UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046592 |
|---|---|
| Receipt number | R000053150 |
| Scientific Title | Patient Transportation in Hospitals Using Automated Personal Mobility |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2022/01/09 14:54:37 |
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Basic information
Public title
Patient Transportation in Hospitals Using Automated Personal Mobility
Acronym
Automated Personal Mobility
Scientific Title
Patient Transportation in Hospitals Using Automated Personal Mobility
Scientific Title:Acronym
Hospital Personal Mobility
Region
| Japan |
Condition
Condition
Outpatients of orthopedic department who are able to operate a power wheelchair.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate if automated mobility could provide a new means of in-hospital transportation and improve safety and convenience, especially for patients who are anxious about walking long distances or who have leg or back problems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation, including safety related to the aircraft and surrounding people, and the patient's sense of security, associated with automated transport by an automated personal mobility system.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The subject is automatically transported to a predetermined location by automated personal mobility. On the outward journey, the vehicle runs in an automatic mode that does not require driving, and at the end of the journey, it is returned to the original location by unmanned operation. In addition, by using cameras installed in the hospital corridor, passing and overtaking scenes will be filmed to verify safety.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Orthopedic patients who are able to walk independently
2) Outpatients who are able to operate an electric wheelchair.
3) Patients who have been fully informed about the study and have given written consent of their own free will with sufficient understanding.
Key exclusion criteria
1) Patients whose general condition is unstable.
2) Other patients who are judged by the investigators to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishiyama |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3223
kenji@ieee.org
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba
Division name
Center for Cybernics Research
Zip code
305-8573
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-5679
Homepage URL
kenji@ieee.org
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Tsukuba Smart City Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research and Development Organization
Address
2-1-1, Amakubo, Tsukuba
Tel
029-853-3749
rinshokenkyu@un.tsukuba.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
| 2022 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053150
