Emovi 3D Knee Assessment Device Intervention for Operational Readiness

NCT06517056 | Recruiting FDA Device

• 1 other identifier: WAMC.2024.0053
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Patellofemoral Pain; Patellofemoral Pain Syndrome

Keywords

Patellofemoral Pain; Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function

  PROMIS asks patients about their functional ability, and symptoms. This tool is designed as a health-focused rather than a disease-focused measurement system. The primary outcome measure will focus on the the Physical Function domains since PFPS is known to limit function during daily and sports \& recreation activities. This is an adaptive questionnaire that is taken in RedCap and contains up to 166 questions that will not all be asked, scored 1-5 on a Likert scale based on limits of function. The primary outcome is the between-group difference in PROMIS Physical Function T-score at 3 months. A linear mixed effects model will be used to analyze the between-group differences across the various time points (repeated measures).

  12 weeks

Secondary Outcomes (5)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

  12 weeks

• Anterior Knee Pain Scale (AKPS)

  12 weeks

• Self-Reported Readiness to Return to Duty

  12 weeks

• Total Lost Duty Days

  12 weeks

• Provider Satisfaction

  12 weeks

Study Arms (2)

Intervention: Knee KG informed physical therapy

EXPERIMENTAL

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.

Device: Emovi Knee Kinesiography

Control: Standard of care physical therapy

NO 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.

Interventions

Emovi Knee Kinesiography 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.

Also known as: KneeKG

Intervention: Knee KG informed physical therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Womack Army Medical Center: lead
• The Geneva Foundation: collaborator

Study Sites (2)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

NOT YET RECRUITING

Womack Army Medical Center

Fort Liberty, North Carolina, 28310, United States

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Don L Goss, DPT, PhD

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Don L Goss, DPT, PhD

CONTACT

9106033147; dgoss@highpoint.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study design is with 1:1 treatment arms: 1) KneeKG informed cared or 2) usual care without any information from the KneeKG

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 24, 2024
• Study Start: October 24, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)