180 Participants Needed

Knee Kinesiography for Anterior Knee Pain

Recruiting at 1 trial location
DL
Overseen ByDon L Goss, DPT, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Womack Army Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Emovi 3D Knee Assessment Device, KneeKG, Knee Kinesiography System for anterior knee pain?

The research suggests that using standardized gestures can improve the accuracy of 3D knee movement measurements, which may enhance the effectiveness of treatments like the Knee Kinesiography System by providing more reliable data on knee function.12345

Is the KneeKG system safe for use in humans?

The KneeKG system is designed to provide reliable movement analysis of the knee joint, and there is no indication of safety concerns in the literature reviewed.678910

How does the Emovi 3D Knee Assessment Device treatment differ from other treatments for anterior knee pain?

The Emovi 3D Knee Assessment Device, also known as KneeKG, is unique because it provides a detailed three-dimensional analysis of knee movement, which helps in accurately diagnosing and evaluating knee conditions. Unlike traditional methods, it uses a non-invasive exoskeleton attachment system to reduce errors caused by skin movement, offering a more precise assessment of knee joint motion.17101112

Research Team

DL

Don L Goss, DPT, PhD

Principal Investigator

Womack Army Medical Center

Eligibility Criteria

This trial is for active duty service members aged 18-50 stationed at Fort Liberty and Schofield Barracks, diagnosed with patellofemoral pain. It's not open to those with a history of traumatic knee injury, rheumatoid or neurological diseases, previous knee surgery, other lower limb injuries, individuals moving from the station within three months, or pregnant women.

Inclusion Criteria

Active Duty Service Member stationed at Fort Liberty and Schofield Barracks
I have been diagnosed with knee pain.

Exclusion Criteria

I have had a serious knee injury, like a torn ligament or meniscus.
I have rheumatoid arthritis or a neurological condition.
I have had knee surgery in the past.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline measures and receive a Knee Kinesiography exam

1 day
1 visit (in-person)

Treatment

Participants receive either KneeKG informed care or usual care for 4 weeks

4 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

  • Emovi 3D Knee Assessment Device
Trial Overview The study tests if using Emovi Knee Kinesiography—a device that assesses knee movement—helps in treating anterior knee pain during physical therapy. Participants are randomly chosen to either receive this new assessment tool or continue with standard care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: Knee KG informed physical therapyExperimental Treatment1 Intervention
Participants in this group will receive care guided by the impairments identified with the KneeKG. The KneeKG exam results in recommended exercises that target the specific biomechanical impairments identified. The exercises and dose given to the participant will be based on what the KneeKG device recommends after the exam. The participant will be seen twice a week for 4 weeks.
Group II: Control: Standard of care physical therapyActive Control1 Intervention
Participants in this arm will have their KneeKG data captured, but this information will not be provided to the physical therapist to inform their care. Instead, physical therapists will deliver care as they normally do in routine clinical practice. The participant will be seen twice a week for 4 weeks.

Emovi 3D Knee Assessment Device is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as KneeKG for:
  • Assessment of knee motion for patients with impaired movement functions of an orthopedic cause
🇨🇦
Approved in Canada as KneeKG for:
  • Assessment of knee motion for patients with impaired movement functions of an orthopedic cause
🇪🇺
Approved in European Union as KneeKG for:
  • Assessment of knee motion for patients with impaired movement functions of an orthopedic cause

Find a Clinic Near You

Who Is Running the Clinical Trial?

Womack Army Medical Center

Lead Sponsor

Trials
22
Recruited
17,100+

Medical Technology Enterprise Consortium

Collaborator

Trials
3
Recruited
340+

The Geneva Foundation

Collaborator

Trials
39
Recruited
13,700+

Findings from Research

Functional knee axes of rotation (fAoRs) provide a more accurate representation of knee motion compared to traditional geometry-based axes, with maximum differences in orientation and location being smaller for fAoRs than for geometry-based axes.
Among the two algorithms tested for calculating fAoRs, the Gamage and Lasenby's sphere fitting algorithm (GL) outperformed the SARA algorithm, showing better alignment with MRI-based reference axes in both orientation and location.
Functional knee axis based on isokinetic dynamometry data: Comparison of two methods, MRI validation, and effect on knee joint kinematics.Van Campen, A., De Groote, F., Bosmans, L., et al.[2013]
A systematic review identified 24 knee-specific patient-reported outcome measures, most of which demonstrated strong reliability and validity, making them useful for assessing knee conditions.
Recommendations for specific conditions include the Cincinnati Knee Rating System and KOOS for ACL injuries, the Kujala Scale for anterior knee pain, and the WOMET for meniscal injuries, highlighting that no single instrument is universally applicable across all knee disorders.
Patient-reported outcome measures for the knee.Wang, D., Jones, MH., Khair, MM., et al.[2022]
A study involving 17 healthy male subjects demonstrated that using a standardized gesture during knee-bends significantly improves the reproducibility of 3D kinematic measurements of the knee.
The standardized knee-bends, performed in a controlled setup, showed a notable increase in the consistency of tibial rotation measurements compared to unconstrained movements, suggesting that gesture standardization is beneficial for accurate knee assessments.
Gesture standardization increases the reproducibility of 3D kinematic measurements of the knee joint.Lavoie, F., Laplante, M., Parent, G., et al.[2019]

References

Functional knee axis based on isokinetic dynamometry data: Comparison of two methods, MRI validation, and effect on knee joint kinematics. [2013]
Patient-reported outcome measures for the knee. [2022]
Gesture standardization increases the reproducibility of 3D kinematic measurements of the knee joint. [2019]
Influence of Severity and Duration of Anterior Knee Pain on Quadriceps Function and Self-Reported Function. [2023]
Translation, cross-cultural adaptation and reliability of the International Knee Documentation Committee (IKDC) subjective knee form and the tampa scale for kinesiophobia (TSK) into Hebrew. [2023]
Usefulness of the Kinect-V2 System for Determining the Global Gait Index to Assess Functional Recovery after Total Knee Arthroplasty. [2022]
The KneeKG system: a review of the literature. [2022]
Diagnostic Performance of MRI for Component Loosening in Total Knee Arthroplasty Compared with Radiography. [2022]
Knee kinetics and kinematics: What are the effects of TKA malconfigurations? [2022]
Description and validation of a navigation system for intra-operative evaluation of knee laxity. [2022]
Three-dimensional knee analyzer validation by simple fluoroscopic study. [2019]
A Novel Method to Estimate the Full Knee Joint Kinematics Using Low Cost IMU Sensors for Easy to Implement Low Cost Diagnostics. [2020]
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