UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024547 |
|---|---|
| Receipt number | 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 17:11:35 |
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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
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
kazuhiro-yasuda@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028253
