The Clinical Efficacy and Neural Correlates on Acupuncture for Lower Extremity Motor Rehabilitation of Post Ischemic Stroke: A Three-Armed Multi-Central Randomized Controlled Trial

注册号:

Registration number:

ITMCTR2000003923

最近更新日期:

Date of Last Refreshed on:

2020-09-11

注册时间:

Date of Registration:

2020-09-11

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺对缺血性卒中后下肢运动功能康复的疗效评价及脑神经关联机制研究

Public title:

The Clinical Efficacy and Neural Correlates on Acupuncture for Lower Extremity Motor Rehabilitation of Post Ischemic Stroke: A Three-Armed Multi-Central Randomized Controlled Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺对缺血性卒中后下肢运动功能康复的疗效评价及脑神经关联机制研究

Scientific title:

The Clinical Efficacy and Neural Correlates on Acupuncture for Lower Extremity Motor Rehabilitation of Post Ischemic Stroke: A Three-Armed Multi-Central Randomized Controlled Trial

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

2018YFE0181700

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:

ChiCTR2000038142 ; ChiMCTR2000003923

申请注册联系人:

鲁海

研究负责人:

张春红

Applicant:

Hai Lu

Study leader:

Chunhong Zhang

申请注册联系人电话:

Applicant telephone:

+86 13821663325

研究负责人电话:

Study leader's telephone:

+86 13821537799

申请注册联系人传真 :

Applicant Fax:

+86 22-27432083

研究负责人传真:

Study leader's fax:

+86 22-27432083

申请注册联系人电子邮件:

Applicant E-mail:

13821663325@163.com

研究负责人电子邮件:

Study leader's E-mail:

drzch1113@tjutcm.edu.cn

申请单位网址(自愿提供):

Study leader's 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:

天津市南开区鞍山西道314号

研究负责人通讯地址:

天津市南开区鞍山西道314号

Applicant address:

314 Anshan Road West, Nankai District, Tianjin, China

Study leader's address:

314 Anshan Road West, Nankai District, Tianjin, China

申请注册联系人邮政编码:

Applicant postcode:

300193

研究负责人邮政编码:

Study leader's postcode:

300193

申请人所在单位:

天津中医药大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2020[K]字048

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

天津中医药大学第一附属医院医学伦理委员会

Name of the ethic committee:

IRB of the First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/9/1 0:00:00

伦理委员会联系人:

贾景蕴

Contact Name of the ethic committee:

Jingyun Jia

伦理委员会联系地址:

天津市西青区昌凌路88号(南院区)

Contact Address of the ethic committee:

88 Changling Road, Liqizhuang Street, Xiqing District, Tianjin, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

天津中医药大学第一附属医院

Primary sponsor:

First Teaching Hospital of The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

研究实施负责(组长)单位地址:

天津市西青区昌凌路88号(南院区)

Primary sponsor's address:

South Hospital District, 88 Changling Road, Liqizhuang Street, Xiqing District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

西青区昌凌路88号(南院区)

Institution
hospital:

The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

Address:

South Hospital District, 88 Changling Road, Liqizhuang Street, Xiqing District

经费或物资来源:

国家重点研发计划项目

Source(s) of funding:

National Key Research and Development Program

研究疾病:

缺血性卒中

研究疾病代码:

8B11.3

Target disease:

Ischemic stroke

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

评价“醒脑开窍”针刺法治疗缺血性卒中急性期下肢运动功能障碍的有效性和安全性。 揭示针刺改善缺血性卒中急性期下肢运动功能障碍与脑神经重组的潜在关联性。

Objectives of Study:

1. To evaluate the efficacy and safety of Xingnao Kaiqiao (XNKQ) acupuncture for the rehabilitation of lower extremity motor dysfunction of acute ischemic stroke. 2. To explore the underlying correlates between the recovery of neurological function and the improvement of lower extremity motor dysfunction by acupuncture for acute ischemic stroke.

