ChiCTR2600118590 版本V1.0 版本创建时间2026/02/09 10:20:52 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：

ChiCTR2600118590 

最近更新日期：

Date of Last Refreshed on：

2026-02-09 10:20:36 

注册时间：

Date of Registration：

2026-02-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

重复经颅磁刺激联合踝关节控制训练对脑卒中足下垂患者下肢运动功能的影响研究

Public title：

Study on the Effect of Repetitive Transcranial Magnetic Stimulation Combined with Ankle Joint Control Training on Lower Limb Motor Function in Stroke Patients with Foot Drop

注册题目简写：

English Acronym：

研究课题的正式科学名称：

重复经颅磁刺激联合踝关节控制训练对脑卒中足下垂患者下肢运动功能的影响研究

Scientific title：

Study on the Effect of Repetitive Transcranial Magnetic Stimulation Combined with Ankle Joint Control Training on Lower Limb Motor Function in Stroke Patients with Foot Drop

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：

孙梦雪 

研究负责人：

孙梦雪 

Applicant：

Sun Mengxue 

Study leader：

Sun Mengxue 

申请注册联系人电话：

Applicant telephone：

+86 15021034341

研究负责人电话：

Study leader's telephone：

+86 21 6618 0208

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：

shayx413@163.com

研究负责人电子邮件：

Study leader's E-mail：

shayx413@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：

上海市宝山区淞南镇长江路860弄25号

研究负责人通讯地址：

上海市宝山区淞南镇长江路860弄25号

Applicant address：

No. 25, Lane 860, Changjiang Road, Songnan Town, Baoshan District, Shangha

Study leader's address：

No. 25, Lane 860, Changjiang Road, Songnan Town, Baoshan District, Shangha

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：

上海市第二康复医院

Applicant's institution：

Second Rehabilitation Hospital of Shanghai

研究负责人所在单位：

上海市第二康复医院

Affiliation of the Leader：

Shanghai Second Rehabilitation Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-28-01

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：

上海市第二康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Second Rehabilitation Hospital Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-20 00:00:00

伦理委员会联系人：

陈叶萍

Contact Name of the ethic committee：

Yeping Chen

伦理委员会联系地址：

上海市宝山区淞南镇长江路860弄25号

Contact Address of the ethic committee：

No. 25, Lane 860, Changjiang Road, Songnan Town, Baoshan District, Shangha

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 66181108

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2211497824@qq.com

研究实施负责（组长）单位：

上海市第二康复医院

Primary sponsor：

Shanghai Second Rehabilitation Hospital

研究实施负责（组长）单位地址：

上海市宝山区淞南镇长江路860弄25号

Primary sponsor's address：

No. 25, Lane 860, Changjiang Road, Songnan Town, Baoshan District, Shangha

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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第二康复医院

具体地址：

上海市宝山区淞南镇长江路860弄25号

Institution
hospital：

Shanghai Second Rehabilitation Hospital

Address：

No. 25, Lane 860, Changjiang Road, Songnan Town, Baoshan District, Shangha

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded

Target disease：

Foot drop after stroke

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：

研究中枢-外周联合疗法对脑卒中足下垂下肢运动功能的影响 1.观察联合组和单纯外周运动治疗组治疗前后脑卒中足下垂患者下肢运动功能指标的变化；2.探讨重复经颅磁刺激联合踝关节控制训练对脑卒中足下垂患者下肢运动功能的影响；3. 探索两者协同作用机制，为临床康复方案制定提供依据。  

Objectives of Study：

To investigate the effect of central-peripheral combined therapy on lower limb motor function in stroke patients with foot drop. 1. To observe changes in lower limb motor function indicators before and after treatment in the combined intervention group and the peripheral exercise therapy-only group of stroke patients with foot drop. 2. To explore the effect of repetitive transcranial magnetic stimulation combined with ankle control training on lower limb motor function in stroke patients with foot drop. 3. To investigate the synergistic mechanism of the two interventions and provide a basis for clinical rehabilitation program formulation.

