ChiCTR2600116634 版本V1.0 版本创建时间2026/01/13 11:01:52 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：

 ChiCTR2600116634 

最近更新日期：

Date of Last Refreshed on：

 2026-01-13 11:01:32 

注册时间：

Date of Registration：

 2026-01-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

镜像治疗对脑卒中后上肢功能康复的临床疗效与神经机制研究

Public title：

Clinical Efficacy and Neural Mechanism of Mirror Therapy on Upper Limb Function Rehabilitation after Stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

镜像治疗对脑卒中后上肢功能康复的临床疗效与神经机制研究

Scientific title：

Clinical Efficacy and Neural Mechanism of Mirror Therapy on Upper Limb Function Rehabilitation 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：

盛施 

研究负责人：

杨唐柱 

Applicant：

Sheng Shi 

Study leader：

Yang Tangzhu 

申请注册联系人电话：

Applicant telephone：

 +86 27 8811 0056

研究负责人电话：

Study leader's
telephone：

+86 27 8811 0060

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：

 405966598@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 tangzhuyang@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：

湖北省武汉市武昌区和平大道杨园建设村98号

研究负责人通讯地址：

湖北省武汉市武昌区和平大道杨园建设村98号

Applicant address：

No. 98, Yangyuan Jianshecun, Heping Avenue, Wuchang District, Wuhan City, Hubei Province, 430063 China

Study leader's address：

No. 98, Yangyuan Jianshecun, Heping Avenue, Wuchang District, Wuhan City, Hubei Province, 430063 China

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：

武汉市武昌医院

Applicant's institution：

Wuhan Wuchang Hospital

研究负责人所在单位：

武汉市武昌医院

Affiliation of the Leader：

Wuhan Wuchang Hospital

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：

 2025-112-01

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：

武汉市武昌医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Wuchang Hospital in Wuhan City

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-21 00:00:00

伦理委员会联系人：

张奇智

Contact Name of the ethic committee：

Qizhi Zhang

伦理委员会联系地址：

湖北省武汉市武昌区和平大道杨园建设村98号

Contact Address of the ethic committee：

No. 98, Yangyuan Jianshecun, Heping Avenue, Wuchang District, Wuhan City, Hubei Province, 430063 China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8811 9815

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：

武汉市武昌医院

Primary sponsor：

Wuhan Wuchang Hospital

研究实施负责（组长）单位地址：

湖北省武汉市武昌区和平大道杨园建设村98号

Primary sponsor's address：

No. 98, Yangyuan Jianshecun, Heping Avenue, Wuchang District, Wuhan City, Hubei Province, 430063 China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

武汉市武昌医院

具体地址：

湖北省武汉市武昌区和平大道杨园建设村98号

Institution
hospital：

Wuhan Wuchang Hospital

Address：

No. 98, Yangyuan Jianshecun, Heping Avenue, Wuchang District, Wuhan City, Hubei Province, 430063 China

经费或物资来源：

自筹

Source(s) of funding：

self-funding

研究疾病：

缺血或出血未知的卒中  

Target disease：

Stroke with unknown ischemia or hemorrhage

研究疾病代码：

8B20

Target disease code：

8B20

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：

本研究旨在通过一项循序渐进的系列研究，系统解决镜像疗法（MT）在脑卒中上肢康复中面临的关键问题，即最佳干预模式不明确与神经机制不清，最终为建立标准化、基于证据的MT临床方案提供依据。 1. 优化MT的对照与动作范式（研究一、二：方法学基础） 通过fNIRS研究，确定最能有效区分真实MT效应与安慰剂效应的假镜像治疗对照方案。系统比较不同手部动作范式（任务导向性 vs. 节律性 vs. 自由活动）对大脑激活模式的影响，确立MT的标准化动作方案。 2. 验证MT的临床疗效与神经机制（研究三：核心验证） 开展一项多中心、评估者盲、优效性随机对照试验，直接比较单手镜像治疗、双手镜像治疗与假镜像治疗对亚急性期脑卒中患者上肢运动功能恢复的短期疗效。综合利用多模态神经影像技术（fNIRS, EEG, TMS-MEP），揭示不同MT模式诱导大脑功能重组与结构重塑的神经可塑性机制，探索其与临床功能改善的相关性。 3. 探索创新技术的可行性（研究四：技术转化） 初步评估自主研发的虚拟现实镜像治疗设备的安全性、耐受性与可用性，为下一代智能化康复技术的开发奠定基础。  

