ChiCTR2600118957 版本V1.0 版本创建时间2026/02/13 09:52:24 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：

 ChiCTR2600118957 

最近更新日期：

Date of Last Refreshed on：

 2026-02-13 09:52:06 

注册时间：

Date of Registration：

 2026-02-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于MI-BCI的软体外骨骼联合功能性电刺激康复系统在脑卒中患者中的临床应用

Public title：

Clinical Application of an MI-BCI-Based Soft Exoskeleton Combined with Functional Electrical Stimulation Rehabilitation System in Stroke Patients

注册题目简写：

基于MI-BCI的软体外骨骼联合功能性电刺激康复系统在脑卒中患者中的临床应用

English Acronym：

Clinical Application of an MI-BCI-Based Soft Exoskeleton Combined with Functional Electrical Stimulation Rehabilitation System in Stroke Patients

研究课题的正式科学名称：

基于MI-BCI的软体外骨骼联合功能性电刺激康复系统在脑卒中患者中的临床应用

Scientific title：

Clinical Application of an MI-BCI-Based Soft Exoskeleton Combined with Functional Electrical Stimulation Rehabilitation System in Stroke Patients

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：

刘静娅 

研究负责人：

刘静娅 

Applicant：

Jingya Liu 

Study leader：

Jingya Liu 

申请注册联系人电话：

Applicant telephone：

 +86 158 0153 0159

研究负责人电话：

Study leader's
telephone：

+86 158 0153 0159

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：

 jealousy313@163.com

研究负责人电子邮件：

Study leader's E-mail：

 jealousy313@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18号

研究负责人通讯地址：

北京市丰台区角门北路18号

Applicant address：

No. 18, Jiaomen North Road, Fengtai District, Beijing

Study leader's address：

No. 18, Jiaomen North Road, Fengtai District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

 100068

研究负责人邮政编码：

Study leader's postcode：

 100068

申请人所在单位：

北京博爱医院

Applicant's institution：

China Rehabilitation Research Center

研究负责人所在单位：

北京博爱医院

Affiliation of the Leader：

China Rehabilitation Research Center

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：

 2026-007-01

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：

中国康复研究中心医学伦理委员会

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：

 2026-01-23 00:00:00

伦理委员会联系人：

孟丽君，何照楠

Contact Name of the ethic committee：

Lijun Meng\Zhaonan He

伦理委员会联系地址：

北京市丰台区角门北路18号

Contact Address of the ethic committee：

No. 18, Jiaomen North Road, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8702 0512

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：

中国康复研究中心

Primary sponsor：

China Rehabilitation Research Center

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)：

丰台区

Country：

China

Province：

Beijing

City：

Fengtai

单位(医院)：

中国康复研究中心

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

China Rehabilitation Research Center

Address：

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

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：

脑卒中后手功能障碍恢复依赖于中枢可塑性的激活和患者主动参与。然而现有脑机接口系统多以单一外设输出为主，难以在手部精细动作层面形成有效的感觉–运动闭环。本研究拟构建一套由高性能运动想象脑机接口驱动的软体手部外骨骼联合功能性电刺激系统，使气动驱动与电刺激在同一中枢运动意图下同步执行，以形成“中枢—外周—中枢”的闭环调控，从而增强皮层激活与主动参与度。  

Objectives of Study：

Recovery of hand function after stroke depends on the activation of central plasticity and active participation of patients. However, existing brain-computer interface systems mostly rely on a single peripheral output, making it difficult to form an effective sensory-motor closed loop at the level of fine hand movements. This study aims to develop a system that combines a high-performance motor imagery brain-computer interface-driven soft hand exoskeleton with functional electrical stimulation, enabling pneumatic actuation and electrical stimulation to be executed simultaneously under the same central motor intention, thereby forming a "central-peripheral-central" closed-loop regulation and enhancing cortical activation and active participation.

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》中脑卒中诊断标准，且经 CT 或 MRI 检查确诊，为首次发病，病程1-3个月 2.年龄 18–65 岁，性别不限。 3.右侧偏瘫，患侧手Brunnstrom 分期1-2期（中重度功能障碍） 4.简易智力状态检查量表(MMSE)＞21分（适用于非文盲受试者） 5.患者或家属知情同意并签署同意书。 6.运动-视觉想象问卷（KVIQ-20）≥55分

Inclusion criteria

1. Diagnosis of stroke in accordance with the Diagnostic Criteria for Major Types of Cerebrovascular Diseases in China (2019), confirmed by CT or MRI; first-ever stroke with a disease duration of 1–3 months. 2. Aged 18–65 years, with no restriction on sex. 3. Right-sided hemiplegia, with the affected hand at Brunnstrom stage I–II, indicating moderate to severe motor impairment. 4. Mini-Mental State Examination (MMSE) score > 21, applicable to non-illiterate participants. 5. The patient or their legal guardian has provided written informed consent. 6. Kinesthetic and Visual Imagery Questionnaire (KVIQ-20) score >= 55

