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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Landing Error Scoring System (LESS)
• Intervention / Treatment: Device: dynamic taping

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.

• Study Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Senior high school athletes in Taiwan; In the first year, the investigators would verify the relation between wearable device and motion analysis and its validity and reliability at stage I (n=15). And the investigators are going to observe the effect of dynamic taping in lower limb biomechanics of high-school soccer or basketball athletes (n=50) at stage II. 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).

Device: dynamic taping; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	1st Year
Observe the effect of dynamic taping in lower limb biomechanics.	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.	1st Year
Observe the effect of dynamic taping in lower limb biomechanics after fatigue protocol.	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.	2nd Year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: CHIEN-HUNG CHEN, MD, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Dynamic taping; Landing Error Scoring System (LESS); ACL injuries
• Other Study ID Numbers: 202101717B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No