Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People

March 15, 2022 updated by: The Hong Kong Polytechnic University

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

Completed

Study Type

Observational

Enrollment (Actual)

59

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

      • Hung Hom, Hong Kong, 000000
        • Hong Kong Polytechnic 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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy subject without patellofemoral joint problem

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

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

  • 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
Patellar displacement, patellar Alta/Baja and patellar tilt angle
Within 1 hour
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
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

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

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)

November 26, 2021

Primary Completion (Actual)

February 9, 2022

Study Completion (Actual)

February 9, 2022

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20038261r

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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