排除标准：

1.存在痴呆（文盲受试者MMSE≤17分），或严重听力、视力、语言障碍无法配合完成训练； 2.患侧上肢存在骨折、严重关节炎、关节置换等影响运动的肌肉、骨骼及神经性疾病； 3.有阿尔茨海默病、帕金森病等所致认知障碍的明确病史； 4.存在脑机接口、软体外骨骼、功能性电刺激或fNIRS相关禁忌症； 5.颅内有金属植入物、金属起搏器或颅骨不完整者。

Exclusion criteria：

1. Presence of dementia (MMSE score ≤ 17 for illiterate participants), or severe hearing, visual, or speech impairments that prevent cooperation with training procedures. 2. Musculoskeletal or neurological conditions affecting the affected upper limb, such as fractures, severe arthritis, joint replacement, or other disorders that interfere with motor function. 3. A confirmed medical history of cognitive impairment caused by neurological diseases, such as Alzheimer’s disease or Parkinson’s disease. 4. Presence of contraindications to brain–computer interface (BCI), soft exoskeleton, functional electrical stimulation (FES), or functional near-infrared spectroscopy (fNIRS). 5. Intracranial metallic implants, metallic pacemakers, or incomplete cranial integrity.

研究实施时间：

Study execute time：

从 From 2025-12-30 00:00:00至 To 2027-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-28 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

常规康复组（阳性对照组）

样本量：

 19

Group：

Conventional Rehabilitation Group (Positive Control Group)

Sample size：

干预措施：

常规康复基础上继续接受常规作业治疗，用以提供标准治疗条件下的参照疗效，作为新型技术评估的对照基础。

干预措施代码：

Intervention：

Participants in this group will receive conventional rehabilitation, including standard occupational therapy, serving as the reference treatment under standard-of-care conditions. This group provides a baseline comparator for evaluating the therapeutic effects of the novel intervention technologies.

Intervention code：

组别：

软体外骨骼 + FES 组（非 BCI）

样本量：

 19

Group：

Soft Exoskeleton + FES Group (Non-BCI Group)

Sample size：

干预措施：

在常规康复基础上，叠加被动软体外骨骼联合功能性电刺激训练。本组用于评估气动软体外骨骼＋FES 在外周执行层面的疗效，并验证其相对于常规康复的非劣性，从而区分“设备本体效应”与“BCI 相关中枢参与效应”。

干预措施代码：

Intervention：

In addition to conventional rehabilitation, participants in this group will receive passive soft exoskeleton–assisted training combined with functional electrical stimulation (FES). This group is designed to evaluate the peripheral execution–level therapeutic effects of the pneumatic soft exoskeleton combined with FES, and to verify its non-inferiority compared with conventional rehabilitation. By excluding brain–computer interface (BCI) involvement, this group allows differentiation between the intrinsic effects of the assistive device and the central nervous system engagement specifically mediated by BCI.

Intervention code：

组别：

BCI外骨骼+ FES 组（试验组）

样本量：

 19

Group：

BCI-Controlled Soft Exoskeleton + FES Group(Intervention Group)

Sample size：

干预措施：

在常规康复基础上，进行基于运动想象脑机接口控制的软体外骨骼联合功能性电刺激训练。本组用于评估 BCI 介导的中枢意图解码是否在同一外设条件下产生增量效应，提高上肢功能恢复的幅度，并进一步探讨其潜在的脑功能重塑效应。

干预措施代码：

Intervention：

Based on conventional rehabilitation, participants in this group will receive motor imagery–based BCI–controlled soft exoskeleton training combined with functional electrical stimulation (FES). This group is intended to assess whether BCI-mediated decoding of motor intention produces an additional therapeutic effect under identical peripheral device conditions, leading to greater improvements in upper limb motor function. Furthermore, this group aims to explore the potential neural plasticity and brain functional reorganization effects associated with BCI-assisted rehabilitation.

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(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国康复研究中心 

单位级别：

 三甲 

Institution
hospital：

China Rehabilitation Research Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer上肢运动功能评定量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Upper Limb Motor Function Assessment Scale

Type：

Primary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

上肢动作研究量表

指标类型：

次要指标

Outcome：

Action ResearchArm Test, ARAT

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

改良Ashworth 评定量表

指标类型：

次要指标

Outcome：

modified Ashworth scale

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

近红外脑功能成像技术

指标类型：

次要指标

Outcome：

Functional near-infrared spectroscopy

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

握力

指标类型：

次要指标

Outcome：

Hand Grip Strength

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

主动关节活动度

指标类型：

次要指标

Outcome：

Active Range of Motion (AROM)

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

感觉评估

指标类型：

次要指标

Outcome：

Sensory evaluation

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

改良 Barthel 指数评定

指标类型：

次要指标

Outcome：

modified Barthel index, MBI

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

蒙特利尔认知评估量表

指标类型：

次要指标

Outcome：

Montreal Cognitive Assessment,MoCA

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

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）：

主要研究者利用统计软件 SPSS 生成指定数量的随机数，随机将受试者分为试验组和对照组。

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

The principal researcher used the statistical software SPSS to generate a specified number of random numbers and randomly divided the subjects into the experimental group and the control group.

