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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Joint Effusion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee Joint Effusion | Other | 60mL saline injection into the supra-patellar region of the knee |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael W. Krzyzewski Human Performance Laboratory | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
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| 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 |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |