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基于协同护理模式的老年脑卒中运动功能障碍分级康复方案的构建及验证
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注册号：

Registration number：

 ChiCTR2500098327 

最近更新日期：

Date of Last Refreshed on：

 2025-03-06 09:11:50 

注册时间：

Date of Registration：

 2025-03-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于协同护理模式的老年脑卒中运动功能障碍分级康复方案的构建及验证

Public title：

Construction and validation of a graded rehabilitation program for geriatric stroke motor dysfunction based on collaborative nursing model

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于协同护理模式的老年脑卒中运动功能障碍分级康复方案的构建及验证

Scientific title：

Construction and validation of a graded rehabilitation program for geriatric stroke motor dysfunction based on collaborative nursing model

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：

朱涵菲 

研究负责人：

李艳 

Applicant：

Zhu Hanfei 

Study leader：

Li Yan 

申请注册联系人电话：

Applicant telephone：

 +86 158 6162 9365

研究负责人电话：

Study leader's
telephone：

+86 181 2122 6551

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：

 1093532334@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1093532334@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：

上海市哈密路419号

研究负责人通讯地址：

上海市哈密路419号

Applicant address：

419 Hami Road, Shanghai, China

Study leader's address：

419 Hami Road, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

 200124

研究负责人邮政编码：

Study leader's postcode：

 200336

申请人所在单位：

江南大学无锡医学院

Applicant's institution：

Wuxi Medical College, Jiangnan University

研究负责人所在单位：

上海交通大学医学院附属同仁医院

Affiliation of the Leader：

Tongren Hospital, Shanghai Jiao Tong University School of 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：

 同仁伦审2025-007-01

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：

上海市同仁医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Tongren Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-10 00:00:00

伦理委员会联系人：

李榕

Contact Name of the ethic committee：

Li Rong

伦理委员会联系地址：

上海市哈密路419号

Contact Address of the ethic committee：

419 Hami Road, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 181 2122 6551

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ly3523@shtrhospital.com

研究实施负责（组长）单位：

上海交通大学医学院附属同仁医院

Primary sponsor：

Tongren Hospital, Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市哈密路419号

Primary sponsor's address：

419 Hami Road, 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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属同仁医院

具体地址：

上海市哈密路419号

Institution
hospital：

Tongren Hospital, Shanghai Jiao Tong University School of Medicine

Address：

419 Hami Road, Shanghai, China

经费或物资来源：

上海交通大学医学院附属同仁医院

Source(s) of funding：

Tongren Hospital, Shanghai Jiao Tong University School of Medicine

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1、医护与家属协同合作为患者制定个性化的康复方案； 2、验证该方案对提高患者运动功能和生活质量的效果； 3、应用协同理论明确专业分工，优化医疗资源的利用； 4、促进患者的整体康复，预防并发症，提高患者预后。  

Objectives of Study：

1. Medical staff and family members work together to develop personalized rehabilitation plans for patients; 2. To verify the effect of the program on improving the motor function and quality of life of patients; 3. Apply the synergy theory to clarify the professional division of labor and optimize the utilization of medical resources; 4. Promote the overall recovery of patients, prevent complications, and improve the prognosis of patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

①精神疾病史； ②其他疾病导致的偏瘫，如脊髓损伤等。

Exclusion criteria：

(1) History of psychiatric illness; (2) Hemiplegia caused by other diseases, such as spinal cord injury.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-03-06 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 30

Group：

Treatment group

Sample size：

干预措施：

1评估：课题小组基于协同护理模式对患者进行体格检查，评估患者个人基本情况、通过MOCA评分确定患者认知情况、通过Brunnstrom分期确定运动功能情况、通过Berg评分确定患者平衡功能、通过BI指数确定日常生活活动能力和采用SAS和SDS评分表确定心理状况，统计各维度得分并根据Brunnstrom分期结果进行康复。 2计划：根据评估结果医生、治疗师、护士与患者及家属协同制定患者个性化的康复目标和计划，Brunnstrom3期患者进行主动结合被动运动的康复，以主动训练为主；4期患者以主动运动为主，5期患者以主动运动结合精细运动训练为主，同时增加生活自理能力的训练。 3宣教：向患者及家属发放自制《老年脑卒中偏瘫患者运动康复健康教育手册》，对患者及家属进行入院宣教，根据患者的当前康复情况与医生、治疗师、家属共同制定每日照顾清单，确定患者的护理等级、饮食原则并让家属协同参与患者的康复管理，起到督促的作用并陪同患者进行康复锻炼。发放患者院内打卡表，由家属记录每日康复训练内容。指导不同分期患者学习不同强度的八段锦。 4院内训练：在院2周患者通过医生制定的康复训练计划完成每日康复训练内容，家属进行监督陪同，护士进行记录打卡，Brunnstrom3期患者以被动结合主动的关节活动度训练、体位转移训练、站立训练、静态平衡训练以及坐式八段锦为主，进行翻身起床等日常生活能力训练；Brunnstrom4期患者以主动运动为主，在3 期运动内容基础上加入行走训练、抗阻训练和肌力训练，坐式八段锦改为站立式八段锦，日常生活能力训练加大难度，可进行穿脱衣训练等；Brunnstrom5期患者以主动运动结合精细运动为主，在4期运动内容基础上加入更精细的日常生活能力的训练，包括上下楼梯、折纸等，加大抗阻训练的阻力，行走训练增加灵活性，加入障碍物锻炼患者绕行和跨步。 5院外训练：出院前对患者再次进行评估，对患者及家属进行宣教，根据患者情况选择不同的居家康复方案，家属进行居家监督打卡，护士通过微信与家属联系，对患者每日康复情况进行监督；患者出院后若转入社区医院或康复中心，则延续院内康复计划继续进行，与社区医护人员进行交接，每周随访。 6评价：在方案实施6周后通过随访再次评估患者的肢体运动功能、平衡功能、日常生活能力及心理健康状况，与入院时进行对比，了解患者的身体功能改善情况。

