Musculoskeletal InjuryNCT05521126
Micro-Doppler Radar: A Gold Standard Comparison
An observational study of Musculoskeletal Injury and Anterior Cruciate Ligament Injuries, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury, Anterior Cruciate Ligament Injuries
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: ACL repair cohort: Penn State Health Bone and Joint clinic control cohort: Penn State University/College of Medicine students and employees, Lebanon Valley College students, community sample
Who may be able to join
- 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
Who cannot join
- High risk cohort
- age <18 or >40
- pregnancy
- institutionalization
- history of cerebral vascular accident
- unable to provide informed consent
Show all 23Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Lebanon Valley College
Annville, Pennsylvania, 17003
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: The Use of Micro-Doppler Radar to Identify Service Members at Risk for Musculoskeletal Injury: A Gold Standard Comparison
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.
Read the 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.
- Keywords
- musculoskeletal injury, anterior cruciate ligament injury, anterior cruciate ligament repair, micro-Doppler radar, motion capture
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| control group | The control group will be individuals who have not had an ACL reconstruction procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy and predictability of MDS differentiation between ACL repair and control group
The investigators hypothesize that MDS will differentiate subjects who have recovered from an ACL reconstruction from a control cohort with accuracy and predictability. Participants will perform drop jumps, sit to stand, and walk on a treadmill in the presence of the micro-Doppler radar. MDS will be obtained for the ACL group as well as control. The micro-Doppler signature projection algorithm (mD-SPA) will then be applied to the data sets showing what percentage of the MDS are successfully classified to the ACL group versus control.
Measured: Day 1
Secondary outcomes (2)
accuracy of MDS differentiation between ACL repair and control groups versus the motion capture system
The investigators hypothesize that MDS will differentiate between the ACL group versus the control group with greater accuracy compared with the MC system. MDS will show greater sensitivity and specificity for correct classification compared with the gold standard MC. Participants will perform drop jumps, sit to stand, and walk on a treadmill while collecting simultaneously the motion capture data and MDS. The data sets will then be analyzed separately and the sensitivity and specificity of each system will be compared.
Measured: Day 1
ability of micro-Doppler radar and deep learning algorithms to automatically produce predictive data
The investigators hypothesize that by incorporating several deep learning algorithms that can extract high-level deep features automatically through hierarchical architectures, the system will be able to automatically produce predictive data that will not require specialized knowledge to operate. This will allow the system to be used by medical assistants or medical technicians who have no expertise in interpretation of the radar MDS. The investigators will accomplish this by applying numerous deep learning algorithms to the MDS to determine which algorithms most accurately and automatically classify the ACL group from control.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start21 Feb 2023
- Primary completion1 Sep 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Lebanon Valley College
- Responsible party
- Principal investigator, Cayce Onks, Milton S. Hershey Medical Center
- Investigators
- Cayce A Onks, DO, MS, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521126
- Sponsor's protocol ID
- STUDY00020118
- Other IDs
- CDMRP-OR210069
- Status last verified
- May 2026
- First submitted
- 26 Aug 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Micro-Doppler Radar to Identify Service Members at Risk for Musculoskeletal Injury: A Gold Standard Comparison
- ClinicalTrials.gov ID
- NCT05521126
- Acronym / sponsor ID
- STUDY00020118
- Keywords
- musculoskeletal injury, anterior cruciate ligament injury, anterior cruciate ligament repair, micro-Doppler radar, motion capture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, Lebanon Valley College
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| control group | – | –The control group will be individuals who have not had an ACL reconstruction procedure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ACL repair cohort: Penn State Health Bone and Joint clinic control cohort: Penn State University/College of Medicine students and employees, Lebanon Valley College students, community sample
Key inclusion criteria (8 listed)
- High risk cohort
- age 18-40
- history of ACL reconstruction
- no current musculoskeletal injuries
- ACL repair between 9 and 24 months prior to recruitment
Key exclusion criteria (23 listed)
- High risk cohort
- age <18 or >40
- pregnancy
- institutionalization
- history of cerebral vascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy and predictability of MDS differentiation between ACL repair and control group
Time frame: Day 1
The investigators hypothesize that MDS will differentiate subjects who have recovered from an ACL reconstruction from a control cohort with accuracy and predictability. Participants will perform drop jumps, sit to stand, and walk on a treadmill in the presence of the micro-Doppler radar. MDS will be obtained for the ACL group as well as control. The micro-Doppler signature projection algorithm (mD-SPA) will then be applied to the data sets showing what percentage of the MDS are successfully classified to the ACL group versus control.
2 secondary outcomes
accuracy of MDS differentiation between ACL repair and control groups versus the motion capture system
Time frame: Day 1
ability of micro-Doppler radar and deep learning algorithms to automatically produce predictive data
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cayce A Onks, DO, MS principal investigator
Milton S. Hershey Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury and Anterior Cruciate Ligament Injuries, run by Milton S. Hershey Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy and predictability of MDS differentiation between ACL repair and control group (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.