UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063501 |
|---|---|
| Receipt number | R000071938 |
| Scientific Title | Effect of Insole Resin Components on Muscle Activity |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 16:29:39 |
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Basic information
Public title
Comparing muscle activity with and without a resin insole component
Acronym
Resin Insole Muscle Effect
Scientific Title
Effect of Insole Resin Components on Muscle Activity
Scientific Title:Acronym
Resin Effect on Muscle activity via Insole
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 compare muscle activity (integrated surface electromyography values) in the trunk, buttocks, thigh, and lower leg under three conditions: (1) no insole, (2) an insole with a resin component, and (3) an insole without a resin component, while performing three movement tasks that resemble nursing duties (standing computer keyboard input, transferring a heavy load between a bed and a wheelchair, and providing care to a patient in bed while bending forward), in order to clarify how the presence or absence of a resin component in the insole affects muscle activity in each body region. In addition, muscle activity will be remeasured under the same conditions after one month of continuous use of the insole with a resin component, to examine changes in muscle activity over time with continued use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison, across the three conditions (1: no insole, 2: insole with a resin component, 3: insole without a resin component), of integrated surface electromyography (iEMG) values in the trunk, buttocks, thigh, and lower leg during each movement task (standing computer keyboard input, transferring a heavy load between a bed and a wheelchair, and providing care to a patient in bed while bending forward). This will be assessed both at the initial measurement and at the measurement taken after one month of continuous use of the insole with a resin component.
Key secondary outcomes
For the same condition (particularly the insole with a resin component), integrated surface electromyography (iEMG) values before and after one month of continuous insole use will be compared using a paired test (paired t-test, Wilcoxon signed-rank test, etc.).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants first perform three movement tasks (5 minutes of standing computer keyboard input, transferring a heavy load between a bed and a wheelchair, and providing care to a patient in bed while bending forward) without wearing an insole, while surface electromyography is recorded from the trunk, buttocks, thigh, and lower leg. After a rest of at least 5 minutes, participants perform the same three tasks while wearing an insole with a resin component, with the same measurements taken. After a further rest of at least 5 minutes, participants perform the same three tasks while wearing an insole without a resin component, with the same measurements taken (initial measurement, completed within a single day). Participants then continue to wear the insole with a resin component in daily life for one month. After one month, the three movement tasks are performed again in the same order (no insole, then insole with a resin component, then insole without a resin component), and muscle activity is remeasured.
Interventions/Control_2
Participants first perform and undergo measurement for the three movement tasks without wearing an insole. After a rest of at least 5 minutes, they perform and undergo measurement for the same three tasks while wearing an insole without a resin component. After a further rest of at least 5 minutes, they perform and undergo measurement for the same three tasks while wearing an insole with a resin component (initial measurement, completed within a single day). Participants then continue to wear the insole with a resin component in daily life for one month. After one month, the three movement tasks are performed again in the same order (no insole, then insole without a resin component, then insole with a resin component), and muscle activity is remeasured.
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
Female
Key inclusion criteria
Female students enrolled at Kobe City College of Nursing who provide their own consent to participate in the study.
Key exclusion criteria
Individuals meeting any of the following: (1) pain in the upper or lower limbs at the time of measurement, (2) low back pain at the time of measurement, (3) a neuromuscular disease causing persistent effects on muscle strength or sensation, or (4) pregnancy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kuniyasu |
| Middle name | |
| Last name | Kamiya |
Organization
Kobe City College of Nursing
Division name
Faculty of Nursing
Zip code
651-2103
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
TEL
0787948074
kuniyasu-kamiya@kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyasu |
| Middle name | |
| Last name | Kamiya |
Organization
Kobe City College of Nursing
Division name
Faculty of Nursing
Zip code
651-2103
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
TEL
0787948074
Homepage URL
kuniyasu-kamiya@kobe-ccn.ac.jp
Sponsor or person
Institute
Kobe City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City College of Nursing
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
Tel
0787948080
rinri@kobe-ccn.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
| 2026 | Year | 11 | Month | 02 | 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
| 2026 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | 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
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071938
