中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500114339
最近更新日期： Date of Last Refreshed on：	2025-12-10 15:20:16
注册时间： Date of Registration：	2025-12-10 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	视觉与视觉-本体感觉整合训练通过感觉重加权改善慢性期脑卒中患者步态：一项随机对照试验
Public title：	Visual and visual–proprioceptive training improve gait via sensory reweighting after chronic stroke: a randomized controlled trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	视觉与视觉-本体感觉整合训练通过感觉重加权改善慢性期脑卒中患者步态：一项随机对照试验
Scientific title：	Visual and visual–proprioceptive training improve gait via sensory reweighting after chronic stroke: a randomized controlled trial
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：	冷洪帅	研究负责人：	孟庆华
Applicant：	Hongshuai Leng	Study leader：	Qinghua Meng
申请注册联系人电话： Applicant telephone：	+86 176 6405 7718	研究负责人电话： Study leader's telephone：	+86 131 0223 1178
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：	202410200044@stu.tjus.edu.cn	研究负责人电子邮件： Study leader's E-mail：	fengxuequan@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：	天津市静海区团泊新城西区东海路16号天津体育学院中国排球学院106办公室	研究负责人通讯地址：	天津市静海区团泊新城西区东海路16号天津体育学院中国排球学院106办公室
Applicant address：	China Volleyball College, Office 106, Tianjin University of Sport, No. 16 Donghai Road, Xiqu District, Tuanbo New City, Jinghai District, Tianjin , China	Study leader's address：	China Volleyball College, Office 106, Tianjin University of Sport, No. 16 Donghai Road, Xiqu District, Tuanbo New City, Jinghai District, Tianjin , China
申请注册联系人邮政编码： Applicant postcode：	301617	研究负责人邮政编码： Study leader's postcode：	301617
申请人所在单位：	天津体育学院
Applicant's institution：	Tianjin University of Sport
研究负责人所在单位：	天津体育学院
Affiliation of the Leader：	Tianjin University of Sport

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	TJUS2024-023	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：	天津体育学院伦理委员会
Name of the ethic committee：	Tianjin University of Sport Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-10-11 00:00:00
伦理委员会联系人：	赵云罡
Contact Name of the ethic committee：	Yungang Zhao
伦理委员会联系地址：	天津市静海区团泊新城西区东海路16号天津体育学院运动生理学与运动医学重点实验室
Contact Address of the ethic committee：	Key Laboratory of Exercise Physiology and Sports Medicine Tianjin University of Sport No. 16, Donghai Road West Area, Tunbo New Town Jinghai District Tianjin, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 153 1571 1049	伦理委员会联系人邮箱： Contact email of the ethic committee：	3197851759@qq.com

研究实施负责（组长）单位：

天津体育学院

Primary sponsor：

Tianjin University of Sport

研究实施负责（组长）单位地址：

天津市静海区团泊新城西区东海路16号天津体育学院中国排球学院106办公室

Primary sponsor's address：

China Volleyball College, Office 106, Tianjin University of Sport, No. 16 Donghai Road, Xiqu District, Tuanbo New City, Jinghai 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	市(区县)：	天津市
Country：	China	Province：	Tianjin	City：	Tianjin
单位(医院)：	天津体育学院	具体地址：	天津市静海区团泊新城西区东海路16号天津体育学院中国排球学院
Institution hospital：	Tianjin University of Sport	Address：	China Volleyball College, Tianjin University of Sport, No. 16 Donghai Road, Xiqu District, Tuanbo New City, Jinghai District, Tianjin , China

经费或物资来源：

经费来源为国家自然科学基金项目(11372223,11102135)天津市自然科学基金项目 (17JCZDJC36000,18JCZDJC35900)，国家体育总局科研项目 (22KJCX077,2022pqky-01,24ZDKJCX11)，天津市体育局科研项目 (22BZ02,24BZ02)和天津市重点医学学科建设项目 (TJYXZDXK-3-002A-3)。

Source(s) of funding：

This study was supported by the National Natural Science Foundation of China (11372223,11102135); the Natural Science Foundation of Tianjin(17JCZDJC36000,18JCZDJC35900); the scientific research projects of the General Administration of Sport of China (22KJCX077,2022pqky-01,24ZDKJCX11); and the Tianjin Sports Bureau Scientific research project(22BZ02, 24BZ02) and the Funded by Tianjin Key Medical Discipline Construction Project (TJYXZDXK-3-002A-3).

研究疾病：

脑卒中

Target disease：

Stroke

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：

在常规康复基础上，本研究以三臂随机对照试验检验视觉眼动训练（VOT）和视觉-本体感觉整合训练（VPI）是否通过感知重加权显著提升慢性期脑卒中患者的舒适步行速度并改善步态对称性。

Objectives of Study：

To test, in a three-arm randomized controlled trial of chronic stroke, whether visual oculomotor training (VOT) and visual–proprioceptive integration training (VPI), added to usual care and standardized gait training, improve comfortable walking speed and gait symmetry via sensory reweighting.

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）最佳矫正后仍影响安全行走的中至重度视觉功能障碍；（2）未控制的前庭疾病；（3）临床上被诊断为足下垂（在3D步态分析中，摇摆中期踝关节背屈峰值< 0°）；（4）显著的颈椎或椎动脉疾病；（5）未控制癫痫或有光敏性癫痫史；（6）禁忌的中等强度步行运动的心肺或循环系统疾病；（7）严重认知或沟通障碍；（8）近3个月接受过专门的视觉/前庭康复；（9）依从性差或拒绝随访。

Exclusion criteria：

(1) Moderate to severe visual impairment that still compromises safe ambulation despite best correction. (2) Uncontrolled vestibular disorder; significant cervical spine or vertebral artery disease. (3) Clinically meaningful foot drop (peak ankle dorsiflexion < 0° during mid-swing on 3D gait analysis). (4) Significant cervical spine or vertebral artery disease. (5) Uncontrolled epilepsy or a history of photosensitive epilepsy. (6) Cardiopulmonary or circulatory conditions that contraindicate moderate-intensity walking exercise. (7) Severe cognitive or communication impairment. (8) Receipt of specialized vision/vestibular rehabilitation within the past 3 months. (9) Poor adherence or refusal of follow-up.

研究实施时间：

Study execute time：

从 From 2024-10-07 00:00:00至 To 2025-07-24 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-10 00:00:00 至 To 2025-02-02 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	15
Group：	Control Group	Sample size：	15
干预措施：	常规康复+标准化步态训练(5次/周) + 时间/注意力匹配活动(3次/周x30分钟，持续12周)	干预措施代码：	1
Intervention：	Conventional rehabilitation combined with standardized gait training (five sessions per week) and supplemented by time/attention-matched activities (three sessions per week for 30 minutes, over 12 weeks).	Intervention code：	1

组别：	视觉眼动训练组	样本量：	15
Group：	visual oculomotor training Group	Sample size：	15
干预措施：	常规康复+标准化步态训练(5次/周) + 扫视/平滑追踪(3次/周x30分钟，持续12周)	干预措施代码：	2
Intervention：	Conventional rehabilitation combined with standardized gait training (five sessions per week) and supplemented by saccadic/smooth pursuit training (three sessions per week for 30 minutes, over 12 weeks).	Intervention code：	2

组别：	视觉-本体感觉整合训练组	样本量：	15
Group：	visual–proprioceptive integration Group	Sample size：	15
干预措施：	常规康复+标准化步态训练(5次/周) + 视觉反馈负重/重心转移(3次/周x30分钟，持续12周)	干预措施代码：	3
Intervention：	Conventional rehabilitation combined with standardized gait training (five sessions per week) and supplemented by weight-bearing/weight-shifting training with visual feedback (three sessions per week for 30 minutes, over 12 weeks).	Intervention code：	3

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)：	天津市职业病防治院	单位级别：	三级
Institution hospital：	Tianjin occupational diseases precaution and therapeutic hospital	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	舒适步行速度	指标类型：	主要指标
Outcome：	Comfortable gait speed	Type：	Primary indicator
测量时间点：		测量方法：	在10 m直线步道上，用 Qualisys 三维运动捕捉（300 Hz）同步两块 Kistler 测力台（1000 Hz）采集；每次评估取≥3个稳定步态周期求平均；评估者与数据分析者盲。单位 m/s。
Measure time point of outcome：		Measure method：	Gait data were collected along a 10-meter straight walkway. Two Kistler force plates (1000 Hz) were synchronized with a Qualisys 3D motion capture system (300 Hz) for data acquisition. A minimum of three steady gait cycles were collected per assessment and averaged for analysis. The assessors and data analysts were blinded to the group allocation. (Units: m/s)

指标中文名：	步长对称性	指标类型：	次要指标
Outcome：	Step-length symmetry	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	足底压力重心对称比	指标类型：	次要指标
Outcome：	Center-of-pressure symmetry ratio	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	髋、膝、踝关节角度	指标类型：	次要指标
Outcome：	Hip, knee, and ankle joint angles	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	足底压力中心	指标类型：	次要指标
Outcome：	Center of Pressure	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	下肢Fugl–Meyer量表评估	指标类型：	次要指标
Outcome：	Fugl-Meyer Assessment	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	步长	指标类型：	次要指标
Outcome：	Step Length	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Berg 平衡量表	指标类型：	次要指标
Outcome：	Berg Balance Scale	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：	无	组织：
Sample Name：	NO	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	42	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）：

