UMIN-CTR Clinical Trial

Basic information
Public title	Non-contact motion analysis of activities of daily living in community-dwelling older adults and risk factors of falls: observational study
Acronym	Risk factors of falls in community-dwelling older adults
Scientific Title	Non-contact motion analysis of activities of daily living in community-dwelling older adults and risk factors of falls: observational study
Scientific Title:Acronym	Risk factors of falls in community-dwelling older adults
Region	Japan

Condition
Condition	older adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of this study are For community-dwelling elderly 1) Motion analysis of activities of daily living by non-contact motion analysis system and development and implementation of falls risks algorithm 2) Motion analysis of activities of daily living in living space and optimization consideration for safe and secure living environment
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fall
Key secondary outcomes	Cognitive function Physical activity gait Daily activity Frailty Depression

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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Primary survey: Community dwelling older adults 1)a person at 60 or over; 2)a person with no clear functional impairment with bodily function; 3)a person who can indicate his/her intention to participate in the study. Secondary survey: 1)a person who can indicate his/her intention to participate in the study; 2)a person who is not limited in activities of daily living or a person who is not limited in activities of daily living by using an assistive device; 3)a person who agrees to place the non-contact motion analysis system in his/house or equivalents like a care facility at least one week; 4)a person who can get approval for 3) from his/her housemate or a person involved (care giver, etc).
Key exclusion criteria	Primary survey and Secondary survey: a person who are judged not to participate by the researcher
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Yagasaki
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	0353632157
Email	yagasaki@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Yagasaki
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	+81353632157
Homepage URL
Email	yagasaki@sfc.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University Global Research Institute(KGRI)
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	Keio University
Address	35 Shinanomachi, Shinjuku, Tokyo
Tel	0353632157
Email	yagasaki@sfc.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	2020 Year 10 Month 05 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	2020 Year 07 Month 15 Day
Date of IRB	2020 Year 08 Month 31 Day
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 10 Month 01 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047891

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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