Walking Gait Biomechanics Following Knee Joint Effusion

Study Overview
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Brief Summary
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The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.

Official Title
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Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion

Conditions
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Knee Injuries, Knee Osteoarthritis

Intervention / Treatment
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* Other: Knee Joint Effusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Chronological age 18-35 at the time of study participation Physically active (at least 30 minutes of physical activity, 3x/week) Tegner Activity Scale score at least 5/10 Exclusion Criteria: History of lower extremity or lumbar spine surgery. History of lower extremity or lumbar spine injury in the prior 6 months. History of major ligamentous damage. Current knee pain. Known neurological condition, autoimmune condition, cardiovascular disease. History of epilepsy, seizures, concussion within the prior 6 months. Currently taking pain altering medication. Fear of needles Unable to read and understand English language Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Joint Effusion<br>Participants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space of the dominant lower extremity. This injection will be conducted under ultrasound guidance by a board-certified orthopedic surgeon. | Other: Knee Joint Effusion<br>* 60mL saline injection into the supra-patellar region of the knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Vertical Ground Reaction Force | Kinetic Loading Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Peak Internal Knee Extension Moment | Kinetic Loading Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Peak Knee Power | Kinetic Loading Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Shank Acceleration | Accelerometer Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Thigh Acceleration | Accelerometer Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Shank Angular Velocity | Gyroscope Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Thigh Angular Velocity | Gyroscope Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quadriceps EMG | Muscle Activity Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Hamstring EMG | Muscle Activity Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in Visual Analog Scale Pain | Pain Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 
| Change in International Knee Documentation Committee | Self-Reported Disability Variable | Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomechanics, inertial measurement unit