UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037693 |
|---|---|
| Receipt number | R000042991 |
| Scientific Title | A randomized controlled trial of prevention of child foot deformation |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2024/02/18 09:41:03 |
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Basic information
Public title
A randomized controlled trial of prevention of child foot deformation
Acronym
A randomized controlled trial of prevention of child foot deformation
Scientific Title
A randomized controlled trial of prevention of child foot deformation
Scientific Title:Acronym
A randomized controlled trial of prevention of child foot deformation
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate anatomical features from the measurement of foot function on children and to examine the effect of care and insole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Morphological evaluation of the foot
Key secondary outcomes
Function of the foot (lower limb muscle strength, balance)
Questionnaire
Sports performance evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Insole (+), Insole (-)
Interventions/Control_2
Care (+), Care (-)
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Being agreed with participation in this study
Key exclusion criteria
1. Individuals with difficulty standing or walking
2. Individuals with acute illness
Target sample size
2100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Faculty of Human Care at Makuhari
Zip code
261-0021
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
TEL
043-273-1111
kazuhiko.yamashita@tohto.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamashita |
Organization
Tohto University
Division name
Faculty of Human Care at Makuhari
Zip code
261-0021
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
TEL
043-273-1111
Homepage URL
kazuhiko.yamashita@tohto.ac.jp
Sponsor or person
Institute
Tohto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For the Promotion of the 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
Tohto University
Address
1-1 Hibino, Mihama-ku, Chiba-city, Chiba
Tel
043-273-1111
maiko.horie@tohto.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
埼玉県の小学校(埼玉県），大阪府の小学校（大阪府），秋田県の高等学校（秋田県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042991
| Research Plan | |
|---|---|
| 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 |
