About this trial
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..
Eligibility criteria
Qualifiers
United States Military Academy cadet between ages of 17-27 years
Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
Disqualifiers
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
Trial design
Treatments tested in this trial
- KneeStim
Treatment groups
Sponsors and collaborators
Keller Army Community Hospital
Lead sponsor
Medical Technology Enterprise Consortium
Collaborator