药物成份或治疗方案详述:

1.试验组(“醒脑开窍”针刺法) (1)“醒脑开窍”针刺法 选穴:内关穴双侧(PC6)、水沟穴(GV26)、三阴交穴患侧(SP6)、阳陵泉穴患侧(GB34)、委中穴患侧(BL40)、丘墟穴患侧(GB40)。 方法:受试者取仰卧位,75%酒精行皮肤消毒,采用一次性针灸针(华佗牌,苏州医疗用品厂有限公司,规格:0.25mm×40mm)。内关穴:直刺0.5~1.0寸(13mm~25mm),针刺得气后施提插捻转结合泻法,双侧同时操作,施手法1min;人中穴:向鼻中隔方向斜刺0.3~0.5寸(8mm~13mm),针刺得气后施重雀啄法,至受试者眼球湿润或流泪为度;三阴交穴:沿胫骨内侧缘与皮肤呈45o角斜刺,进针1.0~1.5寸(25mm~40mm),针刺得气后施提插补法,使患侧下肢抽动3次为度;阳陵泉穴:直刺1.0~1.5寸(25mm~40mm),针刺得气后施提插补法,施手法1min;委中穴:仰卧直腿抬高取穴,直刺1.0~1.5寸(25mm~40mm),施提插泻法,使患侧下肢抽动3次为度;丘墟穴:向照海穴方向直刺0.5~0.8寸(13mm~20mm),针刺得气后施提插补法,施手法1min。除人中穴、委中穴不留针,余穴留针30min;阳陵泉穴、丘墟穴针刺施术后连接SDZ-Ⅱ电子针疗仪(华佗牌,苏州医疗用品厂有限公司,DZ-6x),疏密波(频率5~10HZ),电流(2±1)mA,强度以患者能耐受为度,留针30min。 2.对照1组(“醒脑开窍”针刺法+PT) (1)“醒脑开窍”针刺法:同上。 (2)PT康复:根据患者的功能能力调整活动,主要集中于下肢康复。急性期主要有良肢位摆放和偏瘫侧肢体的被动运动;恢复期适度增加主动—助力运动以及主动运动,床上运动训练,并指导站立及步行训练。PT方案在针刺后立即应用30min。 3.对照2组(假针刺+PT) 选穴:选取上述腧穴的非经非穴,人中穴于原穴水平方向旁开0.2寸(≈5mm),其他腧穴均于原穴水平方向旁开0.4寸(≈10mm)处。 方法:内关穴非经非穴、水沟穴非经非穴、三阴交穴非经非穴、阳陵泉穴非经非穴、委中穴非经非穴、丘墟穴非经非穴,均浅刺0.2~0.3寸(5mm~8mm),无得气感,施平补平泻手法1min。水沟穴非经非穴、委中穴非经非穴不留针,余穴非经非穴留针30min,阳陵泉穴非经非穴与丘墟穴非经非穴连接上述电针仪,无电流输出,留针30min。 4.脑卒中基础治疗 (1)二级预防:抗血小板、抗凝、控压、调脂、降糖等。 (2)预防压疮、肺炎等并发症。 (3)营养支持。

Description for medicine or protocol of treatment in detail:

