Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-27
SponsorKeller Army Community Hospital

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Keller Army Community Hospital

Lead sponsor

Medical Technology Enterprise Consortium

Collaborator