Knee HyperextensionNCT03425968
Lower Extremity Alignment and Dynamic Control With Associated Injury Risk in College Athletes With Knee Hyperextension
An observational study of Knee Hyperextension, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Knee hyperextension, also called genu recurvatum or back knee, is commonly seen in women, people with ligamentous laxity, stroke and cerebral palsy patients. This faulty posture would result in excessive tension of the passive tissues such as anterior cruciate ligament (ACL) and posterior capsule of the knee. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Hyperextension
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2018to 31 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: college athletes in Yang-Ming University and University of Taipei
Who may be able to join
- age ≥ 20 years old
- knee hyperextension ≥ 5⁰
- participate in jump- landing sports
- training at least 3 days per week
- no lower extremity injury last 3 months
Who cannot join
- having knee surgery before
- In the past three months have occurred lower extremity musculoskeletal injury leading the person can't participate in training or competition for at least three days
Trial locations and contacts
1 site in 1 country.
About this study
Knee hyperextension, also called genu recurvatum or back knee, is commonly seen in women, people with ligamentous laxity, stroke and cerebral palsy patients. This faulty posture would result in excessive tension of the passive tissues such as anterior cruciate ligament (ACL) and posterior capsule of the knee. Subjects may also develop compensations at hip and ankle joint, as well as lower extremity malalignment. Muscles surrounding the knee could also become dysfunctional when performing functional tasks requiring stability during terminal knee extension, during which uncontrolled knee hyperextension could easily be utilized to lock the joint for stability in gait and stair climbing. In athletes, landing from a jump on an extended knee is one of the common reasons resulting in ACL injury. Little is known about the injury rate of athletes with knee hyperextension who participate in sports involving jump-landing activities.
The aim of the study is to explore if knee hyperextension is associated with poor lower extremity alignment and dynamic control and injury rate in athletes requiring jump-landing activities.
Read more
One of the study hypothesis is that athlete with knee hyperextension can find more compensatory lower extremity alignments and poor control in dynamic movement than control group.
The other hypothesis is with or without knee hyperextension, the parameter of lower extremity alignment and dynamic control can predict injury rate in jump landing athlete.
Read the detailed description
Investigators expect to recruit 100 subjects into 2 group- control group and knee hyperextension group (KH group). In knee hyperextension group, investigators will include college athletes having knee hyperextension alignment, no lower extremity injuries in past three months, and participating in jump-landing activities. Control group will match the gender, age, height, weight and sports to KH group. Inclusion criteria is the same as KH group, except the knee hyperextension angle is <5⁰ in control group. Every subjects will receive the first time assessment and follow up by filling the injury-follow-up form every months for about four months.
At the first assessment, investigators will measure lower extremity alignments include pelvic angle in sagittal plane, hip anteversion, tibiofemoral angle, knee hyperextension angle in supine and standing position, tibial rotation angle, and navicular drop; lower extremity muscle flexibility include rectus femoris, hamstrings, gastrocnemius, soleus, iliotibial band; lower extremity muscle strength include hip, knee, muscle group; dynamic control task will record tibio-femoral acceleration, angle change ground reaction force and EMG muscle firing during vertical jump and drop jump.
- Conditions
- Knee Hyperextension
- Keywords
- Injury rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee hyperextension group | athletes who has knee hyperextension | |
| Control group | athletes who doesn't have knee hyperextension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury type
Record injury type
Measured: 4 months
Injury duration
time loss during the game or training (days)
Measured: 4 months
Secondary outcomes (18)
Lower extremity alignments-pelvic tilt on sagittal plane
pelvic tilt on sagittal plane in degree
Measured: 1st day
Lower extremity alignments-hip anteversion
hip anteversion in degree
Measured: 1st day
Lower extremity alignments-tibiofemoral angle
tibiofemoral angle in degree
Measured: 1st day
Lower extremity alignments-knee hyperextension angle
knee hyperextension angle in supine and standing posture in degree
Measured: 1st day
Lower extremity alignments-tibial rotation angle
tibial rotation angle in degree
Measured: 1st day
Lower extremity alignments-hip external rotation angle
hip external rotation angle in degree
Measured: 1st day
Lower extremity alignments-hip internal rotation angle
hip internal rotation angle in degree
Measured: 1st day
Lower extremity alignments-navicular drop
navicular drop normalized with foot length in %
Measured: 1st day
Rectus femoris flexibility
measure knee angle in prone knee bend position
Measured: 1st day
Hamstrings flexibility
measure knee angle in 90-90 straight leg raise test
Measured: 1st day
Gastrocnemius flexibility
measure ankle dorsiflexion angle in standing position without rearfoot lift off the floor
Measured: 1st day
Soleus flexibility
measure ankle dorsiflexion angle in knee flex standing position without rearfoot lift off the floor
Measured: 1st day
Iliotibial band flexibility
use Ober's test to measure the angle below horizontal level
Measured: 1st day
Dynamic task parameters-acceleration and angle
anteroposterior acceleration and angle changes at knee joint
Measured: 1st day
Dynamic task parameters-ground reaction force
ground reaction force
Measured: 1st day
Dynamic task parameters-Electromyography (EMG)
use EMG to detect muscle firing during jump task
Measured: 1st day
knee extensors muscle strength
knee extensors by hand held dynamometer
Measured: 1st day
knee flexors muscle strength
knee flexors by hand held dynamometer
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start27 Feb 2018
- Primary completion30 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee HyperextensionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Yin Chen, PhD, Principal investigator, National Yang-Ming University The Department of Physical Therapy and Assistive Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425968
- Sponsor's protocol ID
- YM106052E
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2018
- Last updated
- 10 Apr 2019
- 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 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Alignment and Dynamic Control With Associated Injury Risk in College Athletes With Knee Hyperextension
- ClinicalTrials.gov ID
- NCT03425968
- Acronym / sponsor ID
- YM106052E
- Conditions
- Knee Hyperextension
- Keywords
- Injury rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Feb 2018 (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.
Knee hyperextension, also called genu recurvatum or back knee, is commonly seen in women, people with ligamentous laxity, stroke and cerebral palsy patients. This faulty posture would result in excessive tension of the passive tissues such as anterior cruciate ligament (ACL) and posterior capsule of the knee. Subjects may also develop compensations at hip and ankle joint, as well as lower extremity malalignment. Muscles surrounding the knee could also become dysfunctional when performing functional tasks requiring stability during terminal knee extension, during which uncontrolled knee hyperextension could easily be utilized to lock the joint for stability in gait and stair climbing. In athletes, landing from a jump on an extended knee is one of the common reasons resulting in ACL injury. Little is known about the injury rate of athletes with knee hyperextension who participate in sports involving jump-landing activities.
The aim of the study is to explore if knee hyperextension is associated with poor lower extremity alignment and dynamic control and injury rate in athletes requiring jump-landing activities.
One of the study hypothesis is that athlete with knee hyperextension can find more compensatory lower extremity alignments and poor control in dynamic movement than control group.
The other hypothesis is with or without knee hyperextension, the parameter of lower extremity alignment and dynamic control can predict injury rate in jump landing athlete.
Detailed description
Investigators expect to recruit 100 subjects into 2 group- control group and knee hyperextension group (KH group). In knee hyperextension group, investigators will include college athletes having knee hyperextension alignment, no lower extremity injuries in past three months, and participating in jump-landing activities. Control group will match the gender, age, height, weight and sports to KH group. Inclusion criteria is the same as KH group, except the knee hyperextension angle is <5⁰ in control group. Every subjects will receive the first time assessment and follow up by filling the injury-follow-up form every months for about four months.
At the first assessment, investigators will measure lower extremity alignments include pelvic angle in sagittal plane, hip anteversion, tibiofemoral angle, knee hyperextension angle in supine and standing position, tibial rotation angle, and navicular drop; lower extremity muscle flexibility include rectus femoris, hamstrings, gastrocnemius, soleus, iliotibial band; lower extremity muscle strength include hip, knee, muscle group; dynamic control task will record tibio-femoral acceleration, angle change ground reaction force and EMG muscle firing during vertical jump and drop jump.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee hyperextension group | – | –athletes who has knee hyperextension |
| Control group | – | –athletes who doesn't have knee hyperextension |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- college athletes in Yang-Ming University and University of Taipei
Key inclusion criteria (5 listed)
- age ≥ 20 years old
- knee hyperextension ≥ 5⁰
- participate in jump- landing sports
- training at least 3 days per week
- no lower extremity injury last 3 months
Key exclusion criteria (2 listed)
- having knee surgery before
- In the past three months have occurred lower extremity musculoskeletal injury leading the person can't participate in training or competition for at least three days
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
Injury type
Time frame: 4 months
Record injury type
Injury duration
Time frame: 4 months
time loss during the game or training (days)
18 secondary outcomes
Lower extremity alignments-pelvic tilt on sagittal plane
Time frame: 1st day
Lower extremity alignments-hip anteversion
Time frame: 1st day
Lower extremity alignments-tibiofemoral angle
Time frame: 1st day
Lower extremity alignments-knee hyperextension angle
Time frame: 1st day
Lower extremity alignments-tibial rotation angle
Time frame: 1st day
Lower extremity alignments-hip external rotation angle
Time frame: 1st day
Lower extremity alignments-hip internal rotation angle
Time frame: 1st day
Lower extremity alignments-navicular drop
Time frame: 1st day
Rectus femoris flexibility
Time frame: 1st day
Hamstrings flexibility
Time frame: 1st day
Gastrocnemius flexibility
Time frame: 1st day
Soleus flexibility
Time frame: 1st day
Iliotibial band flexibility
Time frame: 1st day
Dynamic task parameters-acceleration and angle
Time frame: 1st day
Dynamic task parameters-ground reaction force
Time frame: 1st day
Dynamic task parameters-Electromyography (EMG)
Time frame: 1st day
knee extensors muscle strength
Time frame: 1st day
knee flexors muscle strength
Time frame: 1st day
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 10 Apr 2019.
Related trials for Knee Hyperextension
Recruiting
Engaging Kids With Robotic Exoskeletons and Gamification
Genu Recurvatum, Crouch Gait
Enrolling by invitation
Comparison of Open Vs Closed Kinetic Chain Exercises in Genu Recurvatum Among Stroke Patients
Cerebrovascular Accident (Stroke), Knee Hyperextension
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.
Wen-Yin Chen, PhD principal investigator
National Yang-Ming University The Department of Physical Therapy and Assistive Technology
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 Knee Hyperextension, 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 5 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 10 Apr 2019. 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?
Injury type (time frame: 4 months). The study lists 2 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 10 Apr 2019.