Michael W. Krzyzewski Human Performance Laboratory
Durham, North Carolina, 27705, United States
NCT Number: NCT03805464
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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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60mL saline injection into the supra-patellar region of the knee
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Kinetic Loading Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Kinetic Loading Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Kinetic Loading Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Accelerometer Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Accelerometer Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Gyroscope Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Gyroscope Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Muscle Activity Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Muscle Activity Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Pain Variable
Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Self-Reported Disability Variable
Duke University
Other
Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion
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