UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050119 |
|---|---|
| Receipt number | R000056143 |
| Scientific Title | Is it possible to selectively train the peroneus longus and peroneus brevis muscles? |
| Date of disclosure of the study information | 2023/01/24 |
| Last modified on | 2023/01/24 15:42:45 |
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Basic information
Public title
Is it possible to selectively train the peroneus longus and peroneus brevis muscles?
Acronym
Is it possible to selectively train the peroneus longus and peroneus brevis muscles?
Scientific Title
Is it possible to selectively train the peroneus longus and peroneus brevis muscles?
Scientific Title:Acronym
Is it possible to selectively train the peroneus longus and peroneus brevis muscles?
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether two different strength training methods can selectively alter the morphology of the peroneus longus and peroneus brevis in the long term by implementing the two different strength training methods for 8 weeks.
Basic objectives2
Others
Basic objectives -Others
To examine new strength training methods for the peroneal muscles.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in muscle cross-sectional area, muscle thickness, and muscle brightness of the peroneal muscles using an ultrasound imaging system.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The task movement was ankle eversion on the right leg using a Thera-Band. The ball of the foot task in which a Thera-Band was placed on the ball of the foot and pushed out from the contact point. The number of times the task movement is performed is two sets of 100 repetitions at a speed of 1 repetition/second.
Interventions/Control_2
The fifth metatarsal task in which the Thera-Band was pushed out from the base of the fifth metatarsal. All the task movements are to be performed with the right foot. The number of times the task movement is performed is two sets of 100 repetitions at a speed of 1 repetition/second.
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
1. Men and women who are at least 18 years old and less than 30 years old at the time of obtaining consent.
2. Patients who do not have orthopedic diseases of the lower limbs at the time of obtaining consent.
3. Persons who can give written consent to participate in this study.
Key exclusion criteria
1. Those who have a conflict of interest, such as the relationship between the person in charge of the research and the research subject being a faculty member and a student, and the student attending the lectures of the person in charge of the research
2. Other parties deemed inappropriate by the person in charge of the research to conduct this research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Graduate School of Hiroshima University
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Arima |
Organization
Graduate School of Hiroshima University
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5413
Homepage URL
satoshi-arima4646@hiroshima-u.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Hiroshima university
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-seisaku@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
| 2023 | Year | 01 | Month | 24 | 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
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | 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
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
