UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047283 |
|---|---|
| Receipt number | R000053450 |
| Scientific Title | The Effect of Non-verbal Communication Function of a Human-like Robot on Cognitive Function of the older adults |
| Date of disclosure of the study information | 2022/03/25 |
| Last modified on | 2023/03/26 12:56:10 |
* 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
The Effect of Non-verbal Communication Function of a Human-like Robot on Cognitive Function of the older adults
Acronym
The Effect of Non-verbal Communication Function of a Human-like Robot on Cognitive Function of the older adults
Scientific Title
The Effect of Non-verbal Communication Function of a Human-like Robot on Cognitive Function of the older adults
Scientific Title:Acronym
The Effect of Non-verbal Communication Function of a Human-like Robot on Cognitive Function of the older adults
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of non-verbal communication functions of a humanoid robot (Actroid) on human conversation and cognitive functions, and to identify potential needs and desires for a humanoid robot. Furthermore, the objective was to create a speech (emotional) corpus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
cognitive and communication function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Have a conversation for about 30min. with a robot that has movements and perform cognitive function tests during the conversation.
Interventions/Control_2
Have a conversation for about 30min. with a robot that has no movement, and performs a cognitive function test in the conversation.
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
Older person: Older than 70 years old. Gender is not required. Those who are independent in daily life and can give informed consent.
Steakholder (family, staff): Any age and gender. Those who can give informed consent.
Key exclusion criteria
(1) Persons with severe cognitive impairment and severe higher brain dysfunction
(2) Persons with dementia and higher brain dysfunction with developmental disabilities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
9808575
Address
Aobaku seiryomachi 4-1 Sendai
TEL
7178559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
9808575
Address
Aobaku seiryomachi 4-1 Sendai
TEL
0227178561
Homepage URL
toshimi.ogawa.e6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Internal Affairs and Communications
Strategic Information and Communications R&D Promotion Programme
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 Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2022 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053450
