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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027083
Receipt No. 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

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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
Email 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
Email ksugiyama@med.tohoku.ac.jp

Sponsor
Institute Liaison Center for Innovative Dentistry /Department of International and Community Oral Health,Tohoku University Graduate School of Dentistry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031042

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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