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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024803
Receipt No. R000028540
Scientific Title The physiological effects of the supportive robotic device, HAL: hemodynamic responses of healthy adult during the motion with the HAL single joint type
Date of disclosure of the study information 2016/11/16
Last modified on 2016/11/11

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Basic information
Public title The physiological effects of the supportive robotic device, HAL: hemodynamic responses of healthy adult during the motion with the HAL single joint type
Acronym The hemodynamic responses by the HAL single joint type
Scientific Title The physiological effects of the supportive robotic device, HAL: hemodynamic responses of healthy adult during the motion with the HAL single joint type
Scientific Title:Acronym The hemodynamic responses by the HAL single joint type
Region
Japan

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

Objectives
Narrative objectives1 To promote a better understanding for robotic application, we evaluate the hemodynamic
responses as a physiological adaptation during the motion with or without a HAL single joint type.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The hemodynamic responses by near-infrared spectroscopy
Key secondary outcomes EMG, subjective assessment of HAL use

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The motion with 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
29 years-old >=
Gender Male and Female
Key inclusion criteria (1) healthy adults (20-29 years-old)
(2) voluntary participation by signboard
(3) obtaining the informed consent following the understanding of the research
Key exclusion criteria (1) patient with orthopedic diseases related to the task-difficulties
(2) diagnosis experience of psychiatry or neurology
(3) student belonging to the researcher's class
(4) judgement as an unsuitable subject by the principal investigator or researcher
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Urakawa Susumu
Organization Hiroshima Univ
Division name Dept of Musculoskeletal Functional Research and Regeneration
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5430
Email urkawas@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Urakawa Susumu
Organization Hiroshima Univ
Division name Dept of Musculoskeletal Functional Research and Regeneration
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5430
Homepage URL
Email urkawas@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Univ
Institute
Department

Funding Source
Organization Hiroshima Univ
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
2016 Year 11 Month 16 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 11 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
2016 Year 11 Month 11 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028540

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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