UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054130 |
|---|---|
| Receipt number | R000061806 |
| Scientific Title | Experiment of Human-computer interaction using electrical muscle stimulation |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/10/15 09:14:21 |
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Basic information
Public title
Experiment of Human-computer interaction using electrical muscle stimulation
Acronym
HCI experiment using EMS
Scientific Title
Experiment of Human-computer interaction using electrical muscle stimulation
Scientific Title:Acronym
HCI experiment using EMS
Region
| Japan |
Condition
Condition
Normal people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore design methods for effective intervention methods for human sensory-motor functions for application to entertainment, and to conduct motion induction and movement measurement using a electrical muscle stimulation in the laboratory on healthy subjects. Specifically, we will provide kinematic intervention and tactile and audiovisual feedback by adding muscle electrical stimulation to the limbs using small-current electrical muscle stimulation and video and audio. The effects of the intervention, such as muscle contraction, motor function, and perception, will be clarified.
Basic objectives2
Others
Basic objectives -Others
This study aims to explore design methods for effective intervention methods for human sensory-motor functions for application to entertainment, and to conduct motion induction and movement measurement using a electrical muscle stimulation in the laboratory on healthy subjects. Specifically, we will provide kinematic intervention and tactile and audiovisual feedback by adding muscle electrical stimulation to the limbs using small-current electrical muscle stimulation and video and audio. The effects of the intervention, such as muscle contraction, motor function, and perception, will be clarified.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Body position and posture data during electrical stimulation
Key secondary outcomes
- Changes in the amount of force exerted by electrical stimulation (acquired by force sensors)
- Changes in electromyogram and myophonogram
- Changes in EMG and muscle phonogram
- Changes in subjective evaluation (sense of exercise initiative and sense of body ownership) by questionnaire
- Changes in the state of measurement (video and audio)
- Changes in time spent on tasks
- Correspondence between physical information data and changes in measurement data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
In this study, the intervention corresponds to the application of electrical muscle stimulation to the participants for research purposes.The maximum duration of the experiment is 3 hours.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Persons who are able to obtain free and voluntary written consent for participation in research from the person concerned.
(ii) Persons who are between 18 and 65 years of age at the time of obtaining consent.
Key exclusion criteria
(i) Patients who use medical electrical devices implanted in the body such as a pacemaker
(ii) Patients who use life-supporting medical electric equipment such as artificial heart lungs
(iii) Those who use medical electrical equipment such as electrocardiographs
(iv) Those who are prohibited from exercising by a physician
(v) Those who are under the influence of alcohol
(vi) You have a fever (38 degree or higher)
(vii) Persons who are unable to understand the contents of the experiment by themselves
(viii) Persons with heart disease or suspected heart disease
(ix) Those who are pregnant or have just given birth
(x) Those with sensory disturbance due to severe peripheral circulatory disturbance caused by diabetes mellitus, etc.
(xi) Patients with high blood pressure
(xii) Patients with respiratory disorders
(xiii) Rheumatism, gout, osteoarthritis, etc.
(xiv) Patients with severe blood circulation disorder such as venous blood flow disorder or thrombosis
(xv) Those with acute symptoms of bones, joints, or internal organs
(xvi) Those with physical abnormalities
(xvii) Those who participate for the purpose of rehabilitation
(xviii) Those who are undergoing treatment at other medical institutions
(xix) Those who have skin rashes caused by alcohol
(xx) Those who have concerns about their health
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Seito |
| Middle name | |
| Last name | Matsubara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Augmentation Research Center
Zip code
2770882
Address
6-2-3 Kashiwanoha, Kashiwa-city, Chiba
TEL
05035228520
seito-matsubara@aist.go.jp
Public contact
Name of contact person
| 1st name | Seito |
| Middle name | |
| Last name | Matsubara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Augmentation Research Center
Zip code
277-0882
Address
6-2-3 Kashiwanoha, Kashiwa-city, Chiba
TEL
05035228520
Homepage URL
seito-matsubara@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (Japan)
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
National Institute of Advanced Industrial Science and Technology (AIST)
Address
1-1-1 Higashi, Tsukuba-City, 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 | 06 | 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 | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | 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 | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061806
