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

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Injuries

In brief

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..

Key facts

Study ID

NCT06341868

Run by

Keller Army Community Hospital

People needed

60

Starts

2024-09-19

Expected to finish

2026-09-01

Last updated by the study team

2026-01-02

Who can join

Age: 17 and older, up to 27. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• 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
• Any meniscus tear precluding weight bearing for 6 weeks.

Where it is running

• Keller Army Community Hospital — West Point, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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