ChiCTR2500109851 版本V1.1 版本创建时间2025/09/25 17:39:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500109851 

最近更新日期：

Date of Last Refreshed on：

 2025-09-25 17:31:10 

注册时间：

Date of Registration：

 2025-09-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

上肢周围神经损伤患者回授法教育模块的开发

Public title：

DEVELOPMENT OF A TEACH-BACK EDUCATIONAL MODULE FOR PATIENTS WITH PERIPHERAL NERVE INJURIES IN THE UPPER LIMB

注册题目简写：

English Acronym：

研究课题的正式科学名称：

上肢周围神经损伤患者回授法康复教育模块的开发与初步验证研究

Scientific title：

Development and Preliminary Validation of a Teach-Back Rehabilitation Education Module for Patients with Upper Limb Peripheral Nerve Injury

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：

史东东 

研究负责人：

王骏 

Applicant：

Dongdong Shi 

Study leader：

Jun Wang 

申请注册联系人电话：

Applicant telephone：

 +86 138 2977 6964

研究负责人电话：

Study leader's
telephone：

+86 136 0618 0365

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：

 bingxue11wangzi@sina.cn

研究负责人电子邮件：

Study leader's E-mail：

 wangjun2115@suda.edu.cn

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：

中国江苏扬州江都区仙女镇鸿江花园10栋401室

研究负责人通讯地址：

江苏省无锡市滨湖区梁溪路 999 号-无锡第九人民医院-康复医学科

Applicant address：

Room 401, Building 10, Hongjiang Flower Garden, Xiannu Township,Yangzhou, Jiangsu, P.R. China

Study leader's address：

Department of Rehabilitation Medicine , Wuxi No.9 People's Hospital, No. 999 Liangxi Road, Binhu District, Wuxi City, Jiangsu Province, P.R. China

申请注册联系人邮政编码：

Applicant postcode：

 225200

研究负责人邮政编码：

Study leader's postcode：

 214062

申请人所在单位：

马来西亚国立大学健康科学学院

Applicant's institution：

Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan

研究负责人所在单位：

无锡市第九人民医院

Affiliation of the Leader：

Wuxi No.9 People's Hospital

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：

 KS2025026

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：

无锡市第九人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Wuxi No.9 People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-08 00:00:00

伦理委员会联系人：

刘宇

Contact Name of the ethic committee：

YU LIU

伦理委员会联系地址：

江苏省无锡市滨湖区梁溪路 999 号-无锡第九人民医院-伦理委员会

Contact Address of the ethic committee：

Medical Ethics Committee, Wuxi No.9 People's Hospital, No. 999 Liangxi Road, Binhu District, Wuxi City, Jiangsu Province, P.R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 510 8581 1599

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：

无锡市第九人民医院

Primary sponsor：

Wuxi No.9 People's Hospital

研究实施负责（组长）单位地址：

江苏省无锡市滨湖区梁溪路 999 号

Primary sponsor's address：

No. 999 Liangxi Road, Binhu District, Wuxi City, Jiangsu Province, P.R. 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)：

江苏

市(区县)：

无锡

Country：

China

Province：

Jiangsu

City：

单位(医院)：

无锡市第九人民医院

具体地址：

江苏省无锡市滨湖区梁溪路 999 号

Institution
hospital：

Wuxi No.9 People's Hospital

Address：

No. 999 Liangxi Road, Binhu District, Wuxi City, Jiangsu Province, P.R. China

国家：

马来西亚

省(直辖市)：

吉隆坡联邦直辖区

市(区县)：

吉隆坡市

Country：

Malaysia

Province：

Federal Territory of Kuala Lumpur

City：

Kuala Lumpur

单位(医院)：

马来西亚国立大学

具体地址：

马来西亚吉隆坡联邦直辖区吉隆坡市拉惹穆达阿都阿兹路 50300 号 马来西亚国民大学（UKM）吉隆坡校区 健康科学学院 康复和特殊需求研究中心

Institution
hospital：

Universiti Kebangsaan Malaysia (UKM)

Address：

Level G, Blok E, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

上肢周围神经损伤  

Target disease：

PERIPHERAL NERVE INJURIES IN THE UPPER LIMB

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：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

