ChiCTR2500113227 版本V1.0 版本创建时间2025/11/26 10:46:26 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：

ChiCTR2500113227 

最近更新日期：

Date of Last Refreshed on：

2025-11-26 10:46:22 

注册时间：

Date of Registration：

2025-11-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

体外冲击波在治疗肌肉不同初长度下脑卒中患者下肢痉挛的临床疗效

Public title：

The Clinical Efficacy of Extracorporeal Shock Wave Therapy in Treating Lower Limb Spasticity in Stroke Patients with Varied Initial Muscle Lengths

注册题目简写：

English Acronym：

研究课题的正式科学名称：

体外冲击波在治疗肌肉不同初长度下的脑卒中痉挛的临床疗效

Scientific title：

The Clinical Efficacy of Extracorporeal Shock Wave Therapy in Treating Stroke-Induced Spasticity at Various Initial Muscle Lengths

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：

蒋留军 

研究负责人：

蒋留军 

Applicant：

Jiang Liujun 

Study leader：

Jiang Liujun 

申请注册联系人电话：

Applicant telephone：

+86 153 0040 0417

研究负责人电话：

Study leader's telephone：

+86 153 0040 0417

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：

1729046116@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1729046116@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：

上海市宝山区陆翔路108号华山医院宝山院区

研究负责人通讯地址：

上海市宝山区陆翔路108号华山医院宝山院区

Applicant address：

Baoshan Branch, Huashan Hospital, 108 Luxiang Road, Baoshan District, Shanghai

Study leader's address：

Baoshan Branch, Huashan Hospital, 108 Luxiang Road, Baoshan District, Shanghai

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：

复旦大学附属华山医院

Applicant's institution：

Huashan Hospital affiliated to Fudan University

研究负责人所在单位：

复旦大学附属华山医院

Affiliation of the Leader：

Huashan Hospital affiliated to Fudan University

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：

(2022)临审第(532)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：

Ethics Review Committee of Huashan Hospital affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2022-07-20 00:00:00

伦理委员会联系人：

吴翠云

Contact Name of the ethic committee：

Wu Cuiyun

伦理委员会联系地址：

上海市静安区乌鲁木齐中路12号

Contact Address of the ethic committee：

12 Urumqi Middle Road, Jing'an District, 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：

Huashan Hospital affiliated to Fudan University

研究实施负责（组长）单位地址：

上海市静安区乌鲁木齐中路12号

Primary sponsor's address：

12 Urumqi Middle Road, Jing'an District, 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

市(区县)：

Country：

China

Province：

Shanghai Municipality

City：

单位(医院)：

复旦大学附属华山医院

具体地址：

上海市静安区乌鲁木齐中路12号

Institution
hospital：

Huashan Hospital affiliated to Fudan University

Address：

12 Urumqi Middle Road, Jing'an District, Shanghai

经费或物资来源：

院级课题（复旦大学附属华山医院）

Source(s) of funding：

Hospital-level Project (Huashan Hospital Affiliated to Fudan University)

Target disease：

Stroke spasm

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

本研究的主要目的是评价体外冲击波在治疗肌肉不同初长度下的脑卒中痉挛的临床疗效，分别利用体外冲击波作用于放松状态和牵伸状态下踝跖屈肌，比较干预前后受试者小腿痉挛状态的临床量表、下肢运动功能量表、日常生活能力量表、神经电生理、10m步速等结果，分析经体外冲击波治疗后踝跖屈肌痉挛状态的改变、运动功能变化。本研究的次要目的是根据体外冲击波治疗效果，间接推断肌肉不同状态下体外冲击波治疗脑卒中后痉挛状态的机制。以期为后续探讨最佳治疗周期、治疗频率和综合康复提供方向、理论基础。  

