UMIN-CTR Clinical Trial

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)
Email	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
Email	tomochiro@keio.jp

Sponsor
Institute	School of Medicine Keio University Institute for Integrated Sports Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039511