Landing Error Scoring System (LESS)NCT05288296
The Effect of Dynamic Taping to Improve the Landing Strategy in Athletes.
A study testing dynamic taping in people with Landing Error Scoring System (LESS), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Landing Error Scoring System (LESS)
- What is being tested?
- dynamic taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Landing Error Scoring System (LESS)
- Being tested
- dynamic taping
- Keywords
- Dynamic taping, Landing Error Scoring System (LESS), ACL injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic tapingDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: dynamic taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3rd Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Aug 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Landing Error Scoring System (LESS)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- CHIH-KUAN WU, MD, Principal investigator, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288296
- Sponsor's protocol ID
- 202002434B0
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Taping to Improve the Landing Strategy in Athletes.
- ClinicalTrials.gov ID
- NCT05288296
- Acronym / sponsor ID
- 202002434B0
- Conditions
- Landing Error Scoring System (LESS)
- Keywords
- Dynamic taping, Landing Error Scoring System (LESS), ACL injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes in Taiwan | Experimental | Device: dynamic tapingIn 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) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic taping1. 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. | Device | Athletes in Taiwan |
Primary outcome
Landing Error Scoring System (LESS) Score
Time frame: 1st Year
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.
Landing Error Scoring System (LESS) Score
Time frame: 2nd Year
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.
Landing Error Scoring System (LESS) Score
Time frame: 3rd Year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Landing Error Scoring System (LESS)
Not yet recruiting
Kinesio Taping for the Knee and Ankle: Acute Impact on Balance, Proprioception, and ACL Risk
ACL Injury, Kinesiotape
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHIH-KUAN WU, MD principal investigator
Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic taping in people with Landing Error Scoring System (LESS), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Landing Error Scoring System (LESS) Score (time frame: 1st Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.