Objectives of Study：

The main purpose of this study was to evaluate the clinical efficacy of extracorporeal shockwave in the treatment of stroke spasm with different initial lengths of muscles. Extracorporeal shockwave was applied to the ankle plantar flexors under relaxation and extension, respectively, and the results of clinical scale, lower limb motor function scale, daily living ability scale, neuroelectrophysiology, and 10m step speed of the subjects before and after the intervention were compared. The changes of spasticity and motor function of ankle plantar flexor after extracorporeal shock wave therapy were analyzed. The secondary purpose of this study was to indirectly infer the mechanism of extracorporeal shock wave therapy for post-stroke spasticity in different muscle states according to the effects of extracorporeal shock wave therapy. In order to provide the direction and theoretical basis for the follow-up study of the optimal treatment cycle, treatment frequency and comprehensive rehabilitation.

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.自愿参加，受试者无精神性病变，能充分理解、配合本试验，并愿意签署同意书，如受试者因利手侧偏瘫，无法签名，可征得其同意后由其法定代理人代签知情同意书； 2.符合第四届全国脑血管病学术会议制定的脑卒中诊断标准且经头颅CT或MRI检查诊断明确； 3.单侧偏瘫，偏瘫侧踝跖屈肌群改良Ashworth量表评分>1级，非偏瘫侧肢体肌张力正常； 4.首次发生脑卒中或既往发生过腔隙性脑梗死而无后遗症存在； 5.受试者脑卒中病程2个月-1年，病情稳定； 6.18岁＜=年龄＜=80岁，男女不限，左右利手不限； 7.意识清醒，听理解基本正常，能配合治疗和评估； 8.在体位改变过程中（受试者在两人帮助下进行床-轮椅转移）无明显不适，血压、心率、呼吸平稳，无疼痛、胸闷、气急、头晕、头痛等不适，可耐受仰卧或俯卧位30分钟； 9.在有/无辅助步行器帮助下具有一定行走能力。

Inclusion criteria

1. Voluntary participation, the subjects have no mental disorders, can fully understand and cooperate with this trial, and are willing to sign the consent form. If the subjects are hemiplegic on the dominant side and unable to sign, their legal representatives can sign the informed consent form with their consent. 2.They meet the diagnostic criteria for stroke formulated by the Fourth National Academic Conference on Cerebrovascular Diseases and have a clear diagnosis confirmed by head CT or MRI. 3.They have unilateral hemiplegia, with a modified Ashworth scale score of the ankle plantar flexor muscle group on the hemiplegic side greater than grade 1, and normal muscle tone on the non-hemiplegic side. 4.They have had their first stroke or have had lacunar infarction in the past without sequelae. 5.The course of stroke in the subjects is 2 months to 1 year, and the condition is stable. 6.Age range: 18 to 80 years old, gender and handedness are not limited. 7.Consciousness is clear, auditory comprehension is basically normal, and they can cooperate with treatment and assessment. 8.There is no obvious discomfort during changes in body position (the subjects are assisted by two people to transfer from bed to wheelchair), blood pressure, heart rate, and breathing are stable, and there is no pain, chest tightness, shortness of breath, dizziness, headache or other discomfort. They can tolerate the supine or prone position for 30 minutes. 9.They have a certain walking ability with or without the assistance of a walking aid.

排除标准：

1.既往患有糖尿病等可能存在周围神经损害、帕金森病等可致高肌张力、合并有肌肉病变的患者； 2.存在严重认知、言语、视力、听力障碍（如聋哑人）或精神障碍等影响检查及治疗者； 3.合并有肿瘤、严重的呼吸、心、肝、肾、内分泌和造血系统等疾病者,如充血性心力衰竭者、高血压未能控制者，血压高于140/90mmHg、活动性肝病，肝肾功能不全者； 4.所测关节本身存在疾患（例如严重感染、挛缩、关节手术、风湿或类风湿性关节炎）； 5.存在神经电生理、超声评估、体外冲击波治疗的禁忌症（如出血性疾病，凝血功能障碍患者可能引起局部组织出血、治疗区域存在血栓、严重认知障碍和精神疾病患者、皮破损、发热、肿瘤病史、妊娠期、哺乳期等）； 6.服用影响肌张力药物者，近3个月使用肉毒素注射者； 7.正在参加其他临床试验者。

