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

NCT ID: NCT05346939

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Landing Error Scoring System (LESS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

dynamic taping

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

CHIEN-HUNG CHEN, MD

Role: PRINCIPAL_INVESTIGATOR

Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202101717B0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tianjin University of Sport
NCT06616493 COMPLETED NA