ChiCTR2400082761 版本V1.0 版本创建时间2024/04/07 15:41:57 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：

ChiCTR2400082761 

最近更新日期：

Date of Last Refreshed on：

2024-04-07 15:41:52 

注册时间：

Date of Registration：

2024-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

虚拟现实下具身技术对脑卒中后上肢功能障碍的作用研究

Public title：

The effect of virtual reality (VR) embodiment therapy for upper limb dysfunction after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

虚拟现实下具身技术对脑卒中后上肢功能障碍的作用研究

Scientific title：

The effect of virtual reality (VR) embodiment therapy for upper limb 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：

公晨 

研究负责人：

王于领 

Applicant：

Chen Gong 

Study leader：

Yuling Wang 

申请注册联系人电话：

Applicant telephone：

+86 137 1923 4092

研究负责人电话：

Study leader's telephone：

+86 130 5444 5587

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：

gongch33@mail.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

wangyul@mail.sysu.edu.cn

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：

广东省广州市天河区员村二横路26号

研究负责人通讯地址：

广东省广州市天河区员村二横路26号

Applicant address：

No. 26 , Yuancun Er Heng Road, Tianhe District, Guangzhou City, Guangdong Province, China

Study leader's address：

No. 26 , Yuancun Er Heng Road, Tianhe District, Guangzhou City, Guangdong Province, China

申请注册联系人邮政编码：

Applicant postcode：

510655

研究负责人邮政编码：

Study leader's postcode：

510655

申请人所在单位：

中山大学附属第六医院

Applicant's institution：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第六医院

Affiliation of the Leader：

The Sixth Affiliated Hospital of Sun Yat-sen 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：

2024ZSLYEC-071

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：

中山大学附属第六医院医学伦理委员会

Name of the ethic committee：

The Human Research Ethics Committee at the Sixth Affiliated Hospital of Sun Yat-Sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-01-31 00:00:00

伦理委员会联系人：

吴倩

Contact Name of the ethic committee：

Qian Wu

伦理委员会联系地址：

广东省广州市天河区员村二横路26号

Contact Address of the ethic committee：

No. 26 , Yuancun Er Heng Road, Tianhe District, Guangzhou City, Guangdong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 3837 9764

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zslyllb@mail.sysu.edu.cn

研究实施负责（组长）单位：

中山大学附属第六医院

Primary sponsor：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省广州市天河区员村二横路26号

Primary sponsor's address：

No. 26 , Yuancun Er Heng Road, Tianhe District, Guangzhou City, Guangdong Province, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学附属第六医院

具体地址：

天河区员村二横路26号

Institution
hospital：

The Sixth Affiliated Hospital of Sun Yat-sen University

Address：

No. 26 , Yuancun Er Heng Road, Tianhe District

经费或物资来源：

本研究得到以下项目的部分支持：1）2024 年广州市科技计划市校联合资助项目（PI：范明明）；2）2023 年广州市科技计划市校联合资助项目（编号：2023A03J0001）；3）广东省泛在物联网综合通信、传感与计算重点实验室（编号：2023B1212010007）。

Source(s) of funding：

This work is partially supported by 1) 2024 Guangzhou Science and Technology Program City-University Joint Funding Project (PI: Mingming Fan); 2) 2023 Guangzhou Science and Technology Program City-University Joint Funding Project (No. 2023A03J0001) ; 3) Guangdong Provincial Key Lab of Integrated Communication, Sensing and Computation for Ubiquitous Internet of Things (No.2023B1212010007).

Target disease：

Stroke

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：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：探究 VR 下对脑卒中患者上肢康复训练过程中施加身体具身技术对患者上肢功能障碍疗效作用。 次要目的：探究 VR 下对脑卒中患者上肢康复训练过程中施加身体具身技术对训练动机和参与度的激励作用。  

Objectives of Study：

Primary objective: to explore the effectiveness of embodiment technology under VR on upper limb rehabilitation of patients with stroke. Secondary objective: to explore the effect of applying embodiment technology under VR to the upper limb rehabilitation training of patients with stroke on motivation and participation.

