UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of data collecting systems of functioning using International Classifications of Functioning, Disability and Welfare
Title of the study (Brief title)	Development of data collecting systems using ICF
Region	Japan

Condition
Condition	Disease which requires rehabilitation such as stroke, spinal cord injury, fracture etc.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to develop the data set and data collecting systems using ICF and to develop standardized metrics based on the data to facilitate implementation of ICF in Japan.
Basic objectives2	Others
Basic objectives -Others	Development of data collecting systems and standardized metrics based on the framework of ICF
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Not applicable
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients older than 20 who agreed to participate the study
Key exclusion criteria	Exclude the patients who have problems in consciousness or cognition and cannot follow the instructions or answer questionnaires.
Target sample size	2000

Research contact person
Name of lead principal investigator	Eiichi Saitoh
Organization	Fujita Health University, School of Medicine
Division name	Department of Rehabilitation Medicine I
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	Yuki Senju
Organization	Fujita Health University, Schoole of Medicine
Division name	Department of Rehabilitation Medicine I
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Japan
TEL	0562-93-2167
Homepage URL
Email	rehabmed@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In this study, the following researches would be done: - to develop the ICF data set and data collecting systems - to collect data based on the newly developed systems - to develop standardized metrics based on the collected data, using Rasch analysis.

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030149