The Effect of Dynamic Taping to Improve the Landing Strategy in Athletes.

This study will be conducted in three years: In the first year, we would recruit male and female high school soccer athletes to observe the effect of dynamic taping on landing error scoring system under fatigue status. In the second year, we would recruit junior high school, high school and college athlete to establish a native model of single-leg and double-leg LESS, then in advanced, confirm the ability to predict ACL injuries. In the third year, we will focus on high-risk subjects evaluated by LESS and athlete with ACL reconstruction to observe the supportive effect of dynamic taping.

Study Overview

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

Detailed Description

ACL injuries occur most frequently in sports involving pivoting sudden deceleration. In Taiwan, it was estimated that at least 1,000 cases of patients require ACL reconstruction annually. Despite the improving of surgical technique, there is 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.

According to previous studies, the Landing Error Scoring System (LESS) is a clinical assessment tool to do field evaluation. We could predict the possibility of ACL injuries by the change of biomechanics. However, there are still many factors affecting the LESS, such as fatigue, single or double leg landing, age, sex and specific sport...etc., and comprehensive studies are absent.

Dynamic taping is a newly developing technique with better elasticity and extensibility. Studies showed that dynamic taping improve the biomechanics of knee joint. Hence, we can adjust the faulty movement as soon as possible to prevent the occurrence of ACL injuries.

This study will be conducted in three years: In the first year, we would recruit male and female high school soccer athletes to observe the effect of dynamic taping on landing error scoring system under fatigue status. In the second year, we would recruit junior high school, high school and college athlete to establish a native model of single-leg and double-leg LESS, then in advanced, confirm the ability to predict ACL injuries. In the third year, we will focus on high-risk subjects evaluated by LESS and athlete with ACL reconstruction to observe the supportive effect of dynamic taping.

• Study Type: Interventional
• Enrollment (Anticipated): 990
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1st Year: senior high school soccer athletes
• 2nd Year: junior/senior high school and college athlete
• 3dr Year: high-risk subjects evaluated by LESS and athlete with ACL reconstruction

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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Athletes in Taiwan; In the first year, we would recruit senior high school soccer athletes (n=30) to observe the difference with/without dynamic taping on landing error scoring system under fatigue status. (2x2 cross-over study) In the second year, we would recruit junior/senior high school and college athlete (n=900) to establish a native model of single-leg and double-leg LESS, then in advanced, confirm the ability to predict ACL injuries. In the third year, we will focus on high-risk subjects evaluated by LESS and athlete with ACL reconstruction (n=60) to observe the supportive effect of dynamic taping. (2x2 cross-over study)

Device: dynamic taping; The intervention of dynamic tape can improve the LESS, which also means that we may reduce the probability of ACL injury through the intervention of dynamic tape.; By establish a native model of single-leg and double-leg LESS can predict the occurrence of ACL injury early and further prevent it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landing Error Scoring System (LESS) Score	Recruit senior high school soccer athletes (n=30) to observe the difference with/without dynamic taping on landing error scoring system under fatigue status. 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.	1st Year
Landing Error Scoring System (LESS) Score	Recruit junior/senior high school and college athlete (n=900) to establish a native model of single-leg and double-leg LESS. 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
Landing Error Scoring System (LESS) Score	Recruit high-risk subjects evaluated by LESS and athlete with ACL reconstruction (n=60) to observe the supportive effect of dynamic taping. 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.	3rd Year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: CHIH-KUAN WU, MD, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (ACTUAL): March 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Dynamic taping; Landing Error Scoring System (LESS); ACL injuries
• Other Study ID Numbers: 202002434B0

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