Recruiting

Dynamic Muscular Electrical Stimulation

Sponsor:

Keller Army Community Hospital

Code:

NCT06341868

Conditions

Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex: All

Age: 17 - 27

Healthy Volunteers: Not accepted

Interventions

KneeStim

Study Details

Brief summary:

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

Anterior Cruciate Ligament Injuries

Study ID

NCT06341868

Start date

Sep 19, 2024

Status verified date

Dec, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 27

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Standard of Care + KneeStim controlled low intensity

Low intensity range

experimental: Standard of Care + KneeStim flexible intensity

Flexible to high intensity range

Interventions

KneeStim

Participant will be randomized to either be in control or experimental group

Primary outcome measure

  • Change in gait post-operatively assessed by the KneeStimTM Device [ Time Frame: 6 weeks;3, 6, 9, 12 months post-operative ]

Central Contacts and Locations

Central contacts

Natalia B Prando, MA

315-774-8368natalia.b.prando.ctr@health.mil

Madison Mach, PhD

315-774-8368madison.s.mach.ctr@health.mil

Locations

Keller Army Community Hospital

Recruiting

West Point, New York, United States, 10996

Contacts

Natalia B Prando, MA

315-774-8368natalia.b.prando.ctr@health.mil

Madison Mach, PhD

315-774-8368madison.s.mach.ctr@health.mil

More Information

Sponsor

Keller Army Community Hospital

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

  • knee
  • Anterior Cruciate Ligament
  • Gait
  • Neuromuscular electric stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Keller Army Community Hospital on 2026-01-02.