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 | 2024/10/04 09:19:44 |
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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
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
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
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
115
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
Completed
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
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047891