Objectives of Study：

This study aims to systematically address the key challenges in mirror therapy (MT) for upper limb rehabilitation after stroke—namely, the lack of consensus on optimal intervention protocols and unclear neural mechanisms—through a stepwise series of investigations. The ultimate goal is to provide an evidence-based foundation for standardizing clinical MT application. (1) Optimizing MT Control Conditions and Movement Paradigms (Studies 1 & 2: Methodological Foundation) ? To identify the most effective sham-MT control condition that best distinguishes the specific effects of genuine MT from placebo effects, using functional near-infrared spectroscopy (fNIRS). ? To systematically compare the effects of different hand movement paradigms (task-oriented vs. rhythmic vs. free movement) on brain activation patterns, establishing a standardized movement protocol for MT. (2) Validating the Clinical Efficacy and Neural Mechanisms of MT (Study 3: Core Validation) ?To conduct a multicenter, assessor-blinded, superiority randomized controlled trial (RCT) to directly compare the short-term efficacy of unilateral MT, bilateral MT, and sham MT on upper limb motor function recovery in patients with subacute stroke. ?To utilize multi-modal neuroimaging techniques (fNIRS, EEG, TMS-MEP) to elucidate the neuroplastic mechanisms—specifically, brain functional reorganization and structural remodeling—induced by different MT modes, and to explore their correlation with clinical functional improvements. (3) Exploring the Feasibility of Innovative Technology (Study 4: Technology Translation) ?To preliminarily evaluate the safety, tolerability, and usability of a self-developed virtual reality-based mirror therapy (VR-MT) device, laying the groundwork for the development of next-generation intelligent rehabilitation technologies.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

·健康受试者 1.18至80岁之间的男性或女性患者； 2.右利手（爱丁堡利手问卷得分≥80%），无左利手或双手同利史。 ·脑卒中患者 1.18至80岁之间的男性或女性患者； 2.发病后1-6个月内； 3.上肢Fugl-Meyer评分为10-45分，保留基本抓握功能（如手掌抓握、物体释放）； 4.MMSE≥24分，无严重认知障碍； 5.无精神疾病，无神经肌肉疾病，无严重失语症或听力理解障碍。

Inclusion criteria

Healthy subjects 1. Male or female patients aged between 18 and 80 years old; 2. Right-handed (Edinburgh Handedness Inventory score >= 80%), without left-handedness or bilateral handedness history. Stroke patients 1.Male or female patients aged between 18 and 80 years old; 2. Within 1-6 months after onset; 3. Upper limb Fugl-Meyer score is 10-45 points, with basic grasping function retained (such as palm grasping, object release); 4.MMSE score >= 24 points, without severe cognitive impairment; 5. No mental illness, no neurological muscle disease, no severe aphasia or hearing comprehension impairment.

排除标准：

健康受试者 1.排除严重视力障碍（如未矫正的重度近视 / 远视、视野缺损）； 2.特殊原因无法参与完整实验。 ·脑卒中患者 1.双侧卒中或严重共济失调； 2.镜像视觉诱发癫痫病史； 3.严重关节挛缩（被动ROM受限＞50%）。

Exclusion criteria：

Healthy subjects 1. Exclude severe visual impairments (such as uncorrected severe myopia / hyperopia, visual field defects); 2.Special reasons preventing participation in the complete experiment. Stroke patients 1.Bilateral stroke or severe ataxia; 2. History of epilepsy induced by mirror vision; 3. Severe joint contractures (passive ROM limitation > 50%).

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-16 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

双手镜像治疗组（第三部分）

样本量：

 46

Group：

The bilateral mirror therapy group (Part Three)

Sample size：

干预措施：

患者双手同时执行对称性动作，健侧手活动通过镜面反射形成患侧手的视觉反馈。

干预措施代码：

Intervention：

The patient performed symmetrical movements with both hands. The movement of the healthy hand created visual feedback for the affected hand through mirror reflection.

Intervention code：

组别：

单手镜像治疗组（第三部分）

样本量：

 46

Group：

The single-handed mirror therapy group (Part Three)

Sample size：

干预措施：

仅健侧手在镜前活动，患侧手隐藏于镜后并保持静止。

干预措施代码：

Intervention：

Only the healthy hand moves in front of the mirror, while the affected hand is hidden behind the mirror and remains stationary.

