UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054065 |
|---|---|
| Receipt number | R000061726 |
| Scientific Title | Experiments for upper-limb movements using the exoskeleton robot "KINARM" and cognitive tasks |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/04 18:04:29 |
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Basic information
Public title
Experiments for upper-limb movements using the exoskeleton robot "KINARM" and cognitive tasks
Acronym
Experiments for upper-limb movements using the exoskeleton robot and cognitive tasks
Scientific Title
Experiments for upper-limb movements using the exoskeleton robot "KINARM" and cognitive tasks
Scientific Title:Acronym
Experiments for upper-limb movements using the exoskeleton robot and cognitive tasks
Region
| Japan |
Condition
Condition
None.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate changes in sense of agency and motor control during robot-assisted motor intervention.
Basic objectives2
Others
Basic objectives -Others
Investigation of the relationship between sense of agency and motor control
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Upper-limb movement coordinates obtained during the experiment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Robotic motor intervention (assist: high) and visual feedback of movement
Interventions/Control_2
Robotic motor intervention (assist: medium) and visual feedback of movement
Interventions/Control_3
Robotic motor intervention (assist: low) and visual feedback of movement
Interventions/Control_4
Visual feedback of movement
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals capable of providing written consent for participation based on their own free will.
Key exclusion criteria
1. Patients with severe cardiovascular, respiratory, or neurological diseases, or those with a history of such conditions
2. Individuals with impairments and disorders in the upper limbs (amputation, fractures, severe trauma, etc.)
3. Individuals who are pregnant or may be pregnant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Murai |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Human Augmentation Research Center
Zip code
2770882
Address
Kashiwa 2 Campus, University of Tokyo, 6-2-3 Kashiwanoha, Kashiwa, Chiba
TEL
05035223115
a.murai@aist.go.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Murai |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Human Augmentation Research Center
Zip code
2770882
Address
Kashiwa 2 Campus, University of Tokyo, 6-2-3 Kashiwanoha, Kashiwa, Chiba
TEL
05035223115
Homepage URL
a.murai@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
N/A
Address
N/A
Tel
N/A
N/A
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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061726
| 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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| Registered date | File name |
