ChiCTR2500115318 版本V1.0 版本创建时间2025/12/24 16:47:24 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：

 ChiCTR2500115318 

最近更新日期：

Date of Last Refreshed on：

 2025-12-24 16:47:18 

注册时间：

Date of Registration：

 2025-12-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

桥式运动联合Draw-in技术训练对脑卒中患者步行稳定性的改善研究

Public title：

A Study on the Improvement of Gait Stability through Combined Bridge-Type Exercise and abdominal drawing-in maneuver in Stroke Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

桥式运动联合Draw-in技术训练对脑卒中患者步行稳定性的改善研究

Scientific title：

A Study on the Improvement of Gait Stability through Combined Bridge-Type Exercise and abdominal drawing-in maneuver 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：

苏剑清 

研究负责人：

苏剑清 

Applicant：

Su Jianqing 

Study leader：

Su Jianqing 

申请注册联系人电话：

Applicant telephone：

 +86 153 2008 1763

研究负责人电话：

Study leader's
telephone：

+86 21 6618 1108

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：

 Sjq19930815@163.com

研究负责人电子邮件：

Study leader's E-mail：

 Sjq19930815@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：

上海市宝山区长江路860弄25号

研究负责人通讯地址：

长江路860弄25号

Applicant address：

NA. 25 Lane 860, Changjiang Road, Baoshan District, Shanghai

Study leader's address：

No.25, Lane 860, Changjiang Road

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海市第二康复医院

Applicant's institution：

the Second Rehabilitation Hospital of Shanghai

研究负责人所在单位：

上海市第二康复医院

Affiliation of the Leader：

Shanghai Second Rehabilitation Hospital

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：

 2025-24-01

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：

上海市第二康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Second Rehabilitation Hospital Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-20 00:00:00

伦理委员会联系人：

陈叶萍

Contact Name of the ethic committee：

Yeping Chen

伦理委员会联系地址：

长江路860弄25号

Contact Address of the ethic committee：

No.25, Lane 860, Changjiang Road

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6618 1108

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 2211497824@qq.com

研究实施负责（组长）单位：

上海市第二康复医院

Primary sponsor：

Shanghai Second Rehabilitation Hospital

研究实施负责（组长）单位地址：

长江路860弄25号

Primary sponsor's address：

No.25, Lane 860, Changjiang Road

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)：

上海市第二康复医院

具体地址：

长江路860弄25号

Institution
hospital：

Shanghai Second Rehabilitation Hospital

Address：

No.25, Lane 860, Changjiang Road

经费或物资来源：

宝山区卫生健康委优青（育才）计划

Source(s) of funding：

Baoshan District Health Commission ExcellentYouth (Yucai) Program

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：

通过观察桥式运动联合ADIM训练对脑卒中患者立位平衡及步行稳定性的影响，明确桥式运动联合ADIM训练对脑卒中患者步行稳定性的治疗作用，并探索其对患者步行信息及日常生活活动能力的影响及可能的作用机制，为其在脑卒中康复治疗中的应用提供理论和实践基础。  

Objectives of Study：

This study investigates the effects of combined bridge exercise and ADIM training on standing balance and gait stability in stroke patients. It aims to clarify the therapeutic role of this combined approach in enhancing gait stability, while exploring its impact on patients' gait information and activities of daily living capabilities, along with potential underlying mechanisms. The findings will provide a theoretical and practical foundation for its application in stroke rehabilitation therapy.

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.年龄55-75岁；
2.首次脑出血或者脑梗死并经头颅 CT 或 MRI 检查证实；
3.Holden 步行功能分级（FAC）I 级以上且 Brunnstrom 下肢分级Ⅲ级以上；
4.患者下肢肌力≥3级；
5.生命体征稳定，血压控制在正常范围内，心功能良好者；
6.意识清醒，愿配合康复治疗者（MMSE评分≥24分）；
7.自愿参加本研究并签署知情同意书；
8.患者病程在2周至1年以内。

Inclusion criteria

1.Aged 55–75 years; 2.First-time cerebral haemorrhage or cerebral infarction confirmed by cranial CT or MRI scan; 3.Holden Functional Ambulation Classification (FAC) Grade I or above and Brunnstrom Lower Limb Classification Grade III or above; 4.Lower limb muscle strength >= Grade 3; 5.Stable vital signs, blood pressure within normal range, and good cardiac function; 6.Alert consciousness and willingness to cooperate with rehabilitation therapy (MMSE score >= 24); 7.Voluntary participation in this study and signing of informed consent; 8.Disease duration within 2 weeks to 1 year.