Intervention code：

组别：

假镜像治疗组（第三部分）

样本量：

 46

Group：

The pseudo-mirror therapy group (Part Three)

Sample size：

干预措施：

根据第一部分研究结果，选择“最假”的假镜像治疗（透明玻璃、不透明隔板或无镜子）作为对照。

干预措施代码：

Intervention：

Based on the results of the first part of the study, the "most fake" pseudo-mirror treatment (transparent glass, opaque partition, or no mirror) was selected as the control group.

Intervention code：

组别：

假镜像治疗1（第一部分）

样本量：

 60

Group：

False Mirror Therapy 1 (Part One)

Sample size：

干预措施：

透明玻璃替代镜子，其余同真实镜像治疗。所有研究对象，包括健康者30例和患者30例，均依次接受3种 sham 镜像治疗和1种真实镜像治疗。所有干预的顺序采用随机交叉设计，在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

Transparent glass was used instead of mirrors. The rest was the same as the real mirror therapy. All the research subjects, including 30 healthy individuals and 30 patients, were successively subjected to 3 types of sham mirror therapy and 1 type of real mirror therapy. The sequence of all the interventions adopted a random crossover design, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

假镜像治疗2（第一部分）

样本量：

 60

Group：

False Mirror Therapy 2 (Part One)

Sample size：

干预措施：

不透明隔板，其余同真实镜像治疗。所有研究对象，包括健康者30例和患者30例，均依次接受3种 sham 镜像治疗和1种真实镜像治疗。所有干预的顺序采用随机交叉设计，在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

Opaque partition, the rest is the same as the real mirror therapy. All the research subjects, including 30 healthy individuals and 30 patients, were successively subjected to 3 types of sham mirror therapy and 1 type of real mirror therapy. The sequence of all the interventions adopted a random crossover design, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

假镜像治疗3（第一部分）

样本量：

 60

Group：

False Mirror Therapy 3 (Part 1)

Sample size：

干预措施：

无镜子，双手同步执行相同动作。所有研究对象，包括健康者30例和患者30例，均依次接受3种 sham 镜像治疗和1种真实镜像治疗。所有干预的顺序采用随机交叉设计，在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

Without a mirror, both hands perform the same action simultaneously. All the research subjects, including 30 healthy individuals and 30 patients, were successively subjected to 3 types of sham mirror therapy and 1 type of real mirror therapy. The sequence of all the interventions adopted a random crossover design, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

真实镜像治疗（第一部分）

样本量：

 60

Group：

True Mirror Therapy (Part One)

Sample size：

干预措施：

健手在镜前执行任务，患侧隐藏于镜后，产生镜像视觉反馈。所有研究对象，包括健康者30例和患者30例，均依次接受3种 sham 镜像治疗和1种真实镜像治疗。所有干预的顺序采用随机交叉设计，在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

The healthy hand performs the task in front of the mirror, while the affected side is hidden behind the mirror, creating a mirror-image visual feedback. All the research subjects, including 30 healthy individuals and 30 patients, were successively subjected to 3 types of sham mirror therapy and 1 type of real mirror therapy. The sequence of all the interventions adopted a random crossover design, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

镜像治疗手部动作范式1（第二部分）

样本量：

 60

Group：

Mirror therapy hand movement paradigm 1 (Part 2)

Sample size：

干预措施：

健手执行标准化功能性任务（腕屈伸/手开合/对指等），节拍器控制（1Hz）。本研究采用随机交叉设计。共60名研究对象（健康者与患者各30例）均接受了3种手部动作范式的镜像治疗。所有干预顺序均通过随机化分配，并在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

The healthy hand performs standardized functional tasks (wrist flexion/extension / hand opening/closing / finger opposition, etc.), with the metronome control (1Hz). This study employed a randomized crossover design. A total of 60 research subjects (30 healthy individuals and 30 patients) all received mirror therapy based on three hand movement paradigms. All intervention sequences were randomly assigned, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

镜像治疗手部动作范式2（第二部分）

样本量：

 60

Group：

Mirror therapy hand movement paradigm 2 (Part 2)

Sample size：

干预措施：

健手自由活动（无节律或任务限制，仅要求持续运动）。本研究采用随机交叉设计。共60名研究对象（健康者与患者各30例）均接受了3种手部动作范式的镜像治疗。所有干预顺序均通过随机化分配，并在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

