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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026249
Receipt No. R000030149
Scientific Title Development of data collecting systems of functioning using International Classifications of Functioning, Disability and Welfare
Date of disclosure of the study information 2017/02/24
Last modified on 2017/02/21

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Basic information
Public title Development of data collecting systems of functioning using International Classifications of Functioning, Disability and Welfare
Acronym Development of data collecting systems using ICF
Scientific Title Development of data collecting systems of functioning using International Classifications of Functioning, Disability and Welfare
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiichi Saitoh
Organization Fujita Health University, School of Medicine
Division name Department of Rehabilitation Medicine I
Zip code
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Senju
Organization Fujita Health University, Schoole of Medicine
Division name Department of Rehabilitation Medicine I
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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