Using a wearable electrical stimulation device to improve recovery after knee surgery in military cadets
Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction
This study is testing if a new wearable device can help military cadets recover faster and better after knee surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 17 Years to 27 Years |
| Sex | All |
| Sponsor | Keller Army Community Hospital Federal |
| Locations | 1 site (West Point, New York) |
| Trial ID | NCT06341868 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a novel wearable electrical stimulation device, KneeStim, on the recovery of military academy cadets following anterior cruciate ligament reconstruction. Over a 12-week period, participants will wear the KneeStim device to assess its impact on their gait, muscle mass, and overall recovery outcomes. The study will include various assessments such as body composition analysis, MRI, strength testing, and patient-reported outcomes to evaluate the effectiveness of the device compared to standard rehabilitation methods. The goal is to determine if KneeStim can enhance recovery and expedite the return to full duty for these cadets.
Who should consider this trial
Good fit: Ideal candidates for this study are United States Military Academy cadets aged 17-27 who are undergoing anterior cruciate ligament reconstruction.
Not a fit: Patients with previous knee surgeries or certain medical conditions that contraindicate the use of the KneeStim device may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery times and functional outcomes for patients undergoing ACL reconstruction.
How similar studies have performed: While neuromuscular electrical stimulation has been used in physical therapy, this specific application with the KneeStim device is relatively novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
West Point, New York
- Keller Army Community Hospital — West Point, New York, United States (Recruiting)
Study contacts
- Principal investigator: Shawn M Gee, MD — Keller Army Community Hospital
- Study coordinator: Natalia B Prando, MA
- Email: natalia.b.prando.ctr@health.mil
- Phone: 315-774-8368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.