UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021314 |
|---|---|
| Receipt number | R000024580 |
| Scientific Title | Effect of a human-type communication robot on the cognitive function of elderly people |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/03/06 14:37:10 |
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Basic information
Public title
Effect of a human-type communication robot on the cognitive function of elderly people
Acronym
A human-type communication robot and the cognitive function
Scientific Title
Effect of a human-type communication robot on the cognitive function of elderly people
Scientific Title:Acronym
A human-type communication robot and the cognitive function
Region
| Japan |
Condition
Condition
cognitive function
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effects of a human-type communication robot on the cognitive function of elderly people living a nursing home. We observe them for 2 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mental state examination score using the Mini-Mental State Examinaton (MMSE) test, 2 months after the intervention
Key secondary outcomes
judgement, and verbal memory function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Communicating with the robot
2 months
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Good health was required for participation and was assessed by physical examination, blood chemistry panel, lipid profile and complete blood count.
Key exclusion criteria
Persons who reject to participate the program
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanako Ikeya |
Organization
The University of Tokyo
Division name
Department of Advanced Clinical Science and Therapeutics
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
81-3-5800-9116
ikeya0330@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Ikeya |
Organization
The University of Tokyo
Division name
Department of Advanced Clinical Science and Therapeutics
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
81-3-5800-9116
Homepage URL
ikeya0330@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Foundation, Health Science Center Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024580
