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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024547
Receipt No. R000028253
Scientific Title The verification of recreation robot to enhance the social relationship-building ability of dementia patients
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/24

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Basic information
Public title The verification of recreation robot to enhance the social relationship-building ability of dementia patients
Acronym The verification of the robot to enhance the social relationship-building ability of dementia
Scientific Title The verification of recreation robot to enhance the social relationship-building ability of dementia patients
Scientific Title:Acronym The verification of the robot to enhance the social relationship-building ability of dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To enhance the social relationship building ability of dementia by performing robot operation incorporating cooperation elements of interest.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Emotional analysis,Cognitive assessment,
NM scale
Key secondary outcomes Maximum acceleration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Intervention of the robot is carried out five times within two weeks.
Intervention time per is carried out in 20 minutes.
Interventions/Control_2 Interventions that do not use the robot is carried out five times within two weeks.
Intervention time per is carried out in 20 minutes.
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
65 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Everyday life degree of autonomy 3 below
Possible person coarse behavior of hand
Sufficient joint mobility
Key exclusion criteria Heart failure that are not controlled
Acute myocardial infarction
Active myocarditis, or pericarditis
Unstable angina of
Acute systemic embolism, or pulmonary embolism
Acute infection
Thrombophlebitis
Ventricular tachycardia or refractory ventricular arrhythmia,
Severe ventricular outflow tract obstruction
Arterial hypertension that is not controlled, if you have entered the subject of other intervention study at the same time (check verbally to care worker and physical therapist in charge)
If you are affected by a magnetic force or radio waves
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code
Address Shinjuku-ku, Tokyo Waseda-cho, 27 Waseda University Green Computing System Institute 40, Building 603
TEL 03-3203-4427
Email jubi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Yasuda
Organization Waseda University
Division name Faculty of Science and Engineering National Institute of Advanced Science and Technology Institute
Zip code
Address Shinjuku-ku, Tokyo Waseda-cho, 27 Waseda University Green Computing System Institute 40, Building 60
TEL 03-3203-4427
Homepage URL
Email kazuhiro-yasuda@aoni.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 11 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
2016 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2016 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028253

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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