UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062029 |
|---|---|
| Receipt number | R000070979 |
| Scientific Title | Development of a Method for Evaluating the Water Content and Mechanical Properties of Muscle-Tendon Tissue Using Electromyography and Mechanical Vibration Measurements |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/23 15:54:33 |
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Basic information
Public title
Development of a Method for Evaluating the Water Content and Mechanical Properties of Muscle-Tendon Tissue Using Electromyography and Mechanical Vibration Measurements
Acronym
Development of a Method for Evaluating the Water Content and Mechanical Properties of Muscle-Tendon Tissue Using Electromyography and Mechanical Vibration Measurements
Scientific Title
Development of a Method for Evaluating the Water Content and Mechanical Properties of Muscle-Tendon Tissue Using Electromyography and Mechanical Vibration Measurements
Scientific Title:Acronym
Development of a Method for Evaluating Muscles and Tendons Using Electromyography and Mechanical Vibration Measurement
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify, through phantom experiments and human subjects, whether the tissue vibration indices obtained using MyotonPRO and myoelectrography reflect the hydration status of muscle-tendon tissue, and to examine the potential for evaluating the mechanical properties of muscle-tendon tissue using these indices.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to verify, through phantom experiments and human subjects, whether the tissue vibration indices obtained using MyotonPRO and myoelectrography reflect the hydration status of muscle-tendon tissue, and to examine the potential for evaluating the mechanical properties of muscle-tendon tissue using these indices.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MyotonPRO, Electromyography, Muscle Strength, Muscle and Tendon Morphology
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ccompression, repeatitive exercise
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 18 or older; healthy adults; individuals without orthopedic conditions affecting the lower limbs; individuals without neuromuscular disorders; individuals whose condition does not interfere with participation in the study
Key exclusion criteria
History of lower limb surgery; history of Achilles tendon disorders; conditions presenting with lower limb edema; cardiovascular disease; pregnancy; individuals for whom DOMS-inducing exercise is difficult
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomonobu |
| Middle name | |
| Last name | Ishigaki |
Organization
Niigata University of Health and Welafare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
09059566675
t.ishigaki612@gmail.com
Public contact
Name of contact person
| 1st name | Tomonobu |
| Middle name | |
| Last name | Ishigaki |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
09059566675
Homepage URL
t.ishigaki612@gmail.com
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
Tel
09059566675
t.ishigaki612@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2038 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070979
