Walking Gait Biomechanics Following Knee Joint Effusion

NCT03805464 | Completed

• 1 other identifier: Pro00100862
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Knee Osteoarthritis

Keywords

biomechanics; inertial measurement unit

Outcome Measures

Primary Outcomes (7)

• Change in Peak Vertical Ground Reaction Force

  Kinetic Loading Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Peak Internal Knee Extension Moment

  Kinetic Loading Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Peak Knee Power

  Kinetic Loading Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Shank Acceleration

  Accelerometer Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Thigh Acceleration

  Accelerometer Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Shank Angular Velocity

  Gyroscope Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Thigh Angular Velocity

  Gyroscope Variable

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Secondary Outcomes (4)

• Change in Quadriceps EMG

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Hamstring EMG

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in Visual Analog Scale Pain

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

• Change in International Knee Documentation Committee

  Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Study Arms (1)

Knee Joint Effusion

EXPERIMENTAL

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

Interventions

Knee Joint Effusion OTHER

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

Knee Joint Effusion

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Michael W. Krzyzewski Human Performance Laboratory

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Knee Injuries; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 29, 2019
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: January 22, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)