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：

单盲试验。试验主要对研究者进行设盲，由于研究者不知道受试者的具体情况，他们在收集数据和评估时能够保持中立态度，减少数据收集过程中的偏倚和误差。

Blinding：

Single-blind trial. The experiment mainly blinds the researchers. Since the researchers do not know the specific circumstances of the subjects, they can maintain a neutral attitude when collecting data and conducting evaluations, reducing bias and errors in the data collection process.

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

数据采集 （1）患者基本信息与临床评估数据 采集患者年龄、性别、损伤类型（如脑卒中、脑外伤）、损伤部位（左侧大脑）、病程时间及既往治疗史等基本信息。 采用标准化评估工具对上肢功能进行评估，包括 Fugl-Meyer 上肢运动功能评定量表（FMA-UE）、改良 Ashworth 痉挛量表（MAS）、握力及主动关节活动度（AROM），用于量化患者上肢运动功能、肌力及肌张力。 （2）脑机接口（BCI）数据 采集 BCI 系统记录的脑电图（EEG）信号数据，包括频率特征、波幅及脑区分布等参数，并记录基于 EEG 信号解码的运动意图相关数据。 （3）软体手部外骨骼数据 记录软体手部外骨骼训练过程中的运行参数及执行状态，包括助力模式、关节运动轨迹、运动幅度、运动速度及训练时长等。 （4）功能性电刺激（FES）数据 记录功能性电刺激的参数设置，包括刺激强度、频率、脉冲宽度及刺激时长，并记录患者对刺激的耐受性及反应情况。 （5）大脑激活数据 采用功能性磁共振成像（fMRI）或近红外光谱成像（fNIRS）技术，采集患者在任务执行过程中的大脑皮层血流变化或氧合血红蛋白浓度变化，用于评估大脑激活情况。 数据管理 （1）数据录入与存储 临床评估数据人工录入电子数据库；设备采集数据（BCI、软体外骨骼、FES、fMRI、fNIRS）由设备系统导出为电子文件，并按统一格式和命名规则进行存储。 （2）数据清洗与质量控制 对数据进行完整性和准确性检查，去除重复或错误数据，处理缺失数据；对信号数据进行质量检查，去除明显噪声和伪迹。建立数据质量控制流程，定期审核数据，确保数据真实、准确、可追溯。

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

Data Collection (1) Participant Information and Clinical Assessment Data Basic demographic and clinical information will be collected, including age, sex, type of injury (e.g., stroke, traumatic brain injury), lesion location (left hemisphere), disease duration, and prior treatment history. Upper limb function will be assessed using standardized assessment tools, including the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), Modified Ashworth Scale (MAS), hand grip strength, and active range of motion (AROM), to quantitatively evaluate upper limb motor function, muscle strength, and muscle tone. (2) Brain–Computer Interface (BCI) Data Electroencephalography (EEG) signals recorded by the BCI system will be collected, including frequency features, signal amplitude, and cortical spatial distribution, as well as motor intention–related data decoded from EEG signals. (3) Soft Hand Exoskeleton Data Operational parameters and execution status of the soft hand exoskeleton during training will be recorded, including assistance mode, joint motion trajectories, movement amplitude, movement velocity, and training duration. (4) Functional Electrical Stimulation (FES) Data FES parameter settings will be recorded, including stimulation intensity, frequency, pulse width, and stimulation duration, along with participants’ tolerance and responses to stimulation. (5) Brain Activation Data Functional magnetic resonance imaging (fMRI) or functional near-infrared spectroscopy (fNIRS) will be used to collect changes in cerebral cortical blood flow or oxygenated hemoglobin (HbO) concentration during task performance, to evaluate brain activation patterns. Data Management (1) Data Entry and Storage Clinical assessment data will be manually entered into an electronic database. Device-generated data (BCI, soft exoskeleton, FES, fMRI, and fNIRS) will be exported directly from the respective systems as electronic files and stored according to predefined formats and naming conventions. (2) Data Cleaning and Quality Control Data will be checked for completeness and accuracy, with duplicate or erroneous entries removed and missing data appropriately handled. Signal data will undergo quality checks to remove obvious noise and artifacts. A data quality control process will be implemented with regular data audits to ensure data integrity, accuracy, and traceability.

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：

  2026-02-13 09:52:06