针对上肢周围神经（正中神经、尺神经、桡神经）损伤患者存在的健康教育缺口，本研究旨在开发一套基于回授法（Teach-Back）的个性化康复教育模块，突破传统单向信息传递的局限性。通过整合患者需求分析、多学科专家协作及动态反馈机制，解决以下核心问题： 1.需求评估：了解目标对象的康复需求，涵盖功能恢复、心理支持及经济负担等维度； 2.教育效能低下：构建双向互动式教育路径，通过“知识复述-反馈修正”闭环提升患者知识内化率； 3.资源分布不均：设计可跨场景（医院-社区-家庭）应用的模块化内容，适配不同医疗资源配置水平。  

Objectives of Study：

In response to the health education gaps among patients with upper limb peripheral nerve injuries (median nerve, ulnar nerve, radial nerve), this study aims to develop a personalized rehabilitation education module based on the Teach-Back method, breaking through the limitations of traditional one-way information transmission. By integrating patient needs analysis, multidisciplinary expert collaboration, and a dynamic feedback mechanism, the study addresses the following core issues:? Needs Assessment: Understand the rehabilitation needs of the target population, covering dimensions such as functional recovery, psychological support, and economic burden;? Low Educational Effectiveness: Construct a two-way interactive educational pathway, and improve the rate of patients' knowledge internalization through a closed loop of "knowledge retelling - feedback and revision";? Uneven Resource Distribution: Design modular content applicable across multiple scenarios (hospital - community - family) to adapt to different levels of medical resource allocation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

PhaseⅠ-患者 i.年龄在18至60岁的成年人。 ii.受到影响正中神经、尺神经和/或桡神经的单个或多个神经损伤。损伤类型将通过病历确认。 iii.在2024年6月1日至2025年5月31日期间接受过手术。 iv.能够阅读和用中文交流。 Phase Ⅱ-专家 i. 康复医生、手部及显微外科医生以及心理健康专家：在各自康复、手部外科和心理健康领域拥有专业培训，且具备至少5年的专业经验。 ii. 职业治疗师、物理治疗师以及护士：拥有学士学位及以上学历，并且在手部外科和康复领域具备至少5年的专业经验。 Phase Ⅲ-专家 i. 康复医生、手部及显微外科医生和心理健康专家：在各自康复、手部外科和心理健康领域拥有专业培训，且具备至少5年的专业经验。 ii. 职业治疗师、物理治疗师和护士：拥有学士学位及以上学历，并且在手部外科和治疗领域具备至少5年的专业经验。 iii. 语言能力：参与者必须具备足够的英语水平，以理解、评估并完成英语评估工具。 Phase Ⅲ-患者 i. 年龄在18至60岁之间的成年人。 ii. 单次或多次神经损伤，影响正中神经、尺神经和/或桡神经。损伤类型将通过病历确认。 iii. 在2024年5月1日至2025年5月31日期间接受过手术。 iv. 能够阅读中文并用普通话交流。

Inclusion criteria

Phase Ⅰ - Patients? i. Adults aged 18 to 60 years.? ii. Single or multiple nerve injuries affecting the median nerve, ulnar nerve, and/or radial nerve. The type of injury will be confirmed by medical records.? iii. Having undergone surgery between June 1, 2024, and May 31, 2025.? iv. Able to read and communicate in Chinese.? Phase II - Experts? i. Rehabilitation physicians, hand and microsurgery surgeons, and mental health specialists: Having received professional training in their respective fields of rehabilitation, hand surgery, and mental health, with at least 5 years of professional experience.? ii. Occupational therapists, physical therapists, and nurses: Holding a bachelor’s degree or above, with at least 5 years of professional experience in the fields of hand surgery and rehabilitation.? Phase III - Experts? i. Rehabilitation physicians, hand and microsurgery surgeons, and mental health specialists: Having received professional training in their respective fields of rehabilitation, hand surgery, and mental health, with at least 5 years of professional experience.? ii. Occupational therapists, physical therapists, and nurses: Holding a bachelor’s degree or above, with at least 5 years of professional experience in the fields of hand surgery and therapy.? iii. Language proficiency: Participants must have a sufficient level of English to understand, evaluate, and complete English assessment tools.? Phase III - Patients? i. Adults aged between 18 and 60 years.? ii. Single or multiple nerve injuries affecting the median nerve, ulnar nerve, and/or radial nerve. The type of injury will be confirmed by medical records.? iii. Having undergone surgery between May 1, 2024, and May 31, 2025.? iv. Able to read Chinese and communicate in Mandarin.

