UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051538 |
|---|---|
| Receipt number | R000058802 |
| Scientific Title | Relationship between Dynamic Postural Control and Osgood-Schlatter Disease in Male Junior Youth Soccer Players -An Investigation Using an Inertial Measurement Unit (IMU) |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2023/11/16 13:42:39 |
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Basic information
Public title
Relationship between Dynamic Postural Control and Osgood-Schlatter Disease in Male Junior Youth Soccer Players
-An Investigation Using an Inertial Measurement Unit (IMU)
Acronym
Relationship between Dynamic Postural Control and Osgood-Schlatter Disease in Male Junior Youth Soccer Players
-An Investigation Using an Inertial Measurement Unit (IMU)
Scientific Title
Relationship between Dynamic Postural Control and Osgood-Schlatter Disease in Male Junior Youth Soccer Players
-An Investigation Using an Inertial Measurement Unit (IMU)
Scientific Title:Acronym
Relationship between Dynamic Postural Control and Osgood-Schlatter Disease in Male Junior Youth Soccer Players
-An Investigation Using an Inertial Measurement Unit (IMU)
Region
| Japan |
Condition
Condition
Osgood-Schlatter Disease
Classification by specialty
| Pediatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the dynamic postural control in Osgood-Schlatter disease patients by conducting kinematic analysis of male junior youth soccer players using an IMU, which can be universally used in sports, and analyzing their dependence on the knee joint extension mechanism in terms of coordination with multiple body segments.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to clarify the dynamic postural control ability of patients with Osgood-Schlatter disease, and to use this information for prevention of the disease, symptom improvement, and rehabilitation.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Kinematic data in squatting and standing long jump movements
Key secondary outcomes
Postural control strategies for the upper limb during the standing long jump movement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
squatting
Interventions/Control_2
standing long jump
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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male
Key inclusion criteria
Male junior youth soccer players on Gunma Prefecture soccer teams
Key exclusion criteria
Persons experiencing pain during exercise due to some disease, etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Wada |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8945
h191c012@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Wada |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8945
Homepage URL
h191c012@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
027-220-8945
h191c012@gunma-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 | 07 | Month | 07 | 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
37
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
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2024 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058802
| 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 |
