UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058349 |
|---|---|
| Receipt number | R000066702 |
| Scientific Title | Development of a dual closed-loop finger function training method using AI robots and transauricular vagus nerve stimulation |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/02 16:31:26 |
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Basic information
Public title
Development of a dual closed-loop finger function training method using AI robots and transauricular vagus nerve stimulation
Acronym
Development of a dual closed-loop finger function training method
Scientific Title
Development of a dual closed-loop finger function training method using AI robots and transauricular vagus nerve stimulation
Scientific Title:Acronym
Development of a dual closed-loop finger function training method
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effectiveness of a dual closed-loop finger function training method combining AI robots and transauricular vagus nerve stimulation for acquiring finger movements (guwashi) that are difficult to perform for healthy subjects. To achieve this, the angles of the proximal interphalangeal joints of the middle, ring, and little fingers during the performance of guwashi will be compared before and after training.
Basic objectives2
Others
Basic objectives -Others
nothing
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure the angles of the proximal and distal interphalangeal joints of the middle, ring, and little fingers using a finger goniometer (joint angle meter) when performing the Guwashi exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control group: No finger movement training was performed, and joint angle assessment was performed only on the first day and four days later.
Interventions/Control_2
Group without AI robots: Participants perform finger movement exercises on their own without wearing robots. Movement speed is adjusted according to signals from the robots below. Training is conducted every other day for three days.
Interventions/Control_3
AI robot group: Training was conducted using MELTz (FrontAct, Japan), with the robot hand attached in a seated position with the shoulder joint in the neutral position, the elbow joint flexed at 90 deg, and the forearm in a pronated position. Electromyography (EMG) signals are recorded using six pairs of disposable silver chloride electrodes attached to the middle and ring finger regions of the flexor digitorum muscles, the ulnar side of the wrist flexor muscles, the middle and ring finger regions of the extensor digitorum muscles, and the ulnar side of the wrist extensor muscles. The electrode attachment sites are identified using transcutaneous electrical stimulation to locate the muscle bellies. The robotic hand assists movement to three limb positions grasp, relaxation, and full finger extension based on the EMG activity patterns of the six muscles. This is a single-closed-loop training device where movement is activated when the subject exhibits the appropriate EMG activity pattern corresponding to the grasp action. Each position is changed over one second in response to the robot's signal and held for five seconds. Training is conducted for three consecutive days, with each day consisting of five sets of 20 repetitions of the three limb positions in sequence, synchronized with the machine's voice, followed by a one-minute rest period.
Interventions/Control_4
AI robot with taVNS group: An electronic goniometer is attached to the little finger, and the same training as the AI robot group is performed. When the proximal interphalangeal joint of the little finger exceeds a flexion angle of 45 deg, the stimulation device is set to output a trigger signal. The intensity of vagus nerve stimulation performed via the ear is set to the midpoint between the perceptual threshold and pain threshold, with a stimulus width of 100 micro seconds, frequency of 25 Hz, and stimulus duration of 500 ms. The single closed loop training device is activated, and the vagus nerve is stimulated in a dual closed loop configuration when the ring finger is extended and the little finger is flexed. In functional recovery training for post stroke hemiplegic patients using a cervical implantable VNS approved by the U.S. FDA, vagus nerve stimulation is delivered at the timing when the patient's reaching movement reaches the target point. The design and stimulation parameters are adopted in accordance with this approach.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following criteria
Healthy adults aged 18 years or older
Those who have applied to participate in this study through posters posted in the Hiroshima University School of Medicine Research Building and the Health Sciences Research Building
Those who can provide written consent to participate in this study
Those who have scored 90 or higher on the Edinburgh Handedness Test.
Key exclusion criteria
Individuals with a history of or concurrent central nervous system, neuromusculoskeletal, or cardiovascular diseases
Individuals with metal implants (such as pacemakers, cochlear implants, etc.) in their bodies
Individuals with skin conditions at the electrode application site or hand unit attachment site
Pregnant women
Individuals with a conflict of interest, such as those enrolled in courses
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hikari |
| Middle name | |
| Last name | KIRIMOTO |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Sensorimotor Neuroscience
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
0822575445
hkirimotomo@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikari |
| Middle name | |
| Last name | Kirimoto |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Sensorimotor Neuroscience
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
0822575445
Homepage URL
hkirimotomo@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.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
| 2025 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066702