干预措施代码：

Intervention：

1. Evaluation: The research team conducted a physical examination of the patient based on the collaborative care model, assessed the patient's basic personal condition, determined the patient's cognitive status through the MOCA score, determined the motor function through the Brunnstrom stage, determined the patient's balance function through the Berg score, determined the ability of daily living activities and the psychological status using the SAS and SDS score sheets through the BI index, counted the scores of each dimension and carried out rehabilitation according to the results of the Brunnstrom stage. 2. Plan: According to the evaluation results, doctors, therapists, nurses, patients and their families work together to formulate personalized rehabilitation goals and plans for patients, and patients in Brunnstrom stage 3 undergo rehabilitation with active combined with passive exercise, mainly active training; Stage 4 patients mainly had active exercise, and stage 5 patients mainly had active exercise combined with fine motor training, and at the same time increased the training of self-care ability. 3. Publicity: Distribute the self-made "Sports Rehabilitation Health Education Manual for Elderly Stroke and Hemiplegia Patients" to patients and their families, carry out admission education for patients and their families, formulate a daily care list with doctors, therapists and family members according to the current rehabilitation situation of patients, determine the patient's nursing level and dietary principles, and let family members participate in the rehabilitation management of patients, play a role in supervising and accompanying patients for rehabilitation exercises. Distribute in-hospital punch sheets to patients, and family members record the content of daily rehabilitation training. Instruct patients at different stages to learn Baduanjin of different intensities. 4. In-hospital training: After 2 weeks in the hospital, patients complete the daily rehabilitation training content through the rehabilitation training plan formulated by the doctor, and the family members supervise and accompany them, and the nurses record and punch in, and the patients in Brunnstrom stage 3 mainly carry out daily life ability training such as turning over and getting up with passive combined with active joint range of motion training, body position transfer training, standing training, static balance training and sitting Baduanjin; Patients with stage 4 Brunnstrom mainly took active exercise, and on the basis of stage 3 exercise content, walking training, resistance training and muscle strength training were added, and the seated Baduanjin was changed to the standing Baduanjin, and the daily living ability training was more difficult, and dressing and undressing training could be carried out. Patients with stage 5 Brunnstrom mainly combined with active movement combined with fine motor skills, and on the basis of stage 4 motor content, more refined training of daily living ability, including going up and down stairs, origami, etc., increased resistance training, walking training increased flexibility, and obstacles were added to exercise patients to bypass and stride. 5. Out-of-hospital training: before discharge, the patient is re-evaluated, the patient and his family are educated, different home rehabilitation programs are selected according to the patient's condition, the family members are supervised and clocked in at home, and the nurse contacts the family through WeChat to supervise the patient's daily recovery; If the patient is transferred to a community hospital or rehabilitation center after discharge, the in-hospital rehabilitation program will be continued, and the handover with the community medical staff will be followed up weekly. 6. Evaluation: After 6 weeks of program implementation, the patient's limb motor function, balance function, daily living ability and mental health status were re-evaluated through follow-up, and compared with the time of admission to understand the improvement of the patient's physical function.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control group

Sample size：

干预措施：

开展常规康复训练指导，包括物理治疗、物理因子治疗、作业治疗等。30min/次，2次/天，每周训练5天，持续14天，同时进行重复经颅磁刺激治疗，每周训练5天，持续14天。护士为患者提供疾病相关知识及康复要点等方面的宣教，指导患者健康饮食、合理用药、规律作息，遵医嘱对患者的康复活动进行健康指导，但通常不单独强调每位患者活动锻炼的具体时间与频率。出院后每月进行一次电话随访。

干预措施代码：

Intervention：

Carry out routine rehabilitation training guidance, including physical therapy, physical factor therapy, occupational therapy, etc. 30min/time, 2 times/day, 5 days a week for 14 days, while repeated transcranial magnetic stimulation therapy was performed, 5 days a week for 14 days. Nurses provide patients with education on disease-related knowledge and key points of rehabilitation, guide patients to eat healthily, use drugs rationally, work and rest regularly, and provide health guidance to patients on rehabilitation activities according to the doctor's instructions, but usually do not emphasize the specific time and frequency of each patient's activities and exercises. Follow-up phone calls are conducted once a month after discharge.

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 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海交通大学医学院附属同仁医院 

单位级别：

 三级 

Institution
hospital：

Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer运动功能评定量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Berg平衡量表

指标类型：

次要指标

Outcome：

Berg Balance Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑/抑郁自评量表

指标类型：

次要指标

Outcome：

Self-Rating Anxiety /Self-rating depression scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

Modified Barthel index

Type：

Secondary 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

 使用后保存  

说明

Fate of sample：

Preservation 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 60 岁 years
最大 Max age 120 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）：

由研究者采用抽签法随机抽取入组患者

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

Patients were randomly selected by the investigator using the lottery method

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：

对干预组和对照组患者实施单盲

Blinding：

Single-blinding was administered to patients in the intervention and control groups

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：

病例记录表和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：

CRF and 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：

  2025-03-06 09:11:41
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