排除标准：

PhaseⅠ-患者 i.存在严重合并症，包括心血管疾病、呼吸系统疾病或其他可能影响康复过程或参与的显著健康问题。 ii.认知障碍或严重心理健康问题，影响他们对康复的理解或参与能力，如病历所述。 Phase Ⅱ-专家 无特殊 Phase Ⅲ-专家 参加过焦点小组讨论的专家。 Phase Ⅲ-患者 i. 存在严重合并症，包括心血管疾病、呼吸系统疾病或其他可能影响康复过程或参与度的重大健康问题。 ii. 存在认知障碍或严重的精神健康问题，影响其对参与的理解或能力，如病历所述。 iii. 参加过第一阶段需求评估或在第一阶段拒绝参加的患者。

Exclusion criteria：

Phase I - Patients? i. Presence of severe comorbidities, including cardiovascular diseases, respiratory diseases, or other significant health issues that may affect the rehabilitation process or participation.? ii. Cognitive impairment or severe mental health problems that affect their ability to understand or participate in rehabilitation, as stated in medical records.? Phase II - Experts? No specific exclusion criteria.? Phase III - Experts? Experts who have participated in focus group discussions.? Phase III - Patients? i. Presence of severe comorbidities, including cardiovascular diseases, respiratory diseases, or other major health issues that may affect the rehabilitation process or participation.? ii. Presence of cognitive impairment or severe mental health problems that affect their ability to understand or participate, as stated in medical records.? iii. Patients who have participated in the Phase Ⅰ needs assessment or refused to participate in Phase Ⅰ.

研究实施时间：

Study execute time：

从 From 2025-09-30 00:00:00至 To 2026-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-30 00:00:00 至 To 2026-08-01 00:00:00

干预措施：

Interventions：

组别：

PhaseⅠ-患者

样本量：

 15

Group：

PhaseI-Patients

Sample size：

干预措施：

招募15例上肢神经损伤术后患者，采用半结构化访谈提纲，通过主题编码识别三大核心需求（功能重建、疼痛管理、心理支持）及四大障碍（经济压力、健康素养不足、康复资源断层、家庭支持缺失）。

干预措施代码：

Intervention：

Fifteen patients with upper limb nerve injury who have undergone surgery will be recruited. A semi-structured interview outline will be used, and through thematic coding, three core needs (functional reconstruction, pain management, psychological support) and four barriers (economic pressure, insufficient health literacy, gaps in rehabilitation resources, lack of family support) will be identified.

Intervention code：

组别：

Phase Ⅱ - 专家

样本量：

 6

Group：

Phase II - Experts

Sample size：

干预措施：

组织6领域专家（职业治疗、手外科、心理学等）开展焦点小组讨论，基于前期需求报告构建包含6大模块（神经保护、关节活动训练等）的教育框架，配套开发10分钟/节的教学视频、患者/治疗师版本手册。

干预措施代码：

Intervention：

Experts from 6 fields (including occupational therapy, hand surgery, psychology, etc.) will be organized to conduct focus group discussions. Based on the preliminary needs report, an educational framework consisting of 6 modules (including nerve protection, joint mobility training, etc.) will be constructed. Supporting teaching videos (10 minutes per session) and manuals for patients and therapists will also be developed.

Intervention code：

组别：

Phase Ⅲ - 专家

样本量：

 10

Group：

Phase III - Experts

Sample size：

干预措施：

10名未参与前期设计的专家采用PEMAT-A/V工具评估开发材料。

干预措施代码：

Intervention：

Ten experts who did not participate in the previous design will use the PEMAT-A/V tool to evaluate the developed materials.