排除标准：

1.严重内脏器官疾病等；
2.伴有严重认知与言语功能障碍或不能配合；
3.经过专门体育训练者；
4.伴有帕金森、脊髓损伤等影响躯干稳定性疾病。

Exclusion criteria：

1.Severe internal organ diseases, etc.;
2.Those with severe cognitive and speech impairments or inability to cooperate;
3.Individuals who have undergone specialised athletic training;
4.Those with conditions affecting trunk stability, such as Parkinson's disease or spinal cord injury.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2027-10-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 45

Group：

Study group

Sample size：

干预措施：

常规康复训练联合桥式运动+ADIM

干预措施代码：

Intervention：

Conventional rehabilitation training combined with bridge exercises and ADIM

Intervention code：

组别：

对照组

样本量：

 45

Group：

control group

Sample size：

干预措施：

常规康复训练

干预措施代码：

Intervention：

Conventional training

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)：

 上海市第二康复医院 

单位级别：

 二级乙等 

Institution
hospital：

Shanghai Second Rehabilitation Hospital

Level of the institution：

Secondary B

测量指标：

Outcomes：

指标中文名：

Tinetti平衡与步态量表

指标类型：

次要指标

Outcome：

Tinetti Performance Oriented Mobility Assessment

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

包括平衡评估和步态评估2部分，得分越高，表示平衡及步行能力越好。

Measure time point of outcome：

Incorporation within one week

Measure method：

Comprising two sections: balance assessment and gait assessment. A higher score indicates better balance and walking ability.

指标中文名：

威斯康星步态量表

指标类型：

次要指标

Outcome：

Wisconsin Gait Scale

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

通过检查负重关节和步态各阶段的重心改变来识别偏瘫步态的偏差。

Measure time point of outcome：

Incorporation within one week

Measure method：

Identify deviations in the gait of hemiplegic individuals by examining changes in the centre of gravity during weight-bearing joints and across the various phases of gait.

指标中文名：

稳定极限测试

指标类型：

次要指标

Outcome：

Limits of stability

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

LOS是对自主运动系统的评估，用于检测人体向各个方向移动重心COG的最大距离，主要显示移动反应时间、移动速度、移动距离和移动方向控制等数据。测试方法是患者听到开始指令后，迅速直腿控制重心向前、后、左、右4个方向移动，膝盖不能弯曲，每个方向保持10s。

Measure time point of outcome：

Incorporation within one week

Measure method：

LOS is an assessment of the autonomous motor system designed to measure the maximum distance the body's centre of gravity (COG) can be shifted in all directions. It primarily records data on movement reaction time, movement speed, movement distance, and directional control. The test procedure requires the patient, upon hearing the start command, to swiftly shift their centre of gravity in four directions—forward, backward, left, and right—while maintaining a straight leg position without bending

指标中文名：

10米最大步行速度测试

指标类型：

次要指标

Outcome：

10-meter maximum walking test

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

准备10m长的步行通道，保证患者安全前提下，让患者以其自身能完成的平常速度和最快速度从直线起始段走向终末端，分别记录患者经过 2m 的点和 8m 的点所需要的时间，共测试3次，取测试平均值纳入分析。

Measure time point of outcome：

Incorporation within one week

Measure method：

Prepare a 10-metre-long walking corridor. Under conditions ensuring patient safety, have the patient walk from the starting point to the end of the straight section at both their usual pace and their maximum achievable speed. Record the time taken to reach the 2-metre mark and the 8-metre mark. Conduct three trials in total, taking the average of the three test times for analysis.

