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Search / Trial NCT06341868

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

Launched by KELLER ARMY COMMUNITY HOSPITAL · Mar 25, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Knee Anterior Cruciate Ligament Gait Neuromuscular Electric Stimulation

ClinConnect Summary

This clinical trial is investigating the effects of a new device called KneeStim, which is a wearable electrical stimulation knee sleeve, on the recovery of military academy cadets after they have surgery to repair a torn anterior cruciate ligament (ACL). The study aims to see how wearing this device for 12 weeks after surgery can improve walking, muscle mass, and overall recovery. Cadets aged 17 to 27 who are undergoing ACL reconstruction may be eligible to participate, provided they haven't had prior surgeries on the same knee and don’t have certain medical conditions that would prevent them from using the device.

Participants in the trial will wear the KneeStim during their rehabilitation sessions for five weeks and throughout their daily activities for an additional six weeks. They will also undergo various tests to measure their body composition, strength, and how well they are walking. The researchers will compare those using the standard rehabilitation with the KneeStim at different intensities to see which approach leads to better recovery outcomes. This trial is important because it could help improve recovery methods for young athletes recovering from ACL injuries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. United States Military Academy cadet between ages of 17-27 years
  • 2. undergoing anterior cruciate ligament reconstruction
  • Exclusion Criteria:
  • 1. Previous ligamentous surgery in ipsilateral knee
  • 2. Concomitant or prior high tibial osteotomy (HTO)
  • 3. Concomitant or prior cartilage restoration procedure
  • 4. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
  • 5. 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
  • 6. Meniscus tear precluding weight bearing for 6 weeks.

About Keller Army Community Hospital

Keller Army Community Hospital (KACH) is a premier military medical facility dedicated to providing high-quality healthcare to active-duty service members, their families, and retirees. As a clinical trial sponsor, KACH is committed to advancing medical research and improving patient outcomes through rigorous clinical studies. The hospital fosters a collaborative environment that integrates cutting-edge research with compassionate care, ensuring that innovative therapies and interventions are accessible to those it serves. KACH adheres to the highest ethical standards and regulatory guidelines, emphasizing patient safety and scientific integrity throughout the clinical trial process.

Locations

West Point, New York, United States

Patients applied

0 patients applied

Trial Officials

Shawn M Gee, MD

Principal Investigator

Keller Army Community Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported