UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034655
Receipt No. 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 2018/10/30

* 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 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
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
2018 Year 10 Month 16 Day
Date of IRB
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
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


Contact us.