1. Experimental group (XNKQ acupuncture) (1) XNKQ acupuncture Acupoints: bilateral PC6, GV26, affected side SP6, affected side GB34, affected side BL40, affected side GB40. Acupuncture Manipulation: With the participants in the supine position, and after skin disinfection by 75% alcohol cotton ball, using Hwato brand disposable acupuncture needles (size 0.25 × 40mm, produced by Suzhou Medical Supplies Factory Co., Ltd., Suzhou, China). PC6: acupuncture needles were inserted approximately 0.5 to 1.0 B-cun (13mm-25mm) into the skin perpendicularly, applying combinative manipulation (lifting-thrusting and twirling-rotating) with reducing method bilaterally for 1 min. GV26: Oblique insert upwards to the nasal septum for 0.3-0.5 B-cun (8mm-13mm) with heavy bird-pecking method until the patient's eyeballs have moistened or tears flow. SP6: Oblique insert the point edged the posterior tibia by 45° with skin for 1.0-1.5 B-cun (25mm-40mm), and apply tonifying method of lifting-thrusting till the affected side lower limb has jerked 3 times. GB34: acupuncture needles were inserted perpendicularly into the skin approximately 1.0-1.5 B-cun (25mm-40mm), applying tonifying method of lifting-thrusting for 1minutes. BL40: Perpendicular insert with the affected side lower limb straight raised for 45°, and apply reducing method of lifting-thrusting till the lower limb has jerked 3 times. GB40: acupuncture needles were inserted perpendicularly into the skin approximately 0.5-0.8 B-cun (13mm-20mm) towards KI6, applying tonifying method of lifting-thrusting for 1minutes. Following needle insertion, small, equal manipulations of twirling, lifting, and thrusting were performed on needles to reach de qi (a composite of sensations including soreness, numbness, distention, heaviness, and other sensations). Each acupoints retained needles lasting for 30 minutes besides GV26 and BL40. Paired electrodes from the SDZ-Ⅱ electroacupuncture apparatuses (Hwato brand, Suzhou Medical Supplies Factory Co., Ltd., Suzhou, China, DZ-6x) were attached transversely to the needle handles at affected side GB34 and GB40 after manipulation. The electroacupuncture stimulation lasted for 30 minutes with a dilatational wave of 5 to 10 Hz and a current intensity of 1 to 3 mA (preferably with the skin around the acupoints shivering mildly without pain). 2. Control group 1(XNKQ acupuncture + PT) (1) XNKQ acupuncture: As above. (2) Physical Therapy: Focusing on the lower limb rehabilitation, adjusted flexibly according to patients motor function. Acute stage: Good limb position put and passive motion in affected side limb. Recovery stage: adding active motion, exercise training, standing training and walking training on the bed by degrees, under the guidance of therapist. PT was performed for 30min after acupuncture immediately. 3. Control group 2 (sham acupuncture + PT) Acupoints: Sham acupoint nearby the above acupoints: The sham PC6, SP6, BL40, GB34 and GB40 points were 0.4 B-cun (≈10 mm) lateral to PC6, SP6, BL40, GB34, and GB40 points, and the sham GV26 point was 0.2 B-cun (≈5 mm) horizontal to GV26. Acupuncture Manipulation: The sham PC6, SP6, BL40, GB34 and GB40 were shallow needle insertion, approximately 0.2 to 0.3 B-cun (5mm-8mm), with mild reinforcing-reducing method at above sham acupoints for 1 min without de qi. Each sham acupoints retained needles lasting for 30 minutes besides sham GV26 and sham BL40. GB34 and GB40 were attached to the above electroacupuncture apparatuses with no electricity output for 30min. 4. basic treatments for stroke (1) Secondary prevention: antiplatelet, anticoagulation, blood pressure regulation, lipid-lowering, glucose-lowering, etc. (2) Complication prevetion: pressure ulcers and pneumonia, etc. (3) Nutritional support.

纳入标准:

(1)符合缺血性脑卒中的诊断标准,且为首次发作; (2)卒中发作后后2~14天,生命体征平稳(格拉斯哥昏迷量表(GCS)评分>8分); (3)基底节区(内囊)和(或)放射冠梗死灶(直径>1.5cm),伴下肢运动功能障碍(肌力≤3级),可合并上肢运动功能障碍(NIHSS 为 3~15分); (4)40~70 岁; (5)右利手; (6)知情同意并签署知情同意书者。

Inclusion criteria

1. Patients who meet the diagnostic criteria of ischemic stroke, and it is the first attack; 2. Patients with stable vital signs 2-14 days after stroke onset (GCS score > 8); 3. Basal ganglia (internal capsule) and (or) corona radiata infarction (diameter > 1.5cm), accompanied by lower extremity motor dysfunction (muscle strength <= 3), can be combined with upper limb motor dysfunction (NIHSS score 3-15); 4. Patients aged 40-70 years; 5. Right handed patients; 6. Patients who have informed consent and signed informed consent.

排除标准:

(1)本次卒中前已日常活动依赖; (2)已接受溶栓或取栓治疗的卒中患者; (3)针刺部位感染和(或)不能耐受针刺治疗; (4)患有其他严重的伴发疾病(失语症、下肢中-重度水肿、下肢静脉血栓形成、下肢动脉硬化闭塞、糖尿病下肢血管病变、周围神经病、脊髓病变、脑外伤、颅内感染、脑肿瘤等)、继发疾病(如心、肝、肾功能衰竭等); (5)存在MRI检查禁忌症(幽闭恐怖症,手术植入金属装置等); (6)简短精神状态量表(MMSE)得分:文盲<17 分,小学<20 分,中学以上<24 分;汉密尔顿抑郁量表(HAMD-17)得分>17 分;汉密尔顿焦虑量表(HAMA)得分≥14分。

Exclusion criteria:

1. The subjects who had been dependent on daily activities before the stroke; 2. Stroke patients who have received thrombolysis or thrombectomy treatment; 3. Infection of acupuncture site and (or) objects unable to tolerate acupuncture treatment; 4. Patients with other serious concomitant diseases (aphasia, moderate to severe edema of lower limbs, venous thrombosis of lower limbs, arteriosclerosis occlusion of lower limbs, diabetic lower extremity vascular disease, peripheral neuropathy, myelopathy, brain trauma, intracranial infection, brain tumor, etc.), secondary diseases (such as heart, liver, renal failure, etc.); 5. Patients with contraindications to MRI (claustrophobia, surgical implantation of metal devices, etc.); 6. Subjects with MMSE score: illiterate < 17, primary school < 20, middle school and above < 24; Hamilton Depression Scale (HAMD-17) score > 17; Hamilton Anxiety Scale (HAMA) score >= 14.

