Clinical Efficacy of “Conduct Qi with Mindwill” Exercise in Intervening Early Post-Stroke Depression and Characteristics of Electroencephalogram Signals

注册号:

Registration number:

ITMCTR2000003562

最近更新日期:

Date of Last Refreshed on:

2020-08-14

注册时间:

Date of Registration:

2020-08-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

“以意行气”功法干预脑卒中后早期抑郁的临床疗效及脑电信号特性研究

Public title:

Clinical Efficacy of “Conduct Qi with Mindwill” Exercise in Intervening Early Post-Stroke Depression and Characteristics of Electroencephalogram Signals

注册题目简写:

English Acronym:

研究课题的正式科学名称:

“以意行气”功法干预脑卒中后早期抑郁的临床疗效及脑电信号特性研究

Scientific title:

Clinical Efficacy of “Conduct Qi with Mindwill” Exercise in Intervening Early Post-Stroke Depression and Characteristics of Electroencephalogram Signals

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:

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:

ChiCTR2000035588 ; ChiMCTR2000003562

申请注册联系人:

孙萍萍

研究负责人:

孙萍萍

Applicant:

sun pingping

Study leader:

sun pingping

申请注册联系人电话:

Applicant telephone:

+86 021-51323093

研究负责人电话:

Study leader's telephone:

+86 13816995171

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:

13816995171@163.com

研究负责人电子邮件:

Study leader's E-mail:

13816995171@163.com

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:

上海浦东新区蔡伦路1200号

研究负责人通讯地址:

上海浦东新区蔡伦路1200号

Applicant address:

200 Cailun Road, Pudong New Area, Shanghai

Study leader's address:

200 Cailun Road, Pudong New Area, Shanghai

申请注册联系人邮政编码:

Applicant postcode:

201203

研究负责人邮政编码:

Study leader's postcode:

201203

申请人所在单位:

上海中医药大学

Applicant's institution:

Shanghai 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:

2019-125

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee:

Ethics Committee of Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2019/12/23 0:00:00

伦理委员会联系人:

殷从全

Contact Name of the ethic committee:

Yin Congquan

伦理委员会联系地址:

上海浦东新区蔡伦路1200号

Contact Address of the ethic committee:

200 Cailun Road, Pudong New Area, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-65161782-8122

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:

上海中医药大学附属岳阳中西医结合医院

Primary sponsor:

Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号

Primary sponsor's address:

110 Ganhe Road, Hongkou District, 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(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

虹口区甘河路110号

Institution
hospital:

Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District

经费或物资来源:

院内课题( KY111.30.57)

Source(s) of funding:

In-hospital Project (KY111.30.57)

研究疾病:

脑卒中后抑郁

研究疾病代码:

ICD-10 中枢神经系统性疾病(G00-G09)

Target disease:

Post-stroke Depression

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:

卒中后抑郁(PSD)是卒中后躯体障碍合并情绪障碍的身心疾患,严重影响卒中的恢复,而基于中医整体观,调身、调息、调神的“以意行气”功法是“身心同康”共治的对症疗法。脑电图能反映神经元群体的综合电生理活动,提供丰富的生理或心理信息。本研究通过脑电信号观察健康人练习“以意行气”功法的作用,并对功法治疗的PSD患者进行NIHSS、SS-QOL、HAMD-24临床量表评估,探讨功法的临床疗效。再以客观指标EEG观察功法治疗前后PSD患者脑电信号的影响,探析四个频域脑电信号、大脑网络功能连接、局部及全局信息处理效率特征性的改变,为临床PSD患者提供安全可靠的补充疗法,为传统功法寻求客观依据。

Objectives of Study:

Post-stroke depression (PSD) is a physical and mental illness caused by post-stroke physical disorder combined with mood disorder, which seriously affects the recovery of stroke. Based on the holistic view of TCM, the "mind and body" method of regulating body, breath and spirit is the symptomatic therapy of "body and mind together with health". Electroencephalogram (EEG) can reflect the comprehensive electrophysiological activities of neurons and provide abundant physiological or psychological information. In this study, eeg signals were used to observe the effect of exercise of "mind and breath" in healthy people, and clinical scales of NIHSS, SS-QOL and HAMD-24 were used to evaluate the clinical efficacy of exercise therapy in PSD patients. Furthermore, the effects of EEG on THE EEG of PSD patients before and after the treatment were observed with objective indicators, and the characteristic changes in the four frequency domain EEG signals, brain network functional connections, and local and global information processing efficiency were analyzed, so as to provide safe and reliable supplementary therapy for clinical PSD patients and to seek objective basis for the traditional performance method.

