ChiCTR2500112743 版本V1.0 版本创建时间2025/11/19 09:09:35 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：

 ChiCTR2500112743 

最近更新日期：

Date of Last Refreshed on：

 2025-11-19 09:09:28 

注册时间：

Date of Registration：

 2025-11-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一种基于失衡-反馈-电刺激环路的防跌倒应激装置研发及临床评价

Public title：

Development and Clinical Assessment of a Closed-Loop, Feedback-Triggered Electrical Stimulation System for Fall Prevention

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一种基于失衡-反馈-电刺激环路的防跌倒应激装置研发及临床评价

Scientific title：

Development and Clinical Assessment of a Closed-Loop, Feedback-Triggered Electrical Stimulation System for Fall Prevention

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：

余科伟 

研究负责人：

龚鹏 

Applicant：

Yu Kewei 

Study leader：

Gong Peng 

申请注册联系人电话：

Applicant telephone：

 +86 180 6904 8668

研究负责人电话：

Study leader's
telephone：

+86 188 0460 8937

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：

 1901993778@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 Ericgong0613@163.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：

中国浙江省杭州市西湖区莫干山路219号

研究负责人通讯地址：

中国浙江省杭州市西湖区莫干山路219号

Applicant address：

No. 219 Moganshan Rd, Xihu District, Hangzhou, Zhejiang, China

Study leader's address：

No. 219 Moganshan Rd, Xihu District, Hangzhou, Zhejiang, China

申请注册联系人邮政编码：

Applicant postcode：

 310005

研究负责人邮政编码：

Study leader's postcode：

 310005

申请人所在单位：

浙江中医药大学附属第三医院

Applicant's institution：

The Third Affiliated Hospital of Zhejiang Chinese Medical University

研究负责人所在单位：

浙江中医药大学附属第三医院

Affiliation of the Leader：

The Third Affiliated Hospital of Zhejiang Chinese Medical 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：

 ZSLL-KY-2025-004-01

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：

浙江中医药大学附属第三医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-15 00:00:00

伦理委员会联系人：

燕晴

Contact Name of the ethic committee：

Yan Qing

伦理委员会联系地址：

中国浙江省杭州市西湖区莫干山路219号

Contact Address of the ethic committee：

No. 219 Moganshan Rd, Xihu District, Hangzhou, Zhejiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8723 8255

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：

浙江中医药大学附属第三医院

Primary sponsor：

The Third Affiliated Hospital of Zhejiang Chinese Medical University

研究实施负责（组长）单位地址：

中国浙江省杭州市西湖区莫干山路219号

Primary sponsor's address：

No. 219 Moganshan Rd, Xihu District, Hangzhou, Zhejiang, 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)：

浙江

市(区县)：

Country：

china

Province：

Zhejiang

City：

单位(医院)：

浙江中医药大学附属第三医院

具体地址：

中国浙江省杭州市西湖区莫干山路219号

Institution
hospital：

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Address：

No. 219 Moganshan Rd, Xihu District, Hangzhou, Zhejiang, China

经费或物资来源：

国家中医药综合改革示范区科技共建项目（GZY-KJS-ZJ-2025-058）

Source(s) of funding：

The National Traditional Chinese Medicine Comprehensive Reform Pilot Zone Science and Technology Co-construction Project (GZY-KJS-ZJ-2025-058)

研究疾病：

老年肌少症  

Target disease：

Senile Sarcopenia

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：

本项目拟研发一种基于失衡-反馈-电刺激环路的防跌倒应激置，应用 SVM 向量模型为基本算法的数字化传感器，预测跌倒行为的发生，并根据薄弱肌群选择相应电刺激点位（阿是穴）干预跌倒行为的发生，恢复人体平衡状态，构建数据准确、设备便携、操作简易、效果显著未特点的失衡-反馈-电刺激系统。首先，通过肌力测定对不同跌倒倾向下薄弱肌群进行评估，选择合适的电刺激点位，供不同人群进行个性化选择； 其次，通过SVM支持向量机构建算法，计算各轴跌倒的加速度阈值，实现数字化传感器的制作；再次，通过调整电刺激的电流强度、频率、时间等技术参数实现不同平衡能力老年人的个性化干预方案，探索特异性电刺激模式下肌力收缩与平衡恢复的防跌倒方案。最后，基于跌倒倾向因素的评估，个性化选择电刺激模式与刺激点位的干预方案，采用中医康复治疗手段结合现代康复治疗技术实现综合提升老年人防跌倒能力的目标。  

