ChiCTR2500098882 版本V1.0 版本创建时间2025/03/14 15:13:00 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：

 ChiCTR2500098882 

最近更新日期：

Date of Last Refreshed on：

 2025-03-14 15:12:42 

注册时间：

Date of Registration：

 2025-03-14 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

可穿戴外骨骼设备辅助下的运动训练对半月板修复术后功能恢复探索性研究

Public title：

An exploratory study on the recovery of meniscus repair function through exercise training assisted by wearable exoskeleton equipment

注册题目简写：

可穿戴外骨骼设备对半月板修复术后功能恢复探索性研究

English Acronym：

An exploratory study of wearable exoskeleton equipment on functional recovery after meniscal repair surgery

研究课题的正式科学名称：

可穿戴外骨骼设备辅助下的运动训练对半月板修复术后功能恢复探索性研究

Scientific title：

An exploratory study on the recovery of meniscus repair function through exercise training assisted by wearable exoskeleton equipment

研究课题代号(代码)：

Study subject ID：

 KY2023-062

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：

KY2023-062

申请注册联系人：

张树蓉 

研究负责人：

戈允申 

Applicant：

Shurong Zhang 

Study leader：

Yunshen Ge 

申请注册联系人电话：

Applicant telephone：

 +86 135 6435 3836

研究负责人电话：

Study leader's
telephone：

+86 138 1768 0942

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：

 zhangshurong@huashan.org.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhangshurong@huashan.org.cn

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：

上海市静安区华山路433号

研究负责人通讯地址：

上海市静安区华山路433号

Applicant address：

433 Huashan Road, Jin'an District, Shanghai

Study leader's address：

433 Huashan Road, Jin'an District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

 200040

研究负责人邮政编码：

Study leader's postcode：

 200040

申请人所在单位：

复旦大学附属华山医院运动医学科

Applicant's institution：

Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China

研究负责人所在单位：

复旦大学附属华山医院运动医学科

Affiliation of the Leader：

Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China

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：

 (2023)临审第(062)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：

复旦大学附属华山医院伦理审查委员会

Name of the ethic committee：

Ethical Review Committee of Huashan Hospital Affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-04-23 00:00:00

伦理委员会联系人：

吴翠云

Contact Name of the ethic committee：

Cuiyun Wu

伦理委员会联系地址：

上海市乌鲁木齐中路12号

Contact Address of the ethic committee：

12 Urumqi Middle Road, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 5288 8045

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：

复旦大学附属华山医院

Primary sponsor：

Fudan University Affiliated Huashan Hospital

研究实施负责（组长）单位地址：

上海市乌鲁木齐中路12号

Primary sponsor's address：

12 Urumqi Middle Road, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属华山医院运动医学科

具体地址：

乌鲁木齐中路12号

Institution
hospital：

Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China

Address：

12 Urumqi Middle Road

经费或物资来源：

自筹

Source(s) of funding：

self-funded

研究疾病：

半月板损伤  

Target disease：

meniscus injury

研究疾病代码：

ICD-10: S83.2

Target disease code：

ICD-10: S83.2

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：

通过单中心的前瞻性的随机对照研究，评价可穿戴外骨骼设备辅助下的运动训练对关节镜下半月板修复术后改善肌肉萎缩的影响，以及对膝关节功能，本体感觉，生活状态的影响。  

Objectives of Study：

Through a single-center prospective randomized controlled study, we evaluated the effect of exercise training assisted by wearable exoskeleton equipment on improving muscle atrophy after arthroscopic meniscal repair, as well as its effect on knee joint function, proprioception, and living conditions.

药物成份或治疗方案详述：

拟纳入至少28名患者进行1:1分组： 第一组：常规康复组：物理因子+运动训练+步行训练； 第二组：外骨骼辅助行走训练组：常规康复+外骨骼辅助行走训练。 纳入常规康复组的患者在术后进行我科目前已经实施的术后0-6周的康复治疗。其中包括物理因子、运动训练和步行训练三个方面，按照术后时间及患者自身情况，规范化进阶治疗。患者每周到医院进行一次康复指导，其余在家自行完成。对所有纳入外骨骼辅助行走训练研究的患者在术前1周进行一次可穿戴外骨骼设备辅助下的适应性步行训练，为期20分钟，踝跖屈辅助动力参数的选择基于患者身体重量的20% 至 25%。正式入组以后，患者在医院随访时，增加以下肢动力型柔性外骨骼穿戴下的平地步行训练，每周一次，每次治疗时间20分钟。外骨骼组训练每次步行训练总时长与常规康复组的患者中步行训练时长一致，为20分钟。 