药物成份或治疗方案详述：

正式开展实验前为实验组患者说明实验流程，并完成fNIRS静息态评估。评估后患者在实验操作人员的邀请下佩戴VR头显并参与热身训练，以熟悉训练过程。实验正式开始后，患者在白天完成医院内原有的常规康复训练后，在晚上再次佩戴VR头显完成虚拟现实康复训练。实验过程中由操作员全程陪同、监督、完成指定的肢体外展、外旋、伸展、屈曲等动作，实现虚拟现实环境内的抓取等日常生活中的活动。每次实验后再开展访谈询问患者在训练过程中的自我感受。每次虚拟现实下的训练时长为30min。 总共训练周期为两周，每周训练六天。实验在开展到第一周结束和第二周结束时，再分别对患者进行fNIRS静息态评估。对于对照组患者，则在实验开始前直接完成fNIRS静息态评估，并同实验组一致，在白天完成原有的常规康复训练。之后在晚上由本实验的实验人员监督下完成与试验组相同的非VR环境下的特定动作训练。额外的日常康复训练时间同实验组实验时长一致，为30分钟。试验周期同为两周，每周训练六天。实验在开展到第一周结束和第二周结束时，再分别对患者进行fNIRS静息态评估。 

Description for medicine or protocol of treatment in detail：

The experimental procedure was explained to the patients in the experimental group and the fNIRS resting state assessment was completed before the experiment was formally conducted. After the assessment, patients were invited by the experiment operator to wear the VR headset and participate in the warm-up training to familiarize themselves with the training process. After the experiment officially started, the patients completed the original routine rehabilitation training in the hospital during the day, and then wore the VR headset again at night to complete the virtual reality rehabilitation training. During the experiment, the operator accompanied, supervised, and completed the specified limb abduction, external rotation, extension, flexion, etc., to realize the grasping and other daily life activities in the virtual reality environment. Interviews were conducted after each experiment to ask the patients about their self-perception during the training process. The duration of each training session in virtual reality was 30 min. The total training period was two weeks, six days per week. At the end of the first week and the end of the second week of the experiment, the patients were assessed by fNIRS resting state. For the control group, the patients completed the fNIRS resting state assessment directly before the start of the experiment, and completed the regular rehabilitation training during the daytime in the same way as the experimental group. Afterwards, the patients completed the same non-VR specific movement training in the evening under the supervision of the experiment's experimenter as the experimental group. The duration of the additional daily rehabilitation training was the same as that of the experimental group, which was 30 minutes. The experimental period was the same two weeks, with six days of training per week. The experiment was carried out to the end of the first week and the end of the second week before the patients were assessed with the fNIRS resting state assessment, respectively.  

纳入标准：

1.临床诊断为脑卒中，且经CT或MRI影像学证实； 2.距离首次发病时间三个月以上； 3.具备基本认知能力，MMSE评估得分在22分以上； 4.具有上肢功能障碍（上肢肩关节肌力评级为2级到4级；Fugl-Meyer上肢功能评分（FMA-UE）10-65分）； 5.同意参与本研究。

Inclusion criteria

1. Clinical diagnosis of stroke and confirmed by CT or MRI imaging; 2. More than three months from the time of the first onset of the disease; 3. Participants have basic cognitive ability with an MMSE assessment score of 22 or more; 4. Participants have upper extremity dysfunction (upper extremity shoulder muscle strength rating of 2 to 4; Fugl-Meyer Upper Extremity Function Score (FMA-UE) 10-65); 5. Participants agree to participate in this study.

排除标准：

1. 有除脑卒中之外的其他神经系统疾病史; 2. 有精神疾病或服用精神疾病药物史； 3. 有明确的接受性或表达性失语； 4. 有视力、听力障碍； 5. 正在参与其他临床研究。

Exclusion criteria：

1. A history of neurological disorders other than stroke. 2. A history of mental illness or medication for mental illness; 3. Participants have a definite receptive or expressive aphasia 4. Participants have visual or hearing impairment; 5. Participants is participating in another clinical study.

研究实施时间：

Study execute time：

从 From 2024-01-31 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-01 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

23

Group：

Experiment Group

Sample size：

干预措施：

正式开展实验前为实验组患者说明实验流程，并完成fNIRS静息态评估。评估后患者在实验操作人员的邀请下佩戴VR头显并参与热身训练，以熟悉训练过程。实验正式开始后，患者在白天完成医院内原有的常规康复训练后，在晚上再次佩戴VR头显完成虚拟现实康复训练。实验过程中由操作员全程陪同、监督、完成指定的肢体外展、外旋、伸展、屈曲等动作，实现虚拟现实环境内的抓取等日常生活中的活动。每次实验后再开展访谈询问患者在训练过程中的自我感受。每次虚拟现实下的训练时长为30min。 总共训练周期为两周，每周训练六天。实验在开展到第一周结束和第二周结束时，再分别对患者进行fNIRS静息态评估。