Objectives of Study：

This project proposes the development of a fall-prevention device based on an imbalance-feedback-electrical stimulation loop. Utilizing a digital sensor with a Support Vector Machine (SVM) algorithm as its core, the device aims to predict fall incidents and intervene by applying electrical stimulation to corresponding points (Ashi points) based on identified weak muscle groups, thereby restoring balance and constructing an accurate, portable, user-friendly, and effective imbalance-feedback-electrical stimulation system. First, muscle strength assessment will be used to evaluate weak muscle groups under different fall-prone conditions, and appropriate electrical stimulation points will be selected to provide personalized options for diverse populations. Second, an SVM-based algorithm will be developed to calculate acceleration thresholds for falls along various axes, enabling the creation of a digital sensor. Third, by adjusting technical parameters such as current intensity, frequency, and duration of electrical stimulation, personalized intervention protocols will be tailored for older adults with varying balance capabilities, exploring fall-prevention strategies through muscle contraction and balance recovery under specific electrical stimulation modes. Finally, based on assessments of fall risk factors, personalized electrical stimulation modes and points will be selected for intervention. By integrating traditional Chinese medicine rehabilitation approaches with modern rehabilitation technologies, the project aims to comprehensively enhance fall prevention capabilities among older adults.

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）可保持站姿； 2）可独立行走，不借助他人、假肢或助行器等； 3）认知功能正常，能够理解试验流程； 4）老年人要求年龄 60～80 岁； 5）过去三个月内未接受过针灸及康复治疗; 6）Berg 平衡量表得分 21～40 分之间。

Inclusion criteria

1) Able to maintain a standing position; 2) Able to walk independently without assistance from others, prosthetics, or walking aids; 3) Normal cognitive function, capable of understanding the trial procedures; 4)Elderly participants must be aged 60–80 years; 5) Have not received acupuncture or rehabilitation therapy within the past three months; 6) Berg Balance Scale score between 21 and 40 points.

排除标准：

1）一年内下肢外伤史； 2）严重的心肺系统疾病； 3）严重神经系统疾病； 4）意识障碍，严重视觉障碍、听觉障碍及语言障碍，以及其他健康评估不能完成者; 5）无法或难以依从研究程序； 6）受试过程中因其他原因无法完成者。

Exclusion criteria：

1) History of lower limb trauma within the past year; 2) Severe cardiopulmonary diseases; 3) Severe neurological disorders; 4) Impaired consciousness, severe visual or hearing impairment, speech disorders, or other conditions that preclude completion of health assessments; 5) Inability or difficulty complying with the study procedures; 6) Inability to complete the trial due to other reasons during the participation.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-09 00:00:00 至 To 2027-01-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 10

Group：

Experimental Group

Sample size：

干预措施：

电刺激

干预措施代码：

Intervention：

Electrical Stimulation

Intervention code：

组别：

对照组

样本量：

 10

Group：

Controled Group

Sample size：

干预措施：

常规康复训练

干预措施代码：

Intervention：

Conventional Rehabilitation Training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 浙江中医药大学附属第三医院 

单位级别：

 三级甲等 

Institution
hospital：

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution：

Tertiary A,

测量指标：

Outcomes：

指标中文名：

berg平衡量表

指标类型：

主要指标

Outcome：

Berg Balance Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

计时起立-行走测试

指标类型：

次要指标

Outcome：

Timed Up and Go Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6米步速测试

指标类型：

次要指标

Outcome：

6-Meter Walk Test

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：

标本中文名：

无

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 60 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）：

