Actively Recruiting
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
Led by Keller Army Community Hospital · Updated on 2026-01-02
60
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
K
Keller Army Community Hospital
Lead Sponsor
M
Medical Technology Enterprise Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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..
CONDITIONS
Official Title
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- United States Military Academy cadet between ages of 17-27 years
- Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
You will not qualify if you...
- 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 including use of pacemaker, defibrillators, or other implanted electronic devices
- 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 preventing feeling a pinprick
- Undiagnosed pain syndromes
- Any meniscus tear precluding weight bearing for 6 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Keller Army Community Hospital
West Point, New York, United States, 10996
Actively Recruiting
Research Team
N
Natalia B Prando, MA
CONTACT
M
Madison Mach, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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