ChiCTR2600120775 版本V1.0 版本创建时间2026/03/19 14:46:44 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：

 ChiCTR2600120775 

最近更新日期：

Date of Last Refreshed on：

 2026-03-19 14:46:24 

注册时间：

Date of Registration：

 2026-03-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

定向外力干扰联合全身振动训练对提高老年人平衡能力的研究

Public title：

Effect of Combined Directional External Force Perturbation and Whole-Body Vibration Training on Improving Balance Ability in Older Adults

注册题目简写：

定向干扰联合振动训练改善老年平衡

English Acronym：

Combined Perturbation and Vibration Training for Balance in Elderly

研究课题的正式科学名称：

定向外力干扰联合全身振动训练对提高老年人平衡能力的研究

Scientific title：

Effect of Combined Directional External Force Perturbation and Whole-Body Vibration Training on Improving Balance Ability in Older Adults

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：

文一博 

研究负责人：

文一博 

Applicant：

Yibo Wen 

Study leader：

Yibo Wen 

申请注册联系人电话：

Applicant telephone：

 +86 134 7609 1262

研究负责人电话：

Study leader's
telephone：

+86 134 7609 1262

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：

 359729316@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 359729316@qq.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：

武汉市硚口区汉正街473号

研究负责人通讯地址：

武汉市硚口区汉正街473号

Applicant address：

No. 473, Hanzheng Street, Qiaokou District, Wuhan City, Hubei Province, 430033, China

Study leader's address：

No. 473, Hanzheng Street, Qiaokou District, Wuhan City, Hubei Province, 430033, 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：

武汉市第四医院

Applicant's institution：

Wuhan Fourth Hospital

研究负责人所在单位：

武汉市第四医院

Affiliation of the Leader：

Wuhan Fourth Hospital

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：

 伦审字(KY2025-202-01)号

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：

武汉市第四医院伦理委员会

Name of the ethic committee：

Ethics Committee of Wuhan Fourth Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-16 00:00:00

伦理委员会联系人：

夏平

Contact Name of the ethic committee：

Ping Xia

伦理委员会联系地址：

武汉市硚口区汉正街473号

Contact Address of the ethic committee：

No. 473, Hanzheng Street, Qiaokou District, Wuhan City, Hubei Province, 430033, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 6883 4993

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：

武汉市第四医院

Primary sponsor：

Wuhan Fourth Hospital

研究实施负责（组长）单位地址：

武汉市硚口区汉正街473号

Primary sponsor's address：

No. 473, Hanzheng Street, Qiaokou District, Wuhan City, Hubei Province, 430033, 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)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

武汉市第四医院

具体地址：

武汉市硚口区汉正街473号

Institution
hospital：

Wuhan Fourth Hospital

Address：

No. 473, Hanzheng Street, Qiaokou District, Wuhan City, Hubei Province, 430033, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

研究疾病：

跌倒风险  

Target disease：

Risk of Falls

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探究定向外力干扰下的平衡训练及定向外力干扰联合全身振动训练对改善老年人平衡能力的效果，以期使老年人能够在更安全更有效的前提下提升平衡能力，降低跌倒风险，减轻家庭经济负担和社会医疗负担。  

Objectives of Study：

This study aims to investigate the effects of balance training under directional external force perturbation and its combination with whole-body vibration training on improving balance ability in older adults. The goal is to enable the elderly to enhance their balance capacity in a safer and more effective manner, thereby reducing the risk of falls, alleviating the financial burden on families, and decreasing the societal healthcare burden.

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.年龄≥60周岁，能自主活动的老年人； 2.近期无腰腿痛症状； 3.近期无下肢关节疼痛； 4.无腰椎及下肢手术史； 5.近期无额外自主锻炼计划。

Inclusion criteria

1. Aged >= 60 years, able to ambulate independently. 2. No recent symptoms of low back or leg pain. 3. No recent lower limb joint pain. 4. No history of lumbar spine or lower limb surgery. 5. No additional self-directed exercise plans in the recent period.

