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

Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction

Who can join

Ages 17 to 27 · All sexes

Inclusion Criteria:

1. United States Military Academy cadet between ages of 17-27 years
2. Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction

Exclusion Criteria:

1. Concomitant or prior high tibial osteotomy (HTO)
2. Concomitant or prior cartilage restoration procedure
3. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
4. Contraindications to using the KneeStim device

   \- Use of pacemaker, defibrillators, or other implanted electronic devices, as this may cause electric shock, burns, electrical interference, or death Unstable angina or decompensated heart failure Epilepsy or history of seizure disorder Pregnancy or planning to become pregnant (Self reported) Critical ischemia of lower limbs Moderate to severe dementia Altered sensation at the knee such that the user cannot feel a pinprick Undiagnosed pain syndromes
5. Any meniscus tear precluding weight bearing for 6 weeks.

About the study

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..

What is being tested

• KneeStim (device)

Sponsor: Keller Army Community Hospital · Participants: 60 · Started: Sep 19, 2024

Contact the study team

• Natalia B Prando, MA · Phone: 315-774-8368
• Madison Mach, PhD · Phone: 315-774-8368

Official record on ClinicalTrials.gov — NCT06341868

Locations in the U.S.

Conditions

• Anterior Cruciate Ligament Injuries

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.