UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055319 |
|---|---|
| Receipt number | R000063216 |
| Scientific Title | A study on the effect of remote training systems on trainees |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/08/23 14:16:49 |
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Basic information
Public title
A study on the effect of remote training systems on trainees
Acronym
A study on the effect of remote training systems on trainees
Scientific Title
A study on the effect of remote training systems on trainees
Scientific Title:Acronym
A study on the effect of remote training systems on trainees
Region
| Japan |
Condition
Condition
Those who feel discomfort when raising their arms (e.g. frozen shoulder)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of changes in trainee motivation and sense of distance from the trainer using a remote training system.
Basic objectives2
Others
Basic objectives -Others
Sensory evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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 user is immersed in the VR space using a head-mounted display and can perform specified actions.
Coordinate movements based on vision, hearing, and somatosensation.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must be able to provide written consent to participate in the study of their own free will.
Participants who experience discomfort when lifting their shoulders are preferred, but this is not a requirement.
Key exclusion criteria
Those with serious shoulder, elbow, or wrist disorders.
Those whose body types are unable to wear the special clothing (L size) provided by the experimenter.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Ogata |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Augmentation Research Center (HARC)
Zip code
277-0882
Address
6-2-3 Kashiwanoha, Kashiwa, Chiba
TEL
050-3522-8414
ogata.kunihiro@aist.go.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Ogata |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Augmentation Research Center (HARC)
Zip code
277-0882
Address
6-2-3 Kashiwanoha, Kashiwa, Chiba
TEL
050-3522-8414
Homepage URL
ogata.kunihiro@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization(NEDO)
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
AIST bioethics committee
Address
1-1-1 Higashi, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.jp
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
| 2024 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063216
