UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification of recreation robot to enhance the social relationship-building ability of dementia patients
Title of the study (Brief title)	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	Hiroyasu Iwata
Organization	Waseda University
Division name	Faculty of Science and Engineering
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	Kazuhiro Yasuda
Organization	Waseda University
Division name	Faculty of Science and Engineering National Institute of Advanced Science and Technology Institute
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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