Unrestricted free movement of the healthy hand (without rhythm or task restrictions, only requiring continuous movement). This study employed a randomized crossover design. A total of 60 research subjects (30 healthy individuals and 30 patients) all received mirror therapy based on three hand movement paradigms. All intervention sequences were randomly assigned, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

镜像治疗手部动作范式3（第二部分）

样本量：

 60

Group：

Mirror therapy hand movement paradigm 3 (Part 2)

Sample size：

干预措施：

健手执行节律性非功能性动作（匀速握拳/旋前旋后等），节拍器控制（1Hz）。本研究采用随机交叉设计。共60名研究对象（健康者与患者各30例）均接受了3种手部动作范式的镜像治疗。所有干预顺序均通过随机化分配，并在各干预阶段之间设置了足够的洗脱期，以消除残留效应。

干预措施代码：

Intervention：

The healthy hand performs rhythmic non-functional movements (such as maintaining a constant fist position, pronation and supination, etc.), with the metronome controlling (at 1Hz). This study employed a randomized crossover design. A total of 60 research subjects (30 healthy individuals and 30 patients) all received mirror therapy based on three hand movement paradigms. All intervention sequences were randomly assigned, and sufficient washout periods were set between each intervention stage to eliminate residual effects.

Intervention code：

组别：

虚拟现实结合镜像治疗（第四部分）

样本量：

 20

Group：

Virtual Reality Combined with Mirror Therapy (Part Four)

Sample size：

干预措施：

通过虚拟现实技术增强传统镜像治疗的视觉-运动反馈。

干预措施代码：

Intervention：

Enhancing the visual-motor feedback of traditional mirror therapy through virtual reality technology.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 武汉市 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 武汉市武昌医院 

单位级别：

 三甲 

Institution
hospital：

Wuhan Wuchang Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

 重庆市 

Country：

China

Province：

Chongqing

City：

Chongqing

单位(医院)：

 重庆医科大学附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Chongqing Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer 上肢评定量表 (FMA-UE)

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment for Upper Extremity

Type：

Primary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。第四部分，基线（T0），干预结束（T1）。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention. Part Four: Baseline (T0), Intervention Completion (T1).

Measure method：

指标中文名：

动作研究手臂测试（ARAT）

指标类型：

次要指标

Outcome：

Action Research Arm Test

Type：

Secondary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

改良Barthel指数 (MBI)

指标类型：

次要指标

Outcome：

Modified Barthel Index

Type：

Secondary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

脑卒中影响量表（SIS）的手功能子域

指标类型：

次要指标

Outcome：

Hand Function Subdomain of the Stroke Impact Scale (SIS)

Type：

Secondary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

近红外脑功能成像氧合血红蛋白浓度变化（fNIRS-ΔHbO）

指标类型：

主要指标

Outcome：

Changes in oxygenated hemoglobin concentration measured by functional near-infrared spectroscopy (fNIRS-ΔHbO)

Type：

Primary indicator

测量时间点：

第一部分和第二部分，每次干预的干预前静息态（5min）、干预中（20min）、干预后即刻（5min）。

测量方法：

Measure time point of outcome：

The first and second parts: Before, during and immediately after each intervention, the resting state was measured for 5 minutes, 20 minutes during the intervention, and 5 minutes immediately after the intervention.

Measure method：

指标中文名：

运动诱发电位（MEP）

指标类型：

附加指标

Outcome：

Motor evoked potential (MEP)

Type：

Additional indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

脑电图（EEG）

指标类型：

附加指标

Outcome：

Electroencephalography (EEG)

Type：

Additional indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

视觉模拟评分法

指标类型：

次要指标

Outcome：

Visual Analog Scale

Type：

Secondary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

简易精神状况检查量表

指标类型：

次要指标

Outcome：

Mini-Mental State Examination

Type：

Secondary indicator

测量时间点：

第三部分，基线（T0）：干预前1周内。干预中（T1）：第2周末。干预后（T2）：第4周末。随访（T3）：干预结束后3个月。随访（T4）:干预结束后6个月。

测量方法：

Measure time point of outcome：

Part Three, Baseline (T0): Within one week before the intervention. Intervention Period (T1): The second weekend. Post-intervention (T2): The fourth weekend. Follow-up (T3): 3 months after the intervention. Follow-up (T4): 6 months after the intervention.