排除标准：

1.生命体征不稳定，例如脑出血或者脑血栓急性期； 2.各种原因所致关节不稳、骨折未愈合又未做内固定、骨关节肿瘤、全身情况较差、病情不稳定者； 3.严重的心肺功能不全； 4.下肢静脉血栓； 5.意识不清，无法按照治疗师指导训练； 6.有严重内出血倾向； 7.全身有严重感染和高热等； 8.同期正在进行其他有规律的训练或运动； 9.患有骨质疏松（双能X线吸收测定T值 ≤ -2.5）； 10高血压危险分级为中危及以上。

Exclusion criteria：

1. Unstable vital signs (e.g., acute phase of cerebral hemorrhage or cerebral thrombosis). 2. Joint instability from any cause, unhealed fractures without internal fixation, bone or joint tumors, poor general condition, or medically unstable status. 3. Severe cardiac or pulmonary insufficiency. 4. Deep vein thrombosis (DVT) of the lower limbs. 5. Impaired consciousness, unable to follow the therapist's instructions. 6. Tendency for severe internal hemorrhage. 7. Systemic severe infection and high fever, etc. 8. Concurrent participation in other regular training or exercise programs. 9. Diagnosed osteoporosis (Dual-energy X-ray absorptiometry T-score <= -2.5). 10. Hypertension with a risk classification of medium risk or higher.

研究实施时间：

Study execute time：

从 From 2025-12-17 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-22 00:00:00 至 To 2026-02-14 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 22

Group：

control group

Sample size：

干预措施：

受试者需完成常规锻炼动作：屈膝半蹲、提踵、深蹲三个动作。每个动作完成4组，每组6次，组间休息30s。

干预措施代码：

Intervention：

Participants were required to perform the routine exercise protocol, which comprised three movements: knee-bend half-squats, heel raises, and full squats. Each exercise was conducted in 4 sets of 6 repetitions, with a 30-second rest interval between sets.

Intervention code：

组别：

试验组1

样本量：

 22

Group：

Intervention Group 1

Sample size：

干预措施：

训练时受试者需在频率33Hz，振幅2mm的振动平台上完成常规锻炼动作

干预措施代码：

Intervention：

During the training sessions, participants performed the routine exercise protocol on a vibration platform set at a frequency of 33 Hz and an amplitude of 2 mm.

Intervention code：

组别：

试验组2

样本量：

 22

Group：

Intervention Group 2

Sample size：

干预措施：

定向外力干扰：选取合适的弹力带，将弹力带固定于患者的腰间，治疗师手持弹力带向患者的一个方向施加拉力，治疗师逐渐增大拉力同时受试者尽量保持重心位置不动，当受试者感到外力较大时或自觉无法抵抗外力快要无法维持重心时告知治疗师，治疗师即不再增加拉力并保持此时拉力的大小和方向不变。同时另外两位治疗师位于受试者左右两侧，保护受试者安全。本次试验分别从四个方向上施加定向外力干扰，分别为正前方，正后方，正左方和正右方，每次仅从一个方向施加外力。每次施加外力的持续时间30s间歇30s为一组，每个方向训练4组，训练总时长约为15~20min。同常规锻炼组锻炼时长基本一致。

干预措施代码：

Intervention：

Directional External Force Perturbation: A suitable elastic band was selected and secured around the participant’s waist. The therapist held the band and applied a pulling force in one direction. While the therapist gradually increased the force, the participant was instructed to maintain their center of gravity as steadily as possible. When the participant felt the force was substantial or perceived that they were about to lose balance, they informed the therapist, who then ceased increasing the force and maintained the current magnitude and direction. Two additional therapists were positioned on either side of the participant to ensure safety. In this trial, directional perturbations were applied from four distinct directions: directly anterior, posterior, left, and right. Perturbation was applied from only one direction at a time. Each perturbation consisted of a 30-second force application followed by a 30-second rest interval, constituting one set. Four sets were performed for each direction, resulting in a total training duration of approximately 15 to 20 minutes, which was consistent with the duration of the routine exercise group.

