UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041970
Receipt number 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 2023/09/14 11:38:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Keio University

Institute

Department

Personal name



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

No longer recruiting

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

2023 Year 09 Month 14 Day



Link to view the page

Value
https://center6.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