UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041314 |
|---|---|
| Receipt number | R000047131 |
| Scientific Title | Effect of functional foot orthoses for the muscle stiffness after running. |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2023/08/18 16:50:40 |
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Basic information
Public title
Influence for muscle stiffness after running on the foot supporter
Acronym
Influence for muscle stiffness after running on the foot supporter
Scientific Title
Effect of functional foot orthoses for the muscle stiffness after running.
Scientific Title:Acronym
Effect of foot orthoses
Region
| Japan |
Condition
Condition
normal population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this project is to investigate for effect of the functional foot orthoses to the muscle stiffness after running.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the stiffness of the lower leg muscles (i.e. gastrocnemius, soleus, flexor digitorum longs, peroneus longus)
Key secondary outcomes
Borg scale after running
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
functional foot orthoses
Interventions/Control_2
sham orthoses
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
having the Exercise habits (2days/week)
Key exclusion criteria
having the any pain in lower limb at the time of testing.
person can not run at 60 minutes.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | Kudo |
| Last name | Kudo |
Organization
Morinomiya University of medical sciences
Division name
Physical therapy
Zip code
559-8611
Address
Nanko-kita 1-26-16, Suminoe ward, Osaka city, Osaka
TEL
0666166911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintarou |
| Middle name | Kudo |
| Last name | Kudo |
Organization
Morinomiya University of medical sciences
Division name
Physical therapy
Zip code
559-8611
Address
Nanko-kita1-26-16, Suminoe-ward, Osaka city, Osaka
TEL
0666166911
Homepage URL
kudo@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of medical sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society of the promotion of 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
Morinomiya University of Medical Sciences, ethics committee
Address
Nanko-kita,1-26-16, Suminoe ward, Osaka city, Osaka
Tel
06-6616-6911
kenkyu@morinomiya-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
| 2020 | Year | 08 | Month | 17 | 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
20
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
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047131
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
