UMIN-CTR Clinical Trial

Basic information
Public title	Development of equipment to enable evacuation to the floor above the staircase
Acronym	Development of equipment to enable evacuation to the floor above the staircase
Scientific Title	Development of equipment to enable evacuation to the floor above the staircase
Scientific Title:Acronym	Development of equipment to enable evacuation to the floor above the staircase
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of pull-up time and pull-up force of the prototype machine by human power
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pulling time, pulling power
Key secondary outcomes	Subjectivity of Burden and Likelihood of raising

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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Pulling up the prototype with dummy on it to the upper floor of the staircase 2 conditions 2 days
Interventions/Control_2	Pulling a stretcher with a dummy on it up the stairs to the upper floor 1 conditions 2 days
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Medical illness Motility disorder
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Miyasaka
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL	011-688-2232
Email	tmiyasaka-hus@umin.ac.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Miyasaka
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL	011-688-2232
Homepage URL
Email	tmiyasaka-hus@umin.ac.jp

Sponsor
Institute	Hokkaido University of Science
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University of Science
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
Tel	011-688-2232
Email	tmiyasaka-hus@umin.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 05 Month 08 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	30
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	2022 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 31 Day
Last follow-up date	2024 Year 05 Month 30 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 05 Month 08 Day
Last modified on	2022 Year 05 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054363

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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