UMIN-CTR Clinical Trial

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
Email	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
Email	kenji@ieee.org

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053150