- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04982679
Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People
Patellofemoral pain is a common disease, and it often couples with patellar malalignment. Previously, imbalance of the different quadriceps muscle heads was believed to be a causative factor of patellar malignment. However, findings from electromyography studies on quadriceps activities and patellar alignment in the last two decades were inconsistent. In order to better understand the relationship between quadriceps muscle imbalance and patellar malalignment, shear wave elastography (SWE), which can measure the passive and active muscle stiffness, may shed some new lights to this area. This study aims to examine whether the quadriceps muscle stiffness can predict the patellar position. The healthy young adult will be recruited in this study. Active and passive quadriceps muscle stiffness will be measured with the SWE in different conditions and the result will be correlated with the patellar position measured with magnetic resonance imaging (MRI). Also, electromyography (EMG) activity will be measured during the active stiffness measurement so as to establish the level of agreement between the EMG and SWE data. Linear regression will be used to calculate the relationship between different factors. The total number of subjects needed will be 55 by setting an effect size of 0.15 with two predictors, 80% power, and α at 0.05 in the linear regression.
This project will be conducted at PolyU campus and an MRI clinic in Hong Kong. Hopefully, it could be started in July 2021 and will last for 1 year.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Hung Hom, Hong Kong, 000000
- Hong Kong Polytechnic University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy and in the range between 18 and 45 years.
Exclusion Criteria:
- Knee pain in the last 3 months;
- Previous history of knee surgery;
- People with contraindications to having MRI scanning.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patellofemoral Joint Alignment measured by MRI scanning
Time Frame: Within 1 hour
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Patellar displacement, patellar Alta/Baja and patellar tilt angle
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Within 1 hour
|
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Muscle stiffness measured by ultragraph using shear wave elastography
Time Frame: Within 1 hour
|
Raw data of vastus lateralis, rectus femoris and vastus medialis obliquus shear modulus
|
Within 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle activity measured by electromyography
Time Frame: Within 1 hour
|
EMG data of vastus lateralis, rectus femoris and vastus medialis obliquus
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Within 1 hour
|
|
Muscle strength
Time Frame: Within 0.5 hour
|
Maximum isometric knee extensor muscle strength at specific joint angle (30 degrees and 60 degrees knee flexion)
|
Within 0.5 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20038261r
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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