Micro-Doppler Radar: A Gold Standard Comparison

NCT ID: NCT05521126

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed 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.

Conditions

Musculoskeletal Injury; Anterior Cruciate Ligament Injuries

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

high risk/ACL repair cohort

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

No interventions assigned to this group

control group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Lebanon Valley College

UNKNOWN

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cayce Onks

Associate Professor of Family Medicine and Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cayce A Onks, DO, MS

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Lebanon Valley College

Annville, Pennsylvania, United States

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

CDMRP-OR210069

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00020118

Identifier Type: -

Identifier Source: org_study_id