Intervention code：

组别：

Phase Ⅲ-患者

样本量：

 10

Group：

Phase III-Patients

Sample size：

干预措施：

10位在无锡市第九人民医院进行手术和康复的上肢神经损伤患者对开发材料进行评估。

干预措施代码：

Intervention：

Ten patients with upper limb nerve injury who underwent surgery and rehabilitation at Wuxi No.9 People's Hospital will evaluate the developed materials.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

 无锡市 

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 无锡市第九人民医院 

单位级别：

 三甲 

Institution
hospital：

Wuxi No.9 People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视听材料版患者教育材料评估工具（PEMAT-A/V）

指标类型：

主要指标

Outcome：

Patient Education Materials Assessment Tool for Audiovisual Materials (PEMAT-A/V)

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：

无

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 18 岁 years
最大 Max age 60 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）：

无

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

None

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：

Blinding：

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

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）：

我们将以论文的形式公布试验方案，对有需要原始数据的科研工作者，可以提供原始数据

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

we will publish the study protocol and will provide original data if required

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：

一、病例记录表（Case Record Form, CRF）? CRF 设计与内容：采用定制化纸质表单，含两类核心记录：①定性数据记录（患者访谈、专家讨论关键信息，含对象基本信息、内容摘要及双签名核对栏）；②定量评估记录（各类评估量表数据，含填写说明及缺失值备注栏）。? CRF 数据采集流程：线下采集用 “录音笔录制 + CRF 同步记录”，线上采集（跨区域场景）用 “腾讯会议录制 + CRF 回溯补记”，均在 48 小时内由 2 名研究者核对确认并双签名。? CRF 存储归档：统一存放于无锡市第九人民医院科研科档案柜，按 “研究阶段 - 数据类型” 分类归档，建立借阅登记本确保可追溯。? 二、电子采集和管理系统（Electronic Data Capture, EDC）? EDC 系统选择与功能：因样本量小（患者 25 例、专家约 16 人），采用 “Excel+Word” 简易体系：①Excel 管理定量数据，含患者基础信息、评估得分表及数据核查表，设有效性规则及每周逻辑核查；②Word 管理定性数据，将录音 / 会议内容转录为文字稿，按主题编码整理并关联原始记录编号。? 电子数据安全：电子数据由研究指定人员专人保管，统一保存至无锡市第九人民医院科研科指定存储位置，个人信息去标识化（用编号代替姓名，隐藏联系方式关键信息）。

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

Ⅰ. Case Record Form (CRF)? CRF Design and Content? A customized paper-based form is adopted, containing two types of core records: ① Qualitative data records (key information from patient interviews and expert discussions, including basic information of participants, content summaries, and a double-signature verification column); ② Quantitative assessment records (data from various evaluation scales, including filling instructions and a missing value annotation column).? CRF Data Collection Process? Offline data collection: Conducted via "recording with a voice recorder + simultaneous CRF recording";? Online data collection (for cross-regional scenarios): Conducted via "recording with Tencent Meeting + retrospective CRF supplementation".? All data will be verified, confirmed, and double-signed by 2 researchers within 48 hours.? CRF Storage and Archiving? All CRFs are uniformly stored in the file cabinet of the Scientific Research Department of Wuxi Ninth People's Hospital, and archived by "research phase - data type". A borrowing registration book is established to ensure traceability.? II. Electronic Data Capture (EDC) System? EDC System Selection and Functions? Due to the small sample size (25 patients, approximately 16 experts), a simple system consisting of "Excel + Word" is adopted:? 1) Excel is used to manage quantitative data, including patients' basic information, evaluation score sheets, and data verification forms. Validity rules are set, and weekly logical verification is conducted;? 2) Word is used to manage qualitative data: audio/meeting content is transcribed into text manuscripts, organized by thematic coding, and linked to the serial numbers of original records.? Electronic Data Security? Electronic data is kept by designated researchers in charge of the study, and uniformly stored in the designated storage location of the Scientific Research Department of Wuxi Ninth People's Hospital. Personal information is de-identified (names are replaced with serial numbers, and key information of contact methods is hidden).?

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：

  2025-09-25 17:30:58