Clinical trial NCT05346939: To Analyze the Kinematic Change of Lower Limb During Jumping Task With Wearable Device - 2-year Program
Official title: To Analyze the Kinematic Change of Lower Limb During Jumping Task With Wearable Device - 2-year Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Landing Error Scoring System (LESS)
Keywords: Dynamic taping
Landing Error Scoring System (LESS)
ACL injuries
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 115
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The first year, the investigators would verify the relation between wearable device and motion analysis and its validity and reliability (n=15). And the investigators are going to observe the effect of dynamic taping in lower limb biomechanics of high-school soccer and basketball athletes (n=50). 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 (n=50). In order to exclude the influence of sequence and learning effect, a cross-over study was used, and the interval between the two tests was about 2 weeks.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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
* Pregnant
* Visual coordination impairment

Primary outcomes:
measure: 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).
timeFrame: 1st Year
measure: Observe the effect of dynamic taping in lower limb biomechanics.
timeFrame: 1st Year
measure: Observe the effect of dynamic taping in lower limb biomechanics after fatigue protocol.
timeFrame: 2nd Year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
name: CHIEN-HUNG CHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: