ChiCTR2500105495 版本V1.0 版本创建时间2025/07/04 10:03:49 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：

 ChiCTR2500105495 

最近更新日期：

Date of Last Refreshed on：

 2025-07-04 10:03:43 

注册时间：

Date of Registration：

 2025-07-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

镜像疗法结合反复促通疗法对脑卒中后手功能障碍患者的临床疗效观察

Public title：

Observation on the clinical efficacy of mirror therapy combined with repeated facilitation therapy in patients with hand dysfunction after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

镜像疗法结合反复促通疗法对脑卒中后手功能障碍患者的临床疗效观察

Scientific title：

Observation on the clinical efficacy of mirror therapy combined with repeated facilitation therapy in patients with hand dysfunction after stroke

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：

刘永香 

研究负责人：

严璐 

Applicant：

Liu Yongxiang 

Study leader：

Yan Lu 

申请注册联系人电话：

Applicant telephone：

 +86 188 8693 0528

研究负责人电话：

Study leader's
telephone：

+86 177 8564 7071

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：

 2581647525@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 859571400@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：

贵州省贵阳市花溪区花溪大学城栋青路4号

研究负责人通讯地址：

贵州省贵阳市云岩区飞山街83号

Applicant address：

No. 4, Dongqing Road, Huaxi University Town, Huaxi District, Guiyang, Guizhou

Study leader's address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou

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：

贵州中医药大学

Applicant's institution：

Guizhou University of Traditional Chinese Medicine

研究负责人所在单位：

贵州中医药大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

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：

 KY202401100

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：

贵州中医药大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Guizhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-17 00:00:00

伦理委员会联系人：

马武开

Contact Name of the ethic committee：

Ma Wukai

伦理委员会联系地址：

贵州省贵阳市云岩区飞山街83号

Contact Address of the ethic committee：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 136 0855 3702

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：

贵州中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

研究实施负责（组长）单位地址：

贵州省贵阳市云岩区飞山街83号

Primary sponsor's address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州

市(区县)：

贵阳

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

贵州中医药大学第二附属医院

具体地址：

贵州省贵阳市云岩区飞山街83号

Institution
hospital：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou

经费或物资来源：

贵州省教育厅及贵州中医药大学

Source(s) of funding：

The Department of Education of Guizhou Province and Guizhou University of Chinese Medicine

研究疾病：

脑卒中  

Target disease：

Stroke

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.探索神经可塑性在脑卒中后手功能障碍康复中的作用 基于“神经可塑性“理论探讨镜像疗法与反复促通疗法在脑卒中后手功能障碍患者康复过程中的应用价值，旨在验证单一疗法与联合疗法在康复治疗中的实际效果。 2.验证“中枢-外周-中枢”闭环康复理念的临床应用效果 本研究基于“中枢-外周-中枢”闭环康复理念，综合运用中枢干预（镜像疗法）和外周干预（反复促通疗法），旨在促进患者受损手功能的恢复，提高其日常生活活动能力。  

Objectives of Study：

1. To explore the role of neural plasticity in the rehabilitation of hand dysfunction after stroke, based on the theory of "neural plasticity", this paper discusses the application value of mirror therapy and repeated promoting therapy in the rehabilitation process of patients with hand dysfunction after stroke, aiming to verify the actual effect of single therapy and combined therapy in rehabilitation treatment. 2. Verify the clinical application effect of the "central - peripheral - Central" closed-loop rehabilitation concept This study is based on the "central - peripheral - central" closed-loop rehabilitation concept and comprehensively employs central intervention (mirror therapy) and peripheral intervention (repeated patency promotion therapy), aiming to promote the recovery of the damaged hand function of patients and improve their activities of daily living.

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《中国各类主要脑血管病诊断要点2019》中缺血性脑卒中和出血性脑卒中诊断标准； （2）年龄18~75岁，首次发病； （3）病程在2周至6个月； （4）左侧或右侧偏瘫，偏瘫侧手功能运动障碍； （5）偏瘫侧手功能Brunnstrom分级为I-III级，患侧手肌张力MAS≤1+级。 （6）坐位平衡≥1级； （7）意识清楚，生命体征平稳，病情稳定，无认知功能障碍； （8）自愿参加本研究，并签署知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria for ischemic stroke and hemorrhagic stroke as stipulated in the "Key Points for the Diagnosis of Various Major Cerebrovascular Diseases in China 2019"; (2) Age 18-75 years old, first onset; (3) The course of the disease ranges from 2 weeks to 6 months; (4) Left or right hemiplegia, with motor dysfunction of the hemiplegic hand; (5) The Brunnstrom classification of hand function on the hemiplegic side is grade I-III, and the muscle tone MAS of the affected hand is <= grade 1+. (6) Sitting balance >= level 1; (7) Clear consciousness, stable vital signs, stable condition, and no cognitive dysfunction; (8) Voluntarily participate in this study and sign the informed consent form.

