UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024803 |
|---|---|
| Receipt number | 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 15:25:51 |
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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
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
urkawas@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Univ
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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