研究实施时间:

Study execute time:

From 2020-01-01

To      2022-12-31

征募观察对象时间:

Recruiting time:

From 2020-10-01

To      2022-06-01

干预措施:

Interventions:

组别:

对照2组

样本量:

20

Group:

controlled group 2

Sample size:

干预措施:

假针刺+PT

干预措施代码:

Intervention:

sham acupuncture+PT

Intervention code:

组别:

试验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

“醒脑开窍”针刺法

干预措施代码:

Intervention:

"XNKQ" acupuncture

Intervention code:

组别:

对照1组

样本量:

20

Group:

controlled group 1

Sample size:

干预措施:

“醒脑开窍”针刺法+PT

干预措施代码:

Intervention:

"XNKQ" acupuncture+PT

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

单位级别:

三级甲等

Institution/hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第二医院

单位级别:

三级甲等

Institution/hospital:

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

单位级别:

三级甲等

Institution/hospital:

West China Hospital of Sichuan University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

美国国立卫生研究院卒中量表(NIHSS)

指标类型:

次要指标

Outcome:

National Institutes of Health Stroke Scale (NIHSS)

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks,12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

针刺得气感问卷

指标类型:

附加指标

Outcome:

Massachusetts Acupuncture Sensation Scale (MASS)

Type:

Additional indicator

测量时间点:

3周、6周

测量方法:

由指定医师测评

Measure time point of outcome:

3 weeks, 6 weeks

Measure method:

assess by specific practitioner

指标中文名:

徒手肌力分级法评定标准(MMT)

指标类型:

次要指标

Outcome:

Manual Muscle Testing (MMT)

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

多模态核磁检测

指标类型:

主要指标

Outcome:

multimodal MRI

Type:

Primary indicator

测量时间点:

基线、6周

测量方法:

sMRI、rest-state fMRI、task fMRI、DTI

Measure time point of outcome:

baseline, 6 weeks

Measure method:

sMRI, rest-state fMRI, task fMRI, DTI

指标中文名:

中风病诊断与疗效评定标准

指标类型:

次要指标

Outcome:

Efficacy Evaluation of Stroke of TCM

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

简明版脑卒中影响量表(SIS-16)

指标类型:

次要指标

Outcome:

Stroke Impact Scale (SIS-16)

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

改良Barthel指数(MBI)

指标类型:

次要指标

Outcome:

Modified Barthel Index (MBI)

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

改良Ashworth痉挛评定量表(MAS)

指标类型:

次要指标

Outcome:

Modified Ashworth Scale (MAS)

Type:

Secondary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

Fugl-Meyer评定量表

指标类型:

主要指标

Outcome:

Fugl-Meyer Assessment (FMA)

Type:

Primary indicator

测量时间点:

基线、3周、6周、12周、24周

测量方法:

由指定医师测评

Measure time point of outcome:

baseline, 3 weeks, 6 weeks, 12 weeks, 24 weeks

Measure method:

assess by specific practitioner

指标中文名:

Bang's盲法信赖度测定(BI)

指标类型:

附加指标

Outcome:

Bang's blinding Index (BI)

Type:

Additional indicator

测量时间点:

3周、6周

测量方法:

由指定医师测评

Measure time point of outcome:

3 weeks, 6 weeks

Measure method:

assess by specific practitioner

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

外周血

Sample Name:

Blood

Tissue:

Peripheral Blood

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

粪便

组织:

Sample Name:

Feces

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

正在进行

Recruiting

年龄范围:

最小 40
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究采用中央分层区组随机。由数据管理人员在纳入第一例患者之前,由计算机程序生成随机数字序列。以疾病严重程度(NIHSS评分)作为分层因素(2层),区组长度为6(3种干预)。

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

This study will employ central stratified blocked randomization. The random number sequence will be generated by computer before the first subject of study involved by data manager. The severity of stroke (NIHSS score) will be the factor for stratifying (two stratification), and the length of the block will&#32

盲法:

开放性试验

Blinding:

Open label trial.

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):

开放数据库

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

Open database

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:

数据采集使用CRF,数据管理采用ResMan。

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

CRF is used for data acquisition and ResMan is used for data management.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above