Lower Extremity Alignment and Dynamic Control With Associated Injury Risk in College Athletes With Knee Hyperextension

April 8, 2019 updated by: National Yang Ming University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • 北投區
      • Taipei City, 北投區, Taiwan, 112
        • National Yng Ming University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

college athletes in Yang-Ming University and University of Taipei

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Knee hyperextension group
athletes who has knee hyperextension
Control group
athletes who doesn't have knee hyperextension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Injury type
Time Frame: 4 months
Record injury type
4 months
Injury duration
Time Frame: 4 months
time loss during the game or training (days)
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower extremity alignments-pelvic tilt on sagittal plane
Time Frame: 1st day
pelvic tilt on sagittal plane in degree
1st day
Lower extremity alignments-hip anteversion
Time Frame: 1st day
hip anteversion in degree
1st day
Lower extremity alignments-tibiofemoral angle
Time Frame: 1st day
tibiofemoral angle in degree
1st day
Lower extremity alignments-knee hyperextension angle
Time Frame: 1st day
knee hyperextension angle in supine and standing posture in degree
1st day
Lower extremity alignments-tibial rotation angle
Time Frame: 1st day
tibial rotation angle in degree
1st day
Lower extremity alignments-hip external rotation angle
Time Frame: 1st day
hip external rotation angle in degree
1st day
Lower extremity alignments-hip internal rotation angle
Time Frame: 1st day
hip internal rotation angle in degree
1st day
Lower extremity alignments-navicular drop
Time Frame: 1st day
navicular drop normalized with foot length in %
1st day
Rectus femoris flexibility
Time Frame: 1st day
measure knee angle in prone knee bend position
1st day
Hamstrings flexibility
Time Frame: 1st day
measure knee angle in 90-90 straight leg raise test
1st day
Gastrocnemius flexibility
Time Frame: 1st day
measure ankle dorsiflexion angle in standing position without rearfoot lift off the floor
1st day
Soleus flexibility
Time Frame: 1st day
measure ankle dorsiflexion angle in knee flex standing position without rearfoot lift off the floor
1st day
Iliotibial band flexibility
Time Frame: 1st day
use Ober's test to measure the angle below horizontal level
1st day
Dynamic task parameters-acceleration and angle
Time Frame: 1st day
anteroposterior acceleration and angle changes at knee joint
1st day
Dynamic task parameters-ground reaction force
Time Frame: 1st day
ground reaction force
1st day
Dynamic task parameters-Electromyography (EMG)
Time Frame: 1st day
use EMG to detect muscle firing during jump task
1st day
knee extensors muscle strength
Time Frame: 1st day
knee extensors by hand held dynamometer
1st day
knee flexors muscle strength
Time Frame: 1st day
knee flexors by hand held dynamometer
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YM106052E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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