ChiCTR2600117564 版本V1.0 版本创建时间2026/01/26 16:30:18 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：

ChiCTR2600117564 

最近更新日期：

Date of Last Refreshed on：

2026-01-26 16:30:01 

注册时间：

Date of Registration：

2026-01-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

周围神经选择性切断术及转移术联合康复训练对中枢性上肢痉挛瘫的临床疗效及机制探索

Public title：

Clinical efficacy and mechanical exploration of peripheral nerve selective excision and transfer combined with rehabilitation training in central upper limb spastic paralysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

周围神经选择性切断术及转移术联合康复训练对中枢性上肢痉挛瘫的临床疗效及机制探索

Scientific title：

Clinical efficacy and mechanical exploration of peripheral nerve selective excision and transfer combined with rehabilitation training in central upper limb spastic paralysis

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：

李军 

研究负责人：

李军 

Applicant：

Li Jun 

Study leader：

Li Jun 

申请注册联系人电话：

Applicant telephone：

+86 13426489069

研究负责人电话：

Study leader's telephone：

+86 10 87569087

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：

lijun2009crrc@163.com

研究负责人电子邮件：

Study leader's E-mail：

lijun2009crrc@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：

北京市丰台区角门北路10号

研究负责人通讯地址：

北京市丰台区角门北路10号

Applicant address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

Study leader's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

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：

北京市中国康复研究中心北京博爱医院

Applicant's institution：

China Rehabilitation Research Center,Beijing Bo'ai Hospital,Beijing

研究负责人所在单位：

北京博爱医院

Affiliation of the Leader：

Beijing Bo'ai 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：

2024-127-02

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：

中国康复研究中心医学伦理委员会科研与医疗新技术新项目伦理组

Name of the ethic committee：

Medical Ethics Committee of China Rehabilitation Research Center

伦理委员会批准日期：

Date of approved by ethic committee：

2024-12-28 00:00:00

伦理委员会联系人：

何照楠

Contact Name of the ethic committee：

He Zhaonan

伦理委员会联系地址：

北京市丰台区角门北路10号

Contact Address of the ethic committee：

No. 10, Jiaomen North Road, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 87020512

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hznhzk@163.com

研究实施负责（组长）单位：

北京博爱医院

Primary sponsor：

Beijing Bo'ai Hospital

研究实施负责（组长）单位地址：

北京市丰台区角门北路10号

Primary sponsor's address：

No.10, Jiaomen North Road, Fengtai District,Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京博爱医院

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

Beijing Bo'ai Hospital

Address：

No. 10, Jiaomen North Road, Fengtai District

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

optional project

Target disease：

Central nervous system injury diseases, such as stroke, cerebral palsy, traumatic brain injury, spastic paralysis of the upper limbs during the recovery period of spinal cord injury patients

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：

观察周围神经选择性切断术+转移术或联合康复训练治疗中枢性上肢痉挛瘫患者痉挛的临床疗效及脑可塑性机制的探索。  

Objectives of Study：

Observation of the clinical efficacy and exploration of brain plasticity mechanisms in the treatment of spasticity in patients with central upper limb spastic paralysis by peripheral nerve selective dissection + transfer or combined rehabilitation training.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.12岁以上的脑卒中、脑瘫（偏瘫、三肢瘫、四肢瘫）、创伤性脑损伤、脑肿瘤、脑血管意外等中枢神经系统损伤伴肢体痉挛或中枢性痉挛瘫患者一年后出现上肢痉挛，且近3个月痉挛程度无变化； 2.痉挛状态经保守治疗（物理治疗、作业治疗、药物、肉毒毒素注射等）后无明显改善或复发； 3.改良Ashworth量表（MAS）≥2级，不伴上肢畸形。

Inclusion criteria

1. Patients over 12 years old with stroke, cerebral palsy (hemiplegia, triple limb palsy, quadriple limb palsy), traumatic brain injury, cerebral tumor, cerebrovascular accident and other central nervous system injuries with limb spasticity or central spastic palsy develop spasticity of the upper limbs after one year and the degree of spasticity is unchanged in the last 3 months; 2. Spasticity state is not significantly improved or relapsed by conservative treatments (physical therapy, occupational therapy, medication, botulinum toxin injections, etc.); 3. Modified Ashworth Scale (MAS) >= grade 2 without upper limb deformity.

