Anterior Cruciate Ligament ReconstructionNCT04629092
The Effect of Upper Limbs Motion During Single-leg Jump Landing After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effect of upper limbs motion on lower limb biomechanics and muscle activity during single-leg jump landing after anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2019to 6 Dec 2019
- Phase
- Observational
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Age between 20-50 years old
Who may be able to join
- Only one leg has operation of ACL reconstruction
- At least 1 year after ACLR or have been back to sports
- Exercise in sports regularly.
Who cannot join
- Other operation of lower extremity exclude ACLR
- Any diseases or poor condition that will affect jumping or deterioration after jumping.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Upper Limbs Motion on Lower Limb Biomechanics and Muscle Activity During Single-leg Jump Landing After Anterior Cruciate Ligament Reconstruction
The aim of this study is to investigate the effect of upper limbs motion on lower limb biomechanics and muscle activity during single-leg jump landing after anterior cruciate ligament reconstruction.
Read the detailed description
More and more people join in different sports in recent years. But the incidence of sports injury also increases. And the most frequently occurring and debilitating knee injury in sports is rupture of the anterior cruciate ligament (ACL). Patients who aim to return to their preinjury sports should undergo anterior cruciate ligament reconstruction (ACLR) in order to maximize knee stability. The overall incidence rate of a second ACL injury within 24 months after ACLR was nearly 6 times greater than that in healthy participants. Although many studies have showed about biomechanical and neuromuscular risk factors during jump landing which were thought to associate with the secondary injury after ACLR, these studies all focused on the motion of lower extremity. But actually, people often use their upper limbs to catch or throw a ball during jump landing in playground. Whether the upper limbs motion will affect the muscle coordination of lower extremity during jump landing is still unknown. Therefore, the purpose of our study is to investigate the effect of upper limbs motion during single-leg jump landing after ACLR.
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics of lower-limb during landing phase
The data will be collected by VICON motion capture system, include hip, knee and ankle joint angle in three plane. (frontal plane, sagittal plane and transverse plane)
Measured: from taking off to landing, about 5 seconds.
Kinetics of knee joint during landing phase
The data will be collected by VICON motion capture system and calculated by inverse dynamics, include knee flexion/extension moment, abduction/adduction moment, internal/external rotation moment.
Measured: from taking off to landing, about 5 seconds.
Muscle onset time of lower-limb muscles during landing phase
The data will be collected by wireless electromyography, include rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus.
Measured: from taking off to landing, about 5 seconds.
Muscle activation of lower-limb muscles during landing phase
The data will be collected by wireless electromyography, include rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, anterior tibialis, medial gastrocnemius
Measured: from taking off to landing, about 5 seconds.
Muscle activation-Hamstring and Quadriceps ratio (H/Q ratio) during landing phase
The data will use the amount of hamstring and quadriceps muscle activation to calculate H/Q ratio.
Measured: from taking off to landing, about 5 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start26 Jul 2019
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629092
- Sponsor's protocol ID
- YM108023E
- Status last verified
- May 2019
- First submitted
- 15 Aug 2019
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Limbs Motion on Lower Limb Biomechanics and Muscle Activity During Single-leg Jump Landing After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04629092
- Acronym / sponsor ID
- YM108023E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 16 Nov 2020 (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.
The aim of this study is to investigate the effect of upper limbs motion on lower limb biomechanics and muscle activity during single-leg jump landing after anterior cruciate ligament reconstruction.
Detailed description
More and more people join in different sports in recent years. But the incidence of sports injury also increases. And the most frequently occurring and debilitating knee injury in sports is rupture of the anterior cruciate ligament (ACL). Patients who aim to return to their preinjury sports should undergo anterior cruciate ligament reconstruction (ACLR) in order to maximize knee stability. The overall incidence rate of a second ACL injury within 24 months after ACLR was nearly 6 times greater than that in healthy participants. Although many studies have showed about biomechanical and neuromuscular risk factors during jump landing which were thought to associate with the secondary injury after ACLR, these studies all focused on the motion of lower extremity. But actually, people often use their upper limbs to catch or throw a ball during jump landing in playground. Whether the upper limbs motion will affect the muscle coordination of lower extremity during jump landing is still unknown. Therefore, the purpose of our study is to investigate the effect of upper limbs motion during single-leg jump landing after ACLR.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Age between 20-50 years old
Key inclusion criteria (3 listed)
- Only one leg has operation of ACL reconstruction
- At least 1 year after ACLR or have been back to sports
- Exercise in sports regularly.
Key exclusion criteria (2 listed)
- Other operation of lower extremity exclude ACLR
- Any diseases or poor condition that will affect jumping or deterioration after jumping.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinematics of lower-limb during landing phase
Time frame: from taking off to landing, about 5 seconds.
The data will be collected by VICON motion capture system, include hip, knee and ankle joint angle in three plane. (frontal plane, sagittal plane and transverse plane)
Kinetics of knee joint during landing phase
Time frame: from taking off to landing, about 5 seconds.
The data will be collected by VICON motion capture system and calculated by inverse dynamics, include knee flexion/extension moment, abduction/adduction moment, internal/external rotation moment.
Muscle onset time of lower-limb muscles during landing phase
Time frame: from taking off to landing, about 5 seconds.
The data will be collected by wireless electromyography, include rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus.
Muscle activation of lower-limb muscles during landing phase
Time frame: from taking off to landing, about 5 seconds.
The data will be collected by wireless electromyography, include rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, anterior tibialis, medial gastrocnemius
Muscle activation-Hamstring and Quadriceps ratio (H/Q ratio) during landing phase
Time frame: from taking off to landing, about 5 seconds.
The data will use the amount of hamstring and quadriceps muscle activation to calculate H/Q ratio.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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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.
Li-Wei Chou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by National Yang Ming Chiao Tung University 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 2 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: finished, as of the sponsor's last update on 16 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Kinematics of lower-limb during landing phase (time frame: from taking off to landing, about 5 seconds.). The study lists 5 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 Nov 2020.