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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031498
Receipt No. R000035687
Scientific Title Effects of cyborg-type robot suit HAL on stand-up and sit-down exercise in normal subjects
Date of disclosure of the study information 2018/03/01
Last modified on 2019/03/07

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Basic information
Public title Effects of cyborg-type robot suit HAL on stand-up and sit-down exercise in normal subjects
Acronym Effects of HAL on stand-up and sit-down exercise in normal subjects
Scientific Title Effects of cyborg-type robot suit HAL on stand-up and sit-down exercise in normal subjects
Scientific Title:Acronym Effects of HAL on stand-up and sit-down exercise in normal subjects
Region
Japan

Condition
Condition normal subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the effects of lumbar-type HAL on cardiopulmonary burden during stand-up and sit-down exercise in normal subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes cardiopulmonary indices (O2 uptake, CO2 output, minute ventilation) during stand-up and sit-down exercise
Key secondary outcomes heart rate, blood pressure, and ratings of subjective exercise intensity during exercise

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1) wearing of lumbar-type Robot suit HAL
2) stand-up and sit-down exercise and squat exercise for 3 min both wearing and not wearing HAL
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

Not applicable
Gender Male and Female
Key inclusion criteria Eligible subjects are needed to fulfill all requirements as follows;
・a person who is over 20 years old,
・a person who understands an informed consent of this study, and signs his/her name on a consent sheet.
・a person whose weight is within 40 to 90 kg, and height is within 150 to 190 cm.
Key exclusion criteria Exclusion criteria are given as below:
・a person who correspond to contraindications of exercise testing.
・a person who are not able to attend this study due to orthopedic, central/peripheral nervous-system, or social problem.
・a person whose informed consent is obtained because of disturbance of his/her consciousness, or cognition disorder.
・a person who is considered not to complete the exercise test.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Koike
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Cardiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Email koike@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Koike
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Cardiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Homepage URL
Email koike@md.tsukuba.ac.jp

Sponsor
Institute Department of Cardiology, Faculty of Medicine, University of Tsukuba
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
Address
Tel
Email

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 筑波大学附属病院/University of Tsukuba Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ahajournals.org/doi/10.1161/circ.138.suppl_1.12765
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 Completed
Date of protocol fixation
2018 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035687

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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