UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031498
Receipt number 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 14:31:35

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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 or person

Institute

Department of Cardiology, Faculty of Medicine, University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.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