UMIN-CTR Clinical Trial

Basic information
Public title	The differences in choice reaction time with changes in trunk tilt and lumbar lordosis angle in Sitting Volleyball
Acronym	The choice reaction time in Sitting Volleyball
Scientific Title	The differences in choice reaction time with changes in trunk tilt and lumbar lordosis angle in Sitting Volleyball
Scientific Title:Acronym	The choice reaction time in Sitting Volleyball
Region	Japan

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

Objectives
Narrative objectives1	Sitting Volleyball (SV) is a para-sport mainly played by lower limb disabilities. Players are required to respond quickly to the ball in the sitting position. For quick responses in the standing position, it is desirable to tilt the trunk forward 1), and the reaction time decreases as the lumbar lordosis angle increases 2). Similarly, SV players are generally coached to tilt their trunk forward with an upright pelvis. However, there are as many players tilt their trunk backward as tilt their trunk forward. It is likely that tilting the trunk backward can move quicker. Trunk tilt and lumbar lordosis angle may affect choice reaction time (CRT) in the sitting position as well as standing position, even though their relationship is unclear. This study aimed to clarify the influence of the trunk tilt and lumbar lordosis angle on CRT in the sitting position.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.choice reaction time 2.lumbar lordosis angle Both 1 and 2 are measured on the day of measurement
Key secondary outcomes	age hight body weight BMI sports history

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	RT was measured by Reaction MR(Takei Scientific Instruments, Japan.). Subjects sat on the center mat placed 1.5 meters ahead of the lamp with their hip and knee joints flexed in forward tilt posture(FTP)and backward tilt posture(BTP). They were instructed to move to left or right direction as soon as possible after light emission. The trunk tilt angle was set at 0 degree when the line joining the acromion and greater trochanter was vertical to the floor. FTP and BTP were defined as trunk forward and backward tilt angles of 20 degree and 30 degree, respectively. The lumbar lordosis angle at start position was measured by Spinal Mouse(Index, Japan). Intervention is only on the day of measurement.The measurement is performed three time.
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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Men and women between the age of 20 and 35 at the time of consent 2.At least 5 years of sports experience 3.Those who have written consent to participate in this study
Key exclusion criteria	1.People with orthopedic disease on upper limb, lower limb and trunk at the time of consent 2.People who are deemed inappropriate by the researcher to conduct this research 3.The researcher and the research target are in a teacher-student relationship, and the student is taking a lecture from the researcher
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Urabe
Organization	Graduate School of Hiroshima University
Division name	Biomedical & Health Sciences
Zip code	734-8553
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5405
Email	yurabe@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Noriaki Middle name Last name Maeda
Organization	Graduate School of Hiroshima University
Division name	Biomedical & Health Sciences
Zip code	734-8553
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5410
Homepage URL
Email	norimmi@hiroshima-u.ac.jp

Sponsor
Institute	Department of Sport Rehabilitation Graduate School of Biomedical and Health Science Hiroshima University 1-2-3 Kasumi, Minami-ku, Hiroshima Japan
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University Certified Ethics Committee
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel	082-257-5555
Email	protocol@cimr.hiroshima-u.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	2020 Year 01 Month 15 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	30
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	2020 Year 01 Month 14 Day
Date of IRB	2020 Year 01 Month 14 Day
Anticipated trial start date	2020 Year 01 Month 14 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 15 Day
Last modified on	2021 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044043