Exclusion criteria：

1.Patients with a history of diabetes and other conditions that may cause peripheral nerve damage, Parkinson's disease and other conditions that may cause high muscle tone, and those with concurrent muscle diseases; 2.Those with severe cognitive, speech, vision, hearing impairments (such as deaf-mutes) or mental disorders that affect examination and treatment; 3.Those with concurrent tumors, severe respiratory, heart, liver, kidney, endocrine and hematopoietic system diseases, such as patients with congestive heart failure, uncontrolled hypertension, blood pressure higher than 140/90mmHg, active liver disease, liver and kidney insufficiency; 4.Those with joint disorders in the measured joint itself (such as severe infection, contracture, joint surgery, rheumatoid or rheumatoid arthritis); 5.Those with contraindications for nerve electrophysiology, ultrasound assessment, and extracorporeal shock wave therapy (such as bleeding disorders, patients with coagulation dysfunction that may cause local tissue bleeding, presence of thrombosis in the treatment area, severe cognitive and mental disorders, skin damage, fever, history of tumors, pregnancy, lactation, etc.); 6.Those taking drugs that affect muscle tone, and those who have received botulinum toxin injections within the last 3 months; 7.Those currently participating in other clinical trials.

研究实施时间：

Study execute time：

从 From 2022-08-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-01-12 00:00:00 至 To 2026-06-30 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

常规康复采用Bobath技术为主物理治疗，患侧肢体各关节的被动运动，包括肩胛带的活动，活动度从小到大，以不引起患者疼痛为宜，健患侧翻身练习，腕、踝关节背伸牵张练习，躯干肌、髋膝踝关节的控制训练，坐位站位平衡训练，步行训练，ADL训练等，痉挛期患者强调痉挛肌放松，诱导分离运动训练，软瘫期患者强调保持正确姿态，侧卧坐起训练。

干预措施代码：

 01

Intervention：

Bobath technique is used as the main physical therapy for routine rehabilitation. The passive movement of all joints of the affected limb, including scapular band activity, ranging from small to large, should not cause pain to the patient. The exercise of turning over the affected side, wrist and ankle back extension exercise, trunk muscle, hip, knee and ankle control training, sitting and standing balance training, walking training, ADL training, etc. Patients with spasticity emphasized relaxation of spasticity muscle and induced separation exercise training, while patients with soft paralysis emphasized maintaining correct posture and lateral sitting up training.

Intervention code：

组别：

放松组

样本量：

20

Group：

Relaxation group

Sample size：

干预措施：

放松组在常规康复治疗基础上用体外冲击波沿着腘横纹至跟腱的直线区域来回治疗小腿三头肌肌腹，能级：1.5-2.5Bar，频率：8-10Hz，探头：D20s，共治疗2000次，每周做2次，相邻间隔大于2天，共做4次（共2周）。以不引起患者明显疼痛为标准。

干预措施代码：

 02

Intervention：

In the relaxation group, on the basis of conventional rehabilitation treatment, extracorporeal shock wave was used to treat the abdominal muscles of the calf triceps muscle back and forward along the linear area from the popliteal stripe to the Achilles tendon, energy level: 1.5-2.5Bar, frequency: 8-10Hz, probe: D20s, a total of 2000 treatments were performed twice a week, and the adjacent interval was greater than 2 days, a total of 4 times (2 weeks). Do not cause significant pain in the patient as standard.

