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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046098
Receipt No. R000052586
Scientific Title A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/17

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Basic information
Public title A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Acronym A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Scientific Title A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Scientific Title:Acronym A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Region
Japan

Condition
Condition Pediatric patients, rehabilitation patients, oncology-related patients(obstetrics and gynecology, breast surgery, medical oncology), nurses
Classification by specialty
Hematology and clinical oncology Breast surgery Obsterics and gynecology
Pediatrics Rehabilitation medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this project is to pursue the new possibilities of family-type robots in the medical and healthcare fields and to establish new relationships between humans and robots, such as patients, their families, and healthcare professionals. This study is to conduct a preliminary investigation for this purpose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes To evaluate the change in the state of mind before and after the introduction of LOVOT to patients and their parents or medical staff.
To evaluate behavioral changes on the video for rehabilitation patients.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1
Rehabilitation patients will be monitored for a total of two weeks, one week each with and without LOVOT. All other patients and health care providers will be assessed for one week with LOVOT.
Rehabilitation patients will be monitored for a total of two weeks, one week each with and without LOVOT. All other patients and health care providers will be tested for 1 week with LOVOT.
Interventions/Control_2
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
5 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients were selected by the attending physician based on their disease and condition.
Key exclusion criteria The patients who are unsuitable by attending physician in consideration of their disease and condition.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Kobayashi
Organization St. Marianna University School of Medicine
Division name Medical Information and Communication Technology Research
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
TEL 044-977-8111
Email yasukoba@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Kobayashi
Organization St. Marianna University School of Medicine
Division name Medical Information and Communication Technology Research
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
TEL 044-977-8111
Homepage URL
Email yasukoba@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Medical Information and Communication Technology Research
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
Medical Information and Communication Technology Research
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 St. Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
Tel 044-977-8111
Email yasukoba@marianna-u.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
2021 Year 11 Month 17 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
2020 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 20 Day
Last follow-up date
2022 Year 01 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
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052586

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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