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Completed

NCT Number: NCT03805464

Walking Gait Biomechanics Following Knee Joint Effusion

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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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael W. Krzyzewski Human Performance Laboratory

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee Joint Effusion

Other

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

Primary outcomes

  1. Change in Peak Vertical Ground Reaction Force

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Kinetic Loading Variable

  2. Change in Peak Internal Knee Extension Moment

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Kinetic Loading Variable

  3. Change in Peak Knee Power

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Kinetic Loading Variable

  4. Change in Shank Acceleration

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Accelerometer Variable

  5. Change in Thigh Acceleration

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Accelerometer Variable

  6. Change in Shank Angular Velocity

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Gyroscope Variable

  7. Change in Thigh Angular Velocity

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Gyroscope Variable

Secondary outcomes

  1. Change in Quadriceps EMG

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Muscle Activity Variable

  2. Change in Hamstring EMG

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Muscle Activity Variable

  3. Change in Visual Analog Scale Pain

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Pain Variable

  4. Change in International Knee Documentation Committee

    Time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

    Self-Reported Disability Variable

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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