随机方法：由与临床团队独立的统计人员采用计算机随机数法生成三臂 1:1:1 的分配序列。使用 R 软件（v4.x，blockrand 包）按分层+区组随机生成：分层因素为基线舒适步行速度、视觉表型（正常/异常）与卒中类型（缺血/出血）；区组采用变长区组大小 3 和 6以降低可预见性。随机化过程记录随机种子与时间戳并形成随机化日志。序列由统计人员交由不参与招募/评估/干预的研究协调员封存，采用顺序编号、双封口不透明信封实施分配隐藏。受试者完成基线评估并确认为合格后，按编号依次启封/系统分配，现场记录受试者编号、启封时间、执行人；任何异常或偏离均记录并上报。

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

An independent statistician, separate from the clinical team, generated a 1:1:1 three-arm allocation sequence using a computer-based random number method. The randomization was performed using R software (version 4.x, blockrand package), employing a stratified permuted-block design. Stratification factors included baseline comfortable walking speed, visual phenotype (normal/abnormal), and stroke type (ischemic/hemorrhagic). Variable block sizes of 3 and 6 were used to minimize predictability. The randomization process, including the random seed and timestamp, was logged. The allocation sequence was securely transferred to a research coordinator (not involved in recruitment, assessment, or intervention) for concealment. Allocation was concealed using sequentially numbered, sealed, opaque envelopes. After eligible subjects completed baseline assessments, the corresponding envelope was opened in sequential order, and the subject was assigned to the group. The subject ID, unsealing time, and executor were documented on-site. Any deviations or exceptions were recorded and reported.

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：

盲法：受试者与治疗师因干预性质不盲；结局评估者与数据分析者盲。评估与训练分时分区进行，受试者被明确告知不得向评估者透露分组；数据库以 A/B/C 代号录入，至数据锁定后方统一解盲。若出现意外揭盲，立即由第二名盲评估者完成当次评估；随机时间戳、分配日志与任何方案偏离均按预设SOP记录与审计。

Blinding：

Due to the nature of the interventions, participants and treating therapists were necessarily unblinded. However, outcome assessors and data analysts remained blinded to group allocation throughout the trial. To protect the blinding, assessment and training sessions were conducted separately in distinct locations and at different time slots. Participants were explicitly instructed not to disclose their group assignment to the assessors. In the database, group assignments were coded as A, B, or C. The blinding for the analysts was maintained until the database was locked, after which the master code was broken for the final analysis. In the event of an accidental unblinding of an assessor, the subsequent assessments for that participant were to be performed by a second, blinded assessor. The randomization timestamp, allocation log, and any protocol deviations were recorded and audited according to a pre-specified Standard Operating Procedure (SOP).

是否共享原始数据： IPD sharing	是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）：	本研究的原始数据计划在主要研究结果发表后 6 个月内开放共享。共享方式：通过临床试验公共管理平台 ResMan（www.medresman.org.cn）对本研究的去标识化个体参与者数据（IPD）及相关数据说明进行公示，但不提供直接下载。任何有合理学术需求的研究者，在获得伦理委员会批准且不侵犯受试者隐私的前提下，可通过电子邮件联系本研究负责人申请获取相关去标识化数据，联系邮箱：202410200044@stu.tjus.edu.cn 。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The original data of this study will be made available for sharing within 6 months after publication of the primary study results. Mode of sharing: De-identified individual participant data (IPD) and the accompanying data documentation for this study will be listed on the public clinical trial management platform ResMan (www.medresman.org.cn ), but will not be directly downloadable. Any researcher with a reasonable academic request, upon obtaining approval from an ethics committee and under the condition that participant privacy is not compromised, may contact the principal investigator of this study by email (202410200044@stu.tjus.edu.cn ) to apply for access to the relevant de-identified data.
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：	研究数据通过纸质病例记录表（CRF）采集，并录入 Excel 电子表格进行管理，定期进行双人核对和备份。所有数据保存在受密码保护的计算机中，仅研究团队可访问。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data were collected using paper Case Report Forms (CRFs) and managed in electronic spreadsheets (Excel). Double-entry verification and regular backups were performed. All data were stored on password-protected computers accessible only to the research team.
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：	2025-12-10 15:20:11