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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053150


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name