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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026713
Receipt No. R000030646
Scientific Title The effects of reduction of cardiopulmonary burden using a hybrid assistive limb (HAL) on healthy adults
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/08

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Basic information
Public title The effects of reduction of cardiopulmonary burden using a hybrid assistive limb (HAL) on healthy adults
Acronym Cardiopulmonary load-reduction effects of HAL
Scientific Title The effects of reduction of cardiopulmonary burden using a hybrid assistive limb (HAL) on healthy adults
Scientific Title:Acronym Cardiopulmonary load-reduction effects of HAL
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Human assistive limb (HAL) has been developed to improve motor disorder due to central nervous system disease, or neuromuscular disease. HAL could be applyed to the patients whose exercise tolerance was seriously impaired with an internal organ derangement, especially with heart failure, according to the theory of HAL, which support voluntary movements bia torque of exoskeleton. Before applying to the patient with heart failure practically, we try to investigate whether HAL is able to reduce cardiopulmonary load during exercise for healthy 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) at an identical exercise load (speed).
Key secondary outcomes The changes of heart rate and blood pressure.
The ratings of subjective exercise intensity.

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 Wearing human assistive limb (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
90 years-old >
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, such as decompensated heart failure, unstable angina, symptomatic aortic valve stenosis, symptomatic hypertropic obstructive cardiomyopathy, exercise-induced arrhythmia, acute myocarditis, or systemic inflammatory disease.
・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 10

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 city, Ibaraki prefecture
TEL 029-853-3143
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 city, Ibaraki prefecture
TEL 029-853-3143
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00421-018-4040-7
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
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 30 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
2017 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030646

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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