Patellofemoral PainNCT06517056
Emovi 3D Knee Assessment Device Intervention for Operational Readiness
A study testing Emovi Knee Kinesiography in people with Patellofemoral Pain and Patellofemoral Pain Syndrome, run by Womack Army Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain, Patellofemoral Pain Syndrome
- What is being tested?
- Emovi Knee Kinesiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2024to Oct 2025
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Womack Army Medical Center
Fort Liberty, North Carolina, 28310
Don L Goss, DPT, PhD, 910-603-3147, dgoss@highpoint.edu
- Not yet recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Dan Rhon, 253-293-0154, drhon@genevausa.org
About this study
Official title: Objective Dynamic and 3D Knee Assessment Medical Device to Improve Recovery and Accelerate Return to Readiness in Service Members With Knee Pain
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.
Read the 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
- Being tested
- Emovi Knee Kinesiography
- Keywords
- Patellofemoral Pain, Patellofemoral Pain Syndrome
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emovi Knee KinesiographyDevice
Also called KneeKG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (5)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
This PROMIS tool focuses on pain interference in daily life. This questionnaire is adaptive taken in RedCap and contains up to 41 questions that will not all be asked. It is scored on a 5 point Likert scale based on limitation due to pain.
Measured: 12 weeks
Anterior Knee Pain Scale (AKPS)
The Anterior Knee Pain Scale is a 13-item more specific questionnaire related to PF pain which will allow to assess pain and symptoms during specific loading-activities. The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points. Athletes would receive a score of 100 if they showed no signs of anterior knee pain.
Measured: 12 weeks
Self-Reported Readiness to Return to Duty
The Self-Reported Readiness to Return to Duty questionnaire consists of three questions to assess perceived readiness to return to duty
Measured: 12 weeks
Total Lost Duty Days
Tracking the amount of duty days a soldier missed while enrolled in protocol.
Measured: 12 weeks
Provider Satisfaction
A provider satisfaction survey will be used to measure patient satisfaction with quality of physical therapy care.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start24 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is with 1:1 treatment arms: 1) KneeKG informed cared or 2) usual care without any information from the KneeKG
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Womack Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation
- Responsible party
- Sponsor
- Investigators
- Don L Goss, DPT, PhD, Principal investigator, Womack Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517056
- Sponsor's protocol ID
- WAMC.2024.0053
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Dynamic and 3D Knee Assessment Medical Device to Improve Recovery and Accelerate Return to Readiness in Service Members With Knee Pain
- ClinicalTrials.gov ID
- NCT06517056
- Acronym / sponsor ID
- WAMC.2024.0053
- Conditions
- Patellofemoral Pain, Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain, Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Womack Army Medical CenterUS federal agency
- Collaborators
- The Geneva Foundation
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Jul 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design is with 1:1 treatment arms: 1) KneeKG informed cared or 2) usual care without any information from the KneeKG
| Arm | Type | Receives |
|---|---|---|
| Intervention: Knee KG informed physical therapy | Experimental | Device: Emovi Knee KinesiographyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emovi Knee KinesiographyAlso: KneeKGAll 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. | Device | Intervention: Knee KG informed physical therapy |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time frame: 12 weeks
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).
5 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Time frame: 12 weeks
Anterior Knee Pain Scale (AKPS)
Time frame: 12 weeks
Self-Reported Readiness to Return to Duty
Time frame: 12 weeks
Total Lost Duty Days
Time frame: 12 weeks
Provider Satisfaction
Time frame: 12 weeks
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 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Don L Goss, DPT, PhD principal investigator
Womack Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emovi Knee Kinesiography in people with Patellofemoral Pain and Patellofemoral Pain Syndrome, run by Womack Army 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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?
Contact Don L Goss, DPT, PhD (9106033147, dgoss@highpoint.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (time frame: 12 weeks). 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 16 Jul 2025.