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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041970
Receipt No. R000047891
Scientific Title Non-contact motion analysis of activities of daily living in community-dwelling older adults and risk factors of falls: observational study
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/01

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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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