UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034655 |
|---|---|
| Receipt number | R000039511 |
| Scientific Title | Relationship of Aponeurosis Stiffness with Previous History of Hamstrings Strain in Elite Rugby Players :Shear Wave Elastography Evaluation |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2020/03/26 10:51:26 |
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Basic information
Public title
Relationship of Aponeurosis Stiffness with Previous History of Hamstrings Strain in Elite Rugby Players :Shear Wave Elastography Evaluation
Acronym
Relationship of Aponeurosis Stiffness with Previous History of Hamstrings Strain in Elite Rugby Players
Scientific Title
Relationship of Aponeurosis Stiffness with Previous History of Hamstrings Strain in Elite Rugby Players :Shear Wave Elastography Evaluation
Scientific Title:Acronym
Relationship of Aponeurosis Stiffness with Previous History of Hamstrings Strain in Elite Rugby Players
Region
| Japan |
Condition
Condition
Hamstrings Strain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate relationship between stiffness of hamstrings injured side and uninjured side by using Shear Wave Elastography.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hamstrings aponeurosis stiffness of injured side (kPa)
and uninjured side at resting position.
Key secondary outcomes
Hamstrings muscle Stiffness of injured side (kPa) and uninjured side at resting position.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Rugby Players who have previous history of hamstrings strain
Key exclusion criteria
Someone who has severe internal, musculoskeletal, or psychiatric disease cannot participate the study safely.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Kawai |
Organization
School of Medicine Keio University, Tokyo
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-3353-1211(62183)
tomochiro@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Kawai |
Organization
School of Medicine Keio University
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-3353-1211(62183)
Homepage URL
tomochiro@keio.jp
Sponsor or person
Institute
School of Medicine Keio University
Institute for Integrated Sports Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kobe Graduate School
Name of secondary funder(s)
Konan Hospital
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
甲南病院 (兵庫県)、神戸製鋼ラグビー部クラブハウス (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 31 | 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
11
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delated evaluation due to schedule issue
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
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Evaluating hamstrings aponeurosis stiffness of injured side (kPa)
and uninjured side at resting position.
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039511
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
