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Development and psychometric evaluation of a Chinese version of the PaArticular Scales
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注册号:

Registration number:

ChiCTR2000030413 

最近更新日期:

Date of Last Refreshed on:

2020-03-01 

注册时间:

Date of Registration:

2020-03-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件 中文版關節攣縮活動參與量表的發展及心理計量特質分析 

Public title:

Development and psychometric evaluation of a Chinese version of the PaArticular Scales 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中文版關節攣縮活動參與量表的發展及心理計量特質分析 

Scientific title:

Development and psychometric evaluation of a Chinese version of the PaArticular Scales 

研究课题代号(代码):

Study subject ID:

馬偕醫學院 (RD1080112) 

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:

陳貞蓉 

研究负责人:

陳以昌 

Applicant:

Chen-Jung Chen 

Study leader:

Yi-chang Chen 

申请注册联系人电话:

Applicant telephone:

+886 919818364 

研究负责人电话:

Study leader's telephone:

+886 4 2463-6731 

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:

jan6110@mmc.edu.tw 

研究负责人电子邮件:

Study leader's E-mail:

tom610713@yahoo.com.tw 

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:

中國臺灣新北市三芝區中正路三段46號 

研究负责人通讯地址:

中國臺灣臺中大到四段1230巷20-3號3樓之3 

Applicant address:

46 Section 3, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan, China 

Study leader's address:

Room 3, Third Floor, No. 20-3, 1230th Lane, Fourth Section, Taichung Port Road, Situn District, Taichung City 40764, Taiwan, China 

申请注册联系人邮政编码:

Applicant postcode:

407 

研究负责人邮政编码:

Study leader's postcode:

407 

申请人所在单位:

馬偕醫學院 

Applicant's institution:

Mackay Medical College 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

馬偕醫學院 

Primary sponsor:

Mackay Medical College 

研究实施负责(组长)单位地址:

新北市三芝區中正路三段46號 

Primary sponsor's address:

46 Third Section, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

臺灣

市(区县):

新北市

Country:

China

Province:

Taiwan

City:

New Taipei City

单位(医院):

馬偕醫學院

具体地址:

新北市三芝區中正路三段46號

Institution
hospital:

Mackay Medical College

Address:

46 Third Section, Zhongzheng Road, Sanzhi District

经费或物资来源:

馬偕醫學院 (RD1080112) 

Source(s) of funding:

Mackay Medical College (RD1080112) 

研究疾病:

關節攣縮 

Target disease:

Joint contractures 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究目的是發展關節攣縮參與量表中文版並評估心理計量特性,再將發展出的量表投入實際運用中,並詳細評估再測信度、客觀性、內部一致性信度和效標效度。 

Objectives of Study:

To develop a Chinese version of the PaArticular Scales of joint contractures and evaluate the psychometric characteristics. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

參與者收案條件標準: (1)大於或等於65歲; (2)入住機構超過半年; (3)具備填寫或回答問卷的語言技能; (4) 經醫生、護士或治療師證實,在任一處重要關節(膝、髖、踝、肩、肘和手)有嚴重關節攣縮。嚴重關節攣縮的定義為四點量表(four-point scale)評分為3(損失>2/3關節活動度)( Hoang, Gandevia, & Herbert, 2014)。在仰臥或側臥的姿勢下,使用測角器(goniometer)以四點量表(four-point scale)測量左右兩側上肢(肩部、肘部和腕部)和下肢(髖部、膝部和踝部)12個主要關節的被動關節活動度(Hoang, Gandevia, & Herbert, 2014)。0 = 正常(關節活動度無損失);1 = 輕度(mild)(損失≦1/3關節活動度);2 = 中度(moderate)(損失≦2/3關節活動度);3 = 嚴重(severe)(損失>2/3關節活動度)。四點量表主要優點是可以在有限時間內,測量數量眾多的關節活動度 (Hoang, Gandevia, & Herbert, 2014)。四點量表運用在測試長照機構居住關節攣縮患者的樣本中的施測者間信度(inter-rater reliability)是可接受的(acceptable)。Kendall的tau係數=0.62,拔靴法(bootstrapped)95%信賴區間(CI) = 0.49-0.74(Kwah, Harvey, Diong, & Herbert, 2012)。 

Inclusion criteria

(1) Aged >=65 years old; (2) more than 6 months living at the facility; (3) having the language skills to fill out or answer the questionnaire; (4) severe joint contractures in any one important joint (knee, hip, ankle, shoulder, elbow and hand) with confirmation from a doctor, a nurse, or a therapist. Severe joint contractures were defined as 3 on a 4-point scale (loss > 2/3 of joint range of motion). 

排除标准:

收案排除標準是具認知功能障礙者及神經檢查診斷有重大精神疾病者。 

Exclusion criteria:

Those with cognitive impairment and major mental illness diagnosed by physicians were excluded. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-07-01 

干预措施:

Interventions:

组别:

Case series

样本量:

175

Group:

Case series

Sample size:

干预措施:

問卷調查

干预措施代码:

Intervention:

a cross-sectional survey

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

台灣 

市(区县):

新北市 

Country:

China 

Province:

Taiwan 

City:

New Taipei 

单位(医院):

馬偕醫學院 

单位级别:

大學 

Institution
hospital:

Mackay Medical College  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

關節攣縮活動參與量表

指标类型:

主要指标 

Outcome:

Chinese version of the PaArticular Scales

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:

活動參與

组织:

Sample Name:

activity and participation

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 65 years
最大 Max age 120 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):

採多階段取樣法隨機抽樣,採用三階段分層隨機抽樣方法抽出等機率隨機樣本。三階段抽樣過程如下:(1)從北中南部區域中各抽出4個長照機構﹔(2)抽出長照機構後,先與長照機構負責人電話聯繫,取得同意後,擇日與負責人、事務人員與長照機構住民舉行研究說明會,經由長照機構住民同意後,由各個機構護理長(head nurses)篩選符合條件的長照機構住民名冊﹔(3)再由名冊中採簡單隨機取樣方法以電腦亂數表方式從中隨機選取15-30位(12個長照機構共175-350位)住民。

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

臨床試驗政策

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

https://clinicaltrials.gov/

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:

問卷紀錄採集

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

a cross-sectional survey

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-01
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