Description for medicine or protocol of treatment in detail：

It is planned to enroll at least 28 patients into 1:1 groups: Group 1: Conventional rehabilitation group: physical factors + exercise training + walking training; Group 2: Exoskeleton-assisted walking training group: conventional rehabilitation + exoskeleton-assisted walking training. Patients included in the conventional rehabilitation group will undergo postoperative rehabilitation treatment for 0-6 weeks that our department has currently implemented. It includes three aspects: physical factors, exercise training and walking training, and standardized and advanced treatment according to the postoperative time and the patient's own condition. Patients go to the hospital for rehabilitation guidance once a week and complete the rest by themselves at home. All patients included in the exoskeleton-assisted walking training study underwent a 20-minute adaptive walking training assisted by a wearable exoskeleton device 1 week before surgery. The ankle plantar flexion assist power parameters were selected based on 20% of the patient's body weight. to 25%. After formal enrollment, patients were added to flat ground walking training wearing lower limb powered flexible exoskeletons during follow-up visits in the hospital, once a week, and each treatment lasted 20 minutes. The total duration of each walking training session in the exoskeleton group was consistent with the walking training duration for patients in the conventional rehabilitation group, which was 20 minutes. 

纳入标准：

1) 年龄≥18岁，小于60岁的患者； 2) 在我中心接受单侧膝关节镜手术修复半月板损伤的患者且术后第二天起对术侧负重无限制的患者； 3) 术前双侧大腿围度差异＜2 cm； 4) 四肢骨骼肌肉质量指数（SMI）：男性≥7.0kg/m2，女性≥5.7kg/m2； 5) 惯用手的握力：男性≥26kg，女性≥18kg； 6) 术后双侧大腿围度差异>3 cm； 7) 术后三周可以脱拐完全负重； 8) 患侧踝关节具有充分的被动活动角度，若存在踝关节跖屈挛缩，挛缩角度不超过5度； 9) 能够理解并签署知情同意书。

Inclusion criteria

1) Patients aged >=18 years old and less than 60 years old; 2) Patients who undergo unilateral knee arthroscopic surgery to repair meniscal injuries in our center and who have no restrictions on weight-bearing on the surgical side starting from the second day after surgery; 3) The difference in bilateral thigh circumference before surgery is less than 2 cm; 4) Skeletal muscle mass index (SMI) of limbs: male >=7.0kg/m2, female >=5.7kg/m2; 5) Grip strength of dominant hand: male >=26kg, female >=18kg; 6) The difference in bilateral thigh circumference after surgery is >3 cm; 7) You can be off crutches and fully weight-bearing three weeks after surgery; 8) The ankle joint on the affected side has sufficient passive movement angle. If there is plantar flexion contracture of the ankle joint, the contracture angle shall not exceed 5 degrees; 9) Able to understand and sign the informed consent form.

排除标准：

1) 另一侧膝关节接受手术的患者； 2) 非初次手术的患者； 3) 合并处理软骨损伤、韧带损伤的患者； 4) 合并怀疑肿瘤或恶心肿瘤的患者； 5) 系统性疾病导致膝关节症状的如痛风性关节炎、风湿性关节炎等； 6) 膝关节术后出现感染、伤口愈合不佳以及术后三周时关节活动度未达到90°； 7) 髌前疼痛VAS疼痛评分超过2分； 8) 合并糖尿病、高血压、甲状腺功能障碍； 9) 其他原因造成无法长距离步行的患者； 10) 伴有有严重的肌骨、心脏、神经、皮肤和前庭系统合并症； 11) 静息心率低于50次/分钟或高于100次/分钟，静息血压低于90/60 mmHg或高于200/100 mmHg； 12) 外骨骼使用的任何禁忌症，如: 聚氨酯过敏、孕期、腿长差异、身高/体重限制，设备接触点开放性溃疡等。

Exclusion criteria：

1) Patients who have undergone surgery on the other knee joint; 2) Patients who are not undergoing surgery for the first time; 3) Combined treatment of patients with cartilage damage and ligament damage; 4) Patients with suspected tumors or nauseated tumors; 5) Systemic diseases causing knee joint symptoms such as gouty arthritis, rheumatoid arthritis, etc.; 6) Infection after knee joint surgery, poor wound healing, and joint range of motion not reaching 90° three weeks after surgery; 7) Prepatellar pain VAS pain score exceeds 2 points; 8) Combined with diabetes, hypertension, and thyroid dysfunction; 9) Patients who are unable to walk long distances due to other reasons; 10) Accompanied by severe musculoskeletal, cardiac, neurological, skin and vestibular system comorbidities; 11) Resting heart rate is lower than 50 beats/minute or higher than 100 beats/minute, resting blood pressure is lower than 90/60 mmHg or higher than 200/100 mmHg; 12) Any contraindications for exoskeleton use, such as: polyurethane allergy, pregnancy, leg length differences, height/weight restrictions, open ulcers at device contact points, etc.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-10 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

常规康复组

样本量：

 14

Group：

Conventional rehabilitation group

Sample size：

干预措施：

纳入常规康复组的患者在术后进行我科目前已经实施的术后0-6周的康复治疗。其中包括物理因子、运动训练和步行训练三个方面，按照术后时间及患者自身情况，规范化进阶治疗。患者每周到医院进行一次康复指导，其余在家自行完成。

干预措施代码：

Intervention：

Patients included in the conventional rehabilitation group will undergo postoperative rehabilitation treatment for 0-6 weeks that our department has currently implemented. It includes three aspects: physical factors, exercise training and walking training, and standardized and advanced treatment according to the postoperative time and the patient's own condition. Patients go to the hospital for rehabilitation guidance once a week and complete the rest by themselves at home.

Intervention code：

组别：

外骨骼辅助行走训练组

样本量：

 14

Group：

Exoskeleton-assisted walking training group

Sample size：

干预措施：

对所有纳入外骨骼辅助行走训练研究的患者在术前1周进行一次可穿戴外骨骼设备辅助下的适应性步行训练，为期20分钟，踝跖屈辅助动力参数的选择基于患者身体重量的20% 至 25%。正式入组以后，患者在医院随访时，增加以下肢动力型柔性外骨骼穿戴下的平地步行训练，每周一次，每次治疗时间20分钟。外骨骼组训练每次步行训练总时长与常规康复组的患者中步行训练时长一致，为20分钟。

干预措施代码：

Intervention：

All patients included in the exoskeleton-assisted walking training study underwent a 20-minute adaptive walking training assisted by a wearable exoskeleton device 1 week before surgery. The ankle plantar flexion assist power parameters were selected based on 20% of the patient's body weight. to 25%. After formal enrollment, patients were added to flat ground walking training wearing lower limb powered flexible exoskeletons during follow-up visits in the hospital, once a week, and each treatment lasted 20 minutes. The total duration of each walking training session in the exoskeleton group was consistent with the walking training duration for patients in the conventional rehabilitation group, which was 20 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 复旦大学附属华山医院 

单位级别：

 三甲 

Institution
hospital：

Fudan University Affiliated Huashan Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

股四头肌内侧头的肌肉厚度

指标类型：

主要指标

Outcome：

Muscle thickness of medial head of quadriceps

Type：

Primary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

超声波测量

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

ultrasound measurement

指标中文名：

疼痛

指标类型：

次要指标

Outcome：

Pain

Type：

Secondary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

VAS 疼痛评分

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

VAS pain score

指标中文名：

膝关节功能

指标类型：

次要指标

Outcome：

knee function

Type：

Secondary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

KOOS膝关节功能评分 ，Lysholm膝关节评分

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

KOOS(Knee Injury and Osteoarthritis Outcome Score), Lysholm Score

指标中文名：

生活质量评分

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

SarQoL量表

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

SarQoL scale, Sarcopenia & Quality of Life Scale

指标中文名：

身体素质

指标类型：

主要指标

Outcome：

Body Index

Type：

Primary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

身体质量指数（BMI），四肢骨骼肌肉质量指数（SMI），肌肉占体重比，肌肉力量，静息血压，静息心率；

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

Body mass index (BMI), limb skeletal muscle mass index (SMI), muscle to body weight ratio, muscle strength, resting blood pressure, resting heart rate;

指标中文名：

下肢动态监测

指标类型：

次要指标

Outcome：

Lower limb dynamic monitoring

Type：

Secondary indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

患侧步频、步长、对称率、患侧踝关节角度、输送机械功率、

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

Step frequency, step length, symmetry rate of the affected side, ankle joint angle of the affected side, mechanical transmission power,

指标中文名：

下肢力量

指标类型：

附加指标

Outcome：

lower limb strength

Type：

Additional indicator

测量时间点：

术前2周，术后第3、6、12周

测量方法：

大腿伸膝、屈膝肌肉力量

Measure time point of outcome：

2 weeks before surgery, 3, 6, and 12 weeks after surgery

Measure method：

Thigh knee extension and knee flexion muscle strength

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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Stata/BE17.0软件，按试验组与对照组1:1的比例采用区组用随机化方法产生随机编码，所选择的区组（block）长度和随机数初值种子参数等作为保密数据一起密封在随机化总表中。受试者筛选成功后，研究者严格按照受试者进入研究的顺序依次随机分配，按照随机系统提供的分组结果进行试验。整个试验过程中，研究者不得对产生的随机号及受试者分配到的组别进行修改。

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

This study used Stata/BE17.0 software, and used block randomization to generate random codes according to the ratio of 1:1 between the experimental group and the control group. The selected block length and random number initial value seed parameters were used as Confidential data are sealed together in the randomization master list. After the subjects are successfully screened, the researcher will randomly allocate the subjects in strict accordance with the order in which they enter the study, and conduct the experiment according to the grouping results provided by the randomization system. During the entire trial process, researchers are not allowed to modify the random numbers generated and the groups to which subjects are assigned.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

none

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）：

预计在2026年12月31日，采用华山医学研究院HIMedc平台 https://himedc.huashan.org.cn:5288/index.php?action=myprojects

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

December 31, 2026, Using EDC web-based database redcap: HIMedc https://himedc.huashan.org.cn:5288/index.php?action=myprojects

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：

CRF

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

CRF

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：

  2025-03-14 15:12:42