药物成份或治疗方案详述:

两组患者均给予神经内科基础治疗,如使用营养神经药物,控制血压、血糖、血脂,改善循环,对症支持治疗及中医活血通络药物,使用所有药物不产生抗抑郁效果,在常规诊疗的基础上,两组分别进行下述治疗: 常规组:常规康复治疗及心理支持干预。 1、偏瘫后手法技术 (1)上肢部:仰卧位,以功能障碍侧为主 a.医者施扌衮法于痉挛优势侧(屈侧)肌腹部;轻拍上肢伸肌,用掌擦法于痉挛劣势侧(伸侧)至该侧皮肤温热感为度。 b.医者将患肢缓慢伸肘、伸腕和伸指关节后较快速屈肘、屈腕和屈指关节。缓慢充分地做前臂的旋前、旋后运动。 c.患者仰卧,医者一手握住患手四指,另一手控制患手拇指,并将五个手指及腕关节均置于伸展位,辅助患者上举、外展、内收及旋转上肢,幅度由小到大。 d.患者仰卧,患者肩关节外展 55°,屈曲 30°,治疗师挤压肩关节,增加本体感觉。 (2)躯干部: a.患者仰卧,屈膝屈髋,双手抱膝。医者将患者身体向左右方向轻轻摇动。 b.患者坐位,治疗师一手置于患者胸骨柄,一手置于胸椎后作 8 字环绕的姿势控制训练。 (3)下肢部:以功能障碍侧为主。 a.施扌衮法于痉挛优势侧(大腿伸侧)肌腹部;用掌擦法于痉挛劣势侧(大腿屈侧)至皮肤温热感为度。 b.患者取仰卧位,患脚支撑在床上,医者一手固定患侧踝关节,另一手辅助患者做背屈、外翻踝关节动作。 c.患者仰卧,在膝关节保持伸展位的状态下练习髋关节屈曲。开始时由健侧带动患侧,或医者予以辅助。 d.患者仰卧,双下肢屈髋、屈膝,双足全脚掌支撑于床面,进行髋关节内收、外展的控制训练。 e.患者在俯卧位或站立位,在保持髋关节伸展状态下进行屈曲膝关节训练,反复训练至掌握;站立位,髋关节伸展、膝关节屈曲状态下的踝关节背屈训练。 f.牵伸技术:牵伸容易痉挛的肌肉如肱二头肌、胸大肌、旋前圆肌、屈腕屈指肌群、大腿内收肌群,髂腰肌、股四头肌,腘绳肌、小腿三头肌等。 2、偏瘫后遗症期训练方法 (1)立位平衡训练 (2)步行训练 3、作业治疗 a.日常生活活动训练,如更衣、进食、转移、拧毛巾、刷牙、剃须、梳头、洗澡。 b.肩外展内收作业训练:绘图、坐位平举体操棒训练、写大字等。 c.肘伸屈作业训练:锤钉木板或钉制木盒、调和黏土等。 d.腕伸屈、桡尺偏作业训练:腕关节训练器械、锤钉、绘画、坐位使用Meditouch 中的 3D感受器或手套等。 e.手指精细活动作业训练:捡拾珠子或豆、串珠、打结、编织、插钉、弹 琴、书法、珠算、绘画、拼图、拧螺钉等。 f.髋膝伸屈作业训练:上下楼、踏自行车等。 g.踝伸屈作业训练:脚踏缝纫机、踏自行车等。 h.肩部力量、手部握力及上肢本体感觉训练训练。 i.平衡与认知训练。 j.进行患肢和躯干力量、耐力及关节活动度训练。 心理支持干预: a.在提供适当照料和保证安全的前提下,保护患者自尊心,提高自信。治疗 师言语及行动上尽量避免损害患者的自尊心,耐心对待患者在日常生活及进行康复治疗时出现情绪反复二便给予适当遮掩,生活用品的摆放尽量方便患者的取放, 既保护患者的安全,使患者明白到自己还是能做一些事情的,使之经常处于成功体验的精神状态中。 b.讲明抑郁的危害性及表现,争取家属配合。 c.提高患者对疾病的了解,降低对功能障碍的恐惧感。在建立良好医患关系的基础上,不妨预先告知患者肢体等功能恢复的过程和可能后果,帮助患者正确认识脑卒中后的功能障碍,消除对残疾的恐惧感,坦然接受角色的转换。 d.鼓励患者以积极态度接受康复治疗。通过单独交谈、卫生宣教等手段。了解康复计划和具体程序,强调康复治疗是一个学习、锻炼的反复过程,是“脑功能的重组与重建”与被动接受的临床治疗不一样,需要患者的配合才能取得良好效果。 e.对患者在生活和训练上出现的进步予以充分鼓励。安排几个病情相似的患者为一组,鼓励患者之间的交流,安插有趣的认知游戏,在提高认知功能的同时,转移抑郁等不良情绪。 治疗组:常规康复治疗及“以意行气”功法方案。 常规康复治疗同上。 “以意行气”功法包括:①深呼吸技术:仰卧位,屈膝,保持腹壁松弛,在呼吸运动过程中专注于当下运动,保持呼吸深长匀缓,一吸一呼在10s内完成。将注意力集中在呼吸的感觉上专注于呼吸或呼吸所带动的胸廓及腹部起伏。每天听音频,运动想象激活练习。每次练习10分钟,每日一次。②聆听大自然放松导引法30分钟版,闭眼聆听,音量控制在患者自我感觉舒适为度。③坐位观看简化肢体动作练习视频,听音频口令,坐位练习简化韦驮献杵第一式、简化韦驮献杵第二式、简化韦驮献杵第三式。每次练习15分钟,每日一次。

