Adolescent Baseball PlayersNCT06637241
Risk Stratification Care for Injury Prevention in Taiwan Adolescent Baseball Players
A study testing Risk stratification care in people with Adolescent Baseball Players, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Due to frequent practices and competitions, Taiwanese adolescent baseball players gradually accumulate fatigue, leading to injuries in their throwing arms. Previous research on baseball has primarily focused on the epidemiology of sports injuries, biomechanical analysis of throwing motions, and the effectiveness of… Read more about this study
- Who is it for?
- Ages 12 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Baseball Players
- What is being tested?
- Risk stratification care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Oct 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All youths who are members of their school's baseball team and are willing to participate in the study with parental consent.
- Agree to participate in the trial and complete the participant consent form.
Who cannot join
- A history of significant musculoskeletal or neurological injuries (or functional abnormalities).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Effectiveness of Injury Prevention Between Risk Stratification Care and Usual Care in Taiwan Adolescent Baseball Players: a Cluster Randomized Controlled Trial.
Due to frequent practices and competitions, Taiwanese adolescent baseball players gradually accumulate fatigue, leading to injuries in their throwing arms. Previous research on baseball has primarily focused on the epidemiology of sports injuries, biomechanical analysis of throwing motions, and the effectiveness of injury prevention interventions. Based on our previous research on the quality of life of Taiwanese adolescent baseball players, we have gained a general understanding of the impact of throwing arm injuries on these athletes. This study aims to stratify the injury risks of these baseball players based on past research and provide corresponding care guidelines according to different risk levels. We will compare this care model with standard care through a cluster randomized controlled trial, aiming to verify that this model is effective, efficient, and more clinically applicable than previous injury prevention interventions. Ultimately, we hope to promote this care model across all youth baseball teams in Taiwan.
Read the detailed description
Baseball involves repetitive throwing motions that place considerable stress on the shoulder and elbow, leading to throwing arm injuries. Previous studies have shown that baseball players are at a higher risk of upper limb injuries compared to the general population, particularly pitchers. In Major League Baseball (MLB) in the United States, more than half of the injuries are to the upper limbs, and 48.4% of these are caused by throwing motions. Since throwing is a crucial part of baseball, injuries to the throwing arm can result in significant disability, both in sports and non-sports contexts. These disabilities not only affect the performance of baseball players but also have broader implications, including psychological and social impacts.
Recently, the importance of patient-reported outcomes (PRO) in clinical research has been increasingly recognized. In the past, clinical assessments focused primarily on physician evaluations of physical examinations and diagnostic test results. However, these measures may not accurately reflect patients\' actual experiences. PROs can help physicians assess patients\' health-related quality of life (HRQOL). This concept has also started to gain traction in the field of sports medicine.
Taiwanese adolescent baseball players face varying degrees of injury risk based on their defensive positions. In addition, measuring HRQOL may help identify injury risks that cannot be determined solely by their defensive positions. For high-risk baseball players, early referral to a physician for further examination and treatment can greatly aid in preventing injuries or facilitating recovery and return to the field after an injury. To identify high-risk individuals among a group of baseball players, our research team has collaborated with several junior high and high school baseball teams in Kaohsiung (including seven junior high schools and one high school).
- Conditions
- Adolescent Baseball Players
- Being tested
- Risk stratification care
- Keywords
- Throwing arm injury, Stratified care for injury risk, Long term follow up, Health-related quality of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk stratification careBehavioural
In this group, Taiwanese adolescent baseball players are categorized into high-risk, medium-risk, and low-risk groups based on injury risk from a previous study. High-risk players receive sports protection education and physician referrals for shoulder and elbow assessments, with further imaging if necessary. Common issues like Little League shoulder and elbow are managed with conservative treatments. The sports protection education includes the Modified Yokohama Baseball-9 (mYKB-9), a program that significantly reduces injuries with exercises targeting shoulder and elbow health. Medium-risk players receive mYKB-9 education only, while low-risk players are observed without changes to their training methods.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Schools assigned to the usual care management group will receive a visit from one of the co-principal investigators, who will explain the project to the coaches and athletic trainers but request that they do not change their existing training plans or care practices. However, medical consultation or referral contact information will be provided if needed. |
| Risk stratification care | Experimental | All baseball players at schools assigned to the injury risk-stratified care group will be categorized into high-risk, medium-risk, and low-risk groups. Baseball players in the high-risk group will receive not only sports protection education but will also be referred to a physician for further care. The sports protective education is taught by a sports injury prevention specialist from the Sports Injury Prevention System for Student Athletes of the Sports Administration. This education includes a prevention program known as the Modified Yokohama Baseball-9 (mYKB-9), which has been clinically validated to effectively reduce shoulder and elbow joint injuries in adolescent baseball players by nearly half. The program consists of nine exercises, including five stretches, two thoracic mobility exercises, and two lower limb balance exercises. Receives: Behavioral: Risk stratification care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Arm Scale for Throwers (FAST)
This study strives to observe changes in the quality of life among Taiwanese adolescent baseball players over the course of a year. To achieve this, the questionnaire will be administered multiple times, with visits to the schools for measurements once per season (every 3 months). The primary measurement tool will be the Chinese version of the FAST scale, which has been validated in preliminary research.
Measured: From enrollment to the end of study at 12 months.
