UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059729 |
|---|---|
| Receipt number | R000067557 |
| Scientific Title | Relationship between Chronic Ankle Instability and Dynamic Postural Control in Male Youth Soccer Players - An Investigation Using an Inertial Measurement Unit (IMU) - |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/10 21:19:08 |
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Basic information
Public title
Relationship between Chronic Ankle Instability and Dynamic Postural Control in Male Youth Soccer Players
- An Investigation Using an Inertial Measurement Unit (IMU) -
Acronym
Relationship between Chronic Ankle Instability and Dynamic Postural Control in Male Youth Soccer Players
- An Investigation Using an Inertial Measurement Unit (IMU) -
Scientific Title
Relationship between Chronic Ankle Instability and Dynamic Postural Control in Male Youth Soccer Players
- An Investigation Using an Inertial Measurement Unit (IMU) -
Scientific Title:Acronym
Relationship between Chronic Ankle Instability and Dynamic Postural Control in Male Youth Soccer Players
- An Investigation Using an Inertial Measurement Unit (IMU) -
Region
| Japan |
Condition
Condition
Chronic Ankle Instability in soccer
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ankle sprains are one of the most frequently occurring injuries in sports activities. It is reported that up to 40% of individuals who sustain an ankle sprain develop residual Chronic Ankle Instability (CAI). Recurrent sprains are thought to increase the risk of re-injury, often due to subsequent biomechanical alterations. Furthermore, for the prevention and treatment of CAI and ankle sprains, it is considered essential to comprehensively evaluate and intervene not only on the locally injured site but also on the coordination and biomechanics of the entire lower limb.
Therefore, the purpose of this study was to conduct a kinematic analysis of single-leg drop jump landings in high school male soccer players using a field-portable Inertial Measurement Unit (IMU). By analyzing the inter-segmental coordination across multiple body segments, this research aims to contribute to the future prevention of ankle sprains and the onset of CAI.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to elucidate differences in kinematic characteristics and multi-segmental coordination during the landing phase of a single-leg drop jump in high school male soccer players with Chronic Ankle Instability (CAI) compared to a control group, using a Inertial Measurement Unit (IMU).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Kinematic Data of Single-Leg Drop Jump Landings in Forward, Forward-Diagonal, and Lateral Directions
Key secondary outcomes
Ankle joint range of motion
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
Prevention
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
Single-Leg Drop Jump Landings in Forward, Forward-Diagonal, and Lateral Directions. Ankle joint range of motion
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Male high school soccer players (grades 10-12) enrolled in a high school within Gunma Prefecture
2) Individuals from whom assent and parental/guardian informed consent were obtained after reading the study's explanatory documents
3) Individuals who were able to participate in their regular team practices without restriction
4) Individuals who met the criteria for either the CAI group or the Control group based on the results of the Japanese version of the Cumberland Ankle Instability Tool (CAIT-J) and the Instability Ankle Criteria (IAC) questionnaire:
･CAI group:
(1) A score of <=25 on the CAIT-J
(2) A "yes" response to all selection criteria for CAI on the IAC questionnaire
･Control group:
(1) A score of =>26 on the CAIT-J
(2) A "no" response to one or more of the selection criteria for CAI on the IAC questionnaire
Key exclusion criteria
1) Individuals experiencing pain during jumping or landing activities due to any orthopedic condition
2) Individuals unable to participate in regular team practices due to pain, or any orthopedic or internal medical conditions
3) Individuals who did not provide consent after reading the explanatory document (including those who did not consent to being video-recorded)
4) Individuals with a history of surgery on either lower extremity
5) Individuals who had sustained an acute injury to any lower extremity joint (including the ankle) within the three months prior to study participation, which resulted in an inability to practice for one or more days
6) Individuals with a potential skin allergy or sensitivity to the adhesive tape used for attaching the IMU sensors
7) For the Control group only: a history of two or more previous sprains to the same ankle
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | TAJIKA |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | TAJIKA |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8945
Homepage URL
tajika@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Tsuyoshi TAJIKA
Funding Source
Organization
Gunma 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
Gunma University Ethics Committee for Medical Research Involving Human Subjects
Address
3-39-5 Showa-machi, Maebashi City, Gunma Prefecture
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2025 | Year | 11 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067557
