UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051188 |
|---|---|
| Receipt number | R000058381 |
| Scientific Title | Preliminary survey on the physical activity of care recipients, under the use or non-use of robotic nursing care device |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/29 16:43:23 |
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Basic information
Public title
Preliminary research on the physical activity of care recipients obtained from various biometric and behavioral sensors, under the use or non-use of robotic nursing care device
Acronym
Preliminary survey on the physical activity of care recipients, under the use or non-use of robotic nursing care device
Scientific Title
Preliminary survey on the physical activity of care recipients, under the use or non-use of robotic nursing care device
Scientific Title:Acronym
Preliminary survey on the physical activity of care recipients, under the use or non-use of robotic nursing care device
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the physical activity of care recipients with and without the use of robotic nursing care devices
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity of care recipients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Regular use of robotic nursing care devices
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have obtained informed consent (IC) as collaborators of this research in advance orally and in writing. Consent is obtained from the individual. For care recipients, select those who have the ability to consent based on cognitive function.
Key exclusion criteria
Those with suspected cognitive decline are judged to be incapable of giving consent and excluded. Exclude people who cannot use stick-on wearable sensors for a long time.
Target sample size
196
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
Homepage URL
kk0724@ncgg.go.jp
Sponsor or person
Institute
National Centre for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562462311
IRB@ncgg.go.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
指定介護老人福祉施設 愛厚ホーム大府苑（愛知県）、住宅型有料老人ホーム さわやかの丘（愛知県）、介護付有料老人ホーム フラワーサーチ大府（愛知県）、介護老人保健施設 ルミナス大府（愛知県）
Special nursing homes for older adults "Ai-kou Home Obuen"(Aichi), and "Ruminas-Obu" (Aichi).
Paid nursing homes for older adults "Flower-Search-Obu" (Aichi) and "Sawayaka-no-Oka" (Aichi).
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | 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
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058381
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