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符合脑卒中诊断标准（经CT/MRI确诊），单侧大脑半球病变；②单侧出现足下垂症状； ③处于脑卒中病程12个月内，生命体征稳定，无严重并发症；④患侧下肢痉挛控制在改良Ashworth评分Ⅱ级及以下，患侧下肢MMT肌力分级在1级及以上，Brunnstrom分期在Ⅲ期及以上； ⑤年龄18-75岁，意识清晰，可配合完成治疗与评估；⑥患者和家属自愿签署知情同意书。

Inclusion criteria

1. Meet the diagnostic criteria for stroke (confirmed by CT/MRI) with unilateral cerebral hemisphere lesion; 2. Present with unilateral foot drop symptoms; 3. Within 12 months of stroke onset, with stable vital signs and no severe complications; 4. Spasticity of the affected lower limb controlled at Modified Ashworth Scale grade II or below, MMT muscle strength grade of the affected lower limb at grade 1 or above, and Brunnstrom stage at stage III or above; 5. Age 18-75 years, with clear consciousness and ability to cooperate with treatment and assessment; 6. Patients and their families voluntarily sign the informed consent form.

排除标准：

①其他原因如外周神经病变、颅脑损伤或肿瘤等导致足下垂的患者；②有颅骨缺损、颅内金属异物、心脏起搏器植入等经颅磁刺激禁忌证；③严重认知障碍、严重偏侧忽略，无法沟通；④皮肤敏感者；⑤合并严重心肺疾病、下肢骨折等影响训练的疾病； ⑥治疗前1个月内接受过其他类似的康复干预研究。

Exclusion criteria：

1. Patients with foot drop caused by other reasons such as peripheral neuropathy, craniocerebral injury, or tumors; 2. Those with contraindications to transcranial magnetic stimulation, such as skull defects, intracranial metal foreign bodies, or pacemaker implantation; 3. Severe cognitive impairment or severe unilateral neglect, making communication impossible; 4. Individuals with sensitive skin; 5. Those with severe cardiopulmonary diseases, lower limb fractures, or other conditions affecting training; 6. Patients who have participated in other similar rehabilitation intervention studies within 1 month before treatment.

研究实施时间：

Study execute time：

从 From 2026-01-30 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-28 00:00:00 至 To 2027-02-28 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

32

Group：

Control group

Sample size：

干预措施：

假刺激+踝关节控制训练

干预措施代码：

Intervention：

Sham stimulation + ankle joint control training

Intervention code：

组别：

试验组

样本量：

32

Group：

Experimental group

Sample size：

干预措施：

重复经颅磁刺激+踝关节控制训练

干预措施代码：

Intervention：

Repetitive transcranial magnetic stimulation+ankle control training

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 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海市第二康复医院 

单位级别：

二级 

Institution
hospital：

Shanghai Second Rehabilitation Hospital

Level of the institution：

Secondary B

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer 下肢运动功能

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment of Lower Extremity Motor Function

Type：

Primary indicator

测量时间点：

干预前和干预4周后

测量方法：

采用Fugl-Meyer下肢运动功能量表评分（FMA-LE）评价下肢运动功能，评估内容涵盖下肢关节的屈/伸、内收/外展、平衡等共17个项目，总分34分，其中每项分为0-2分。得分越高，提示下肢运动功能越好。全程客观评分，需排除疼痛、认知障碍等因素对测试结果的干扰。

Measure time point of outcome：

T0、T4

Measure method：

The Fugl-Meyer Assessment of Lower Extremity Motor Function (FMA-LE) was used to evaluate lower extremity motor function. The assessment covers 17 items including flexion/extension, adduction/abduction, and balance of lower extremity joints, with a total score of 34 points and each item scored on a 0–2 point scale. A higher score indicates better lower extremity motor function. Objective scoring was performed throughout the assessment, and factors such as pain and cognitive impairment that might

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

Modified Barthel Index (MBI)

Type：

Secondary indicator

测量时间点：

干预前和干预4周后

测量方法：

治疗前后，采用改良Barthel指数评定量表（MBI）评估患者的日常生活活动能力。取该量表中自我照顾、括约肌控制、移动、运动4个维度，共10个条目，每个条目根据不同独立能力分为5个等级，得分越高表示日常生活活动能力越好。

Measure time point of outcome：

T0、T4

Measure method：

Before and after treatment, the Modified Barthel Index (MBI) was used to assess the patients' activities of daily living. Four dimensions from this scale were selected: self-care, sphincter control, mobility, and movement, totaling 10 items. Each item is divided into 5 levels based on different independent abilities, with higher scores indicating better activities of daily living.