排除标准：

（1）发病前有其他因素引起的患侧手功能疾病，如先天性手功能障碍、关节挛缩患者、外伤等； （2）严重意识障碍、理解和认知功能障碍、记忆力减退、严重失用、失语等； （3）上肢有创伤、感染、周围血管病变者； （4）存在视力障碍、偏侧忽略者。

Exclusion criteria：

(1) Other factors causing hand function diseases on the affected side before the onset of the disease, such as congenital hand dysfunction, patients with joint contracture, trauma, etc. (2) Severe consciousness disorders, comprehension and cognitive dysfunction, memory loss, severe apraxia, aphasia, etc. (3) Those with trauma, infection or peripheral vascular disease in the upper limbs; (4) Those with visual impairments or hemiplegia.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2025-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-11 00:00:00 至 To 2025-11-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 24

Group：

Control group

Sample size：

干预措施：

（1）内科治疗 参照《中国急性缺血性脑卒中诊治指南2018》和《中国脑出血诊治指南2019》，缺血性脑卒中患者给予抗血小板、降压、控制血糖、改善心肌供血、降脂、稳定斑块、改善脑循环及代谢等相关治疗；出血性脑卒中患者给予脱水、降颅压、营养神经等基础治疗；控制血压、控制血糖、控制血脂等；定期检测患者血、尿、便常规、凝血功能、D-二聚体、生化全项等指标，密切关注生命体征变化、心电图改变等。 （2）康复治疗 参照中国脑血管病临床管理指南（节选版）——卒中康复管理，所有受试者由相对固定且有经验的康复治疗师根据患者病情制定治疗方案并实施治疗，主要包括： ①脑卒中卧床期间应将患者摆放于良肢位：鼓励患侧卧位，适当健侧卧位，尽可能少采用仰卧位，应尽量避免半卧位，保持正确的坐姿、站姿； ②脑卒中卧床期间患者应坚持肢体关节活动度训练，注意保护患侧肢体避免机械性损伤； ③针对相应的肌肉进行功能性电刺激治疗、肌电生物反馈疗法，可以提高瘫痪肢体的肌力和功能； ④应用综合步态分析系统对偏瘫步态进行客观分析，是制订精细化的步行康复训练方案，提高步行康复质量的有效方法。

干预措施代码：

Intervention：

Internal medicine treatment According to the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" and the "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019", patients with ischemic stroke were given relevant treatments such as antiplatelet therapy, blood pressure reduction, blood glucose control, improvement of myocardial blood supply, lipid reduction, plaque stabilization, improvement of cerebral circulation and metabolism; Patients with hemorrhagic stroke were given basic treatments such as dehydration, intracranial pressure reduction and nerve nutrition; Control blood pressure, blood sugar, blood lipid, etc. Regularly test the patients' blood, urine, stool routine, coagulation function, D-dimer, biochemical comprehensive items and other indicators, and closely monitor the changes of vital signs, electrocardiogram changes, etc. (2) Rehabilitation treatment Referring to the Chinese Clinical Management Guidelines for Cerebrovascular Diseases (Selected Version) - Stroke Rehabilitation Management, all subjects were treated by relatively fixed and experienced rehabilitation therapists who formulated treatment plans based on the patients' conditions and implemented the treatment, mainly including: During the period of bedridden after a stroke, the patient should be placed in a good limb position: encourage the affected side to lie down, appropriately lie down on the healthy side, and minimize the use of the supine position. Semi-recumbent positions should be avoided as much as possible, and correct sitting and standing postures should be maintained. ② During the bedridden period of stroke, patients should persist in training the range of motion of limb joints and pay attention to protecting the affected limb to avoid mechanical injury. ③ Functional electrical stimulation therapy and electromyographic biofeedback therapy targeting the corresponding muscles can enhance the muscle strength and function of paralyzed limbs. ④ Applying the comprehensive gait analysis system to objectively analyze the hemiplegic gait is an effective method for formulating a refined walking rehabilitation training program and improving the quality of walking rehabilitation.