排除标准：

1.严重精神或认知障碍，不能配合康复训练； 2.严重原发性疾病或一般身体状况较差； 3.合并严重不可逆肌肉挛缩和骨畸形； 4.有手术或麻醉禁忌证者； 5.长期口服抗痉挛药物如巴氯芬、卡马西平等未停药者。

Exclusion criteria：

1. severe mental or cognitive impairment, unable to cooperate with the rehabilitation training; 2. serious primary disease or poor general physical condition; 3. combined with severe irreversible muscle contracture and bone deformity; 4. contraindications to surgery or anesthesia; 5. long term oral anti-spasticity drugs such as baclofen, carbamazepine, etc. have not been discontinued.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从From 2024-12-26 00:00:00 至 To 2025-11-26 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

12

Group：

Control group

Sample size：

干预措施：

周围神经平衡术

干预措施代码：

Intervention：

Peripheral nerve balancing

Intervention code：

组别：

干预组

样本量：

12

Group：

Intervention group

Sample size：

干预措施：

周围神经平衡术+康复训练

干预措施代码：

Intervention：

Peripheral Nerve Balancing + Rehabilitative Train

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京博爱医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Bo'ai Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

关节活动度测量

指标类型：

次要指标

Outcome：

Range of motion

Type：

Secondary indicator

测量时间点：

术前、术后3天、1周、1个月、3个月、6个月

测量方法：

利用关节量角器，对肘关节（屈曲、伸展）、腕关节（背伸、掌屈）、前臂（旋前、旋后）进行被动活动的测量。

Measure time point of outcome：

Preoperative, 3 days, 1 week, 1 month, 3 months, 6 months postoperative

Measure method：

Using a joint protractor, passive activity was measured at the elbow (flexion, extension), wrist (dorsiflexion, palmar flexion), and forearm (pronation, pronation).

指标中文名：

Fugl-Meyer上肢运动功能量表

指标类型：

次要指标

Outcome：

Fugl-Meyer Upper Extremity Scale

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

FMA-UE分为33个条目，包括肢体反射状态、屈肌伸肌协同运动、伴有协同运动的活动、分离协同运动的活动、腕稳定性、手的握力捏力及手屈伸和手指指鼻的协调能力与速度。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The FMA-UE is divided into 33 entries, including limb reflex status, flexor-extensor synergistic movements, activities with synergistic movements, activities with separated synergistic movements, wrist stability, grip pinch of the hand and hand flexion-extension and finger-finger-nose coordination ability and speed.

指标中文名：

简易上肢运动功能评估测试

指标类型：

次要指标

Outcome：

Simple test for evaluating hand function

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

当检查者发出“开始”口令后，研究对象以最快的速度逐一将测试工具转移到指定位置，检查者测定转移这些工具所用的时间。左右手分别进行测试并记录。时间精确到小数点后两位。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

When the examiner gave the “start” command, the subjects transferred the test instruments one by one to the designated location as fast as possible, and the examiner measured the time taken to transfer the instruments. The left and right hands were tested separately and recorded. Times were recorded to two decimal places.

指标中文名：

改良Barthel指数量表

指标类型：

次要指标

Outcome：

Modified Barthel Index

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

从进食、洗澡、修饰、穿衣等10个方面（3项移动性ADL和7项自理性ADL）评定患者的ADL，每个项目分为5个评分等级（即,不能完成任务,尝试任务但不安全,需要适度的帮助,需要最少的帮助,完全独立）。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

Patients' ADLs were rated in 10 areas (3 mobility ADLs and 7 self-referential ADLs) such as eating, bathing, grooming, dressing, etc., and each item was categorized into 5 rating scales (i.e., unable to complete the task, attempted the task but was unsafe, needed moderate help, needed minimal help, and was completely independent).

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating Anxiety Scale

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

SAS标准分的分界值为50，其中50～59分为轻度焦虑，60～69分为中度焦虑，69分以上为重度焦虑。结合临床症状考虑患有焦虑情绪障碍，量表具有较好的信度和效度。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The cut-off value of SAS standardized score is 50, where 50-59 is mild anxiety, 60-69 is moderate anxiety, and more than 69 is severe anxiety. The scale has good reliability and validity when considered with the clinical symptoms of suffering from anxiety mood disorder.

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-rating Depression Scale

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

20个条目中有10项是正性词陈述句，为反序记分；其余10项是负性词陈述句，按正序记分。获得粗分后乘以1.25后取整，得到标准分。可采用抑郁严重指数（0.25~1.0）来反映被测者的抑郁程度。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

Ten of the 20 entries were positive word statements, scored in reverse order; the remaining 10 were negative word statements, scored in positive order. A crude score was obtained and multiplied by 1.25 and then rounded to obtain a standardized score. A depression severity index (0.25 to 1.0) can be used to reflect the degree of depression of the subject.

