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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038256
Receipt No. 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 2020/10/09

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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
Email 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
Email koyamas@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.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


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