Intervention code：

组别：

镜像疗法组

样本量：

 24

Group：

Mirror therapy group

Sample size：

干预措施：

在上述常规治疗的基础上给予镜像疗法，选择相对安静、背景单一的房间，研究者向患者和家属演示、讲解镜像疗法，获取患者和家属的理解和配合。患者端坐在治疗台前，平面镜垂直放置在患者正前方的台面上，患侧上肢置于镜面背侧盒内，健侧上肢平放于镜面侧；嘱患者注视镜面，健手进行腕屈伸、尺偏、桡偏，手指屈伸、抓握、侧捏、对指，前臂旋前、旋后、移动物体训练，并嘱患者在训练期间努力想象成患侧手在做同样动作，以此诱发患侧活动。以上动作尽量达到最大的关节活动范围，以10种动作为1组训练，每组练习6分钟，共练习4组，各组之间休息2分钟，共干预30min，1次/天，6天/周，共2周

干预措施代码：

Intervention：

On the basis of the above-mentioned conventional treatment, mirror therapy was given. A relatively quiet room with a single background was selected. The researcher demonstrated and explained the mirror therapy to the patient and their family to obtain their understanding and cooperation. The patient sits upright in front of the treatment table. The plane mirror is placed vertically on the table surface directly in front of the patient. The affected upper limb is placed in the dorsal box of the mirror surface, and the healthy upper limb is placed flat on the side of the mirror surface. Instruct the patient to gaze at the mirror surface, perform wrist flexion and extension, ulnar deviation, radial deviation, finger flexion and extension, grasping, side pinching, finger opposition, forearm pronation, supination, and object movement training with the healthy hand, and ask the patient to try to imagine the affected hand performing the same movements during the training period to induce the activity of the affected side. The above movements should aim to achieve the maximum range of joint movement. Train with 10 movements as one set, each set lasting 6 minutes, for a total of 4 sets. Take a 2-minute break between each set for a total of 30 minutes of intervention, once a day, 6 days a week, for a total of 2 weeks

Intervention code：

组别：

反复促通疗法组

样本量：

 24

Group：

Repeated unblocking therapy group,

Sample size：

干预措施：

在常规治疗的基础上给予反复促通疗法，包括以下四个模式： （1）腕背屈促进模式：患者仰卧位，治疗师双膝固定患肘，保持患腕、前臂中立位，拇指置于患手背，其余四指包紧患手，研究者拇指向腕掌屈、前臂旋后的方向快速按压患手背，另一手拇指长距离刮擦患前臂背侧，同时口令“抬腕”，待患者腕背屈和前臂旋前充分完成后，回到初始位置，准备下次操作。 （2）手指集团屈伸促进模式：患者仰卧位，研究者双膝固定患肘，一手握住拇指，另一手食指和中指夹住其余患手指，使前臂旋前、腕背屈、手指伸展；研究者无名指叩击患手指，口令“握拳”，患者抓握同时前臂旋后，研究者拇指顺着腕关节掌屈方向快速按压，口令“伸手”，促进患手指伸展、腕关节掌屈，随后通过患手主动运动和研究者辅助，回到初始位置，准备下次操作。 （3）单手指伸展促进（以食指为例）模式：患者仰卧位，研究者双膝固定患肘，食指和中指轻夹患第3~5指，拇指和无名指轻夹患手掌，使患腕掌屈，另一手拇指放在患食指掌指关节（伸展位），食指放在近端指间关节（屈曲位），中指放在远端指间关节（屈曲位），无名指放在指甲上，研究者用食指快速按压食指，口令“食指伸直”，直到伸到最大范围，随后回到初始位置，准备下次操作；其它手指操作与此相同。 （4）拇指外展促进模式：患者仰卧位，研究者双膝固定患肘，一手拇指合食指捏住患拇指，无名指和小指放在患手大鱼际桡侧，另一手捏住患食指到小指，保持腕中立位，研究者用拇指和食指快速内收牵伸患拇指，用无名指和小指叩击患拇指大鱼际桡侧，同时口令“拇指外展”，直到外展到最大范围，随后回到初始位置，准备下次操作。 一种模式进行150次重复练习，完成后按摩前臂屈侧及桡侧肌肉、手背肌肉作为休息再进行下一种模式，可根据患者配合、耐受程度，调整手法频率；指导患者注意力集中，盯着促进部位，遵口令进行行动，尽量避免代偿和过度用力。30min/次/天，每周六天，共两周

