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临床试验/NCT05346939
NCT05346939Unknown不适用

To Analyze the Kinematic Change of Lower Limb During Jumping Task With Wearable Device - 2-year Program

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
115
试验地点
2
主要终点
Observe the effect of dynamic taping in lower limb biomechanics.

研究概览

简要总结

This study will be conducted in two years: In the first year, the investigators would verify the relation between wearable device and motion analysis and its validity and reliability. In advance, the investigators are going to observe the effect of dynamic taping in lower limb biomechanics of high-school soccer and basketball athletes. In the second year, the investigators would recruit high school soccer and basketball athletes to examine the effect of dynamic taping in lower limb biomechanics under fatigue.

详细描述

In Taiwan, it was estimated that at least 1,000 cases of patients require anterior cruciate ligament (ACL) reconstruction annually. Despite the improving of surgical technique, there are only 65% patients who received the ACL reconstruction return to their pre-injury level of sport. Therefore, to prevent ACL injuries in athletes is critical. The mechanism of ACL injury is greatly associated with lower limb biomechanics.

Motional analysis is the golden standard for biomechanics. However, with the advancement in technology, the investigators could explore lower limb biomechanics conveniently by wearable device. But the validity and reliability need further confirmation.

According to previous studies, the investigators could predict the possibility of ACL injuries by the change of biomechanics, such as hip adduction, internal rotation and knee valgus. Dynamic taping is a newly developing technique with better elasticity and extensibility. Studies showed that dynamic taping improve the biomechanics of knee joint. Hence, the investigators can adjust the faulty movement as soon as possible to prevent the occurrence of ACL injuries.

This study will be conducted in two years: In the first year, the investigators would verify the relation between wearable device and motion analysis and its validity and reliability. In advance, the investigators are going to observe the effect of dynamic taping in lower limb biomechanics of high-school soccer and basketball athletes. In the second year, the investigators would recruit high school soccer and basketball athletes to examine the effect of dynamic taping in lower limb biomechanics under fatigue.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

In this study, the athletic trainer will intervene with a dynamic tape (spiral dynamic technique) using a dynamic tape for the first test and a sham dynamic tape for the second test.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1st Year: 16+ health volunteers
  • 2nd Year: senior high school and college athlete

排除标准

  • Those who are unable to exercise due to acute joint, muscle or nerve injury in the lower extremities
  • Lower extremity surgery within 1 year
  • Head trauma within 6 months
  • Those with vestibular injury within 6 months
  • Allergic to Dynamic tape
  • Visual coordination impairment

结局指标

主要结局

Observe the effect of dynamic taping in lower limb biomechanics.

时间窗: 1st Year

The investigators would recruit senior high school athletes (n=50) to compare the changes of trunk and lower extremities joint angles with dynamic taping intervention. Subjects need to wear the wearable device (KinMAS system) and take double-leg Landing Error Scoring System (LESS) Score test with dynamic taping intervention. The athletic trainer will intervene with spiral dynamic technique by using a dynamic tape for the first test and a sham dynamic tape for the second test, or reverse the order. The Landing Error Scoring System (LESS) with double-leg consists of 17 items; total score is 0-19 points. Higher scores mean a worse outcome.

Understand the correlation between wearable devices (KinMAS system) and Vicon dynamic analysis system, and further assessment of the reliability and validity of the wearable devices (KinMAS system).

时间窗: 1st Year

The investigators would recruit health volunteers (n=15) to verify the relation between wearable device and motion analysis and its validity and reliability. Vicon motion capture system (golden standard) and wearable device (KinMAS system) are used simultaneously to measure the angle changes of the trunk and lower limbs with jump-landing task and counter movement jump.

Observe the effect of dynamic taping in lower limb biomechanics after fatigue protocol.

时间窗: 2nd Year

The investigators would recruit senior high school athletes (n=50) to compare the changes of trunk and lower extremities joint angles with dynamic taping intervention. Subjects need to wear the wearable device (KinMAS system) and take double-leg and single-leg Landing Error Scoring System (LESS) Score tests with dynamic taping intervention after fatigue protocol. The athletic trainer will intervene with spiral dynamic technique by using a dynamic tape for the first test and a sham dynamic tape for the second test, or reverse the order. The Landing Error Scoring System (LESS) with double-leg consists of 17 items, total score is 0-19 points, whereas the single-leg consists of 14 items and total score is 0-16 points. Higher scores mean a worse outcome.

次要结局

未报告次要终点

研究者

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

研究点 (2)

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