指标中文名：

肌肉的基础电生理参数

指标类型：

次要指标

Outcome：

Basic electrophysiological parameters of target muscles

Type：

Secondary indicator

测量时间点：

干预前和干预4周后

测量方法：

通过表面肌电图（sEMG）采集目标肌肉的基础电生理参数，评估神经肌肉功能。记录积分肌电值（iEMG，反映肌肉活动强度），用于评估胫骨前肌（足下垂薄弱核心肌）、腓肠肌（拮抗肌）的激活强度。

Measure time point of outcome：

T0、T4

Measure method：

Basic electrophysiological parameters of target muscles are collected via surface electromyography (sEMG) to evaluate neuromuscular function. The integrated electromyography value (iEMG, which reflects the intensity of muscle activity) is recorded to assess the activation intensity of the tibialis anterior muscle (the weak core muscle for foot drop) and the gastrocnemius muscle (the antagonist muscle).

指标中文名：

10米最大步行速度（10MWT）

指标类型：

次要指标

Outcome：

10-Meter Maximum Walking Speed (10MWT)

Type：

Secondary indicator

测量时间点：

干预前和干预4周后

测量方法：

在直线距离为10m的平地上，标记出起点、2m、8m、终点。让受试者以自身最快的速度从起点走到终点，记录受试者从2m走到8m的时间，时间精确到0.01s。重复测试3次，两次测试之间可以有时间间隔，让受试者休息。取3次测试结果平均值作为10米最大步行速度。测量最大步行速度（单位：m/s），量化日常移动效率，是步行能力的核心指标。

Measure time point of outcome：

T0、T4

Measure method：

On a flat ground with a straight-line distance of 10 meters, mark the starting point, 2m, 8m, and the finishing point. Ask the subject to walk from the starting point to the finishing point at their maximum speed, and record the time it takes for the subject to walk from 2m to 8m, with the time accurate to 0.01 seconds. Repeat the test 3 times, with intervals between the two tests to allow the subject to rest. Take the average of the 3 test results as the 10-meter maximum walking speed. Measurin

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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 岁 years
最大 Max age 75 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）：

试验负责人按照1：1的比例，运用计算机生成的随机数字表进行分组

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

The person in charge of the experiment grouped the subjects using a computer-generated random number table in a 1:1 ratio.

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：

单盲，对评估者隐藏分组

Blinding：

Single blind study with blinded-evaluators

是否共享原始数据：

IPD sharing

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）：

无

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：

采集符合标准的对象，对基线进行筛选。2名培训合格的康复治疗师盲法独立评定，用标准化记录表填写；客观指标借助工具测量，双人核对后录入。纸质数据（如知情同意书、病例报告表 CRF）存放在带锁的文件柜，钥匙由专人保管，借阅需登记（记录 “谁借、借什么、用途、归还时间”）；研究结束时不能销毁，纸质数据移交机构档案室长期保管，电子数据备份至专用服务器（至少双备份，异地存储）。

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

Collect eligible subjects that meet the criteria and screen the baseline. Two qualified rehabilitation therapists, who have received proper training, conduct independent assessments using the blind method and fill out standardized record forms. Objective indicators are measured with tools, checked by two people, and then entered. Paper data (such as informed consent forms, Case Report Forms (CRF)) are stored in locked file cabinets, with keys kept by designated personnel. Borrowing requires registration (recording "who borrowed, what was borrowed, purpose, and return time"). These paper data must not be destroyed at the end of the study; instead, they are transferred to the institutional archives for long-term storage. Electronic data are backed up to a dedicated server (with at least double backups and off-site storage).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-02-09 10:20:36