指标中文名：

脑卒中姿势评定量表

指标类型：

次要指标

Outcome：

Postural Assessment Scale for Stroke Patients

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

用于评估脑卒中患者卧位、坐位和站立位的平衡。该量表由12项评估内容组成,每项分为4个等级,最高为3分,最低为0分,共36分。分数越高,表示平衡功能越好。

Measure time point of outcome：

Incorporation within one week

Measure method：

Used to assess balance in supine, sitting, and standing positions among stroke patients. This scale comprises 12 assessment items, each rated on a 4-point scale ranging from 0 to 3 points, yielding a maximum total score of 36 points. Higher scores indicate better balance function.

指标中文名：

均方根

指标类型：

次要指标

Outcome：

Root Mean Square

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

测试前，选取专用的砂片对电极所贴位置进行皮肤表面的打磨，并用医用酒精棉球擦拭皮肤。将电极片分别贴放于双侧腹横肌和双侧多裂肌。测试患者从坐到站、健侧迈步、患侧迈步共3个动作。每个动作间隔休息2分钟，最终取其平均值分析。

Measure time point of outcome：

Incorporation within one week

Measure method：

Prior to testing, the skin surface at the electrode application sites was abraded using specialised abrasive pads, followed by cleansing with medical alcohol swabs. Electrode pads were then affixed to the bilateral transverse abdominis muscles and bilateral multifidus muscles. The patient performed three movements: rising from a seated to a standing position, stepping with the unaffected side, and stepping with the affected side. A two-minute rest interval was observed between each movement, wit

指标中文名：

中值频率

指标类型：

次要指标

Outcome：

Median Frequency

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

测试前，选取专用的砂片对电极所贴位置进行皮肤表面的打磨，并用医用酒精棉球擦拭皮肤。将电极片分别贴放于双侧腹横肌和双侧多裂肌。测试患者从坐到站、健侧迈步、患侧迈步共3个动作。每个动作间隔休息2分钟，最终取其平均值分析。

Measure time point of outcome：

Incorporation within one week

Measure method：

Prior to testing, the skin surface at the electrode application sites was abraded using specialised abrasive pads, followed by cleansing with medical alcohol swabs. Electrode pads were then affixed to the bilateral transverse abdominis muscles and bilateral multifidus muscles. The patient performed three movements: rising from a seated to a standing position, stepping with the unaffected side, and stepping with the affected side. A two-minute rest interval was observed between each movement, wit

指标中文名：

功能性步态评估表

指标类型：

次要指标

Outcome：

Functional Gait Assessment

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

通过测量行走相关任务中的平衡,反映了时空步态参数和患者独立生活的能力。

Measure time point of outcome：

Incorporation within one week

Measure method：

By measuring balance during gait-related tasks, this reflects spatio-temporal gait parameters and the patient's capacity for independent living.

指标中文名：

活动平衡信心量表

指标类型：

次要指标

Outcome：

Activities-Specific Balance Confidence Scale

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

活动平衡信心量表评估平衡信心，是一份患者自评量表，16个不同的场景和动作，患者对自身在环境中保持平衡的信心。得分为0%表示不自信，而得分为100%表示完全自信。将16个项目的得分相加，然后除以16，计算出平均分。平均分＜67%提示有较高的跌倒风险。

Measure time point of outcome：

Incorporation within one week

Measure method：

The Activity Balance Confidence Scale assesses balance confidence and is a patient self-report questionnaire comprising 16 distinct scenarios and activities. Patients rate their confidence in maintaining balance within these environments. A score of 0% indicates no confidence, while 100% denotes complete confidence. The scores for all 16 items are summed and then divided by 16 to calculate the average score. An average score <67% indicates a higher risk of falling.