Description for medicine or protocol of treatment in detail:

Patients in the two groups were given basic neurological treatment, such as the use of neurotrophic drugs, control of blood pressure, blood glucose and blood lipids, improve circulation, symptomatic support treatment and traditional Chinese medicine to promote blood circulation. The use of all drugs did not produce antidepressant effect. On the basis of routine diagnosis and treatment, the two groups were given the following treatment: Routine group: routine rehabilitation treatment and psychological support intervention. 1. Manipulation techniques after hemiplegia 1. Upper limbs: supine position with the dominant functional disorder side; a. Dab the extensor of the upper limb and rub with the palm The degree of warmth sensation is from the inferior side of spasm (extension side) to the skin of this side. B. The surgeon will slowly extend the elbow, wrist, and knuckle of the affected limb and flex the elbow, wrist, and flexor joints more quickly. Do forearm pronation and pronation slowly and fully. C. The patient lies on the back. The doctor holds the affected hand with four fingers in one hand, controls the thumb of the affected hand with the other hand, and puts five fingers And wrist joints were placed in the extension position to assist patients to lift, abduct, adduction and rotate the upper limb, with the amplitude increasing from small to large. D. In supine position, the shoulder joint of the patient was extended by 55° and flexed by 30°. The therapist squeezed the shoulder joint and increased it Proprioception. (2) Body cadre: A. The patient lies on his back, bends his knees and bends his hips, and holds his knees in both hands. The doctor gently shakes the patient's body to the left and right. B. In the patient's sitting position, the therapist placed one hand on the patient's sternum stalk and the other hand behind the thoracic vertebra for the postural control exercise with the figure of eight around. (3) Lower limbs: Mainly functional impairment side. A. The rolling massage method is applied to the abdominal muscles on the dominant side of the thigh; Rub the palm onto the inferior side of the spasm (large The degree of warmth to the skin. B. The patient was placed in supine position with the affected foot supported on the bed. The doctor fixed the affected ankle joint with one hand and assisted with the other The patient does dorsiflexion and ankle-flap. C. The patient lies on the back and exercises hip flexion with the knee in the extended position. Start by the healthy side Drive the affected side, or medical assistance. D. The patient lies on the back, bends the hips and bends the knees of both lower limbs, supports the whole sole of both feet on the bed surface, and performs the control training of hip joint adduction and abduction. E. The patient flexes the knee in prone or standing position with the hip joint extended Psychological support intervention: a. Protect patient self-esteem and improve self-confidence under the premise of providing appropriate care and ensuring safety. treatment In speech and action to avoid damage to the patient's self-esteem, patience to treat patients in daily life and in the time of rehabilitation treatment sentiment again and again. Give appropriate cover, articles for daily use put patients with convenient take put as far as possible, both to protect the safety of patients, making patients to understand that they still can do some things, so often in the successful experience in the state of mind. B. Explain the harmfulness and manifestations of depression, and strive for family members' cooperation. C. Improve patients' understanding of the disease and reduce their fear of dysfunction. On the basis of establishing a good doctor-patient relationship, patients can be informed in advance of the process and possible consequences of the recovery of limbs and other functions, so as to help patients correctly understand the dysfunction after stroke, eliminate the fear of disability, and calmly accept the change of role. D. Encourage patients to receive rehabilitation treatment in a positive manner. Through individual conversation, health education and other means. To understand the rehabilitation plan and specific procedures, it is emphasized that rehabilitation treatment is a repeated process of learning and exercise, which is different from the passively accepted clinical treatment and requires the cooperation of patients to achieve good results. E. Encourage the patient's progress in life and training. Arrange several patients with similar conditions into a group, encourage communication between patients, install interesting cognitive games, improve cognitive function at the same time, transfer depression and other negative emotions. Treatment group: routine rehabilitation therapy and "mind and spirit" exercise program. Conventional rehabilitation treatment is the same as above. The techniques include: (1) Deep breathing techniques: lying on the back, bending the knees, keeping the abdominal wall loose, focusing on the present movement during the breathing process, keeping the breath deep and steady, and completing one breath and one breath within 10s. Focus on the feeling of the breath focus on the breath or the fluctuations of the chest and abdomen that the breath brings about. Listen to audio every day and exercise with exercise imagination activation. Practice for 10 minutes, once a day. Listen to the 30-minute version of nature relaxation guide, listen with eyes closed, and control the volume at the patient's self-comfortable level. (3) Watch the video of simplified body movements in the sitting position, listen to the audio command, and practice the first simplified weituo offering pestle, the second simplified Weituo offering pestle, and the third simplified Weituo offering pestle in the sitting position. Practice for 15 minutes, once a day.

