NCT06341868 · Keller Army Community Hospital
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
What this study 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.
View original scientific description
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..
Interventions
DEVICE
KneeStim
Participant will be randomized to either be in control or experimental group
Primary outcome measures
Change in gait post-operatively assessed by the KneeStimTM Device
Time frame: 6 weeks;3, 6, 9, 12 months post-operative
Effects of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (femur sagittal angle, tibial sagittal angle, femur coronal angle, tibial coronal angle, femur and tibia coronal velocity)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- United States Military Academy cadet between ages of 17-27 years
- Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction
Exclusion criteria
- 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
- West Point, New York
Collaborators
Medical Technology Enterprise Consortium
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 2, 2026 · Source of record for eligibility and locations