足底筋膜炎患者的足底压力特征分析

注册号:

Registration number:

ChiCTR2600119526 

最近更新日期:

Date of Last Refreshed on:

2026-02-28 10:53:56 

注册时间:

Date of Registration:

2026-02-28 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

足底筋膜炎患者的足底压力特征分析

Public title:

Analysis of Plantar Pressure Characteristics in Patients with Plantar Fasciitis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

足底筋膜炎患者的足底压力特征分析

Scientific title:

Analysis of Plantar Pressure Characteristics in Patients with Plantar Fasciitis

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:

蔡茹 

研究负责人:

蔡茹 

Applicant:

Cai Ru 

Study leader:

Cai Ru 

申请注册联系人电话:

Applicant telephone:

+86 137 9434 6329

研究负责人电话:

Study leader's
telephone:

+86 137 9434 6329

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:

cair@hku-szh.org

研究负责人电子邮件:

Study leader's E-mail:

cair@hku-szh.org

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:

广东省深圳市福田区海园一路一号

研究负责人通讯地址:

广东省深圳市福田区海园一路一号

Applicant address:

No. 1, Haiyuan 1st Road, Futian District, Shenzhen City, Guangdong Province

Study leader's address:

No. 1, Haiyuan 1st Road, Futian District, Shenzhen City, Guangdong Province

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:

香港大学深圳医院

Applicant's institution:

The University of Hong Kong-Shenzhen Hospital

研究负责人所在单位:

香港大学深圳医院

Affiliation of the Leader:

The University of Hong Kong-Shenzhen Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

伦[2026]044

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:

香港大学深圳医院医学伦理委员会

Name of the ethic committee:

The Medical Ethics Committee of The University of Hong Kong-Shenzhen Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-12 00:00:00

伦理委员会联系人:

梁敏飞

Contact Name of the ethic committee:

Liang Minfei

伦理委员会联系地址:

广东省深圳市福田区海园一路香港大学深圳医院科教楼1306

Contact Address of the ethic committee:

No. 1 Haiyuan Road, Futian District, Shenzhen City, Guangdong Province. Hong Kong University Shenzhen Hospital Science and Education Building, Room 1306

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 755 8691 3175

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:

香港大学深圳医院

Primary sponsor:

The University of Hong Kong-Shenzhen Hospital

研究实施负责(组长)单位地址:

广东省深圳市福田区海园一路一号

Primary sponsor's address:

No. 1, Haiyuan 1st Road, Futian District, Shenzhen City, Guangdong

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):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

香港大学深圳医院

具体地址:

广东省深圳市福田区海园一路一号

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital

Address:

No. 1, Haiyuan 1st Road, Futian District, Shenzhen City, Guangdong

经费或物资来源:

Source(s) of funding:

None

研究疾病:

足底筋膜炎  

Target disease:

Plantar Fasciitis

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:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

探讨足底筋膜炎患者的足底压力多因素特征分析,分析足底生物力学对于疾病的作用机制。  

Objectives of Study:

Explore the multi-factor characteristics of foot sole pressure in patients with plantar fasciitis, and analyze the role of foot sole biomechanics in the pathogenesis of the disease.

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:

PF组: 有足部手术史、骨折史、神经系统疾病、类风湿性关节炎、严重肥胖(BMI>30)。 健康组: 近一年内有足部外伤史、手术史、骨折、下肢疼痛;下肢长度有差异;妊娠期。

Exclusion criteria:

PF group: History of foot surgery, fracture, neurological disorders, rheumatoid arthritis, severe obesity (BMI > 30). Healthy group: Within the past year, there has been a history of foot trauma, surgery, fracture, lower limb pain; there is a difference in lower limb length; pregnancy.

研究实施时间:

Study execute time:

From 2025-11-11 00:00:00 To 2028-01-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-03-02 00:00:00 To 2028-01-01 00:00:00

干预措施:

Interventions:

组别:

PF组

样本量:

55

Group:

PF group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

健康组

样本量:

55

Group:

The healthy group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

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):

深圳 

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

香港大学深圳医院 

单位级别:

三甲 

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

时空参数

指标类型:

主要指标

Outcome:

Space-time parameters

Type:

Primary indicator

测量时间点:

测量方法:

机器采集

Measure time point of outcome:

Measure method:

指标中文名:

动力学参数

指标类型:

主要指标

Outcome:

Kinetic parameter

Type:

Primary indicator

测量时间点:

测量方法:

机器采集

Measure time point of outcome:

Measure method:

指标中文名:

稳定性和平衡参数

指标类型:

次要指标

Outcome:

Stability and balance parameters

Type:

Secondary indicator

测量时间点:

测量方法:

机器采集

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

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 18 years
最大 Max age 75 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):

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

None

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:

Blinding:

None

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):

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:

研究中数据采集由足底压力分布测量平台来采集静态站立和动态步行下的足底压力数据,收集的数据由项目负责人查看保存,研究结束后项目负责人保存。

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

In the research, the data collection was carried out by a plantar pressure distribution measurement platform to collect plantar pressure data during static standing and dynamic walking. The collected data were reviewed and saved by the project leader, and were kept by the project leader after the research was completed.

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:

 2026-02-28 10:53:48