Measure method：

指标中文名：

Likert量表

指标类型：

次要指标

Outcome：

Likert Scale

Type：

Secondary indicator

测量时间点：

研究一、二: 每次干预后。研究四: 干预中(T1): 第1周末; 干预结束(T1): 第2周末。

测量方法：

Measure time point of outcome：

Studies 1 & 2: After each intervention session. Study 4: During intervention (T1): End of week 1; Post-intervention (T1): End of week 2.

Measure method：

指标中文名：

系统可用性量表（SUS）

指标类型：

次要指标

Outcome：

System Usability Scale (SUS)

Type：

Secondary indicator

测量时间点：

第四部分，基线（T0），干预结束（T1）。

测量方法：

Measure time point of outcome：

Part Four: Baseline (T0), Intervention Completion (T1).

Measure method：

指标中文名：

功能独立性量表

指标类型：

次要指标

Outcome：

Functional Independence Measure

Type：

Secondary indicator

测量时间点：

研究三: 基线(T0); 干预中(T1): 第2周末; 干预后(T2): 第4周末; 随访(T3): 干预结束后3个月; 随访(T4): 干预结束后6个月

测量方法：

Measure time point of outcome：

Study 3: Baseline (T0); During intervention (T1): End of week 2; Post-intervention (T2): End of week 4; Follow-up (T3): 3 months after intervention; Follow-up (T4): 6 months after intervention

Measure method：

指标中文名：

模拟器症状量表 (SSQ)

指标类型：

主要指标

Outcome：

Simulator Sickness Questionnaire (SSQ)

Type：

Primary indicator

测量时间点：

研究四: 每次干预后

测量方法：

Measure time point of outcome：

Study 4: After each intervention session

Measure method：

指标中文名：

近红外脑功能成像氧合血红蛋白浓度变化（fNIRS-ΔHbO）

指标类型：

次要指标

Outcome：

Changes in oxygenated hemoglobin concentration measured by functional near-infrared spectroscopy (fNIRS-ΔHbO)

Type：

Secondary indicator

测量时间点：

研究三: 基线(T0); 干预后(T2): 第4周末; 随访(T4): 干预结束后6个月。研究四: 基线(T0); 干预结束(T1): 第2周末。

测量方法：

Measure time point of outcome：

Study 3: Baseline (T0); Post-intervention (T2): End of week 4; Follow-up (T4): 6 months after intervention. Study 4: Baseline (T0); Post-intervention (T1): End of week 2.

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：

尚未开始

Not yet 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）：

研究一：假镜像治疗方案优选的fNIRS对照研究 随机序列生成：由一位完全独立于研究团队和数据分析的统计师，使用统计软件（如 SPSS 或 R）生成随机序列。该序列为每名受试者指定一个接受三种干预（真实MT、Sham-MT1、Sham-MT2、Sham-MT3）的独特交叉顺序，以抵消顺序效应。 研究二：镜像治疗手部动作范式优化的fNIRS对照研究 随机序列生成：方法同研究一。由一位独立统计师使用统计软件生成随机序列，为每名受试者指定接受三种不同动作范式（UMT1, UMT2, UMT3）的随机交叉顺序。 研究三：镜像疗法多中心随机对照试验 随机序列生成：采用中央随机化法。随机分配序列由一位完全独立于研究团队的统计师使用 SPSS 或R 软件生成。采用区组随机化（区组长度设为 4 和 6 随机混合），按 1:1:1 比例将受试者分配至三组，并依据“研究中心”和“基线FMA-UE严重程度”进行分层随机，以确保各层内组间的基线均衡。 研究四：VR-MT设备安全性测试研究 随机序列生成：本研究为非随机、开放标签的安全性及可行性研究，其主要目的是评估设备的安全性和耐受性，因此不涉及随机分组。患者组和健康对照组的入组是依据预设的纳入排除标准进行的连续性入组。

