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A Study on the Rehabilitation Efficacy of Progressive Cross-Visual Field Association Training for Post-Stroke isual Field Defects

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注册号：

Registration number：

ChiCTR2600126858 

最近更新日期：

Date of Last Refreshed on：

2026-06-17 15:54:31 

注册时间：

Date of Registration：

2026-06-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于渐进式跨视野关联训练对脑卒中后视野缺损的康复疗效研究

Public title：

A Study on the Rehabilitation Efficacy of Progressive Cross-Visual Field Association Training for Post-Stroke isual Field Defects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于渐进式跨视野关联训练对脑卒中后视野缺损的康复疗效研究

Scientific title：

A Study on the Rehabilitation Efficacy of Progressive Cross-Visual Field Association Training for Post-Stroke isual Field Defects

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：

王雪 

研究负责人：

王雪 

Applicant：

Wang Xue 

Study leader：

Wang Xue 

申请注册联系人电话：

Applicant telephone：

+86 15201234785

研究负责人电话：

Study leader's telephone：

+86 10 87569163

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：

wangxue19830303@126.com

研究负责人电子邮件：

Study leader's E-mail：

wangxue19830303@126.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：

北京市丰台区角门北路10号

研究负责人通讯地址：

北京市丰台区角门北路10号

Applicant address：

No. 10, Jiaomen North Road, Fengtai District, Beijing, China

Study leader's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing, China

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：

中国康复研究中心北京博爱医院

Applicant's institution：

China Rehabilitation Research Center Beijing Boai Hospital

研究负责人所在单位：

北京博爱医院

Affiliation of the Leader：

Beijing Bo'ai Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-055-02

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：

中国康复研究中心医学伦理委员会科研与医疗新技术新项目伦理组

Name of the ethic committee：

Medical Ethics Committee of China Rehabilitation Research Center Beijing Boai Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-08-04 00:00:00

伦理委员会联系人：

何照楠

Contact Name of the ethic committee：

He ZhaoNan

伦理委员会联系地址：

北京市丰台区角门北路10号

Contact Address of the ethic committee：

No. 10, Jiaomen North Road, Fengtai District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 87020512

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hznhzk@163.com

研究实施负责（组长）单位：

北京博爱医院

Primary sponsor：

Beijing Bo'ai Hospital

研究实施负责（组长）单位地址：

北京市丰台区角门北路10号

Primary sponsor's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing, 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)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京博爱医院

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

Beijing Bo'ai Hospital

Address：

No. 10, Jiaomen North Road, Fengtai District, Beijing, China

经费或物资来源：

中国残联课题残疾人康复专项

Source(s) of funding：

CDPF Special Project on Disability Rehabilitation

Target disease：

Post-stroke Visual Field Defect

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：

研究的主要目的是：通过一项随机对照试验，验证“渐进式跨视野关联训练”对脑卒中后视野缺损患者的康复疗效和安全性，以期为临床提供一种有效的新型恢复性治疗手段。 1. 验证核心疗效：重点验证PTJT训练相较于传统的眼球运动训练，是否能更显著地改善脑卒中后视野缺损患者的核心视觉功能指标，即平均视野缺损 和视野指数。 2. 评估综合效益：除了核心视野指标，研究还将评估PTJT对患者的视力、对比敏感度 以及视觉相关生活质量 的提升作用，全面衡量该训练的康复价值。 3. 确认临床应用的安全性与可行性：通过标准化的训练流程和严密监控，评估PTJT训练在临床应用中的安全性（如不良反应发生率）和可操作性，为其在各级医疗机构的推广奠定基础。 4. 为个性化康复提供科学依据：通过收集不同特征患者（如缺损程度、发病时间）的训练响应数据，分析疗效与个体因素的关联，为未来制定更具针对性的脑卒中后视野缺损个性化康复方案积累数据支持。  

