UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051311 |
|---|---|
| Receipt number | R000058504 |
| Scientific Title | Examination of preventive effect of cross-motion swing on groin pain in high school soccer players |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2024/06/14 08:58:29 |
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Basic information
Public title
Examination of the effect of groin pain prevention exercises in high school soccer player
Acronym
Examination of the effect of exercise to prevent groin pain
Scientific Title
Examination of preventive effect of cross-motion swing on groin pain in high school soccer players
Scientific Title:Acronym
Preventive effect of cross-motion swing on groin pain
Region
| Japan |
Condition
Condition
Groin pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the preventive effect of cross-motion swing on groin pain in high school soccer players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of groin pain from study entry to weeks 16-20 in intervention and control groups.
Key secondary outcomes
Location of groin pain, affected side and duration of withdrawal.
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercises for efficient soccer kicking movements will be performed from the beginning of the study until 16-20 weeks.
First, perform a cross-motion swing in the forward and backward direction. The player grabs onto the pillar or shoulder of the partner, and swings the leg on the kicking side and the arm on the pivoting side forward and backward 10 times. After 10 swings, the opposite side is also performed.
Next, perform a lateral direction cross-motion swing. The player grabs onto the pillar or shoulder of the partner, abducts the kicking side hip joint and the pivoting side shoulder joint, then adducts the kicking side hip joint and the pivoting side shoulder joint to make a large swing. After 10 swings, the opposite side is also performed.
Perform 2 sets of 10 swings each in the forward-backward and lateral direction. Performed at the end of each warm-up before games and practices.
Interventions/Control_2
No treatment control group. Practice as usual from the beginning of the study for 16 to 20 weeks.
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
| 15 | years-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Male
Key inclusion criteria
High school soccer players in Saitama Prefecture.
Key exclusion criteria
Who cannot give written consent to participate in this study.
who are unable to start the study at the beginning of the study.
Who are out of practice at the start of the study.
Who have groin pain at the start of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
350-0496
Address
981 Kawakado, Moroyama-machi, Iruma-gun, Saitama
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Mori |
Organization
Medical Corporation JOSC JIN Orthopaedic & Sports Clinic
Division name
Department of Physical Therapy
Zip code
338-0013
Address
3-10-7 Suzuya, Chuo-ku, Saitama city, Saitama
TEL
048-826-6815
Homepage URL
mori84401@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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 Review Committee
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Saitama Medical University Research Administration Center University Ethics Review Committee Secretariat
Tel
049-276-2143
rinri@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
| 2023 | Year | 06 | Month | 10 | 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
135
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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058504
