NCT05346939

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.

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
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 16, 2023

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

April 20, 2022

Last Update Submit

February 15, 2023

Conditions

Keywords

Dynamic tapingLanding Error Scoring System (LESS)ACL injuries

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Senior high school athletes in Taiwan

EXPERIMENTAL

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

Interventions

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.

Senior high school athletes in Taiwan

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

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)

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

  • CHIEN-HUNG CHEN, MD

    Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

January 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

February 16, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations