ChiCTR2500101728 版本V1.0 版本创建时间2025/04/29 10:32:40 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：

 ChiCTR2500101728 

最近更新日期：

Date of Last Refreshed on：

 2025-04-29 10:32:05 

注册时间：

Date of Registration：

 2025-04-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

等速训练联合限制性约束诱导运动疗法治疗缺血性中风后的上肢功能障碍的一项随机对照临床研究

Public title：

A Randomized Controlled Clinical Trial of Isokinetic Training Combined with Constraint-Induced Movement Therapy for Upper Limb Dysfunction After Ischemic Stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

等速训练联合限制性约束诱导运动疗法治疗缺血性中风后的上肢功能障碍的一项随机对照临床研究

Scientific title：

A Randomized Controlled Clinical Trial of Isokinetic Training Combined with Constraint-Induced Movement Therapy for Upper Limb Dysfunction After Ischemic 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：

郑鹏 

研究负责人：

郑鹏 

Applicant：

Peng Zheng 

Study leader：

Peng Zheng 

申请注册联系人电话：

Applicant telephone：

 +86 130 7431 7404

研究负责人电话：

Study leader's
telephone：

+86 130 7431 7404

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：

 zhengpeng7877@163.com

研究负责人电子邮件：

Study leader's E-mail：

 zhengpeng7877@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：

吉林省长春市南关区长春中医药大学附属第三临床医院

研究负责人通讯地址：

吉林省长春市南关区长春中医药大学附属第三临床医院

Applicant address：

The Third Affiliated Hospital of Changchun University of Chinese Medicine, Nanguan District, Changchun City, Jilin Province

Study leader's address：

The Third Affiliated Hospital of Changchun University of Chinese Medicine, Nanguan District, Changchun City, Jilin Province

申请注册联系人邮政编码：

Applicant postcode：

 130118

研究负责人邮政编码：

Study leader's postcode：

 130118

申请人所在单位：

长春中医药大学附属第三临床医院

Applicant's institution：

The Third Affiliated Hospital of Changchun University of Chinese Medicine

研究负责人所在单位：

长春中医药大学附属第三临床医院

Affiliation of the Leader：

The Third Affiliated Hospital of Changchun 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：

 CZDSFYLL2025-012-02

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：

长春中医药大学附属第三临床医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Third Affiliated Clinical Hospital of Changchun University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-07 00:00:00

伦理委员会联系人：

遇准

Contact Name of the ethic committee：

Zhun Yu

伦理委员会联系地址：

吉林省长春市南关区长春中医药大学附属第三临床医院

Contact Address of the ethic committee：

The Third Affiliated Hospital of Changchun University of Chinese Medicine, Nanguan District, Changchun City, Jilin Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 431 8991 2033

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 czdsfyll2020@163.com

研究实施负责（组长）单位：

长春中医药大学附属第三临床医院

Primary sponsor：

The Third Affiliated Hospital of Changchun University of Chinese Medicine

研究实施负责（组长）单位地址：

吉林省长春市南关区长春中医药大学附属第三临床医院

Primary sponsor's address：

The Third Affiliated Hospital of Changchun University of Chinese Medicine, Nanguan District, Changchun City, Jilin Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林

市(区县)：

长春

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

长春中医药大学附属第三临床医院

具体地址：

吉林省长春市南关区长春中医药大学附属第三临床医院

Institution
hospital：

The Third Affiliated Hospital of Changchun University of Chinese Medicine

Address：

The Third Affiliated Hospital of Changchun University of Chinese Medicine, Nanguan District, Changchun City, Jilin Province

经费或物资来源：

自筹

Source(s) of funding：

raise independently

研究疾病：

缺血性卒中  

Target disease：

ischemic 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：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

几年来鲜有研究调查CIMT以及等速训练联合治疗，以及二者是通过何种信号通路促进IS患者的功能恢复。因此，本研究将探讨CIMT结合等速训练是否可通过抑制铁死亡GPX4/MAPK通路减轻IS损伤。本研究通过收集临床患者数据进行假设验证。通过主观及客观量对CIMT结合等速训练的治疗效果进行验证，即通过客观国际量表以及患者的唾液进行检测。  

Objectives of Study：

In recent years, few studies have investigated the combined effects of Constraint-Induced Movement Therapy (CIMT) and isokinetic training, as well as the specific signaling pathways through which these interventions promote functional recovery in ischemic stroke (IS) patients. Therefore, this study aims to explore whether the combination of CIMT and isokinetic training can alleviate IS-induced damage by inhibiting the ferroptosis-related GPX4/MAPK signaling pathway. To test this hypothesis, clinical data from patients were collected and analyzed. The therapeutic efficacy of the combined intervention was evaluated using both subjective and objective measures, including internationally recognized assessment scales and biochemical analysis of patient saliva samples.

