UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053303 |
|---|---|
| Receipt number | R000060827 |
| Scientific Title | Development of a Somatosensory Presentation Technique Using Multipoint Vibration Stimulation to the Elbow Joint |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2025/04/02 08:26:50 |
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Basic information
Public title
Development of a method for presenting body sensations through multiple vibratory stimuli to the elbow joint
Acronym
Sensory Presentatiojn by Multi-Vibration Stimulation
Scientific Title
Development of a Somatosensory Presentation Technique Using Multipoint Vibration Stimulation to the Elbow Joint
Scientific Title:Acronym
Development of a Somatosensory Presentation Technique Using Multipoint Vibration Stimulation to the Elbow Joint
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a method to induce proprioceptive and tactile sensations through vibration stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective intensity of induced sensations (Visual Analogue Scale), distribution of sensations, equivalent force sensation (weight)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
With vibration stimulation
Interventions/Control_2
Without vibration stimulation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who is between 20 and 65 years of age, in good health, and who participates in the study of his/her own free will.
However, if any of the following applies, the subject will not be included in the study
Patients with heart disease, neurological disease, brain disease, and respiratory failure. Pregnant women and those who have a skin rash caused by alcohol. Those who have allergic diseases (including food, metal, and alcohol, but excluding hay fever), those who have high blood pressure, and those who have skin rashes caused by biological tapes. Those who have some health concerns.
Key exclusion criteria
Patients with heart disease, neurological disease, brain disease, and respiratory failure. Pregnant women and those who have a skin rash caused by alcohol. Those who have allergic diseases (including food, metal, and alcohol, but excluding hay fever), those who have high blood pressure, and those who have skin rashes caused by biological tapes. Those who have some health concerns.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Aoyama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-0044
Address
4-2 Aramaki-cho, Maebashi, Gunma, Japan
TEL
027-220-7527
aoyama@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Aoyama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-0044
Address
4-2 Aramaki, Maebashi, Gunma, Japan
TEL
027-220-7527
Homepage URL
aoyama@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Japan Sciety for The Promotion 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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa, Maebashi, Gunma, Japan
Tel
027-220-7111
hitotaisho-ciru@ml.gunma-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
| 2024 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The results suggest that vibratory stimulation from the composite wave of two vibrator placed on the elbow joint evokes a sense of movement in the hands and arms, and induces slight movement.
In addition, tactile sensation was induced by the transducers placed on the elbow joint, which is thought to have stimulated the ulnar nerve and median nerve in the area around the palm.
Results date posted
| 2025 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | 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 | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060827
