Walking Gait Biomechanics Following Knee Joint Effusion

NCT ID: NCT03805464

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2023-05-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Knee Joint Effusion

Intervention Type: OTHER

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

Interventions

Knee Joint Effusion

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Michael W. Krzyzewski Human Performance Laboratory

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00100862

Identifier Type: -

Identifier Source: org_study_id