干预措施代码：

Intervention：

The experimental procedure was explained to the patients in the experimental group and the fNIRS resting state assessment was completed before the experiment was formally conducted. After the assessment, patients were invited by the experiment operator to wear the VR headset and participate in the warm-up training to familiarize themselves with the training process. After the experiment officially started, the patients completed the original routine rehabilitation training in the hospital during the daytime, and then wore the VR headset again in the evening to complete the virtual reality rehabilitation training. During the experiment, the operator accompanied, supervised, and completed the specified limb abduction, external rotation, extension, flexion, and other movements, and realized the grasping and other daily life activities in the virtual reality environment. Interviews were conducted after each experiment to ask the patients about their self-perception during the training process. The duration of each training session in virtual reality was 30 min. The total training period was two weeks, six days per week. At the end of the first week and the end of the second week of the experiment, the patients were assessed by fNIRS resting state.

Intervention code：

组别：

对照组

样本量：

23

Group：

Control Group

Sample size：

干预措施：

对于对照组患者，则在实验开始前直接完成fNIRS静息态评估，并同实验组一致，在白天完成原有的常规康复训练。之后在晚上由本实验的实验人员监督下完成与试验组相同的非VR环境下的特定动作训练。额外的日常康复训练时间同实验组实验时长一致，为30分钟。试验周期同为两周，每周训练六天。实验在开展到第一周结束和第二周结束时，再分别对患者进行fNIRS静息态评估。

干预措施代码：

Intervention：

For the control group, the patients completed the fNIRS resting state assessment directly before the start of the experiment, and completed the regular rehabilitation training during the daytime in the same way as the experimental group. Afterwards, the patients completed the same non-VR specific movement training in the evening under the supervision of the experiment's experimenter as the experimental group. The duration of the additional daily rehabilitation training was the same as that of the experimental group, which was 30 minutes. The experimental period was the same two weeks, with six days of training per week. The experiment was carried out to the end of the first week and the end of the second week before the patients were assessed with the fNIRS resting state assessment, respectively.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

中山大学附属第六医院 

单位级别：

三甲 

Institution
hospital：

The Sixth Affiliated Hospital, Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

上肢运动功能

指标类型：

主要指标

Outcome：

Upper limb motor function

Type：

Primary indicator

测量时间点：

基线（T0）、干预开始后1周（T1）、干预开始后2周（T2）

测量方法：

Fugl-Meyer上肢评估

Measure time point of outcome：

Baseline (T0), 1 weeks after intervention initiation (T1), 2 weeks after intervention initiation (T2)

Measure method：

Fugl-Meyer Upper Extremity Evaluation (FM-UE)

指标中文名：

客观运动能力

指标类型：

次要指标

Outcome：

Objective Mobility

Type：

Secondary indicator

测量时间点：

基线（T0）、干预开始后1周（T1）、干预开始后2周（T2）

测量方法：

各运动平面上的距离或角度

Measure time point of outcome：

Baseline (T0), 1 weeks after intervention initiation (T1), 2 weeks after intervention initiation (T2)

Measure method：

Distance or angle in each plane of motion

指标中文名：

主观运动能力

指标类型：

次要指标

Outcome：

Subjective motor ability

Type：

Secondary indicator

测量时间点：

基线（T0）、干预开始后1周（T1）、干预开始后2周（T2）

测量方法：

半结构化自评量表

Measure time point of outcome：

Baseline (T0), 1 weeks after intervention initiation (T1), 2 weeks after intervention initiation (T2)

Measure method：

Semi-structured Self-Rating Scale

指标中文名：

主观体验

指标类型：

次要指标

Outcome：

Subjective experience

Type：

Secondary indicator

测量时间点：

基线（T0）、干预开始后1周（T1）、干预开始后2周（T2）

测量方法：

半结构化自评量表

Measure time point of outcome：

Baseline (T0), 1 weeks after intervention initiation (T1), 2 weeks after intervention initiation (T2)

Measure method：

Semi-structured Self-Rating Scale

指标中文名：

脑影像学变化

指标类型：

次要指标

Outcome：

Brain imaging changes

Type：

Secondary indicator

测量时间点：

基线（T0）、干预开始后1周（T1）、干预开始后2周（T2）

测量方法：

功能性近红外光谱技术

Measure time point of outcome：

Baseline (T0), 1 weeks after intervention initiation (T1), 2 weeks after intervention initiation (T2)

Measure method：

Functional near infrared spectroscopy (fNIRS)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

不涉及

组织：

Sample Name：

not involved

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 65 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）：

分配序列产生：研究人员利用计算机预先设计好实验可能的顺序方案并随机分配给参与者。为了减少随机序列的可预测性，任何预设的限定细则( 如区组法) 应以附件的形式提供， 而试验招募者或干预措施分配者均不应获得这些数据 分配实施：计算机完成序号分配，研究人员招募受试者，计算机随机完成干预措施分配

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

Allocation sequence generation: Researchers use computers to pre-design the possible sequential protocols for the experiment and randomly allocate them to participants. To reduce the predictability of the randomization sequence, any pre-determined qualifiers (e.g., compartmentalization) should be provided in the form of an annex and should not be available to either the trial recruiter or the intervention distributor. Allocation implementation: the computer completes the serial number assignment, the researcher recruits the subjects, and the computer randomizes the intervention assignment

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：

由于本研究干预的特殊性，本研究为非盲开放设计。但为了尽量减少偏倚，本研究对结局评价者和统计分析者设盲，结局评价者和统计分析者均不清楚受试者的分组情况。 在统计分析结束后或出于安全考虑如受试者因严重不良反应需要终止试验时可以由研究人员揭盲。

Blinding：

Due to the specificity of the intervention in this study, this study was a non-blinded open design. However, in order to minimize bias, this study was blinded to the outcome evaluators and statistical analysts, and neither the outcome evaluators nor the statistical analysts were aware of the grouping of the subjects. The investigators could be unblinded at the end of the statistical analysis or for safety reasons if the subjects needed to terminate the trial due to serious adverse effects.

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

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）：

本研究中使用和分析的数据集将由注册申请人（公晨，gongch33@mail.sysu.edu.cn）提供以用于合理的科研目的。

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

The datasets used and analyzed during the current study will be available from the applicant (Chen Gong, gongch33@mail.sysu.edu.cn) on reasonable request for academic purpose.

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：

结局指标测量时会有两名工作人员在场，一名负责记录，一名负责指导受试者进行测量。这两名工作人员均应有相关评价指标测试经验且受过项目组统一培训，此外，这两名工作人员应不清楚受试者分组情况；本研究所使用的研究工具均为同类研究中广泛应用的工具，信、效度良好，具体内容可见病例报告表（CRF）；记录数据应当场记录在CRF上，并同时签上工作人员签名及日期。若需要更改，需要留下更改痕迹并署名及日期。 为提高受试者参与性和完成随访率，研究开始之前做好受试者教育，强调按照要求完成研究的意义和重要性，鼓励受试者按照要求完成研究；在干预期间研究者使用微信、手机等作为手段与受试者保持合理联系，及时告知干预地点、时间、内容并做好时间预约；叮嘱受试者在研究期间做好特殊事件记录，如不良反应、服药记录，并及时与联系人联系；对于退出或更改治疗方案的受试者，如能继续随访，则继续完成结局数据收集，后续纳入意向性分析，若不可行，则视为缺失，后续统计分析再进行相应处理。 受试者所有评估数据都记录在每个人的病例手册中，并以研究编号数字而非姓名加以标识。研究数据将不会透露给研究小组以外的成员，同时保存在有锁的档案柜中仅供研究人员查阅。

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

Two staff members will be present when the outcome measures are taken, one to record and one to guide the subjects to take the measurements. These two staff members should have relevant experience in evaluation and have received unified training from the program team. In addition, these two staff members should not know the grouping. The research tools used in this study are widely used in similar studies, with good reliability and validity, and the specific contents can be seen in the case report form (CRF). The recorded data shall be recorded on the CRF and signed and dated by the staff member. If CRF needs a change, it needs to leave a change track, sign, and date. In order to improve participants' participation and follow-up completion rate, subjects will be educated before the start of the study, emphasize the significance and importance of completing the study, and encourage participants to complete the study as required. During the intervention period, the researchers used WeChat, mobile phones, and other tools to maintain reasonable contact with the subjects, timely inform the location, time, and content of the intervention, and make appointments. We will keep records of special events during the study, such as adverse reactions and medication records, and keep in touch with participants in time. For subjects who withdrew or changed the treatment plan, if follow-up could be continued, the outcome data collection would continue to be completed, and the intention-to-treat analysis would be included later. If it was not feasible, it would be regarded as missing, and the corresponding treatment would be conducted after follow-up statistical analysis. All assessment data for subjects was recorded in each subject's CRF and identified by study number rather than names or any other ID information. The study data will not be disclosed to members outside the research team and will be kept in a locked filing cabinet for researchers' access only.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

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Name of Registration：

  2024-04-07 15:41:52