Objectives of Study：

The primary objective of this research is to validate the rehabilitation efficacy and safety of "Progressive Trans-hemifield Joint Training" (PTJT) for patients with post-stroke visual field defects through a randomized controlled trial, aiming to provide an effective new restorative treatment approach for clinical practice.Specifically, the objectives can be broken down as follows: 1. Validate Core Efficacy: Focus on verifying whether PTJT training can more significantly improve the core visual function indicators of post-stroke visual field defect patients – namely, Mean Deviation (MD) and Visual Field Index (VFI) – compared to traditional eye movement training. 2. Evaluate Comprehensive Benefits: Beyond the core visual field indicators, the study will also assess PTJT's effect on improving patients' visual acuity (VA), contrast sensitivity (CS), and vision-related quality of life, providing a comprehensive evaluation of the training's rehabilitation value. 3. Confirm Clinical Application Safety and Feasibility: Through standardized training procedures and rigorous monitoring, evaluate the safety (e.g., incidence of adverse reactions) and operability of PTJT training in clinical applications, laying the foundation for its promotion in medical institutions at all levels. 4. Provide Scientific Basis for Personalized Rehabilitation: By collecting the training response data of patients with different characteristics (such as defect degree and onset time), the correlation between curative effect and individual factors was analyzed, so as to accumulate data support for the development of more targeted personalized rehabilitation program for visual field defect after stroke in the future.

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.脑卒中后视野缺损患者； 2.入选患者年龄≥18岁，≤70岁； 3.脑卒中发病时间≥1个月，≤12个月； 4.神智清楚，Mmse评分≥17分，能够配合检查； 5.患者自愿接受治疗并签署知情同意书；

Inclusion criteria

1.Patients with post-stroke visual field defects; 2. Age >=18 years and <=70 years; 3. Time since stroke onset >=1 month and <=12 months; 4. Clear consciousness with MMSE score >=17 points, capable of cooperating with examinations; 5. Voluntarily accept treatment and sign the informed consent form;

排除标准：

1.伴有视神经萎缩、严重黄斑病变； 2.重度认知障碍、精神障碍、意识障碍患者； 3.合并重要器官功能不全； 4.单侧忽略患者；

Exclusion criteria：

1. Accompanied by optic nerve atrophy, severe macular lesions; 2. Patients with severe cognitive impairment, mental disorders, or impaired consciousness; 3. Complicated by insufficiency of major organs; 4. Patients with unilateral neglect.

研究实施时间：

Study execute time：

从 From 2026-06-17 00:00:00至 To 2028-12-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-17 00:00:00 至 To 2028-12-15 00:00:00  

干预措施：

Interventions：

组别：

试验组（PTJT训练组）

样本量：

28

Group：

Experimental Group (PTJT Training Group)

Sample size：

干预措施：

PTJT训练

干预措施代码：

Intervention：

PTJT Training and Eye Movement Training

Intervention code：

组别：

对照组（眼球运动训练）

样本量：

28

Group：

Control Group (Eye Movement Training Group)

Sample size：

干预措施：

眼球运动训练

干预措施代码：

Intervention：

PTJT Training and Eye Movement 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)：

北京博爱医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Bo'ai Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视力

指标类型：

次要指标

Outcome：

Visual Acuity

Type：

Secondary indicator

测量时间点：

治疗前及治疗12周

测量方法：

视力表

Measure time point of outcome：

Before treatment and at 12 weeks

Measure method：

visual acuity chart

指标中文名：

视野指数

指标类型：

次要指标

Outcome：

Visual Field Index

Type：

Secondary indicator

测量时间点：

治疗前及治疗12周

测量方法：

采用 Humphrey 全自动视野计，SITA-Fast 检测程序，按标准化参数进行静态中心视野检查，设备每日开机校准，记录 MD、VFI 数值，基线及干预 12 周复查。

Measure time point of outcome：

Before treatment and at 12 weeks

Measure method：

Static central visual field examination was conducted with Humphrey automated perimeter using the SITA-Fast protocol following standard parameters. The instrument was calibrated daily, and MD and VFI values were recorded at baseline and 12 weeks after intervention.