指标中文名：

表面肌电图

指标类型：

主要指标

Outcome：

Surface electromyography

Type：

Primary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

测试时患者分别进行三种状态（静息状态、被动运动、主动运动）下的测试，以此来观察患者是否存在肌肉震颤、肌力及肌张力的大小。主动运动时，嘱患者最大力进行肘、腕伸展，记录10s内的肘、腕伸展时的iEMG和RMG。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

During the test, patients were tested in three states (resting state, passive movement, and active movement) to observe the presence of muscle tremor, muscle strength and muscle tone. During active exercise, patients were instructed to perform elbow and wrist extension with maximum force, and the iEMG and RMG during elbow and wrist extension were recorded for 10 s. The iEMG and RMG were recorded for 10 s during elbow and wrist extension.

指标中文名：

运动诱发电位

指标类型：

次要指标

Outcome：

Motor Evoked Potential

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

患者采取安静坐位，放松肢体，以患侧大脑半球为刺激部位，刺激中心为大脑M1区，将记录电极贴片贴在患侧拇短展肌的肌腹处，参考电极贴片贴于肌腱处，地线电极贴片贴于同侧腕部，记录患侧拇外展肌MEP的静息阈值、波幅、潜伏期、中枢运动传导时间，以此判断患侧上肢运动功能损伤情况。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patient took a quiet sitting position, relaxed the limbs, the affected side of the cerebral hemisphere as the stimulation site, the stimulation center for the M1 region of the brain, the recording electrode patch on the affected side of the thumb abductor muscle muscle belly, the reference electrode patch on the tendon, the ground electrode patch on the same side of the wrist, recording the affected side of the thumb abductor muscle MEP resting thresholds, amplitude, latency, and central mot

指标中文名：

任务态功能磁共振

指标类型：

次要指标

Outcome：

Task-Based Functional Magnetic Resonance Imaging

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

通过T-fMRI采集患者脑组织血氧水平依赖（blood oxygen level dependent, BOLD）成像数据，进行激活分析、动态因果模型分析、格兰杰因果分析等数据分析。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patients' brain tissue blood oxygen level dependent (BOLD) imaging data were acquired by T-fMRI, and data analysis such as activation analysis, dynamic causal model analysis, and Granger causality analysis were performed.

指标中文名：

脑电图

指标类型：

次要指标

Outcome：

Electroencephalogram

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

EEG能通过记录大脑皮层神经细胞的突触后电位反映脑细微结构的动态变化和功能的改变,确定病人大脑皮质-丘脑通路是否完整来判断脑部的损伤程度。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

EEG can determine the degree of brain damage by recording the postsynaptic potentials of cortical nerve cells, reflecting the dynamic changes in brain microstructure and function, and by determining the integrity of the patient's cortical-thalamic pathway.

指标中文名：

捏力测试

指标类型：

次要指标

Outcome：

Pinch test

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

患者取坐位，以指头-指侧型（拇指远侧指节与示指桡侧面间相对互压的用力方式）相对捏压捏力计，测试3次，每次间隔2分钟，取3次平均值记录最大捏力。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patient was seated, and the maximum pinch force was recorded by relative pinching of the pinch gauge with the fingertip-finger-lateral type (the force of relative reciprocal pressure between the distal phalanx of the thumb and the radial surface of the demonstrated finger) for 3 tests at 2-minute intervals, with the average of the 3 tests taken to record the maximum pinch force.

指标中文名：

握力测试

指标类型：

次要指标

Outcome：

Grip strength test

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

患者取坐位，握力计表面向外，将把手调节至适当宽度，以最大力量进行握力测量，测量3次，每次间隔2分钟，最后取最大值。握力指数=握力（kg）/体重（kg）×100%，正常握力指数≥50%。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patient took a sitting position, the surface of the grip strength meter was outward, the handle was adjusted to the appropriate width, and the grip strength was measured with maximum force, 3 times, each time at an interval of 2 minutes, and the maximum value was taken at the end. Grip strength index = grip strength (kg)/body weight (kg) × 100%, normal grip strength index ≥50%.

指标中文名：

浅感觉评估

指标类型：

次要指标

Outcome：

Shallow sensory assessment

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

患者取坐位，通过相关仪器检测患肢轻触觉和温度觉。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patient is placed in a seated position, and light touch and temperature sensations of the affected limb are detected by means of relevant instruments.

指标中文名：

深感觉评估

指标类型：

次要指标

Outcome：

Deep Sensory Assessment

Type：

Secondary indicator

测量时间点：

术前、术后1个月、3个月、6个月

测量方法：

患者取坐位，通过相关仪器检测患肢振动觉。

Measure time point of outcome：

Preoperative, 1 month, 3 months, 6 months postoperative

Measure method：

The patient is placed in a sitting position and the vibration sensation of the affected limb is detected by means of the relevant instruments.

