UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038256 |
|---|---|
| Receipt number | R000043611 |
| Scientific Title | Empirical research aiming to formulate standard protocols for validation of nursing care robot and equipment |
| Date of disclosure of the study information | 2019/10/09 |
| Last modified on | 2022/04/12 12:28:41 |
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Basic information
Public title
Empirical research aiming to formulate standard protocols for validation of nursing care robot and equipment
Acronym
Empirical research for validation of nursing care robot and equipment
Scientific Title
Empirical research aiming to formulate standard protocols for validation of nursing care robot and equipment
Scientific Title:Acronym
Empirical research for validation of nursing care robot and equipment
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of transfer support (non-wearing) devices
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Record of use of care assist devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of care assist devices 1
Interventions/Control_2
Use of care assist devices 2
Interventions/Control_3
Use of standard wheelchairs
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
1. The subjects who have given written informed consent by themselves.
2. More than 20 years old
Key exclusion criteria
1. Persons with history of brain disease, neurological, muscular disease, heart disease, epilepsy.
2. Having a pacemaker
3. having magnetic devised which cannot be removed from body, such as a cochlear implant.
4. Having an implantable electrode (such as epidural electrode or vagus nerve stimulation electrode)
5. Pregnant women
6. Other persons who are decided by the Research as being inappropriate for entry into the present study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Saitoh |
Organization
Fujita Health University, School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
Fujita Health University, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
koyamas@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
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
| 2019 | Year | 10 | Month | 09 | 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
5
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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
