UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060797 |
|---|---|
| Receipt number | R000069558 |
| Scientific Title | Effects of ACL injury prevention training with and without instruction on movement patterns during change-of-direction maneuvers in adolescent handball players |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 15:12:54 |
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Basic information
Public title
Effects of ACL injury prevention training with and without instruction on movement patterns during change-of-direction maneuvers in elementary and junior high school handball players
Acronym
Effects of ACL Training and Coaching on Elementary and Junior High School Handball Players
Scientific Title
Effects of ACL injury prevention training with and without instruction on movement patterns during change-of-direction maneuvers in adolescent handball players
Scientific Title:Acronym
Effects of ACL Training and Coaching on junior adolescent Handball Players
Region
| Japan |
Condition
Condition
To compare the effects of ACL injury prevention training with and without coaching on risky motions during change-of-direction in adolescent handball players
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most anterior cruciate ligament (ACL) injuries in sports occur through non-contact mechanisms during sudden deceleration, such as change-of-direction and jump-landing maneuvers. While numerous studies have demonstrated that neuromuscular training (NMT) can effectively reduce the incidence of these injuries, there is limited scientific evidence regarding the added value of specific coaching. Specifically, it remains unclear how educating athletes about ACL injury mechanisms and distinguishing between "risky" and "safe" movement patterns during NMT influences the improvement of sudden deceleration motions. For adolescent athletes, who are in a critical stage of motor skill acquisition, mastering proper deceleration techniques is essential for both their long-term athletic careers and lifelong joint health. Therefore, the purpose of this study is to compare the effects of ACL injury prevention training, with and without integrated coaching, on risky movement patterns during change-of-direction maneuvers in adolescent handball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will compare the change-of-direction performance and biomechanical variables before and after the 9-week intervention. Specifically, we will evaluate the completion time of the cutting maneuver along with knee flexion and dynamic valgus angles, trunk anterior/posterior lean, and lateral flexion angles. Furthermore, we will analyze the foot placement of the cutting leg relative to the body center of mass to determine the effects of the training and coaching on movement quality.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We will implement lower-body neuromuscular training known to be effective in preventing anterior cruciate ligament (ACL) injuries. The 9-week training program will be divided into three 3-week phases (Phase 1 to Phase 3), with the training content modified for each phase.
Phase 1 (3 weeks: 5 training sessions and 1 measurement session)
In Phase 1, single-leg squats will be performed. From a single-leg standing position, the participant bends the knee over a period of 5 seconds until the thigh is parallel to the floor, holds that position for 1 second, and then stands up as quickly as possible upon a signal. This exercise is performed in 3 sets of 8 repetitions for each leg.
Phase 2 (3 weeks: 5 training sessions and 1 measurement session)
Single-leg squats will also be performed in Phase 2. However, unlike in Phase 1, participants squat down at maximum speed until the thigh is parallel to the floor upon a signal and hold that position for 3 seconds. Subsequently, they stand up as quickly as possible upon another signal. This exercise is performed in 3 sets of 8 repetitions for each leg.
Phase 3 (3 weeks: 5 training sessions and 1 measurement session)
In Phase 3, single-leg jump-to-landing training will be performed. From a single-leg standing position, the participant squats down as quickly as possible until the knee flexion angle reaches approximately 90 degree upon a signal and then jumps upward as high as possible. Afterward, the participant performs a single-leg landing, squats down until the thigh is parallel to the floor, and holds the position for 3 seconds on one leg. This exercise is performed in 3 sets of 8 repetitions for each leg.
Interventions/Control_2
For the "with-coaching" group (intervention group), we will provide lectures on ACL injury mechanisms, risky deceleration forms, and safe movement patterns. Furthermore, during the training period, direct instructions-such as identifying risky motions and providing corrections to ensure safe movement-will be given for individual performances. In contrast, the "without-coaching" group (control group) will not receive lectures on injury mechanisms or specific movement coaching. They will only be provided with basic instructions regarding general safety and standard forms for training exercises.
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
| 11 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male
Key inclusion criteria
Male athletes aged 11 to 15 years who belong to a handball school club or a handball club team, with at least six months of competitive experience in handball.
Key exclusion criteria
1) Individuals who have sustained a severe injury requiring surgery within the past six months.
2) Individuals who are unable to participate in regular exercise due to pain, illness, or other medical conditions during the study period.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Shimokochi |
Organization
Osaka University of Health and Sport Sciences
Division name
School of Sport Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennangun, Osaka, 590-0496, Japan
TEL
072-453-8903
yshimoko@ouhs.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Shimokochi |
Organization
Osaka University of Health and Sport Sciences
Division name
School of Sport Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennangun, Osaka, 590-0496, Japan
TEL
072-453-8903
Homepage URL
yshimoko@ouhs.ac.jp
Sponsor or person
Institute
Osaka University of Health and Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka University of Health and Sport Sciences
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
Osaka University of Health and Sport Sciences
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka, 590-0496, Japan
Tel
072-453-7022
yshimoko@ouhs.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
Osaka
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 02 | 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
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069558