纳入标准:

(1)符合脑卒中诊断标准,经头颅 CT 或MRI确诊; (2)HAMD-24 评分,在8到20分之间; (3)脑卒中后抑郁轻症,发病1-18个月; (4)年龄≥40周岁 ≤75周岁,性别不限; (5)一个月再无新鲜脑出血或脑梗发作; (6)自愿参加,积极配合本课题,并签署知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria for cerebral apoplexy and be confirmed by head CT or MRI; (2) HamD-24 score, ranging from 8 to 20; (3) Mild poststroke depression, onset 1-18 months; (4) Aged >= 40 <= 75 years, gender not limited; (5) No fresh cerebral hemorrhage or cerebral infarction attack within one month; (6) Participate voluntarily, actively cooperate with the project, and sign the informed consent.

排除标准:

(1)严重脑病、癫痫、药物中毒或药物戒断状态; (2)有明显意识及智能障碍无法理解不配合量表评估者; (3)不能坐位接受检查及治疗的患者; (4)正在进行抗抑郁药物治疗的中重度抑郁患者; (5)患有精神病或经筛查严重痴呆者; (6)合并有心功能不全如心衰、心梗等,肝肾功能不全,消化道出血等严重疾病者; (7)大脑半球出血量达40毫升以上,小脑出血量达15毫升以上,脑干出血量达5毫升以上及蛛网膜下腔出血者; (8)入组前1个月参加过或正在参加其他临床研究者。

Exclusion criteria:

(1) Severe encephalopathy, epilepsy, drug intoxication or drug withdrawal; (2) Those who have obvious consciousness and intelligence disorder, can't understand and don't cooperate with scale evaluator; (3) Patients who cannot sit for examination and treatment; (4) Moderately or severely depressed patients undergoing antidepressant treatment; (5) persons suffering from mental illness or having been screened for severe dementia; (6) Patients with serious diseases such as heart failure, myocardial infarction, liver and kidney dysfunction, gastrointestinal bleeding, etc.; (7) More than 40ml cerebral hemisphere hemorrhage, more than 15ml cerebellar hemorrhage, more than 5ml cerebral stem hemorrhage and subarachnoid hemorrhage; (8) Have participated in or are participating in other clinical researchers in the first month before enrollment.

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 2020-09-01

To      2020-11-01

干预措施:

Interventions:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

功法训练

干预措施代码:

Intervention:

traditional exercise

Intervention code:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

康复训练

干预措施代码:

Intervention:

rehabilitation training

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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等

Institution/hospital:

Yueyang Integrative Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

脑电图

指标类型:

主要指标

Outcome:

EEG

Type:

Primary indicator

测量时间点:

0天,21天

测量方法:

Measure time point of outcome:

0 day, 21 days

Measure method:

指标中文名:

抑郁量表

指标类型:

次要指标

Outcome:

depression scale

Type:

Secondary indicator

测量时间点:

0天,21天,30天

测量方法:

Measure time point of outcome:

0 day, 21 days, 30 days

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

blood

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 40
Min age years
最大 75
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):

采用SPSS23.0 统计软件产生随机数字和分组

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

The random sequence will be generated by the statistician using SPSS 23.0.

盲法:

开放

Blinding:

open-label

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):

公开原始数据日期2021年1月,中国临床试验注册中心公开

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

The original data was released in January 2021, and was released by the China Clinical Trial Registry

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:

例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

No

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