本研究采用分层随机对照的方法。采用SPSS22.0软件生成20个随机数字，将数字依据1:1的比例平均分配到两组当中，即试验组和对照组各10个数字，所产生的随机数字、分组信息转入密封的信封后，由专门负责随机分配的人员保管。当患者经过诊断标准、纳入标准和排除标准多重筛选后，进行基线评估、签署“知情同意书”，最后由专门负责随机分配的人员进行随机化分配。

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

This study adopted a stratified randomized controlled method. Using SPSS 22.0 software, 20 random numbers were generated and allocated at a 1:1 ratio into two groups—10 numbers each for the experimental group and the control group. The generated random numbers and group assignment information were placed into sealed envelopes and kept by personnel dedicated to randomization. After patients underwent multiple screenings based on diagnostic, inclusion, and exclusion criteria, baseline assessments were conducted, and informed consent forms were signed. Finally, the dedicated randomization personnel performed the random allocation.

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：

本研究采用盲法评价，统一由不知分组的课题组成员进行量表总结评分；资料总结阶段采用盲法统计，统一由不知分组的统计人员对研究结果进行统计。研究过程当中，采用治疗实施者、疗效评估者、资料统计者三者分离。本研究严格遵守CONSORT声明、STRICTA标准和SHARE清单的内容条目进行试验设计并报告。

Blinding：

This study used blind evaluation, and the scale was summarized and scored by the members of the research group who were unaware of the grouping. Blinded statistics were used in the data summary stage, and the research results were statistically analyzed by statisticians who were unaware of the grouping. In the process of the study, the treatment implementers, the efficacy evaluators, and the data statisticians were separated. The study was designed and reported in strict adherence to the CONSORT statement, STRICTA standards, and the SHARE checklist.

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

是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）：

本研究的所有原始数据将于试验结束后6个月内共享在 resman平台（https://medresman.org.cn）公开共享。所有数据均经过严格脱敏处理，移除任何个人身份标识信息。共享内容包含原始记录、处理后的运动参数及受试者基线特征数据，同时提供详细数据字典以便重用。数据集将分配唯一DOI标识，并采用CC-BY 4.0知识共享许可协议开放获取，允许使用者基于合理引用方式自由使用。

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

The original data from this study will be publicly shared on the resman platform (https://medresman.org.cn) within six months after the trial completion. All data have undergone rigorous anonymization to remove any personally identifiable information. The shared materials include original records, processed motion parameters, and baseline characteristics of participants, along with a detailed data dictionary to facilitate reuse. The dataset will be assigned a unique DOI and made available under the CC-BY 4.0 Creative Commons license, allowing free access and use with appropriate citation.

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：

本研究采用“纸质病例记录表（CRF）”与“ResMan电子数据采集系统（EDC）”相结合的方式管理数据。CRF依据方案设计，规范填写并采用划线法更正。所有数据经双人独立录入ResMan系统，该系统自动进行逻辑校验与矛盾核查，并生成电子质疑直至数据无误。所有操作均通过审计追踪系统记录。最终数据在解决所有质疑后，经多方审核锁定，确保数据真实、准确、完整且可溯源。

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

This study employs a combined data management approach utilizing "paper-based Case Report Forms (CRFs)" and the "ResMan Electronic Data Capture (EDC)" system. The CRFs were designed according to the study protocol, requiring standardized completion and the use of the line-through correction method for any amendments. All data underwent dual-entry independent input into the ResMan system, which automatically performs logic checks and discrepancy reviews, generating electronic queries until all data issues are resolved. All operations are recorded via an audit trail system. The final dataset is locked after review and approval by authorized personnel following the resolution of all queries, ensuring the data is authentic, accurate, complete, and traceable.

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：

  2025-11-19 09:09:28