指标中文名：

美国国家眼科研究所视觉功能问卷NEI-VFQ-25

指标类型：

次要指标

Outcome：

National Eye Institute 25-Item Visual Functioning Questionnaire

Type：

Secondary indicator

测量时间点：

治疗前及治疗12周

测量方法：

采用经国内信效度验证的中文版 NEI-VFQ-25 量表，由经过统一培训的医护人员在安静独立诊室面对面访谈施测；受试者按佩戴常规矫正眼镜状态作答，原始分按 NEI 官方公式换算为 0～100 标准化得分，分值越高代表视觉相关生活质量越好

Measure time point of outcome：

Before treatment and at 12 weeks

Measure method：

The domestically validated Chinese version of NEI-VFQ-25 questionnaire was administered via face-to-face interview in a quiet independent consulting room by uniformly trained medical staff. All participants completed the questionnaire with habitual corrective lenses worn. Raw scores were converted to standardized scores ranging from 0 to 100 in accordance with official NEI formulas, with higher scores indicating better vision-related quality of life.

指标中文名：

平均视野缺损

指标类型：

主要指标

Outcome：

Mean Deviation

Type：

Primary indicator

测量时间点：

治疗前及治疗12周

测量方法：

采用 Humphrey 全自动视野计，SITA-Fast 检测程序，按标准化参数进行静态中心视野检查，设备每日开机校准，记录 MD、VFI 数值，基线及干预 12 周复查。

Measure time point of outcome：

Before treatment and at 12 weeks

Measure method：

Static central perimetry was performed using Humphrey automated perimeter with SITA-Fast protocol per standardized settings. The instrument was calibrated daily before use, and MD and VFI values were documented at baseline and 12 weeks post-intervention.

指标中文名：

对比敏感度

指标类型：

次要指标

Outcome：

Contrast Sensitivity

Type：

Secondary indicator

测量时间点：

治疗前及治疗12周

测量方法：

使用 MARS 字母/数字对比敏感度检查表进行检测，在统一照明条件下完成测评，结果采用 logCS 记录，测评时点同视力

Measure time point of outcome：

Before treatment and at 12 weeks

Measure method：

Contrast sensitivity was tested with MARS letter/numeral contrast sensitivity chart under standardized illumination, outcomes recorded as logCS at the same time points as visual acuity measurement.

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 18 岁 years
最大 Max age 70 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 计算机生成的随机数字表，通过专门的随机化软件（如：SAS, R 语言等）生成。随机序列将采用区组随机化方法，以保障两组间样本量的均衡

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

computer-generated random number tables, produced by specialized randomization software (e.g., SAS, R language). The randomization sequence will employ a block randomization method to ensure balanced sample sizes between the two groups.

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

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）：

公开日期：课题结题验收完成后 6 个月 共享方式：脱敏后的原始研究数据上传至国家医学科学数据共享服务平台（https://www.nmdc.cn），科研人员可按平台规范提交申请查阅获取数

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

Release date: 6 months after project completion and acceptance.Data sharing method: De-identified raw data will be uploaded to the National Medical Science Data Sharing Platform (https://www.nmdc.cn). Researchers may apply for data access in accordance with the platform’s requirements.

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：

本研究数据分为纸质病历记录表、电子数据管理系统两部分： 纸质病历记录表：统一设计 CRF 病例报告表，现场逐项如实记录受试者基线、干预 12 周各项检测指标、量表评分，纸质资料专人专柜上锁存档。 电子采集和管理系统：实测数据双人录入 Excel 电子数据库，完成录入后交叉核对纠错；原始电子文件存储于医院内部加密电脑，设置访问权限，做好数据备份，严格执行受试者信息脱敏，保护隐私。

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

Data collection and management of this study consist of paper medical records and electronic management system:Paper case report forms (CRFs) are uniformly formulated. Baseline data, test indicators and scale scores at the 12-week follow-up are recorded on-site truthfully. All paper documents are archived by designated staff in locked cabinets.Measured data are double-entered into Excel database and cross-checked for errors. Electronic files are saved on hospital encrypted computers with access control and regular backups. All personal information is de-identified to protect subjects’ privacy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-17 15:54:10
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