Emovi 3D Knee Assessment Device Intervention for Operational Readiness

NCT ID: NCT06517056

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

The purpose of this study is to assess the effectiveness of using a 3D medical assessment device versus usual care to help guide clinical decisions about the management of PFP. The objective is to determine if gathering objective biomechanical data from a three-dimensional (3D) motion capture device leads to more precise and optimal care, ultimately improving physical function and other outcomes compared to participants who receive routine care that is not guided by information from this device.

Participants will be recruited from primary care and physical therapy clinics at participating sites. Authorized study personnel will search electronic medical records (Genesis) to identify potential study participants diagnosed with knee pain.

After consent and enrollment, participants will complete baseline measures and then receive a Knee Kinesiography exam. The participant will be entered into the KneeKG system using a unique participant identifier. After the knee kinesiography exam with the KneeKG, participants will be randomized 1:1 into one of two different treatment arms: 1) KneeKG informed care or 2) usual care without any information from the KneeKG.

Knee mechanics during gait is assessed with a Knee Kinesiography exam. The participant will walk for 5 minutes on a commercial treadmill at their comfortable speed. Three-dimensional (3D) knee kinematics are captured on each leg using the KneeKG system (Emovi, Canada). With this validated FDA cleared medical device, there is an accurate quantification of specific knee biomechanical markers during gait in a clinical setting. There will be two 45-second trials to electronically capture the data which is immediately accessible through automatic reports. Biomechanical markers captured include but are not limited to varus/valgus alignment at stance, varus/valgus alignment at heel strike, knee flexion angle at heel strike, total knee excursion in sagittal plane, tibial rotation at heel strike and throughout gait cycle. The entire procedure will take approximately 15-20 minutes. This procedure will occur at baseline and also again at 12 weeks.

Conditions

Patellofemoral Pain; Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Intervention: Knee KG informed physical therapy

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 Type: EXPERIMENTAL

Emovi Knee Kinesiography

Intervention Type: DEVICE

All participants will receive a KneeKG exam. This device will capture three-dimensional knee kinematics for a participant's knee, using the KneeKG system. Therapists will use these reports and suggested exercises to guide their care for participants in the Intervention group.

Control: Standard of care physical therapy

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Emovi Knee Kinesiography

All participants will receive a KneeKG exam. This device will capture three-dimensional knee kinematics for a participant's knee, using the KneeKG system. Therapists will use these reports and suggested exercises to guide their care for participants in the Intervention group.

Intervention Type: DEVICE

Other Intervention Names

KneeKG

Eligibility Criteria

Inclusion Criteria

• Age 18-50
• Active Duty Service Member stationed at Fort Liberty and Schofield Barracks
• Diagnosis of patellofemoral pain (ICD-10 codes: M25.2 (pain in unspecified knee), M25.561 (pain in right knee), and M25.562 (pain in left knee)

Exclusion Criteria

• Pregnancy
• Known to be leaving that duty station within next 3 months
• Concurrent lower limb injuries (examples include but are not limited to ankle sprain or HS strain)
• Previous knee surgery
• History of traumatic knee injury, such as a ligament tear or meniscal tear
• Presence of rheumatoid or neurological disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Geneva Foundation

OTHER

Sponsor Role: collaborator

Womack Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don L Goss, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Womack Army Medical Center

Locations

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status: NOT_YET_RECRUITING

Womack Army Medical Center

Fort Liberty, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Don L Goss, DPT, PhD

Role: CONTACT

dgoss@highpoint.edu

9106033147

Facility Contacts

Dan Rhon

Role: primary

drhon@genevausa.org

253-293-0154

Don L Goss, DPT, PhD

Role: primary

dgoss@highpoint.edu

910-603-3147

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

WAMC.2024.0053

Identifier Type: -

Identifier Source: org_study_id