老年人顶叶感觉整合中枢调控机制和干预效果研究

注册号:

Registration number:

ChiCTR2600125783 

最近更新日期:

Date of Last Refreshed on:

2026-06-01 00:19:31 

注册时间:

Date of Registration:

2026-06-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

老年人顶叶感觉整合中枢调控机制和干预效果研究

Public title:

Study on the central regulation mechanism and intervention effect of parietal lobe sensory integration in the elderly

注册题目简写:

English Acronym:

研究课题的正式科学名称:

老年人顶叶感觉整合中枢调控机制和干预效果研究

Scientific title:

Study on the central regulation mechanism and intervention effect of parietal lobe sensory integration in the elderly

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:

杨凡 

研究负责人:

杨凡 

Applicant:

Yang Fan 

Study leader:

Yang Fan 

申请注册联系人电话:

Applicant telephone:

+86 133 3548 2889

研究负责人电话:

Study leader's
telephone:

+86 133 3548 2889

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:

275281056@qq.com

研究负责人电子邮件:

Study leader's E-mail:

275281056@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:

北京市海淀区信息路48号

研究负责人通讯地址:

北京市海淀区信息路48号

Applicant address:

No. 48, Xinfupu Road, Haidian District, Beijing

Study leader's address:

No. 48, Xinfupu Road, Haidian District, Beijing

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:

北京体育大学

Applicant's institution:

Beijing Sport University

研究负责人所在单位:

北京体育大学

Affiliation of the Leader:

Beijing Sport University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2026144H

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:

北京体育大学运动科学实验伦理委员会

Name of the ethic committee:

Ethics Approval Form For Sports Science Experiment of Beijing Sport University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-04-24 00:00:00

伦理委员会联系人:

梅涛

Contact Name of the ethic committee:

Mei Tao

伦理委员会联系地址:

北京市海淀区信息路48号

Contact Address of the ethic committee:

No. 48, Xinfupu Road, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 6298 9306

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:

北京体育大学

Primary sponsor:

Beijing Sport University

研究实施负责(组长)单位地址:

北京市海淀区信息路48号

Primary sponsor's address:

No. 48, Xinfupu Road, Haidian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京体育大学

具体地址:

北京市海淀区信息路48号

Institution
hospital:

Beijing Sport University

Address:

No. 48, Xinfupu Road, Haidian District, Beijing

经费或物资来源:

自费

Source(s) of funding:

Self-funded

研究疾病:

无  

Target disease:

None

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:

1.探讨老年人姿势控制过程中顶叶感觉整合的神经激活特征及功能偏侧化变化。 2.探讨单侧顶叶tDCS对老年人感觉整合与姿势控制的即时调控作用。 3.评估长期单侧顶叶tDCS联合VR训练对老年人感觉整合能力的干预效果及神经可塑性机制。  

Objectives of Study:

1. Explore the neural activation characteristics and functional lateralization changes of the parietal lobe during the process of elderly people's posture control. 2. Explore the immediate regulatory effect of unilateral parietal tDCS on the sensory integration and posture control of the elderly. 3. Evaluate the intervention effect and neural plasticity mechanism of long-term unilateral parietal tDCS combined with VR training on the sensory integration ability of the elderly.

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.近6个月有肌肉骨骼损伤; 2.患有视觉或听觉问题、眩晕、前庭系统障碍、严重姿势控制障碍; 3.有脑外科手术史、存在脑肿瘤、周围神经病变; 4.有任何认知障碍或神经系统疾病史(如帕金森病、阿尔茨海默病、脑卒中后遗症); 5.体内有心脏起搏器、或头部有金属植入物等; 6.孕妇或哺乳期妇女; 7.近3月内使用精神类药物,或正在服用治疗任何情绪或神经系统疾病的药物; 8.MMSE<25; 9.tDCS禁忌症

Exclusion criteria:

1. Had musculoskeletal injuries in the past 6 months; 2. Had visual or auditory problems, vertigo, vestibular system disorders, severe postural control disorders; 3. Had a history of brain surgery, existed with brain tumors, peripheral neuropathy; 4. Had any history of cognitive impairment or neurological diseases (such as Parkinson's disease, Alzheimer's disease, sequelae of stroke); 5. Had a pacemaker in the body, or had metal implants in the head, etc.; 6. Pregnant or lactating women; 7. Had used psychotropic drugs in the past 3 months, or was currently taking any medication for treating any emotional or neurological disorders; 8. MMSE score < 25; 9. for tDCS (transcranial direct current stimulation) treatment.

研究实施时间:

Study execute time:

From 2026-05-06 00:00:00 To 2026-12-08 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-01 00:00:00 To 2026-10-22 00:00:00

干预措施:

Interventions:

组别:

干预组1

样本量:

18

Group:

Intervention group 1

Sample size:

干预措施:

右顶叶HD-tDCS结合VR训练

干预措施代码:

Intervention:

Right parietal lobe HD-tDCS combined with VR training

Intervention code:

组别:

干预组2

样本量:

18

Group:

Intervention group 2

Sample size:

干预措施:

左顶叶HD-tDCS结合VR训练

干预措施代码:

Intervention:

Left parietal lobe HD-tDCS combined with VR training

Intervention code:

组别:

对照组

样本量:

18

Group:

Control group

Sample size:

干预措施:

假刺激结合VR训练

干预措施代码:

Intervention:

Sham stimulation combined with VR training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

CHINA

Province:

Beijing

City:

单位(医院):

北京体育大学 

单位级别:

大学 

Institution
hospital:

Beijing Sport University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

氧合血红蛋白浓度

指标类型:

主要指标

Outcome:

Concentration changes of oxy-hemoglobin

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脱氧血红蛋白浓度

指标类型:

主要指标

Outcome:

Deoxyhemoglobin concentration

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

偏侧化指数

指标类型:

主要指标

Outcome:

Lateralization index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉得分

指标类型:

主要指标

Outcome:

Visual score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

本体感觉得分

指标类型:

主要指标

Outcome:

Proprioception score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前庭觉得分

指标类型:

主要指标

Outcome:

Vestibular sensation score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉优势得分

指标类型:

主要指标

Outcome:

Visual advantage score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

综合平衡得分

指标类型:

主要指标

Outcome:

Comprehensive balance score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

罗伯比

指标类型:

主要指标

Outcome:

Romberg ratio

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平衡得分(1-6)

指标类型:

次要指标

Outcome:

Equilibrium score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

反应时长

指标类型:

次要指标

Outcome:

Reaction time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均重心移动速度

指标类型:

次要指标

Outcome:

Mean COG Sway Velocity

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重心摆动速度

指标类型:

次要指标

Outcome:

COG Sway Velocity

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

反应强度

指标类型:

次要指标

Outcome:

Response intensity

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

方向控制得分

指标类型:

次要指标

Outcome:

Direction control score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最大移动距离

指标类型:

次要指标

Outcome:

Maximum moving distance

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

步行时间

指标类型:

次要指标

Outcome:

Walking time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正确率

指标类型:

次要指标

Outcome:

Accurate rate

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:

组织:

Sample Name:

None

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 years
最大 Max age 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):

专门的统计学人士使用随机数字表法进行随机

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

Specialized statisticians use the random number table method for randomization.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

对评估人员隐藏分组

Blinding:

Hiding the groups from the evaluators

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

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:

EDC

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

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:

 2026-06-01 00:19:06