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Walking Gait Biomechanics Following Knee Joint Effusion

Primary Purpose

Knee Injuries, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knee Joint Effusion
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Injuries focused on measuring biomechanics, inertial measurement unit

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michael W. Krzyzewski Human Performance LaboratoryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Knee Joint Effusion

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Peak Vertical Ground Reaction Force
Kinetic Loading Variable
Change in Peak Internal Knee Extension Moment
Kinetic Loading Variable
Change in Peak Knee Power
Kinetic Loading Variable
Change in Shank Acceleration
Accelerometer Variable
Change in Thigh Acceleration
Accelerometer Variable
Change in Shank Angular Velocity
Gyroscope Variable
Change in Thigh Angular Velocity
Gyroscope Variable

Secondary Outcome Measures

Change in Quadriceps EMG
Muscle Activity Variable
Change in Hamstring EMG
Muscle Activity Variable
Change in Visual Analog Scale Pain
Pain Variable
Change in International Knee Documentation Committee
Self-Reported Disability Variable

Full Information

First Posted
January 11, 2019
Last Updated
January 20, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03805464
Brief Title
Walking Gait Biomechanics Following Knee Joint Effusion
Official Title
Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Knee Osteoarthritis
Keywords
biomechanics, inertial measurement unit

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knee Joint Effusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Knee Joint Effusion
Intervention Description
60mL saline injection into the supra-patellar region of the knee
Primary Outcome Measure Information:
Title
Change in Peak Vertical Ground Reaction Force
Description
Kinetic Loading Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Peak Internal Knee Extension Moment
Description
Kinetic Loading Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Peak Knee Power
Description
Kinetic Loading Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Shank Acceleration
Description
Accelerometer Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Thigh Acceleration
Description
Accelerometer Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Shank Angular Velocity
Description
Gyroscope Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Thigh Angular Velocity
Description
Gyroscope Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Secondary Outcome Measure Information:
Title
Change in Quadriceps EMG
Description
Muscle Activity Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Hamstring EMG
Description
Muscle Activity Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in Visual Analog Scale Pain
Description
Pain Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Title
Change in International Knee Documentation Committee
Description
Self-Reported Disability Variable
Time Frame
Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura S Pietrosimone, PT, DPT, PhD
Phone
919.684.8930
Email
laura.pietrosimone@duke.edu
Facility Information:
Facility Name
Michael W. Krzyzewski Human Performance Laboratory
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura S Pietrosimone, PT, DPT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Walking Gait Biomechanics Following Knee Joint Effusion

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