Intervention code：

组别：

牵伸组

样本量：

20

Group：

Draft group

Sample size：

干预措施：

牵伸组在常规康复治疗基础上，由助手先进行小腿三头肌的持续被动牵伸，然后用体外冲击波沿着腘横纹至跟腱的直线区域来回治疗小腿三头肌肌腹，能级：1.5-2.5Bar，频率：8-10Hz，探头：D20s，共治疗2000次，每周做2次，相邻间隔大于2天，共做4次（共2周）。以不引起患者明显疼痛为标准。

干预措施代码：

 03

Intervention：

In the stretching group, on the basis of conventional rehabilitation treatment, the assistant first carried out continuous passive drafting of the calf triceps, and then used extracorporeal shock wave to treat the calf triceps muscle abdomen along the popliteal stripe to the straight line area of the Achilles tendon. Energy level: 1.5-2.5Bar, frequency: 8-10Hz, probe: D20s, a total of 2000 treatments, twice a week, adjacent interval of more than 2 days, a total of 4 times (a total of 2 weeks). Do not cause significant pain in the patient as standard.

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 Municipality 

City：

 

单位(医院)：

复旦大学附属华山医院 

单位级别：

三甲 

Institution
hospital：

Huashan Hospital affiliated to Fudan University

Level of the institution：

Third-class hospital

测量指标：

Outcomes：

指标中文名：

改良 Ashworth 量表评分

指标类型：

主要指标

Outcome：

Modified Ashworth scale score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Fugl-Meyer 运动功能量表评分（下肢）

指标类型：

主要指标

Outcome：

Fugl-Meyer Motor Function scale score (Lower limbs)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良 Tardieu 量表评分

指标类型：

次要指标

Outcome：

Mofidied Tardieu scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良Barthel 指数量表评分

指标类型：

次要指标

Outcome：

Barthel index scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

10米步速测量

指标类型：

次要指标

Outcome：

10 meter pace 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：

神经电生理检查（胫神经H反射）

指标类型：

次要指标

Outcome：

Neurophysiological examination (H-reflex of the tibial nerve)

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：

N/A

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

由课题负责人利用计算机1-60生成随机数，能被3整除的为牵伸组，能被2整除的为放松组，其余的为对照组，患者根据入院时间随机入组。

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

The person in charge of the study used the computer 1-60 to generate random numbers. Those that could be evenly divided by 3 were in the stretch group, those that could be evenly divided by 2 were in the relaxation group, and the rest were in the control group. Patients were randomly enrolled according to the time of admission.

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：

评估者盲法

Blinding：

Evaluator blindness

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

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）：

由于涉及患者隐私及合作协议限制，本研究的原始数据暂不对外共享，但可根据合理需求向通讯作者申请汇总数据的进一步分析结果。

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

Due to the involvement of patient privacy and the restrictions of the cooperation agreement, the original data of this study is not shared externally for the time being. However, further analysis results of the aggregated data can be applied for from the corresponding author based on reasonable needs.

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：

本研究采用电子病例报告表（eCRF）通过OpenClinica系统收集数据，包括基线资料（年龄、性别、病史）、干预记录及量表评估结果（由两名独立治疗师或医生盲法判读）。数据在入组时、治疗第4次结束时及随访各收集一次。 数据存储于医院内部加密服务器，每日增量备份，异地灾备。数据质量控制通过系统自动校验（如数值范围、必填项）及人工抽查（10%随机样本）实现。受试者信息经去标识化处理，仅授权研究人员可通过权限系统访问。研究结束后数据保存10年，匿名数据可依合理要求向合格研究人员开放。

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

In this study, data were collected through the OpenClinica system using electronic case report forms (eCRF), including baseline information (age, gender, medical history), intervention records, and scale assessment results (blinded and interpreted by two independent therapists or doctors). Data were collected once each at the time of enrollment, at the end of the fourth treatment session, and during the follow-up. The data is stored on the hospital's internal encrypted server, with daily incremental backups and off-site disaster recovery. Data quality control is achieved through automatic system verification (such as numerical ranges and required fields) and manual spot checks (10% random samples). The subject information has been de-identified and only authorized for researchers to access through the permission system. After the research is completed, the data will be retained for 10 years. Anonymous data can be made available to qualified researchers upon reasonable request.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-11-26 10:46:22