Secondary outcomes (1)
Injury
Each season, during school visits, the study will examine baseball players in the team who have experienced throwing arm injuries. Coaches will be asked to identify players who have had injuries in the past three months and refer them to the visiting physician for assessment. If physical examination and ultrasound screening confirm abnormalities in the shoulder (such as rotator cuff tendinitis or tears, shoulder labral injuries, etc.) or elbow (such as medial epicondylitis, ulnar collateral ligament injuries, osteochondritis dissecans, etc.), the player will be classified as injured. Injury data will be categorized as follows: injury occurrence (dichotomous data), number of injuries (count data), and severity (ordinal data). The number of injuries will be determined by asking players how many times they have experienced throwing arm injuries in the past three months.
Measured: From enrollment to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Oct 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Baseball PlayersStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637241
- Sponsor's protocol ID
- CMRPG8P0161
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Secondary analysis might be performed after the primary study, so IPD will not be shared immediately after finishing the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effectiveness of Injury Prevention Between Risk Stratification Care and Usual Care in Taiwan Adolescent Baseball Players: a Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06637241
- Acronym / sponsor ID
- CMRPG8P0161
- Conditions
- Adolescent Baseball Players
- Keywords
- Throwing arm injury, Stratified care for injury risk, Long term follow up, Health-related quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to frequent practices and competitions, Taiwanese adolescent baseball players gradually accumulate fatigue, leading to injuries in their throwing arms. Previous research on baseball has primarily focused on the epidemiology of sports injuries, biomechanical analysis of throwing motions, and the effectiveness of injury prevention interventions. Based on our previous research on the quality of life of Taiwanese adolescent baseball players, we have gained a general understanding of the impact of throwing arm injuries on these athletes. This study aims to stratify the injury risks of these baseball players based on past research and provide corresponding care guidelines according to different risk levels. We will compare this care model with standard care through a cluster randomized controlled trial, aiming to verify that this model is effective, efficient, and more clinically applicable than previous injury prevention interventions. Ultimately, we hope to promote this care model across all youth baseball teams in Taiwan.
Detailed description
Baseball involves repetitive throwing motions that place considerable stress on the shoulder and elbow, leading to throwing arm injuries. Previous studies have shown that baseball players are at a higher risk of upper limb injuries compared to the general population, particularly pitchers. In Major League Baseball (MLB) in the United States, more than half of the injuries are to the upper limbs, and 48.4% of these are caused by throwing motions. Since throwing is a crucial part of baseball, injuries to the throwing arm can result in significant disability, both in sports and non-sports contexts. These disabilities not only affect the performance of baseball players but also have broader implications, including psychological and social impacts.
Recently, the importance of patient-reported outcomes (PRO) in clinical research has been increasingly recognized. In the past, clinical assessments focused primarily on physician evaluations of physical examinations and diagnostic test results. However, these measures may not accurately reflect patients\' actual experiences. PROs can help physicians assess patients\' health-related quality of life (HRQOL). This concept has also started to gain traction in the field of sports medicine.
Taiwanese adolescent baseball players face varying degrees of injury risk based on their defensive positions. In addition, measuring HRQOL may help identify injury risks that cannot be determined solely by their defensive positions. For high-risk baseball players, early referral to a physician for further examination and treatment can greatly aid in preventing injuries or facilitating recovery and return to the field after an injury. To identify high-risk individuals among a group of baseball players, our research team has collaborated with several junior high and high school baseball teams in Kaohsiung (including seven junior high schools and one high school).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Schools assigned to the usual care management group will receive a visit from one of the co-principal investigators, who will explain the project to the coaches and athletic trainers but request that they do not change their existing training plans or care practices. However, medical consultation or referral contact information will be provided if needed. |
| Risk stratification care | Experimental | Behavioral: Risk stratification careAll baseball players at schools assigned to the injury risk-stratified care group will be categorized into high-risk, medium-risk, and low-risk groups. Baseball players in the high-risk group will receive not only sports protection education but will also be referred to a physician for further care. The sports protective education is taught by a sports injury prevention specialist from the Sports Injury Prevention System for Student Athletes of the Sports Administration. This education includes a prevention program known as the Modified Yokohama Baseball-9 (mYKB-9), which has been clinically validated to effectively reduce shoulder and elbow joint injuries in adolescent baseball players by nearly half. The program consists of nine exercises, including five stretches, two thoracic mobility exercises, and two lower limb balance exercises. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All youths who are members of their school's baseball team and are willing to participate in the study with parental consent.
- Agree to participate in the trial and complete the participant consent form.
Key exclusion criteria (1 listed)
- A history of significant musculoskeletal or neurological injuries (or functional abnormalities).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk stratification careIn this group, Taiwanese adolescent baseball players are categorized into high-risk, medium-risk, and low-risk groups based on injury risk from a previous study. High-risk players receive sports protection education and physician referrals for shoulder and elbow assessments, with further imaging if necessary. Common issues like Little League shoulder and elbow are managed with conservative treatments. The sports protection education includes the Modified Yokohama Baseball-9 (mYKB-9), a program that significantly reduces injuries with exercises targeting shoulder and elbow health. Medium-risk players receive mYKB-9 education only, while low-risk players are observed without changes to their training methods. | Behavioural | Risk stratification care |
Primary outcome
Functional Arm Scale for Throwers (FAST)
Time frame: From enrollment to the end of study at 12 months.
This study strives to observe changes in the quality of life among Taiwanese adolescent baseball players over the course of a year. To achieve this, the questionnaire will be administered multiple times, with visits to the schools for measurements once per season (every 3 months). The primary measurement tool will be the Chinese version of the FAST scale, which has been validated in preliminary research.
1 secondary outcome
Injury
Time frame: From enrollment to the end of the study at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided. Secondary analysis might be performed after the primary study, so IPD will not be shared immediately after finishing the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk stratification care in people with Adolescent Baseball Players, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Arm Scale for Throwers (FAST) (time frame: From enrollment to the end of study at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.