UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between time of repeated high knee test and degree of trunk movement.
Acronym	Relationship between time of repeated high knee test and degree of trunk movement.
Scientific Title	Assessment of the relationship between the degree of trunk movement in repeated high knee test and sports performance.
Scientific Title:Acronym	Assessment of the relationship between the degree of trunk movement in repeated high knee test and sports performance.
Region	Japan

Condition
Condition	Athletes
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Proof of the link between the degree of trunk movement and performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Root mean square of trunk angular velocity
Key secondary outcomes	Time of high knee test

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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who regularly participate in sports activities
Key exclusion criteria	1) previous surgery or fracture 2) low back or hip pain 3) limited range of hip flexion motion
Target sample size	82

Research contact person
Name of lead principal investigator	1st name Toshimitsu Middle name Last name Ohmine
Organization	Osaka Prefecture University
Division name	Department of Physical Therapy, Faculty of Comprehensive Rehabilitation
Zip code	5838555
Address	3-7-30 Hbikino, Habikino city, Osaka, Japan
TEL	+81-72-950-2111
Email	toshimitsu0605@gmail.com

Public contact
Name of contact person	1st name Toshimitsu Middle name Last name Ohmine
Organization	Osaka Prefecture University
Division name	Department of Physical Therapy, Faculty of Comprehensive Rehabilitation
Zip code	5838555
Address	3-7-30 Hbikino, Habikino city, Osaka, Japan
TEL	+81-72-950-2111
Homepage URL
Email	toshimitsu0605@gmail.com

Sponsor
Institute	Osaka Prefecture University
Institute
Department

Funding Source
Organization	nothing
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	Osaka Prefecture University
Address	3-7-30 Hbikino, Habikino city, Osaka, Japan
Tel	+81-72-950-2111
Email	toshimitsu0605@gmail.com

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	2020 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	28
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	2018 Year 11 Month 01 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2019 Year 12 Month 05 Day
Date of closure to data entry	2019 Year 12 Month 15 Day
Date trial data considered complete	2019 Year 12 Month 15 Day
Date analysis concluded	2020 Year 02 Month 01 Day

Other
Other related information	Young, healthy people were recruited from Osaka Prefecture University students to volunteer to participate in this study. Recruitment was continued from December 10, 2018 until data on 82 individuals could be obtained.

Management information
Registered date	2020 Year 11 Month 07 Day
Last modified on	2020 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048373