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Walking Gait Biomechanics Following Knee Joint Effusion

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03805464
Enrollment
14
Registered
2019-01-15
Start date
2019-01-29
Completion date
2023-05-18
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries, Knee Osteoarthritis

Keywords

biomechanics, inertial measurement unit

Brief summary

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.

Interventions

OTHERKnee Joint Effusion

60mL saline injection into the supra-patellar region of the knee

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Peak Vertical Ground Reaction ForceImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionKinetic Loading Variable
Change in Peak Internal Knee Extension MomentImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionKinetic Loading Variable
Change in Peak Knee PowerImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionKinetic Loading Variable
Change in Shank AccelerationImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionAccelerometer Variable
Change in Thigh AccelerationImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionAccelerometer Variable
Change in Shank Angular VelocityImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionGyroscope Variable
Change in Thigh Angular VelocityImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionGyroscope Variable

Secondary

MeasureTime frameDescription
Change in Quadriceps EMGImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionMuscle Activity Variable
Change in Hamstring EMGImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionMuscle Activity Variable
Change in Visual Analog Scale PainImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionPain Variable
Change in International Knee Documentation CommitteeImmediately Pre- (10 minutes) and Post- (10 minutes) EffusionSelf-Reported Disability Variable

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026