UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027083 |
|---|---|
| Receipt number | R000031042 |
| Scientific Title | Feasibility test for the usage of Pepper, the humanoid robot, in care and diagnosis of dementia |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2017/12/07 16:53:56 |
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Basic information
Public title
Feasibility test for the usage of Pepper, the humanoid robot, in care and diagnosis of dementia
Acronym
Feasibility test for the usage of Pepper, the humanoid robot
Scientific Title
Feasibility test for the usage of Pepper, the humanoid robot, in care and diagnosis of dementia
Scientific Title:Acronym
Feasibility test for the usage of Pepper, the humanoid robot
Region
| Japan |
Condition
Condition
Demented patients and caregivers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility of humanoid robot, Pepper, at facilities before carrying out an intervention study to measure its effect against the activity daily life of demented persons, care burden of caregivers and the assistance in diagnosis of doctors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of persons' smile in daily life, dictation of spoken language, and patterns of speech and gaits.
Key secondary outcomes
The activity degree using transmitters.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
From June 2017 to March 2018, Pepper will be introduced in facilities in order to evaluate which scale can be measured by Pepper, such as the number of persons' smile, dictation of spoken language, and the patterns of speech and gaits.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
100 demented persons and 30 caregivers in nursing home
Key exclusion criteria
None
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kemmyo Sugiyama |
Organization
Tohoku University Graduate School of Dentistry
Division name
Liaison Center for Innovative Dentistry / Department of International and Community Oral Health
Zip code
Address
4-1 Seiryou-cho, Aoba-ward, Sendai City, Miyagi Prefecture, Japan
TEL
022-717-7638
ksugiyama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kemmyo Sugiyama |
Organization
Tohoku University Graduate School of Dentistry
Division name
Liaison Center for Innovative Dentistry / Department of International and Community Oral Health
Zip code
Address
4-1 Seiryou-cho, Aoba-ward, Sendai City, Miyagi Prefecture, Japan
TEL
022-717-7638
Homepage URL
ksugiyama@med.tohoku.ac.jp
Sponsor or person
Institute
Liaison Center for Innovative Dentistry /Department of International and Community Oral Health,Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Smart Ageing International Research Center of Tohoku University
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
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
| 2017 | Year | 05 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031042
| Research Plan | |
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| 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 |
