UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050365 |
|---|---|
| Receipt number | R000057349 |
| Scientific Title | Patellar tendon related pain in middle school athletes and morphological abnormalities of the patellar tendon by ultrasound. |
| Date of disclosure of the study information | 2023/02/16 |
| Last modified on | 2023/02/16 15:01:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Patellar tendon related pain in middle school athletes and morphological abnormalities of the patellar tendon by ultrasound.
Acronym
Patellar tendon related pain in middle school athletes and morphological abnormalities of the patellar tendon by ultrasound.
Scientific Title
Patellar tendon related pain in middle school athletes and morphological abnormalities of the patellar tendon by ultrasound.
Scientific Title:Acronym
Patellar tendon related pain in middle school athletes and morphological abnormalities of the patellar tendon by ultrasound.
Region
| Japan |
Condition
Condition
people with severe deformity, history of trauma, surgery, neurological symptoms, in the lower extremities that may affect walking
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to determine whether morphological abnormalities of the patellar tendon as assessed by ultrasound, can be a predictive factor of patellar tendon related pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patellar tendon related pain, patellar tendon morphologic abnormalities, lower limb muscle activity, lower limb range of motion
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male student
Key exclusion criteria
people with severe deformity, history of trauma, surgery, neurological symptoms, in the lower extremities that may affect walking
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YUUKA |
| Middle name | |
| Last name | YASUURA |
Organization
Kio University Graduate School
Division name
Department of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
P1311071@kio.ac.jp
Public contact
Name of contact person
| 1st name | YUUKA |
| Middle name | |
| Last name | YASUURA |
Organization
Kio University Graduate School
Division name
Department of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
P1311071@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
P1311071@kio.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 | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | 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
Data collected through March 31, 2026 will be used.
Management information
Registered date
| 2023 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057349
