UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023113 |
|---|---|
| Receipt number | R000026480 |
| Scientific Title | The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2019/01/11 13:33:56 |
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Basic information
Public title
The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Acronym
An effect of the increasing at intrinsic muscles of foot for foot arch
Scientific Title
The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Scientific Title:Acronym
An effect of the increasing at intrinsic muscles of foot for foot arch
Region
| Japan |
Condition
Condition
Normal adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of the electrical stimulation on intrinsic foot muscles during gait to make changes supporting the MLA under a dynamic condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
joint moment
foot arch 3D motion
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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
electrical stimulation to intrinsic foot muscles
5 minutes
below pain threshold
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
orthopedics disease in the past now
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | shusaku kanai |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and welfare
Zip code
Address
1-1 Gakuen Machi, Mihara City, Hiroshima-Ken
TEL
0848-60-1120
kanai@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shusaku kanai |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and welfare
Zip code
Address
1-1 Gakuen Machi, Mihara City, Hiroshima-Ken
TEL
0848-60-1120
Homepage URL
kanai@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
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
Address
Tel
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
| 2016 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.foot.2017.08.002
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026480
