UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ankle inversion sprain by Neuromuscular Training and Hopping Training with the low center of gravity in junior high school basketball player.
Title of the study (Brief title)	The effect of ankle inversion sprain by Neuromuscular Training and Hopping Training with the low center of gravity in junior high school basketball player.
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the preventive efficacy of the ankle sprain by the Neuromuscular training using the balance board and hopping training in junior high student basketball player.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The injury rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Neuromuscular training for 15 minute a day will be performed for every warming up in 12 weeks.
Interventions/Control_2	Hopping training for 15 minute a day will be performed for every warming up in 12 weeks.
Interventions/Control_3	A control group performs the usual practice.
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	13 years-old <=
Age-upper limit	15 years-old >=
Gender	Male
Key inclusion criteria	1,Male junior high school basketball player. 2,The player who dose not have any treatment during this study.
Key exclusion criteria	1,The player who couldn't get consent of participation in this study.
Target sample size	120

Research contact person
Name of lead principal investigator	Kiyokazu Akasaka
Organization	Medical Science,Graduate School of Medicine,Saitama Medical University
Division name	Department of Physical Therapy
Address	350-0496 981 Kawakado Moroyamamachi,Irumagun,Saitama
TEL	049-295-8246
Email	akasaka-smc@umin.ac.jp

Public contact
Name of contact person	Kosuke Ono
Organization	Medical Science,Graduate School of Medicine,Saitama Medical University
Division name	Department of Physical Therapy
Address	350-0496 981 Kawakado Moroyamamachi,Irumagun,Saitama
TEL	049-295-8246
Homepage URL
Email	kohsukebe10@gmail.com

Sponsor
Institute	Department of Physical Therapy,Medical Science,Graduate School of Medicine,Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Physical Therapy,Medical Science,Graduate School of Medicine,Saitama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 19 Day
Anticipated trial start date	2017 Year 05 Month 19 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2018 Year 12 Month 14 Day
Date trial data considered complete	2018 Year 12 Month 14 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 06 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031691