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

Study 1: fNIRS Controlled Study for Optimal Sham Mirror Therapy Protocol ? Random Sequence Generation: An independent statistician, completely separate from the research team and data analysis, will generate the random sequence using statistical software (e.g., SPSS or R). This sequence will assign a unique crossover order for each participant to receive the four interventions (Genuine MT, Sham-MT1, Sham-MT2, Sham-MT3) to counteract order effects. Study 2: fNIRS Controlled Study for Optimizing Hand Movement Paradigms in Mirror Therapy ? Random Sequence Generation: The method is the same as in Study 1. An independent statistician will use statistical software to generate a random sequence, specifying the crossover order in which each participant will receive the three different movement paradigms (UMT1, UMT2, UMT3). Study 3: Multicenter Randomized Controlled Trial of Mirror Therapy ? Random Sequence Generation: A central randomization method will be adopted. The random allocation sequence will be generated by a statistician completely independent of the research team using SPSS or R software. Block randomization (with randomly mixed block lengths of 4 and 6) will be used to allocate participants to the three groups in a 1:1:1 ratio. Stratified randomization based on "research center" and "baseline FMA-UE severity" will be implemented to ensure baseline balance between groups within each stratum. Study 4: Safety Testing Study of VR-MT Device ? Random Sequence Generation: This is a non-randomized, open-label safety and feasibility study. Its primary objective is to evaluate the safety and tolerability of the device; therefore, randomization is not involved. Participants for the patient group and the healthy control group will be enrolled consecutively based on predefined inclusion and exclusion criteria.

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：

本研究各子研究的设计与干预特性不同，因此盲法的实施策略与可行性也存在差异。本研究的盲法核心原则是：在条件允许的情况下，尽最大可能对结局评估者和数据分析人员实施盲法。 12.1 各研究盲法实施详情 12.1.1 研究一与研究二（机制探索性交叉研究） 由于不同干预方案（研究一的不同假镜像装置/研究二的不同动作范式）在操作上存在固有差异，难以对受试者和操作治疗师实现完全盲法。为最大限度减少偏倚，本研究采用以下策略： 操作层面部分设盲：对受试者和治疗师统一使用中性术语（如“A/B/C/D方案”）指代不同干预，避免提及分组假设。所有干预均在使用外观一致的镜子、相同的环境中进行，以模糊组间差异。 核心指标全盲评估：所有主要结局指标（fNIRS脑功能数据）和次要结局指标（行为学数据、主观问卷）的处理、评分与统计分析均由完全独立的研究人员在不知晓干预类型的情况下完成。数据在交付分析前已去除所有分组标识。 12.1.2 研究三（多中心随机对照试验） 本研究严格实施评估者盲法和统计师盲法。 受试者盲法：由于BMT/UMT与Sham-MT在体验上存在差异，无法实现完全盲法。但将通过以下方法增强盲法效果： 对所有受试者统一宣称为“研究三种不同的上肢康复训练方法”。Sham-MT组将使用与真实MT组外观完全一致的设备（如使用透明玻璃替代镜子），并执行相同的标准化指导语。在干预第2周和第4周末，使用盲法效果评估问卷（让受试者猜测所属组别并评价确信度）来量化盲法的维持情况。 治疗师：由于需指导特定操作，无法实施盲法。但所有治疗师将接受统一培训，使用标准化脚本进行指导，避免额外提示。 结局评估者：负责进行FMA-UE、ARAT等所有临床量表评估的评估员，完全独立于干预团队，且对分组信息不知情。基线评估在随机分组前完成。评估过程录像以备质量核查。 数据分析者：负责统计分析的统计师在分析完成前不接触分组信息，使用编码（A组、B组、C组）的数据集进行分析。 12.1.3 研究四（设备安全性测试） 本研究为开放性探索性试验，旨在评估新设备的安全性和耐受性。 受试者与治疗师：明确知晓所使用的是试验性VR-MT设备，不实施盲法。 结局评估者与数据分析者：所有安全性数据（不良反应记录）和适用性问卷（SUS评分）的评估与分析人员对受试者来源（患者组/健康组）不知情，以确保评价的客观性。