药物成份或治疗方案详述：

本课题采用随机对照研究方法，以IS后偏瘫患者为研究对象，拟纳入 60 例，使用中央随机系统按 1:1 比例随机分为对照组和治疗组。各临床研究中心严格按照诊断标准、纳入标准和排除标准筛选病例，确定入组后，给予对症治疗，直到完成总观察例数后结束试验，为等速训练联合CIMT的临床推广提供前期有效的临床评价。 对康复治疗师进行关于干预实施的强化培训，并负责执行治疗方案。（对照组) 常规康复治疗和等速训练（UR+IT）组，每日仅接受常规的康复治疗和等速训练。（治疗组）常规康复治疗、等速训练和限制诱导运动疗法（UR+IT+CIMT）组，进行常规康复治疗、等速训练和限制诱导运动疗法。 对照组：①治疗方法：常规康复（UR）以脑卒中康复治疗为主；根据病情程度的不同，采取分期治疗原则，如早期以关节活动度训练为主，中后期以代偿性功能训练为主；等速训练（ IT）根据患者力矩的不同，采取个性化治疗原则，进行等速训练20分钟。②操作方法：每日治疗 1 次，7 天为一个疗程，共治疗 2 个疗程，疗程之间休息 1 天。 治疗组 ①治疗方法：治疗组的患者与观察组的患者除相同的UR与IT治疗外，同时进行限制性强制诱导运动（CIMT）治疗，需在14天的治疗期间内，至少在90%的清醒时间内将限制性手套戴在健侧。②操作方法：每日治疗 1 次，7 天为一个疗程，共治疗 2 个疗程，疗程之间休息 1 天。 两组在基线期、治疗结束后进行结局指标评价。 

Description for medicine or protocol of treatment in detail：

Study Design and Methods This study employs a randomized controlled trial (RCT) design, enrolling 60 patients with hemiplegia following ischemic stroke (IS). Participants will be randomized in a 1:1 ratio into either the control group or the treatment group using a central randomization system. Each clinical research center will strictly adhere to the diagnostic, inclusion, and exclusion criteria for patient screening. After enrollment, patients will receive symptomatic treatment until the total number of observed cases is completed, thereby providing preliminary clinical evaluation for the widespread application of combined isokinetic training and Constraint-Induced Movement Therapy (CIMT). Rehabilitation therapists will undergo intensive training on intervention implementation and will be responsible for executing the treatment protocols. Control Group: Patients will receive conventional rehabilitation therapy and isokinetic training (UR+IT). Daily treatment will consist solely of conventional rehabilitation and isokinetic training. Treatment Group: Patients will receive conventional rehabilitation therapy, isokinetic training, and CIMT (UR+IT+CIMT). In addition to UR and IT, patients in this group will undergo CIMT, which requires wearing a restrictive glove on the unaffected side for at least 90% of waking hours during the 14-day treatment period. Control Group Protocol Treatment Methods: Conventional Rehabilitation (UR): Focuses on stroke rehabilitation, with treatment principles tailored to the disease stage. Early-stage therapy emphasizes joint range of motion training, while mid-to-late-stage therapy focuses on compensatory functional training. Isokinetic Training (IT): Involves personalized isokinetic training based on individual torque measurements, with each session lasting 20 minutes. Operational Details: Treatment is administered once daily, with 7 days constituting one treatment course. A total of 2 courses will be completed, with a 1-day rest period between courses. Treatment Group Protocol Treatment Methods: In addition to UR and IT, patients in the treatment group will undergo CIMT. During the 14-day treatment period, patients must wear a restrictive glove on the unaffected side for at least 90% of waking hours. Operational Details: Treatment is administered once daily, with 7 days constituting one treatment course. A total of 2 courses will be completed, with a 1-day rest period between courses. 

纳入标准：

纳入标准 1.符合缺血性脑卒中诊断标准 2.发病年龄为 18-70 岁之间，性别不限 3.病程 2 周-9 个月 4.患侧上肢功能障碍，肌力为0-3级；或患侧上肢 Brunnstrom分期在Ⅰ-Ⅲ期；无明显的认知功能障碍 5.生命体征平稳，意识清楚；无明显智障，听力无明显障碍，能配合康复训练等基础治疗者 6.签署知情同意书并且能坚持遵从医嘱治疗者

Inclusion criteria

Inclusion Criteria 1. Diagnosis: Patients must meet the diagnostic criteria for ischemic stroke. 2. Age and Gender: Age at onset should be between 18 and 70 years, with no restrictions on gender. 3. Disease Duration: The course of the disease should range from 2 weeks to 9 months. 4. Upper Limb Dysfunction: Patients should exhibit impaired upper limb function on the affected side, with muscle strength graded 0–3 or Brunnstrom stage I–III. Additionally, there should be no significant cognitive impairment. 5. General Health: Patients must have stable vital signs, clear consciousness, no significant intellectual disability, and no severe hearing impairment. They should also be able to cooperate with basic rehabilitation training. 6. Compliance: Patients must provide signed informed consent and demonstrate the ability to adhere to the prescribed treatment regimen.

排除标准：

排除标准 1.中风次数≥3次者 2.合并有心、肝、脾、肺、肾器质性疾病及精神病患者，如心脏支架、癫痫病史、严重意识障碍等严重原发病及恶性肿瘤 3.改良 Ashworth 分级为 0 级或＞III 级 4.不能配合IT，CIMT及UR者，包括不能坚持治疗或私自加用其他治疗，从而影响资料收集及疗效评定者 5.有明确病症不能进行等速训练及限制性诱导运动的患者（如急性期脑外伤、脑出血患者；癫痫病史或脑电图检查显示有癫痫样改变的患者，妊娠期或哺乳期妇女）；有严重皮肤过敏史者 6.合并神经系统其他疾病如多发性周围神经病、糖尿病周围神经病、运动神经元病、神经肌肉接头病变、肌病等；有严重精神疾病患者，如中重度焦虑、抑郁，不适宜接受治疗者 7.病情不稳定或者存在不可控制的健康因素

Exclusion criteria：

Exclusion Criteria 1. Stroke History: Patients with a history of three or more strokes. 2. Severe Comorbidities: Patients with significant organic diseases of the heart, liver, spleen, lungs, or kidneys, as well as psychiatric disorders (e.g., history of cardiac stents, epilepsy, severe cognitive impairment) or malignant tumors. 3. Modified Ashworth Scale: Patients with a Modified Ashworth Scale grade of 0 or greater than III. 4. Non-Compliance: Patients unable to comply with isokinetic training (IT), Constraint-Induced Movement Therapy (CIMT), or conventional rehabilitation therapy (UR), including those who cannot adhere to the treatment regimen or who self-administer additional therapies that may interfere with data collection or efficacy evaluation. 5. Contraindications: Patients with conditions that preclude participation in isokinetic training or CIMT, such as acute traumatic brain injury, cerebral hemorrhage, a history of epilepsy, or electroencephalogram (EEG) findings indicating epileptiform changes. Pregnant or lactating women, as well as those with a history of severe skin allergies, are also excluded. 6. Neurological or Psychiatric Disorders: Patients with other neurological conditions (e.g., polyneuropathy, diabetic neuropathy, motor neuron disease, neuromuscular junction disorders, myopathies) or severe psychiatric disorders (e.g., moderate to severe anxiety or depression) that make them unsuitable for the treatment. 7. Unstable Conditions: Patients with unstable medical conditions or uncontrolled health factors that may interfere with the study.

研究实施时间：

Study execute time：

从 From 2025-02-07 00:00:00至 To 2026-02-06 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2026-02-06 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：

治疗方法：常规康复（UR）以脑卒中康复治疗为主；根据病情程度的不同，采取分期治疗原则，如早期以关节活动度训练为主，中后期以代偿性功能训练为主； 等速训练（IT）根据患者力矩的不同，采取个性化治疗原则，进行等速训练20分钟。操作方法：每日治疗 1 次，7 天为一个疗程，共治疗 2 个疗程，疗程之间休息 1 天。

干预措施代码：

Intervention：

Treatment Methods: Conventional Rehabilitation: The primary focus is on stroke rehabilitation, with treatment principles tailored to the disease stage. In the early stage, therapy emphasizes joint range of motion training, while in the mid-to-late stages, compensatory functional training is prioritized. Isokinetic Training: Personalized isokinetic training is administered based on individual torque measurements, with each session lasting 20 minutes. Operational Details: Treatment is administered once daily, with 7 days constituting one treatment course. A total of 2 courses will be completed, with a 1-day rest period between courses.

Intervention code：

组别：

治疗组

样本量：

 30

Group：

Treatment Group

Sample size：

干预措施：

治疗方法：治疗组的患者与观察组的患者除相同的常规康复（UR）与等速训练（IT）治疗外，同时进行限制性强制诱导运动（CIMT）治疗，需在14天的治疗期间内，至少在90%的清醒时间内将限制性手套戴在健侧。操作方法：每日治疗 1 次，7 天为一个疗程，共治疗 2 个疗程，疗程之间休息 1 天。

干预措施代码：

Intervention：

Treatment Methods: In addition to conventional rehabilitation therapy (UR) and isokinetic training (IT), patients in the treatment group will undergo Constraint-Induced Movement Therapy (CIMT). During the 14-day treatment period, patients are required to wear a restrictive glove on the unaffected side for at least 90% of their waking hours. Operational Details: Treatment is administered once daily, with 7 days constituting one treatment course. A total of 2 courses will be completed, with a 1-day rest period between courses.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林省 

市(区县)：

 长春市 

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

 长春中医药大学附属第三临床医院 

单位级别：

 三甲 

Institution
hospital：

The Third Affiliated Hospital of Changchun University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer上肢功能评定量表

指标类型：

主要指标

Outcome：

Fugl Meyer Upper Limb Function Assessment Scale

Type：

Primary indicator

测量时间点：

基线期，治疗后

测量方法：

Measure time point of outcome：

Baseline period, after treatment

Measure method：

指标中文名：

美国国立卫生研究院卒中量表

指标类型：

次要指标

Outcome：

national institute of health stroke scale

Type：

Secondary indicator

测量时间点：

基线期，治疗后

测量方法：

Measure time point of outcome：

Baseline period, after treatment

Measure method：

指标中文名：

36项简短健康调查量表

指标类型：

次要指标

Outcome：

36‐Item Short Form Health Survey

Type：

Secondary indicator

测量时间点：

基线期，治疗后

测量方法：

Measure time point of outcome：

Baseline period, after treatment

Measure method：

指标中文名：

功能独立性评定量表

指标类型：

次要指标

Outcome：

Functional Independence Measure

Type：

Secondary indicator

测量时间点：

基线期，治疗后

测量方法：

Measure time point of outcome：

Baseline period, after treatment

Measure method：

指标中文名：

改良Ashworth痉挛评定量表

指标类型：

次要指标

Outcome：

Spasticity The Modified Modified Ashworth Scale

Type：

Secondary indicator

测量时间点：

基线期，治疗后

测量方法：

Measure time point of outcome：

Baseline period, after treatment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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）：

使用简单随机方法，用中央随机系统按 1:1 比例随机分为对照组和治疗组。将参与者随机地分配到对照组和治疗组中。每个参与者都有相等的机会被分配到这两组中的任意一个。1:1比例：通过中央系统，确保对照组和治疗组的参与者数量相等。30人会被随机分配到治疗组，30人会被分配到对照组。

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

Simple randomization was used to randomly allocate participants into the treatment and control groups in a 1:1 ratio using a central randomization system. Each participant had an equal chance of being assigned to either group. In the 1:1 ratio, the central system ensured that the number of participants in the treatment group and the control group was equal. A total of 30 participants were randomly assigned to the treatment group, and 30 participants were assigned to 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:

公开/Public

盲法：

对参与者，治疗实施者，结果评估者设盲。

Blinding：

Blind participants, treatment implementers, and outcome assessors.

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）：

公开方式：网路；公开时间：试验完成后6个月公开

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

Public method: Online; Public release time: 6 months after the completion of the experiment

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：

主要使用病例记录表进行采集和管理

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

Case Record Form, CRF

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：

  2025-04-29 10:32:05