Micro-Doppler Radar: A Gold Standard Comparison

Penn State Health

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries; Musculoskeletal Injury

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05521126

STUDY00020118

CDMRP-OR210069 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to see if the study team can use micro-Doppler signal (MDS) technology to determine if someone has had an anterior cruciate ligament (ACL) reconstruction. The investigators will do this by comparing the movement data from a group of people who have had the surgery with a group who has not had the surgery to see if the micro-Doppler radar technology can accurately and predictably tell the difference.

Full description

The objective of this research is to validate that radar MDS can accurately and predictably differentiate individuals at high-risk for MSKI from those who are low risk. The investigators hypothesize that MDS will identify individuals at a high-risk for MSKI more accurately than the gold-standard MC technologies. To test this hypothesis, the investigators propose a case control study that will compare adults who have undergone ACL reconstruction to a control group of healthy adults that has not. Patients who have undergone ACL reconstruction have a 6-24% chance of either re-tearing their ACL or having a subsequent knee surgery on either side within two years of successful completion of surgery and post-surgical rehabilitation. Despite being released for full activities, little is known about what makes this group at high-risk for re-tear. As such, the investigators will use this patient population as a model for identifying an at-risk population for musculoskeletal injury (MSKI). The researchers will simultaneously collect radar micro-Doppler signals and biomechanical motion capture (MC) data in a state-of-the-art human movement lab. Participants will be asked to perform a series of functional activities that will be captured by both the MDS radar and MC systems. The data sets will then be analyzed independently.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

High risk cohort

• age 18-40
• history of ACL reconstruction
• no current musculoskeletal injuries
• ACL repair between 9 and 24 months prior to recruitment

Control cohort

• age 18-40
• never had lower extremity surgery

Exclusion criteria

High risk cohort

• age <18 or >40
• pregnancy
• institutionalization
• history of cerebral vascular accident
• unable to provide informed consent
• inability to perform study activities
• history of hip or knee replacement
• inability to walk or jump without a limp
• current neuromuscular disease
• any surgery in the last 6 months

Control cohort

• age < 18 or > 40
• pregnancy
• institutionalization
• history of Cerebral Vascular Accident
• unable to provide informed consent
• inability to perform study activities
• history of knee or hip replacement
• inability to walk or jump without a limp
• current neuromuscular disease
• history of lower extremity surgery
• any surgery in the last 6 months

Trial design

250 participants in 2 patient groups

high risk/ACL repair cohort

Description:

The high risk cohort will be subjects who have had an ACL reconstruction procedure 9-24 months prior to enrollment.

control group

Description:

The control group will be individuals who have not had an ACL reconstruction procedure.