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：

纳入一周内

测量方法：

具体包括从坐位站起、独立站立、独立坐、由站到坐、床椅转移、闭眼站立、双足并拢站、站立位上肢前伸、站立位从地上拾起物、转身向后看、转身一周、双足交替踏、双足前后站、单腿站立14个项目，每条得分为0~4分，满分为56分，得分越高表明平衡功能越好。

Measure time point of outcome：

Incorporation within one week

Measure method：

Specifically, this includes 14 items: rising from a seated position, independent standing, independent sitting, transitioning from standing to sitting, transferring between bed and chair, standing with eyes closed, standing with feet together, reaching forward with arms while standing, picking up objects from the ground while standing, turning to look behind, turning around completely, alternating foot steps, standing with feet apart, and standing on one leg. Each item is scored from 0 to 4 poin

指标中文名：

由坐到站起测试

指标类型：

次要指标

Outcome：

Sit-To-Stand Test

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

用于量化患者在指令下从坐姿快速上升到站姿的能力。STS量化了将重量从臀部转移到脚所需的时间（重量转移时间）、左右腿之间上升力的对称性（重量对称性）以及站立姿势的重心摆动速度。

Measure time point of outcome：

Incorporation within one week

Measure method：

Used to quantify a patient's ability to rapidly rise from a seated to a standing position under instruction. The STS measures the time required to transfer weight from the hips to the feet (weight transfer time), the symmetry of lifting force between the left and right legs (weight symmetry), and the speed of centre of gravity oscillation during the standing posture.

指标中文名：

计时起立行走测试

指标类型：

主要指标

Outcome：

timed up and go test

Type：

Primary indicator

测量时间点：

纳入一周内

测量方法：

要求受试者从椅子上站起来,快速走3m后转身回到椅子旁边,然后再次坐下,记录完成测试所需的时间。受试者可借助拐杖或其他助行器行走。

Measure time point of outcome：

Incorporation within one week

Measure method：

Subjects were required to rise from a chair, walk briskly for 3 metres, turn around and return to the chair, then sit down again. The time taken to complete the test was recorded. Subjects were permitted to use a walking stick or other walking aid.

指标中文名：

日常生活活动

指标类型：

次要指标

Outcome：

Activity of Daily Living

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

使用Barthel 指数评定法检测患者独立生活活动的能力或需要照顾的程度。

Measure time point of outcome：

Incorporation within one week

Measure method：

The Barthel Index assessment method is employed to evaluate a patient's capacity for independent activities of daily living or the degree of care required.

指标中文名：

重心移动节律性测试

指标类型：

次要指标

Outcome：

Rhythmic Weight-Transfer Test

Type：

Secondary indicator

测量时间点：

纳入一周内

测量方法：

RWS用于检测人体重心COG移动节律控制能力水平，分为前后和左右两个维度的重心COG移动节律检测，节律变化速度有3种：慢速、中速和快速。当患者听到指令后要根据屏幕的提示速度进行左右和前后的移动。

Measure time point of outcome：

Incorporation within one week

Measure method：

RWS is employed to assess an individual's level of control over the rhythmic movement of their centre of gravity (COG), examining COG movement rhythms across both anterior-posterior and lateral dimensions. Three rhythmic speed variations are utilised: slow, medium, and fast. Upon receiving instructions, the patient must move laterally and anterior-posteriorly in accordance with the speed prompts displayed on the screen.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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 55 岁 years
最大 Max age 75 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）：

采用电脑产生的随机数字表以 1：1 的比例将受试者随机分为对照组和试验组。

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

Using computer-generated random numbers, the subjects were randomly divided into control group and intervention group at 1:1.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

研究结果发表后于期刊公开

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

The results were published in journals

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：

所有信息应如实、准确、及时地记录在病例报告表(CRF)中。在实验过程中，将要求专人对相关数据进行管理，参与者的个人信息将严格保密。所有数据都将使用参与者编号进行识别，这些编号不会直接显示参与者的个人信息。没有研究人员的明确许可，数据不会被共享。试验结束时，研究参与者应及时提交CRF，并按要求提交测试总结。研究中心将指定一名监督员检查CRF的完整性和准确性。

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

All information shall be recorded truthfully, accurately and promptly on the Case Report Form (CRF). During the trial, designated personnel will be responsible for managing relevant data, and participants' personal information will be kept strictly confidential. All data shall be identified using participant codes, which shall not directly reveal participants' personal information. Data shall not be shared without explicit permission from the research team. Upon trial completion, the research team shall promptly submit the CRF and provide a test summary as required. The research centre shall designate a supervisor to verify the completeness and accuracy of the CRF.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-24 16:47:18