Blinding：

12.1 Details of Blinding Implementation by Study 12.1.1 Study 1 and Study 2 (Mechanistic Exploratory Crossover Studies) Due to inherent operational differences between the intervention protocols (different sham mirror devices in Study 1 / different movement paradigms in Study 2), it is difficult to achieve complete blinding of participants and operating therapists. To minimize bias, the following strategies will be employed: ? Partial Blinding at the Operational Level: Neutral terms (e.g., "Protocol A/B/C/D") will be used uniformly for participants and therapists to refer to the different interventions, avoiding mention of group hypotheses. All interventions will be conducted using identical-looking mirrores in the same environment to obscure differences between groups. ? Fully Blinded Assessment of Core Outcomes: The processing, scoring, and statistical analysis of all primary outcome measures (fNIRS brain function data) and secondary outcome measures (behavioral data, subjective questionnaires) will be performed by researchers completely independent of the intervention team, who are unaware of the intervention type. All group identifiers will be removed from the data before it is handed over for analysis. 12.1.2 Study 3 (Multicenter Randomized Controlled Trial) This study will strictly implement assessor blinding and statistician blinding. ? Participant Blinding: Complete blinding is not feasible due to experiential differences between BMT/UMT and Sham-MT. However, the following methods will be used to enhance blinding: ? All participants will be uniformly informed that the study is "investigating three different upper limb rehabilitation training methods." ? The Sham-MT group will use devices identical in appearance to the genuine MT groups (e.g., using transparent glass instead of a mirror) and receive the same standardized instructions. ? At the end of weeks 2 and 4 of the intervention, a blinding success questionnaire (asking participants to guess their assigned group and rate their certainty) will be used to quantify the maintenance of blinding. ? Therapists: Blinding is not feasible as therapists need to guide specific operations. However, all therapists will receive uniform training and use standardized scripts for instruction to avoid additional cues. ? Outcome Assessors: Assessors responsible for all clinical scale evaluations (e.g., FMA-UE, ARAT) will be completely independent of the intervention team and unaware of group allocation. Baseline assessments will be completed before randomization. Assessment sessions may be video-recorded for quality audit. ? Data Analysts: The statistician responsible for the statistical analysis will not have access to group information until the analysis is complete, using a coded dataset (Group A, B, C) for analysis. 12.1.3 Study 4 (Device Safety Testing Study) This is an open-label exploratory trial designed to evaluate the safety and tolerability of the new device. ? Participants and Therapists: Will be explicitly aware that an experimental VR-MT device is being used; blinding will not be implemented. ? Outcome Assessors and Data Analysts: Personnel assessing and analyzing all safety data (adverse event records) and usability questionnaires (SUS scores) will be blinded to participant origin (patient group/healthy group) to ensure objective evaluation.

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

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）：

为促进科学研究的透明性和可重复性，本研究承诺在主要研究结果发表后，共享去标识化的个体参与者数据。 共享内容：经过去标识化处理后的个体参与者数据（IPD），以及数据字典和研究方案。 共享时间：数据将在本研究主要结果论文正式发表后6个月内对外开放共享。 共享平台：数据将存储在国家人口健康科学数据中心 这一权威的公共平台。 访问方式：为保护受试者隐私，数据将采取受控访问模式。其他研究人员可通过该平台提交合理的数据使用申请，经本研究团队审核批准后即可获取。

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

To promote the transparency and reproducibility of scientific research, this study commits to sharing de-identified individual participant data (IPD) after the publication of the main research findings. Shared Content: De-identified individual participant data (IPD), along with a data dictionary and study protocol. Timing of Sharing: The data will be made publicly available within six months after the formal publication of the main results paper of this study. Sharing Platform: The data will be stored and shared via the National Population Health Data Center, an authoritative public platform. Access Method: To protect participant privacy, data will be shared under a controlled-access mode. Other researchers may submit reasonable data use applications through this platform; access will be granted upon approval by our research team.

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：

为确保研究数据的真实性、准确性、完整性和可靠性，本研究制定以下数据管理制度，涵盖数据采集、录入、核对、存储及保密的全过程。 25.1 数据定义与分类 源数据：指研究中原始的、首次记录的数据，包括但不限于：知情同意书、受试者筛选表、病历记录、实验室报告、影像学资料、量表评估原始记录纸、fNIRS/EEG等仪器的原始输出文件。 电子数据：指录入到电子数据采集系统中的数据。 25.2 数据采集与记录 采集人员： 临床数据（量表、评估结果）：由经过统一培训并考核合格的研究评估员在现场评估后，立即在专用的《病例报告表（纸版）》上填写。 神经生理数据（fNIRS， EEG， MEP）：由经过设备操作培训的技术员采集，并直接以电子文件形式保存。 记录原则：所有源数据必须及时、准确、清晰、完整地记录。任何修改必须划线更正，注明修改日期和修改人签名，不得涂改或掩盖原始记录。 25.3 数据录入与管理 电子数据采集系统：本研究将采用中国临床试验注册中心的ResMan EDC系统作为中央数据管理平台。 录入人员：由数据录入员（可由研究协调员或指定评估员担任）将CRF上的数据双人独立录入EDC系统。 录入时效性：评估完成后，数据应在72小时内完成录入。 25.4 数据核对与质控制度 本制度采用三级核对机制以确保数据质量： 研究者核对（一级核对）：数据录入员在录入前，需对CRF填写的完整性、逻辑性进行初步检查。 系统自动核对：EDC系统预设逻辑校验规则，对录入的数据进行实时自动检查，对超出范围或存在逻辑矛盾的数据发出质疑。 监查员核对（二级核对）：研究监查员将定期到研究中心进行源数据核查，将EDC系统中的数据与源文件（病历、原始记录等）进行100%核对，确保数据一致性。 25.5 源数据与文件管理 保存：所有源文件和CRF将作为研究档案，妥善保存在研究中心指定的、安全且防火防潮的文件柜中，访问权限受限。 电子数据备份：ResMan系统数据将由平台自动定期备份。本地的神经生理原始数据（如.focs, .set, .avg等格式文件）需在采集后定期备份至医院加密服务器。 25.6 保密与安全 所有涉及受试者个人身份的信息将进行匿名化处理，仅使用研究识别码。 访问EDC系统及电子数据库均需要独立的用户名和密码，并依据角色设置不同的访问权限。 研究结束后，所有数据将按规定存档至少15年。

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

To ensure the authenticity, accuracy, completeness, and reliability of the research data, this study has established the following data management plan, covering the entire process of data collection, entry, verification, storage, and confidentiality. 25.1 Data Definition and Classification ? Source Data: Refers to the original, first-recorded data in the study, including but not limited to: informed consent forms, participant screening logs, medical records, laboratory reports, imaging data, original paper records of scale assessments, and raw output files from instruments such as fNIRS/EEG. ? Electronic Data: Refers to data entered into the electronic data capture (EDC) system. 25.2 Data Collection and Recording ? Collection Personnel: ? Clinical Data (scales, assessment results): Collected by uniformly trained and certified research assessors immediately after on-site evaluation using dedicated paper-based Case Report Forms (CRFs). ? Neurophysiological Data (fNIRS, EEG, MEP): Collected by technicians trained in equipment operation and saved directly as electronic files. ? Recording Principles: All source data must be recorded promptly, accurately, clearly, and completely. Any modifications must be made by striking through the original entry, noting the correction date and the initials of the person making the change; erasures or obliteration of the original record are prohibited. 25.3 Data Entry and Management ? Electronic Data Capture System: This study will use the ResMan EDC system as the central data management platform. ? Entry Personnel: Data entry personnel (who may be research coordinators or designated assessors) will independently enter data from the CRFs into the EDC system using a double-data entry process. ? Entry Timeliness: Data entry should be completed within 72 hours after the assessment is finished. 25.4 Data Verification and Quality Control A three-tier verification mechanism is implemented to ensure data quality: ? Investigator Verification (Tier 1): Before entry, data entry personnel perform an initial check of the CRFs for completeness and logical consistency. ? Automatic System Verification: The EDC system has pre-set logic check rules to automatically verify entered data in real-time, generating queries for data that are out of range or logically inconsistent. ? Monitor Verification (Tier 2): The study monitor will periodically visit the research sites to perform 100% Source Data Verification (SDV), comparing data in the EDC system against source documents (medical records, original recordings, etc.) to ensure consistency. 25.5 Source Data and Document Management ? Storage: All source documents and CRFs will be securely stored as research archives in designated, secure, fireproof, and moisture-proof filing cabinets at the research site with restricted access. ? Electronic Data Backup: Data within the ResMan system will be automatically backed up regularly by the platform. Local raw neurophysiological data files (e.g., .focs, .set, .avg formats) must be regularly backed up to the hospital's encrypted server after acquisition. 25.6 Confidentiality and Security ? All information identifying participants will be anonymized; only a study identification code will be used. ? Access to the EDC system and electronic databases requires unique usernames and passwords, with different access levels set according to user roles. ? After the study concludes, all data will be archived for a minimum of 15 years, as required by regulations.

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  2026-01-13 11:01:32