UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041391 |
|---|---|
| Receipt number | R000047247 |
| Scientific Title | Examination of reliability in measurement of muscle thickness change of vastus lateralis muscle by magnetic stimulation using ultrasonic image |
| Date of disclosure of the study information | 2020/08/16 |
| Last modified on | 2024/08/16 09:03:30 |
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Basic information
Public title
Examination of reliability in measurement of muscle thickness change of vastus lateralis muscle by magnetic stimulation using ultrasonic image
Acronym
Examination of reliability in measurement of muscle thickness change of vastus lateralis muscle by magnetic stimulation using ultrasonic image
Scientific Title
Examination of reliability in measurement of muscle thickness change of vastus lateralis muscle by magnetic stimulation using ultrasonic image
Scientific Title:Acronym
Examination of reliability in measurement of muscle thickness change of vastus lateralis muscle by magnetic stimulation using ultrasonic image
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Record ultrasound images of muscles during magnetic stimulation and clarify intra- and inter-rater reliability in measuring muscle thickness changes automatically calculated by program.
Basic objectives2
Others
Basic objectives -Others
To clarify the coincidence between changes in muscle thickness automatically calculated by program and changes in muscle thickness measured manually.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra- and inter-rater reliability in measuring muscle thickness changes automatically calculated by program.
Key secondary outcomes
The coincidence between changes in muscle thickness automatically measured by a unique program and changes in muscle thickness calculated by manual measurement.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
Subjects with malignant tumor/ infectious disease/ sensory deficit/ acute illness/ diabetes/ hypothermia/ blood circulation disorder, users of medical electrical equipment, pregnant woman, immediately after giving birth, those who could not indicate their intention/epilepsy/serious heart disease
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
2-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Pref
TEL
+81-22-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Genji |
| Middle name | |
| Last name | Abe |
Organization
Tohoku Bunka Gakuen University
Division name
Faculty of Medical Science and Welfare
Zip code
981-8551
Address
6-45-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Pref
TEL
+81-22-233-3158
Homepage URL
genjia@rehab.tbgu.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Tohoku University Graduate School
Address
2-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi Pref
Tel
022-717-7338
izumis@bme.tohoku.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
| 2020 | Year | 08 | 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
15
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047247
