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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037034
Receipt No. R000042192
Scientific Title Development of medical check up system for locomotive syndrome
Date of disclosure of the study information 2019/10/01
Last modified on 2021/09/01

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Basic information
Public title Development of medical check up system for musculoskeletal system
Acronym Development of medical check up system for musculoskeletal system
Scientific Title Development of medical check up system for locomotive syndrome
Scientific Title:Acronym Development of medical check up system for locomotive syndrome
Region
Japan

Condition
Condition Locomotive syndrome
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of locomotive organs indices for prevention of orthopedic/geriatric diseases and functional deterioration
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Locomotive scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Receipt of own result of evaluation of locomotive organs by this system
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
35 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Examinees consent to participate
Key exclusion criteria Examinees do not consent to participate
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takeo
Middle name
Last name Nagura
Organization Keio University, School of Medicine
Division name Department of Clinical Biomechanics
Zip code 1608582
Address 35 Shinanomach, Shinjuku, Tokyo
TEL 0353633812
Email nagura@z8.keio.jp

Public contact
Name of contact person
1st name Sumi
Middle name
Last name Yamashita
Organization Keio University, School of Medicine
Division name Department of Orthopedic Surgery
Zip code 1608582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 0353633812
Homepage URL
Email sumi@a5.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB Board, Keio University
Address 35 Shinanomachi, Shinjuku, Tokyo
Tel 0333531211
Email med-rinri-jimu@adst.keio.ac.jp

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
2019 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 06 Month 12 Day
Date of IRB
2020 Year 03 Month 24 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 12 Day
Last modified on
2021 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042192

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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