指标中文名：

徒手肌力分级检查

指标类型：

次要指标

Outcome：

Manual muscle test

Type：

Secondary indicator

测量时间点：

术前、术后3天、1周、1个月、3个月、6个月

测量方法：

MMT是评估肌肉力量最常用的方法。每块肌肉进行手动测试，并从0（无肌肉收缩）到5（最大阻力下完全抵抗重力的完整运动范围）进行评分。

Measure time point of outcome：

Preoperative, 3 days, 1 week, 1 month, 3 months, 6 months postoperatively

Measure method：

MMT is the most commonly used method for assessing muscle strength. Each muscle is manually tested and scored from 0 (no muscle contraction) to 5 (full range of motion with complete resistance to gravity at maximum resistance).

指标中文名：

改良Asworth量表

指标类型：

主要指标

Outcome：

Modified Ashworth Scale

Type：

Primary indicator

测量时间点：

术前、术后3天、1周、1个月、3个月、6个月

测量方法：

结合关节被动运动，检查者根据在关节活动范围内的运动阻力出现时间和角度范围对肌张力进行评定，共分为6个等级

Measure time point of outcome：

Preoperative, 3 days, 1 week, 1 month, 3 months, 6 months postoperatively

Measure method：

In conjunction with passive joint movements, the examiner rates muscle tone based on the time of onset and angular range of resistance to movement within the range of motion of the joint, which is categorized into six grades.

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 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）：

采用的是计算机随机化法：由1位未参与评估和治疗的研究成员使用SPASS27.0软件生成随机数字，随后填写相应的随机分配卡，并装入不透明的信封中密封，在签署知情同意书后，由患者家属打开信封，从而决定其分组。

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

In this study, 24 patients who met the inclusion criteria were randomly divided into the intervention group and the control group, 12 cases in each group. Intervention group: patients were treated with peripheral nerve balancing + rehabilitation training; control group: patients were treated with peripheral nerve balancing.

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

Blinding：

Single blind study

是否共享原始数据：

IPD sharing

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）：

研究公开发表后半年，邮件联系研究负责人合理获取。

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

Six months after the publication of the research, contact the research leader via email to obtain reasonable information.

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：

一、数据采集：1.纳入研究的患者在术前、术后1个月、术后3个月及术后6个月到门诊或住院部随访，由专业医师进行各项评估。2.对于每个评估指标，严格按照相应的标准和方法进行测量和记录，确保数据的准确性和可靠性。3.在数据采集过程中， 使用病历记录本记录患者的基本信息、治疗过程中的任何异常情况或并发症。二、数据管理：应用SPSS22.0版软件进行数据录入，建立数据库，计量资料采用均数±标准差（x±s）进行统计描述，若不符合正态分布，采用中位数或四分位间距进行统计学描述；满足正态分布采用t检验，不满足正态分布采用非参数检验，组内比较采用配对样本t检验，两组间比较采用两独立样本t检验。等级资料采用非参数秩和检验。组内采用配对Wilcoxon秩和检验，组间对比采用Mann-Whitney U秩和检验。以P≤0.05表示差异具有统计学意义。

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

I. Data collection: 1. Patients included in the study were followed up in outpatient clinic or inpatient department before surgery, 1 month after surgery, 3 months after surgery and 6 months after surgery, and were assessed by professional physicians.2 For each assessment index, measurements and records were made in strict accordance with the corresponding standards and methods, to ensure the accuracy and reliability of the data.3. In the process of data collection, the patients' basic information, any abnormalities or complications in the treatment process, and any other information were recorded in the patient's medical records. Use the medical record book to record the patient's basic information, any abnormalities or complications in the treatment process. Data management: SPSS22.0 software was used for data entry and database establishment. Measurement data were statistically described by mean ± standard deviation (x ± s), and median or interquartile spacing was used for statistical descriptions if they did not meet the normal distribution; t-test was used to satisfy the normal distribution, and non-parametric test was used if they did not satisfy the normal distribution; paired samples t-test was used for comparison within the group, and two independent samples t-test was used for comparison between the two groups. Comparisons between groups were made using the paired samples t-test, and comparisons between two groups were made using the two independent samples t-test. Non-parametric rank-sum test was used for hierarchical data. The paired Wilcoxon rank sum test was used for within-group comparisons, and the Mann-Whitney U rank sum test was used for between-group comparisons. P≤0.05 indicated that the difference was statistically significant.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-26 16:30:01