Walking Gait Biomechanics Following Knee Joint Effusion

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03805464
• Other study ID #: Pro00100862
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Laura S Pietrosimone, PT, DPT, PhD
• Phone: 919.684.8930
• Email: laura.pietrosimone[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Knee Osteoarthritis

Intervention

Other:
• Knee Joint Effusion
60mL saline injection into the supra-patellar region of the knee

Locations

Country	Name	City	State
United States	Michael W. Krzyzewski Human Performance Laboratory	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Vertical Ground Reaction Force	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Peak Internal Knee Extension Moment	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Peak Knee Power	Kinetic Loading Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Shank Acceleration	Accelerometer Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Thigh Acceleration	Accelerometer Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Shank Angular Velocity	Gyroscope Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Primary	Change in Thigh Angular Velocity	Gyroscope Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Secondary	Change in Quadriceps EMG	Muscle Activity Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Secondary	Change in Hamstring EMG	Muscle Activity Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Secondary	Change in Visual Analog Scale Pain	Pain Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
Secondary	Change in International Knee Documentation Committee	Self-Reported Disability Variable	Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion