Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517056
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
Emovi 3D Knee Assessment Device Intervention for Operational Readiness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Objective Dynamic and 3D Knee Assessment Medical Device to Improve Recovery and Accelerate Return to Readiness in Service Members With Knee Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 varusvalgus alignment at stance varusvalgus 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
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 11 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 varusvalgus alignment at stance varusvalgus 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None