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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | older adults | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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). |
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Key exclusion criteria | Primary survey and Secondary survey:
a person who are judged not to participate by the researcher |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |