Explore the therapeutic effect of Tuina on children with autism with heart-liver fire syndrome a fNIRS study

注册号:

Registration number:

ITMCTR2025000205

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于 fNIRS 探究推拿治疗心肝火旺证孤独症儿童的疗效研究

Public title:

Explore the therapeutic effect of Tuina on children with autism with heart-liver fire syndrome a fNIRS study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于 fNIRS 探究推拿治疗心肝火旺证孤独症儿童的疗效研究

Scientific title:

Explore the therapeutic effect of Tuina on children with autism with heart-liver fire syndrome a fNIRS study

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:

申请注册联系人:

丁兰艳

研究负责人:

沈敏

Applicant:

Lanyan Ding

Study leader:

Min Shen

申请注册联系人电话:

Applicant telephone:

13761131785

研究负责人电话:

Study leader's telephone:

18018880579

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:

942412352@QQ.COM

研究负责人电子邮件:

Study leader's E-mail:

minshen223@qq.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:

上海市浦东新区临沂北路265号

研究负责人通讯地址:

上海市浦东新区临沂北路265号

Applicant address:

265 Linyi North Road Pudong New Area Shanghai

Study leader's address:

265 Linyi North Road Pudong New Area Shanghai

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:

上海市特殊儿童康复中心

Applicant's institution:

Shanghai Rehabilitation Center For The Disabled Children

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:

EKLL-2024006

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:

上海市特殊儿童康复中心伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai Rehabilitation Center for The Disabled Children

伦理委员会批准日期:

Date of approved by ethic committee:

2024/12/1 0:00:00

伦理委员会联系人:

陆洋阳

Contact Name of the ethic committee:

YANGYANG LU

伦理委员会联系地址:

上海市浦东新区临沂北路265号

Contact Address of the ethic committee:

265 Linyi North Road Pudong New Area Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

13816475267

伦理委员会联系人邮箱:

Contact email of the ethic committee:

srieckj@163.com

研究实施负责(组长)单位:

上海市特殊儿童康复中心

Primary sponsor:

Shanghai Rehabilitation Center For The Disabled Children

研究实施负责(组长)单位地址:

上海市浦东新区临沂北路265号

Primary sponsor's address:

265 Linyi North Road Pudong New Area Shanghai

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):

上海市特殊儿童康复中心

具体地址:

上海市浦东新区临沂北路265号

Institution
hospital:

Shanghai Rehabilitation Center For The Disabled Children

Address:

265 Linyi North Road Pudong New Area Shanghai

经费或物资来源:

自筹

Source(s) of funding:

self-raised

研究疾病:

孤独症谱系障碍

研究疾病代码:

Target disease:

Autism Spectrum Disorder

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:

旨在利用功能性近红外光谱成像技术从脑功能连接的角度探究推拿治疗在心肝火旺证孤独症儿童中应用的疗效。

Objectives of Study:

The purpose of this study was to explore the therapeutic effect of tuina therapy on autistic children with hyperactive syndrome of heart and liver fire from the perspective of brain functional connection by using functional near-infrared spectroscopy.

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、符合 DMS-5 中制定的 ASD 诊断标准且为心肝火旺证的ASD儿童。 2、年龄 3~7 岁。 3、近3 个月内未进行推拿治疗。 4、患儿家长知情同意并自愿签署知情同意书。

Inclusion criteria

1. Children with ASD who meet the diagnostic criteria for ASD established in DMS-V and have heart-liver fire hyperactivity syndrome. 2. Age 3 ~ 7 years old. 3. Massage treatment has not been performed in the past 3 months. 4. Parents of the child give informed consent and sign the informed consent voluntarily.

排除标准:

1、合并其他器质性疾病及精神性疾病,如精神分裂症、癫痫等。 2、存在听理解、认知功能严重障碍,无法配合完成功能性近红外光谱成像采集。

Exclusion criteria:

1. Combined with other organic diseases and psychiatric diseases such as schizophrenia epilepsy etc. 2. Hearing comprehension and cognitive functions are severely impaired, and functional near-infrared spectral imaging collection cannot be completed.

研究实施时间:

Study execute time:

From 2025-02-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2025-02-01

To      2025-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

17

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

组别:

干预组

样本量:

17

Group:

Intervention group

Sample size:

干预措施:

推拿和常规治疗

干预措施代码:

Intervention:

Tuina and Conventional treatment

Intervention code:

样本总量 Total sample size : 34

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):

上海

Country:

China

Province:

SHANGHAI

City:

SHANGHAI

单位(医院):

上海市特殊儿童康复中心

单位级别:

二级

Institution/hospital:

Shanghai Rehabilitation Center For The Disabled Children

Level of the institution:

Secondary

测量指标:

Outcomes:

指标中文名:

中文版儿童心理教育评核第三版(C-PEP-3):大肌肉

指标类型:

次要指标

Outcome:

Gross Motor(GM)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感觉讯息处理及自我调节功能检核表

指标类型:

主要指标

Outcome:

Sensory Processing and Self-Regulation Checklist

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中文版儿童心理教育评核第三版(C-PEP-3):模仿

指标类型:

次要指标

Outcome:

Visual Motor Imagery(VMI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中文版心理教育量表第三版

指标类型:

主要指标

Outcome:

Chinese Version of the Psycho-Educational Profile-3rd Edition

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中文版儿童心理教育评核第三版(C-PEP-3):小肌肉

指标类型:

次要指标

Outcome:

Fine Motor(FM)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性近红外光谱成像静息态测量的各通道在时间点内 HbO2、HbR 浓度的变化值

指标类型:

主要指标

Outcome:

The change value of HbO2 and HbR concentration in each channel measured by the resting state of functional near-infrared spectroscopy

Type:

Primary 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:

组织:

Sample Name:

NONE

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:

尚未开始

Not yet recruiting

年龄范围:

最小 3
Min age years
最大 7
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):

研究主要负责人通过随机数字表法进行随机分组

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

The study leader in charge of the study conducted random grouping by random number table method.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

/

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

/

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:

CRF

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

CRF

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):

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