干预措施代码：

Intervention：

On the basis of conventional treatment, repeated unblocking therapy is given, including the following four modes: (1) Wrist dorsiflexion promotion mode: The patient lies in a supine position. The therapist fixes the affected elbow with both knees, keeping the affected wrist and forearm in a neutral position. The thumb is placed on the back of the affected hand, and the other four fingers are tightly wrapped around the affected hand. The researcher quickly presses the back of the affected hand with the thumb in the direction of wrist flexion and forearm supination, and the thumb of the other hand is used to scrape the back side of the affected forearm over a long distance. At the same time, the command "raise the wrist" is given. After the patient has fully completed wrist flexion and forearm supination, they return to the initial position. Prepare for the next operation. (2) Finger group flexion and extension promotion mode: The patient lies in the supine position. The researcher fixes the affected elbow with both knees. One hand holds the thumb, and the index and middle fingers of the other hand clamp the remaining affected fingers, causing the forearm to pronate, the wrist to dorsiflex, and the fingers to extend. The researcher tapped the affected finger with the ring finger and commanded "Make a fist". The patient grasped and rotated the forearm backward. The researcher quickly pressed along the direction of palmar flexion of the wrist joint with the thumb and commanded "Reach out", promoting the extension of the affected finger and palmar flexion of the wrist joint. Then, with the active movement of the affected hand and the assistance of the researcher, the patient returned to the initial position, preparing for the next operation. (3) Single-finger extension promotion (taking the index finger as an example) mode: The patient lies in a supine position. The researcher fixes the affected elbow with both knees. The index finger and middle finger gently pinch the third to fifth fingers of the affected wrist, and the thumb and ring finger gently pinch the affected palm, flexed the affected wrist. The thumb of the other hand is placed on the metacarpophalangeal joint of the affected index finger (extended position), the index finger on the proximal interphalangeal joint (flexed position), the middle finger on the distal interphalangeal joint (flexed position), and the ring finger on the nail. The researcher quickly pressed the index finger with the index finger under the command "Straighten the index finger" until it reached the maximum range, and then returned to the initial position to prepare for the next operation. Other finger operations are the same as this. (4) Thumb abduction promotion mode: The patient lies in a supine position. The researcher fixes the affected elbow with both knees. The researcher holds the affected thumb with the thumb and index finger of one hand, and places the ring finger and little finger on the radial side of the thenar eminence of the affected hand. The researcher holds from the index finger to the little finger of the affected hand with the other hand, maintaining a neutral wrist position

Intervention code：

组别：

联合组

样本量：

 24

Group：

Joint group

Sample size：

干预措施：

在常规治疗的基础上，对患者实施镜像疗法（操作手法上述的镜像疗法组）后，再进行反复促通疗法（操作手法同上述的反复促通疗法组），一次共干预1h，每天一次，每周6天，共两周

干预措施代码：

Intervention：

On the basis of conventional treatment, after implementing mirror therapy (the operation method of the mirror therapy group mentioned above) for the patients, repeated unblocking therapy (the operation method is the same as that of the repeated unblocking therapy group mentioned above) is carried out. Each intervention lasts for 1 hour, once a day, 6 days a week, for a total of two weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

  

Country：

China

Province：

Guizhou

City：

单位(医院)：

 贵州中医药大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer手运动量表得分

指标类型：

主要指标

Outcome：

Fugl-Meyer hand exercise 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：

Brunnstrom 手功能分级

指标类型：

次要指标

Outcome：

Brunnstrom hand function grading

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

关节活动度

指标类型：

次要指标

Outcome：

Motion of joint

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：

None

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 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）：

方法采用Excel将96个编号随机分为四组，并将其制作成随机分配的卡片，在卡片上填写编号，并将其放进一个不透明的密封信封内

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

96 numbers were randomly divided into four groups using Excel, and they were made into randomly assigned cards. The numbers were filled in on the cards and placed in an opaque sealed envelope.

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

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）：

原始数据计划于试验结束后6个月内，通过ResMan(www.medresman.org.cn)方式共享

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

The original data is planned within six month after the end of the experiment, it was shared by ResMan (www.medresman.org.cn).

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：

病例记录表，电子采集和管理系统

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

Case Record Form, CRF; Electronic Data Capture, EDC

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：

  2025-07-04 10:03:43