跳至主要内容
临床试验/NCT06637241
NCT06637241已完成不适用

Compare the Effectiveness of Injury Prevention Between Risk Stratification Care and Usual Care in Taiwan Adolescent Baseball Players: a Cluster Randomized Controlled Trial.

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Functional Arm Scale for Throwers (FAST)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •(1) A history of significant musculoskeletal or neurological injuries (or functional abnormalities).

研究组 & 干预措施

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.

干预措施: Risk stratification care (Behavioral)

结局指标

主要结局

Functional Arm Scale for Throwers (FAST)

时间窗: 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.

次要结局

  • Injury(From enrollment to the end of the study at 12 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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