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注册号: Registration number: |
ChiCTR2600120039 |
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最近更新日期: Date of Last Refreshed on: |
2026-03-09 09:27:13 |
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注册时间: Date of Registration: |
2026-03-09 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
肩袖损伤的运动康复干预 |
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Public title: |
Exercise Rehabilitation Intervention for Rotator Cuff Injuries |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
肩袖损伤的运动康复干预 |
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Scientific title: |
Exercise Rehabilitation Intervention for Rotator Cuff Injuries |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
王波 |
研究负责人: |
王波 |
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Applicant: |
Wang Bo |
Study leader: |
Wang Bo |
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申请注册联系人电话: Applicant telephone: |
+86 187 5693 8320 |
研究负责人电话:
Study leader's |
+86 187 5693 8320 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
18756938320@163.com |
研究负责人电子邮件: Study leader's E-mail: |
18756938320@163.com |
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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): |
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申请注册联系人通讯地址: |
中国安徽省合肥市经开区莲花路1688号 |
研究负责人通讯地址: |
中国安徽省合肥市经开区莲花路1688号 |
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Applicant address: |
1688 Lianhua Road, Economic Development Zone, Hefei, Anhui, China |
Study leader's address: |
1688 Lianhua Road, Economic Development Zone, Hefei, Anhui, China |
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申请注册联系人邮政编码: Applicant postcode: |
230601 |
研究负责人邮政编码: Study leader's postcode: |
230601 |
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申请人所在单位: |
合肥师范学院 |
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Applicant's institution: |
Hefei Normal University |
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研究负责人所在单位: |
合肥师范学院 |
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Affiliation of the Leader: |
Hefei Normal University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2024LLSP003 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
合肥师范学院科学研究伦理委员会 |
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Name of the ethic committee: |
Research Ethics Committee of Hefei Normal University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-03-03 00:00:00 | ||
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伦理委员会联系人: |
刘健 |
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Contact Name of the ethic committee: |
Liu Jian |
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伦理委员会联系地址: |
中国安徽省合肥市经开区莲花路1688号 |
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Contact Address of the ethic committee: |
1688 Lianhua Road, Economic Development Zone, Hefei, Anhui, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 137 2106 4188 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
32600794@qq.com |
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研究实施负责(组长)单位: |
合肥师范学院 |
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Primary sponsor: |
Hefei Normal University |
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研究实施负责(组长)单位地址: |
中国安徽省合肥市经开区莲花路1688号 |
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Primary sponsor's address: |
1688 Lianhua Road, Economic Development Zone, Hefei, Anhui, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-funded |
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研究疾病: |
肩袖损伤 |
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Target disease: |
Rotator cuff injury |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
探索肩胛动力纠正训练对青年运动员肩袖损伤的影响,探索其效果及作用机制。 |
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Objectives of Study: |
To explore the influence of scapular dynamic correction training on rotator cuff injuries in young athletes, and to investigate its effect and mechanism of action. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1. 肩部皮肤病或严重皮肤损伤、破溃者; 2. 肩部骨折或手术史者; 3. 严重的心脑血管疾病、心肺功能障碍、肿瘤及出现骨转移者; 4. 颈椎病、冻结肩等相关鉴别疾病; 5. 影像学检查发现损伤部完全断裂或大部分撕裂者; 6. 实验中途退出、不按照实验要求评估及康复训练者。 |
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Exclusion criteria: |
1. Patients with shoulder skin diseases or severe skin damage/ulceration; 2. Patients with a history of shoulder fracture or surgery; 3. Patients with severe cardiovascular/cerebrovascular diseases, cardiopulmonary dysfunction, tumors, or bone metastasis; 4. Patients with differential diagnoses such as cervical spondylosis or frozen shoulder; 5. Patients with complete or substantial rotator cuff tears identified on imaging studies; 6. Patients who withdraw from the study mid-course or fail to comply with required assessments and rehabilitation protocols. |
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研究实施时间: Study execute time: |
从 From 2025-03-03 00:00:00至 To 2026-03-03 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-03-10 00:00:00 至 To 2025-10-10 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
随机数字表法 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Random number table method |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
试验完成后6个月内上传并公开原始数据,ResMan临床试验公共管理平台 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Upload and publicly share the original data within 6 months after trial completion, via the ResMan Clinical Trial Public Management Platform. |
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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: |
本研究采用电子数据采集系统(Electronic Data Capture, EDC)进行数据管理。病例报告表(Case Report Form, CRF)以电子化形式(eCRF)嵌入ResMan临床试验管理系统(www.medresman.org),该系统为基于互联网的EDC平台,支持多中心实时数据录入、自动逻辑核查、数据质疑与响应、审计追踪、权限分级控制及数据库锁定功能。所有研究数据通过eCRF直接录入,确保数据真实、完整、可溯源。数据管理员将定期监控数据质量,发现问题及时发起质疑,由研究者在线回复。数据库在末次受试者末次访视完成后进行锁定,生成最终分析数据库。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
This study employs an Electronic Data Capture (EDC) system for data management. The Case Report Form (CRF) is embedded in electronic form (eCRF) within the ResMan Clinical Trial Management System (www.medresman.org), which is an internet-based EDC platform supporting multi-center real-time data entry, automatic logic checks, data query and response, audit trails, hierarchical permission control, and database locking functions. All research data are directly entered through the eCRF, ensuring authenticity, completeness, and traceability. Data managers will regularly monitor data quality, promptly raising queries when issues are identified, with investigators responding online. The database will be locked after the last visit of the last subject is completed, generating the final analysis database. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |