The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:
* Examine the effects of KneeStim wear on cadets' post-operative gait * Examine changes in site-specific skeletal muscle mass * Examine the changes in patient-reported outcomes * Assess time to return to full duty * Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume) * Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)
Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.
Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..
United States Military Academy cadet between ages of 17-27 years
Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
Concomitant or prior high tibial osteotomy (HTO)
Concomitant or prior cartilage restoration procedure
Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
Contraindications to using the KneeStim device
Parallel
KneeStim
DeviceParticipant will be randomized to either be in control or experimental group
Change in gait post-operatively assessed by the KneeStimTM Device
Effects of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (femur sagittal angle, tibial sagittal angle, femur coronal angle, tibial coronal angle, femur and tibia coronal velocity)
change in gait post-operatively assessed by 3D Motion capture
Kinetic and kinematic biomechanical data will be monitored throughout the return to run phases of rehabilitation in knee and hip joints (walking and running); changes in gait speed (walking and running); changes in join angle range of motion (walking and running); changes in stride length (walking and running)
change in gait post-operatively assessed by force plate instrumented treadmill
Ground reaction forces will be recorded simultaneously with the motion capture system via force plates on an instrumented treadmill to determine force output between limbs during walking and running trials.
change in muscle volume assessed by MRI
Summation of the cross-sectional area and volumetric measurements
ACL graft healing assessed by MRI
Signal intensity will be used to monitor tissue quality throughout healing process
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Keller Army Community Hospital
Lead sponsor
Medical Technology Enterprise Consortium
Collaborator