Intervention code：

组别：

试验组3

样本量：

 22

Group：

Intervention Group 3

Sample size：

干预措施：

在全身振动训练平台上完成定向外力干扰训练

干预措施代码：

Intervention：

Directional external force perturbation training was performed on the whole-body vibration training platform.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 武汉 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 武汉市第四医院 

单位级别：

 三级甲等 

Institution
hospital：

Wuhan Fourth Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

串联Romberg测试

指标类型：

主要指标

Outcome：

Tandem Romberg Test

Type：

Primary indicator

测量时间点：

试验开始前和试验结束各测试一次

测量方法：

受试者双手叉腰并采用两足一前一后足尖接足跟的方式站立，记录睁眼和闭眼所持续站立的时间，手离开腰间或移动位置测试结束

Measure time point of outcome：

Assessments were conducted once before and once after the intervention period.

Measure method：

For the test, participants stood with their feet in a heel-to-toe position, hands on hips. The duration of standing was recorded separately under eyes-open and eyes-closed conditions. The test was terminated if the hands moved away from the hips or if the participant lost balance.

指标中文名：

单腿Romberg测试

指标类型：

主要指标

Outcome：

Single-Leg Romberg Test

Type：

Primary indicator

测量时间点：

试验开始前和试验结束各测试一次

测量方法：

受试者双手叉腰并采用优势脚单脚站立，另一脚屈膝，脚离开地面，记录睁眼和闭眼所持续站立的时间。手离开腰间或移动位置测试结束。

Measure time point of outcome：

Assessments were conducted once before and once after the intervention period.

Measure method：

For this test, participants stood on their dominant leg with hands on their hips, while the non-dominant leg was flexed at the knee and kept off the ground. The standing duration was recorded separately under eyes-open and eyes-closed conditions. The test was terminated if the hands moved away from the hips or if balance was lost.

指标中文名：

计时-起立行走测试

指标类型：

主要指标

Outcome：

Timed Up and Go Test

Type：

Primary indicator

测量时间点：

试验开始前和试验结束各测试一次

测量方法：

受试者坐在有扶手的靠背椅上，身体靠在椅背上，双手放在扶手上，受试者从椅子上站起来并向前走3 m，到达标识点后转身走回椅子前，再次坐到椅子上并靠在椅背上，记录受试者完成整套动作的时间。

Measure time point of outcome：

Assessments were conducted once before and once after the intervention period.

Measure method：

For the test, the participant sat in an armchair with a backrest, leaning against the back with hands resting on the armrests. On the command "Go," the participant stood up, walked forward for 3 meters to a marked point, turned around, walked back to the chair, and sat down, leaning back against the backrest again. The time taken to complete the entire sequence was recorded.

指标中文名：

Pro-Kin平衡测试-静态双足测试

指标类型：

主要指标

Outcome：

Pro-Kin Balance Test - Static Bipedal Test

Type：

Primary indicator

测量时间点：

试验开始前和试验结束各测试一次

测量方法：

受试者赤足双足站立于测试板上，双脚第二脚指对着A2、A8线，双脚跟并拢于A5线。内踝前3cm在电子倾斜板A3/A7线上。测试时双眼统一注视距离1.5米外的“标志物”，禁止目视其他方向或物体。测试开始后受试者尽量保持重心稳定站立30s，电脑将自动记录受试者重心位置，重心移动的速度，重心移动的长度和面积等相关参数。

Measure time point of outcome：

Assessments were conducted once before and once after the intervention period.

