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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047679
Receipt No. R000054363
Scientific Title Development of equipment to enable evacuation to the floor above the staircase
Date of disclosure of the study information 2022/05/08
Last modified on 2022/05/08

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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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