ChiCTR2600116040 版本V1.0 版本创建时间2026/01/05 08:39:26 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：

 ChiCTR2600116040 

最近更新日期：

Date of Last Refreshed on：

 2026-01-05 08:39:20 

注册时间：

Date of Registration：

 2026-01-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

用于脑卒中后患者认知康复的沉浸式虚拟现实：一项随机对照试验

Public title：

Immersive Virtual Reality for Cognitive Rehabilitation in Stroke Patients: Study Protocol for a Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

用于脑卒中后患者认知康复的沉浸式虚拟现实：一项随机对照试验

Scientific title：

Immersive Virtual Reality for Cognitive Rehabilitation in Stroke Patients: Study Protocol for a Randomized Controlled Trial

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：

李济伶 

研究负责人：

华续赟 

Applicant：

Li Jiling 

Study leader：

Hua Xuyun 

申请注册联系人电话：

Applicant telephone：

 +86 187 8775 8061

研究负责人电话：

Study leader's
telephone：

+86 189 1612 0869

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：

 3342044794@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 huaxuyun@shutcm.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Shuguang Hospital

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：

中国上海市浦东新区蔡伦路1200号

研究负责人通讯地址：

中国上海市浦东新区张衡路528号

Applicant address：

No. 1200 Cailun Road, Pudong New Area, Shanghai, China

Study leader's address：

No. 528 Zhangheng Road, Pudong New Area, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

 201210

研究负责人邮政编码：

Study leader's postcode：

 201210

申请人所在单位：

上海中医药大学

Applicant's institution：

Shanghai University of Traditional Chinese Medicine

研究负责人所在单位：

上海市中医药大学附属曙光医院

Affiliation of the Leader：

Shuguang Hospital Affiliated to Shanghai University of Traditional 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：

 2025-1933-273-02

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：

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-31 00:00:00

伦理委员会联系人：

马俊坚

Contact Name of the ethic committee：

Ma Junjian

伦理委员会联系地址：

中国上海市浦东新区张衡路528号

Contact Address of the ethic committee：

No. 528 Zhangheng Road, Pudong New Area, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 2025 6070

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：

上海中医药大学附属曙光医院

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国上海市浦东新区张衡路528号

Primary sponsor's address：

No. 528 Zhangheng Road, Pudong New Area, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属曙光医院

具体地址：

中国上海市浦东新区张衡路528号

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 528 Zhangheng Road, Pudong New Area, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

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：

针对当前脑卒中后认知障碍(PSCI)诊疗中药物治疗覆盖范围有限、传统认知训练疗效波动显著且缺乏个体化方案的瓶颈问题，本研究立足神经可塑性理论与多感官整合机制，创新研发融合虚拟现实技术的动态认知训练系统NeuCir-VR-I。项目通过单中心、随机对照、评估者盲法(因干预方式的直观差异，患者和干预执行者无法盲法，仅评估者采用盲法，并通过统计分析控制偏倚)设计的临床试验，纳入60例PSCI患者，按随机分配原则分为VR干预组与传统康复组，两组均接受为期2周的系统干预;在基线期(T0)、干预后即时(T1)以及干预后四周随访期(T2)这三个关键时间节点收集量表数据。重点关注即时性疗效，将蒙特利尔认知评估量表(MontrealCognitiveAssessment, MoCA)得分作为研究的主要结局指标。综合简易精神状态检查表(Mini-MentalState Examination,MMSE)等标准化认知评估量表，联合EEG、fMRI等神经影像学技术展开多模态数据采集与分析。研究聚焦三大核心目标:其一，系统验证NeuCir-VR-I对PSCI患者认知功能重建的干预效能，明确其对记忆、执行、注意力等多维度认知能力的改善作用;其二，深入解析VR特异性刺激模式下脑功能网络重塑的神经机制及可塑性调控通路;其三，通过与传统康复模式的疗效进行对比，凸显创新方案的临床优势.最终旨在为PSCI患者提供安全、精准、高效的个性化康复解决方案，助力填补临床认知康复领域的技术空白，推动该方向诊疗水平的跨越式发展  

