UMIN-CTR Clinical Trial

Basic information
Public title	Effects of neuromuscular training with water bag on ankle sprains in high school soccer players
Acronym	Effects of neuromuscular training with water bag on ankle sprains in high school soccer players
Scientific Title	Effects of neuromuscular training with water bag on ankle sprains in high school soccer players
Scientific Title:Acronym	Effects of neuromuscular training with water bag on ankle sprains in high school soccer players
Region	Japan

Condition
Condition	ankle sprain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prevent ankle sprains effectively, we plan to conduct research that using a water bag on a balance disc to perform balance training and examine its effectiveness. The additional purpose of this study was to clarify the relationship between the physical characteristics of high school soccer players and ankle sprains.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of ankle sprain injuries in high school soccer players
Key secondary outcomes	Record training time, time spent in the game, presence or absence of injury (location, situation at the time of injury, intensity of pain), time absent from training, and time absent from the game. The intervention group records the presence or absence of training. Prior to the intervention, some questions will be asked for basic information about height and weight, soccer position, practice time, and ankle sprains. Medical checks of balance, range of motion, and muscle strength will be also measured before the start of the intervention and 5 weeks after the intervention.

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Conduct balance training on the balance disc.
Interventions/Control_2	Grasp the water bag and perform balance training on the balance disc.
Interventions/Control_3	Practice only as usual
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	15 years-old <=
Age-upper limit	18 years-old >=
Gender	Male
Key inclusion criteria	Men's high school soccer club members from 1st to 3rd grade of high school Prefectural tournament level high school soccer club member Men's high school soccer player with written consent to participate in this study
Key exclusion criteria	Those who do not give agreement for participation in this study Those who cannot participate this research with any reasons Those who have a sprained ankle at the start of measurement
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Kiyokazu Middle name Last name Akasaka
Organization	Saitama Medical University
Division name	Department of Physical Therapy
Zip code	3500496
Address	981 Kawakado, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL	0492951001
Email	kentoseino1224@gmail.com

Public contact
Name of contact person	1st name Kiyokazu Middle name Last name Akasaka
Organization	Saitama Medical University
Division name	Department of Physical Therapy
Zip code	3500496
Address	981 Kawakado, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL	0492951001
Homepage URL
Email	kentoseino1224@gmail.com

Sponsor
Institute	Saitama Medical University graduate School
Institute
Department

Funding Source
Organization	Saitama Medical University graduate School
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	Saitama Medical University Ethics Committee
Address	38 Morohongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
Tel	0492762143
Email	rinnri@saitama-med.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	2021 Year 05 Month 09 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	2021 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date	2021 Year 05 Month 08 Day
Last follow-up date	2023 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	2021 Year 05 Month 09 Day
Last modified on	2021 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050327