Landing Error Scoring System (LESS)NCT05346939
To Analyze the Kinematic Change of Lower Limb During Jumping Task With Wearable Device - 2-year Program
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 two years: In the first year, the investigators would verify the relation between wearable device and motion analysis and its validity and reliability. Read more about this study
- Who is it for?
- Ages 16 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
- 115 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 30 Sep 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1st Year: 16+ health volunteers
- 2nd Year: senior high school and college athlete
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 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.
Read the detailed description
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
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: dynamic taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2nd Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIEN-HUNG CHEN, MD, Principal investigator, Taoyuan Chang Gung Memorial Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346939
- Sponsor's protocol ID
- 202101717B0
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 16 Feb 2023
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Analyze the Kinematic Change of Lower Limb During Jumping Task With Wearable Device - 2-year Program
- ClinicalTrials.gov ID
- NCT05346939
- Acronym / sponsor ID
- 202101717B0
- Conditions
- Landing Error Scoring System (LESS)
- Keywords
- Dynamic taping, Landing Error Scoring System (LESS), ACL injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Apr 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 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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Senior high school athletes in Taiwan | Experimental | Device: dynamic tapingIn 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1st Year: 16+ health volunteers
- 2nd Year: senior high school and college athlete
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 tapingThe 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. | Device | Senior high school athletes in Taiwan |
Primary outcome
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).
Time frame: 1st Year
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.
Observe the effect of dynamic taping in lower limb biomechanics.
Time frame: 1st Year
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.
Observe the effect of dynamic taping in lower limb biomechanics after fatigue protocol.
Time frame: 2nd Year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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.
CHIEN-HUNG CHEN, 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 2 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 16 Feb 2023. 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?
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). (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 16 Feb 2023.