Objectives of Study：

Aiming at the bottleneck problems in the diagnosis and treatment of post-stroke cognitive impairment (PSCI), including the limited coverage of pharmacotherapy, the significant fluctuation in the efficacy of traditional cognitive training, and the lack of individualized protocols, this study is grounded in the theories of neural plasticity and multisensory integration mechanisms to innovatively develop a dynamic cognitive training system NeuCir-VR-I integrated with virtual reality technology. The project adopts a single-center, randomized controlled, assessor-blinded clinical trial design (owing to the intuitive differences in intervention methods, blinding cannot be implemented for patients and intervention administrators; only assessors are blinded, and bias is controlled through statistical analysis). A total of 60 PSCI patients are enrolled and randomly assigned to either the VR intervention group or the traditional rehabilitation group, with both groups receiving a 2-week standardized intervention. Scale data are collected at three key time points: baseline (T0), immediately post-intervention (T1), and the 4-week follow-up after intervention (T2). With a primary focus on the immediate therapeutic efficacy, the score of the Montreal Cognitive Assessment (MoCA) is set as the primary outcome measure of the study. Combined with standardized cognitive assessment scales such as the Mini-Mental State Examination (MMSE), multimodal data acquisition and analysis are performed by integrating neuroimaging techniques including EEG and fMRI. The study focuses on three core objectives: first, to systematically verify the intervention efficacy of NeuCir-VR-I in reconstructing cognitive functions of PSCI patients and clarify its improvement effects on multi-dimensional cognitive abilities such as memory, executive function, and attention; second, to deeply elucidate the neural mechanisms of brain functional network remodeling and the regulatory pathways of plasticity under VR-specific stimulation patterns; third, to highlight the clinical advantages of the innovative protocol by comparing its therapeutic efficacy with that of traditional rehabilitation models. Ultimately, this study is intended to provide a safe, precise, and efficient personalized rehabilitation solution for PSCI patients, help fill the technical gaps in the field of clinical cognitive rehabilitation, and promote the leaping development of diagnosis and treatment in this direction.

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.符合世界卫生组织(WHO)定义的首次单侧缺血性或出血性中风(通过MRI或CT确认); 2.年龄18-70岁;性别不限; 3.首次发病时间在3月-6月; 4.蒙特利尔认知评估量表(MoCA)评分介于18-25分(提示存在轻度认知障碍); 5.无严重视听障碍或视听障碍，能够配合完成VR训练; 6.自愿参与研究并签署书面知情同意书。

Inclusion criteria

1.First episode of unilateral ischemic or hemorrhagic stroke confirmed by MRI or CT, in accordance with the definition of the World Health Organization (WHO). 2.Aged 18 to 70 years, with no gender restriction. 3.The time of first onset ranges from March to June. 4.Score on the Montreal Cognitive Assessment (MoCA) ranging from 18 to 25 points, indicating mild cognitive impairment. 5.No severe visual or auditory impairment, or with mild visual/auditory impairment that does not affect cooperation in completing VR training. 6.Voluntary participation in the study and provision of written informed consent.

排除标准：

1.排除伴有影响VR干预的感觉障碍或运动功能障碍患者； 2 .无法耐受虚拟现实设备（如晕动症、癫痫史）； 3.存在fMRI或EEG检查禁忌（心脏起搏器、颅内金属异物、皮肤感染等）； 4 .既往有精神疾病史、神经系统疾病、内科疾病或药物滥用导致的认知障碍； 5 .特殊生理状态：妊娠或哺乳期妇女； 6 .正在参加其他临床试验者

Exclusion criteria：

1 .Exclude patients with sensory or motor dysfunction that may interfere with VR intervention. 2. Intolerance to virtual reality equipment (e.g., motion sickness, history of epilepsy). 3 .Presence of contraindications to fMRI or EEG examinations (e.g., cardiac pacemaker, intracranial metallic foreign bodies, skin infection, etc.). 4. A history of cognitive impairment caused by mental illness, neurological diseases, internal medical conditions, or substance abuse. 5 .Special physiological status: pregnant or lactating women.4.6 Concurrent participation in other clinical trials.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2027-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-20 00:00:00 至 To 2027-03-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 30

Group：

Control Group

Sample size：

干预措施：

常规认知训练。纸笔或计算机任务，内容包括记忆力、计算力、注意力、失用症等多种训练方法。30分钟/次，1 次/ 天， 5 天/周，共治疗 2 周。

干预措施代码：

Intervention：

Routine cognitive training consists of paper-and-pencil or computer-based tasks, covering various training methods targeting memory, computational ability, attention, apraxia, and other cognitive domains. The training is conducted for 30 minutes per session, once a day, 5 days a week, with a total treatment duration of 2 weeks.

Intervention code：

组别：

试验组

样本量：

 30

Group：

Experimental Group

Sample size：

干预措施：

在常规干预基础上增加VR虚拟现实训练，包含沉浸式场景训练，运动感知训练，记忆刺激训练，认知游戏化训练，社交互动训练等。30 分钟 / 次、1 次 / 天、5 天 / 周，持续 2 周

干预措施代码：

Intervention：

On the basis of conventional intervention, additional immersive virtual reality (VR) training is provided, including immersive scenario training, motor perception training, memory stimulation training, gamified cognitive training, and social interaction training. The training is conducted for 30 minutes per session, once a day, 5 days a week, for a continuous duration of 2 weeks.

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(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海中医药大学附属曙光医院 

单位级别：

 三甲 

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

蒙特利尔认知评估量表

指标类型：

主要指标

Outcome：

Montreal Cognitive Assessment

Type：

Primary 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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 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）：

本试验采用随机对照试验，通过 SPSS 25.0 生成的随机数字表，制成随机分配卡，用不透明信封密封，信封序号与卡片序号相通。按照纳入的受试者报名的次序进行随机编码，按信封内卡片规定的分组将 60 名被试随机均分为 2 组：试验组（VR）、对照组（常规认知康复治疗）。

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

This study adopts a randomized controlled trial (RCT) design. Random number tables generated by SPSS 25.0 were used to create random assignment cards, which were sealed in opaque envelopes with serial numbers corresponding to the card numbers. Participants were randomly coded in the order of their enrollment, and 60 subjects were randomly divided equally into two groups according to the grouping specified on the cards inside the envelopes: the Experimental Group (VR intervention) and the Control Group (conventional cognitive rehabilitation therapy).

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：

本研究是一项单盲（评估者）随机对照试验。仅对结局评估者实施盲态，受试者与干预实施者因干预形式的直观差异知晓分组分配。所有结局评估者对分组信息完全不知情，不参与干预实施、受试者沟通及不良事件判定的过程中，且需签署盲态执行承诺书，并进行标准化培训。研究期间，结局评估者禁止跨组交流、猜测分组，常规情况下于研究期结束后一次性揭盲后完成统计分析；在符合条件的受试者签署知情同意书后进行随机化。符合标准的参与者通过密封信封随机分配到 VR 干预组与传统康复组。

Blinding：

This study is a single-blind (assessor-blinded) randomized controlled trial. Blinding was only implemented for outcome assessors, while participants and intervention implementers were aware of the group assignments due to the intuitive differences between the intervention modalities. All outcome assessors were completely unaware of the grouping information and were not involved in the implementation of interventions, communication with participants, or determination of adverse events. They were required to sign a blind execution commitment letter and receive standardized training. During the study period, outcome assessors were prohibited from cross-group communication and speculating on group assignments; statistical analysis was routinely completed after a one-time unblinding at the end of the study period. Randomization was performed after eligible participants signed the informed consent form. Qualified participants were randomly assigned to the VR intervention group and the conventional rehabilitation group via sealed envelopes.

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）：

临床试验公共管理平台、http://www.medresman.org.cn、试验结束后六个月内

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

Clinical Trial Public Management Platform http://www.medresman.org.cn Within 6 months after the trial completion

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：

  2026-01-05 08:39:20