-12 00:00:00

伦理委员会联系人：

Tracy Tang

Contact Name of the ethic committee：

Tracy Tang

伦理委员会联系地址：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

Contact Address of the ethic committee：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3400 8541

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：

The Hong Kong Polytechnic University

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

Primary sponsor's address：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Hong Kong Polytechnic University

具体地址：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

Institution
hospital：

The Hong Kong Polytechnic University

Address：

The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong

经费或物资来源：

Health and Medical Research Fund - Research Fellowship Scheme (Reference number: 09230037)

Source(s) of funding：

Health and Medical Research Fund - Research Fellowship Scheme (Reference number: 09230037)

研究疾病：

Fall in older adults  

Target disease：

Fall in older adults

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. The primary aim of the proposed study is to investigate the effect of a 16-week integrated Otago Exercise Program with an AI-embedded smart wearable system on balance control, functional mobility, physical activity level, exercise self-efficacy, and other health outcomes for older adults at individual level in residential care facilities. 2. The secondary aim is to examine how participants perceive their experience in the program to understand their concerns, challenges, and long-term engagement.  

Objectives of Study：

1. The primary aim of the proposed study is to investigate the effect of a 16-week integrated Otago Exercise Program with an AI-embedded smart wearable system on balance control, functional mobility, physical activity level, exercise self-efficacy, and other health outcomes for older adults at individual level in residential care facilities. 2. The secondary aim is to examine how participants perceive their experience in the program to understand their concerns, challenges, and long-term engagement.

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. 65 years or older； 2. Living in residential care facilities； 3. cannot finish chair stand test in 14s； 4. have a score lower than 9 in Short Physical Performance Battery.

Inclusion criteria

1. 65 years or older; 2. Living in residential care facilities; 3. cannot finish chair stand test in 14s; 4. have a score lower than 9 in Short Physical Performance Battery.

排除标准：

1. Need an assistive device to ambulate indoors; 2. Have been hospitalized for >6 months in the past one year; 3. Have a history of any neurological disorders or general medical or musculoskeletal problems that limited functional activities, or have undergone orthopedic surgery to the joints of trunk and/or lower limbs, any current injuries, significant foot deformities; 4. Have severe vision or hearing difficulties or cognitive impairment (Mini Mental State Exam score <24) that limited activities of daily living or communication.

Exclusion criteria：

1. Need an assistive device to ambulate indoors; 2. Have been hospitalized for >6 months in the past one year; 3. Have a history of any neurological disorders or general medical or musculoskeletal problems that limited functional activities, or have undergone orthopedic surgery to the joints of trunk and/or lower limbs, any current injuries, significant foot deformities; 4. Have severe vision or hearing difficulties or cognitive impairment (Mini Mental State Exam score <24) that limited activities of daily living or communication.

研究实施时间：

Study execute time：

从 From 2025-04-19 00:00:00至 To 2026-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-21 00:00:00 至 To 2026-10-01 00:00:00

干预措施：

Interventions：

组别：

IOEP Group

样本量：

 24

Group：

IOEP Group

Sample size：

干预措施：

The integrated Otago Exercise Program (IOEP) group will receive a multimodal exercise program with a smart wearable system

干预措施代码：

Intervention：

The integrated Otago Exercise Program (IOEP) group will receive a multimodal exercise program with a smart wearable system

Intervention code：

组别：

CON Group

样本量：

 24

Group：

CON Group

Sample size：

干预措施：

The control (CON) group will receive the conventional Otago Exercise Program in equivalent contents and time frame as the IOEP group, but without the smart wearable system

干预措施代码：

Intervention：

The control (CON) group will receive the conventional Otago Exercise Program in equivalent contents and time frame as the IOEP group, but without the smart wearable system

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong  

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Hong Kong Polytechnic University 

单位级别：

 University 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Kinematics data

指标类型：

主要指标

Outcome：

Kinematics data

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Foot plantar-force data

指标类型：

主要指标

Outcome：

Foot plantar-force data

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Clinical Scales

指标类型：

主要指标

Outcome：

Clinical Scales

Type：

Primary indicator

测量时间点：

测量方法：

Mini-Balance Evaluation Systems Test (Mini-BESTest), Short Physical Performance Performance Battery (SPPB), etc.

Measure time point of outcome：

Measure method：

Mini-Balance Evaluation Systems Test (Mini-BESTest), Short Physical Performance Performance Battery (SPPB), etc.

指标中文名：

Questionnaires

指标类型：

次要指标

Outcome：

Questionnaires

Type：

Secondary indicator

测量时间点：

测量方法：

Falls Efficacy Scale, Internationnal Physical Activity Questionnaire (IPAQ), etc.

Measure time point of outcome：

Measure method：

Falls Efficacy Scale, Internationnal Physical Activity Questionnaire (IPAQ), etc.

指标中文名：

Follow-up fall incidence

指标类型：

次要指标

Outcome：

Follow-up fall incidence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Semi-structured interviews

指标类型：

附加指标

Outcome：

Semi-structured interviews

Type：

Additional 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：

标本中文名：

None

组织：

Sample Name：

None

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）：

A computer-generated randomization list for concealed allocation will be conducted by a research staff independent of the trial.

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

A computer-generated randomization list for concealed allocation will be conducted by a research staff independent of the trial.

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：

The research assistant (RA1) will oversee all the assessments and will be blinded to the group allocation.

Blinding：

The research assistant (RA1) will oversee all the assessments and will be blinded to the group allocation.

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）：

None

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

None

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：

None

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

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-03-25 16:07:13