Measure method：

For the test, participants stood barefoot on the platform with both feet. The second toes were aligned with lines A2 and A8, and the heels were together on line A5. A point 3 cm anterior to the medial malleolus was positioned on line A3/A7 of the electronic tilt board. During the test, participants were instructed to fix their gaze on a target located 1.5 meters away and to avoid looking in other directions. After initiation, participants were required to stand as steadily as possible for 30 sec

指标中文名：

Pro-Kin平衡测试-稳定极限测试

指标类型：

主要指标

Outcome：

Pro-Kin Balance Test - Limits of Stability Test

Type：

Primary indicator

测量时间点：

试验开始前和试验结束各测试一次

测量方法：

受试者面对显示器自然站立于测试板上，显示器上分有8个光块，从1至8分别为正右方，右前方，正前方，左前方，正左方，左后方，正后方和右后方。每次会有一个光块亮起，当光块亮起时受试者应尽最大努力转换重心，以够到相应目标光块并保持一定时间。测试完成后系统会自动给出各方向上稳定极限的评分。

Measure time point of outcome：

Assessments were conducted once before and once after the intervention period.

Measure method：

For this test, the participant stood facing the monitor on the testing platform. The monitor displayed eight light targets, numbered 1 to 8, corresponding to the following directions: directly right, right-front, directly front, left-front, directly left, left-back, directly back, and right-back. During the test, one light target would illuminate at a time. Upon illumination, the participant was required to shift their center of pressure (COP) as far as possible toward the activated target and m

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 90 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）：

本研究采用区组随机化方法，设区组长度为8。由不参与受试者招募、干预和数据评估的独立统计人员，使用 IBM SPSS Statistics 17.0 软件生成随机分配序列。

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

This study employed a block randomization method with a block size of 8. An independent statistician, who was not involved in subject recruitment, intervention, or data assessment, generated the random allocation sequence using IBM SPSS Statistics 17.0 software.

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：

本研究为结局评估者设盲的随机对照试验。所有平衡功能评估由不知分组情况的独立评估者完成。由于干预措施的特性（全身振动训练需要专用设备，定向外力干扰训练需要治疗师手动操作），对受试者和干预实施者设盲不可行。为减少偏倚，主要结局均采用客观仪器测量指标，数据分析时隐藏分组信息。

Blinding：

This study was an assessor-blinded randomized controlled trial. All balance function assessments were conducted by independent assessors who were blinded to group allocation. Due to the nature of the interventions (whole-body vibration training requires specialized equipment, and directional external force perturbation training involves manual operation by therapists), blinding of participants and intervention implementers was not feasible. To reduce bias, primary outcomes were measured using objective instrument-based indicators, and group information was concealed during data analysis.

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）：

本研究数据可在合理要求下共享。去标识化的参与者数据将于论文发表后3个月向合格研究人员提供。预计共享时间2026年12月12日以后。数据申请请发送至通信作者邮箱（359729316@qq.com），需提交详细的研究方案、伦理批准证明，并签署数据使用协议。

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

The data from this study are available for sharing upon reasonable request. Deidentified participant data will be made available to qualified researchers after the publication of the manuscript. Data requests should be sent to the corresponding author's email (359729316@qq.com) and require submission of a detailed research protocol, ethical approval documentation, and the signing of a data use agreement.

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：

本研究采用专门设计的纸质病例记录表（CRF）进行数据采集。CRF包含受试者筛选、基线信息、干预记录、平衡功能评估结果（Romberg测试、TUG测试、Pro-Kin平衡仪数据）及安全性记录。所有CRF数据由两名研究人员独立录入电子数据库（Microsoft Excel 2019），进行双录入核对及逻辑一致性检查。

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

This study utilized specially designed paper-based case report forms (CRFs) for data collection. The CRFs included sections for participant screening, baseline information, intervention records, balance assessment outcomes (Romberg test, TUG test, Pro-Kin balance system data), and safety records. All CRF data were independently entered into an electronic database (Microsoft Excel 2019) by two research staff members, followed by double-data entry verification and logical consistency checks.

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：

  2026-03-19 14:46:24