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Walking Gait Biomechanics Following Knee Joint Effusion

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ClinicalTrials.gov Identifier: NCT03805464
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Knee Injuries Knee Osteoarthritis Other: Knee Joint Effusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Knee Joint Effusion
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
60mL saline injection into the supra-patellar region of the knee




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805464


Contacts
Contact: Laura S Pietrosimone, PT, DPT, PhD 919.684.8930 laura.pietrosimone@duke.edu

Locations
United States, North Carolina
Michael W. Krzyzewski Human Performance Laboratory Recruiting
Durham, North Carolina, United States, 27705
Contact: Laura S Pietrosimone, PT, DPT, PhD         
Sponsors and Collaborators
Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03805464     History of Changes
Other Study ID Numbers: Pro00100862
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:
biomechanics
inertial measurement unit

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Knee Injuries
Hydrarthrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries
Wounds and Injuries