NCT05288296

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
990

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

March 11, 2022

Last Update Submit

April 18, 2022

Conditions

Keywords

Dynamic tapingLanding Error Scoring System (LESS)ACL injuries

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Athletes in Taiwan

EXPERIMENTAL

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

Interventions

1. 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. 2. By establish a native model of single-leg and double-leg LESS can predict the occurrence of ACL injury early and further prevent it.

Athletes in Taiwan

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • CHIH-KUAN WU, MD

    Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

August 1, 2021

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations