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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036171
Receipt No. R000041210
Scientific Title Observational study on gait change in the physical frailty using digital human technology
Date of disclosure of the study information 2019/03/14
Last modified on 2019/03/12

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Basic information
Public title Study on gait change in the physical frailty using digital human technology
Acronym Study of physical frailty using digital human technology
Scientific Title Observational study on gait change in the physical frailty using digital human technology
Scientific Title:Acronym Observational study of physical frailty using digital human technology
Region
Japan

Condition
Condition Physical frailty
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand characteristics and factors about change of gait in the frailty using the computer simulation.
Basic objectives2 Others
Basic objectives -Others To understand characteristics and factors about change of gait in the frailty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait analysis data
(Marker position, ground reaction force)
Key secondary outcomes

Base
Study type Observational

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Independent walking for six minutes
Informed-consent has been obtained
Key exclusion criteria High-blood pressure(systolic blood pressure less than 180 mmHg or diastolic blood pressure more than 120 mmHg or resting heart rate more than 120/min)
Restricted exercise due to heart function or respiratory function disorder
To need substitute to sign consent form
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Izumi]
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Department of Rehabilitation medicine
Zip code 474-8511
Address 7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Department of Rehabilitation medicine
Zip code 474-8511
Address 7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Toyota motor corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee of the National Center for Geriatrics and Gerontology
Address 7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email ik7710@ncgg.go.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 03 Month 14 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
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 14 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2019 Year 03 Month 12 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041210

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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