UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044152 |
|---|---|
| Receipt number | R000050327 |
| Scientific Title | Effects of neuromuscular training with water bag on ankle sprains in high school soccer players |
| Date of disclosure of the study information | 2021/05/09 |
| Last modified on | 2021/05/11 20:36:10 |
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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
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
kentoseino1224@gmail.com
Sponsor or person
Institute
Saitama Medical University graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
