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

Phase

N/A

Condition

N/A

Treatment

KneeStim

Clinical Study ID

NCT06341868

KACH.2023.0067

23KACH008

Ages 17-27
All Genders

Study 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..

Eligibility Criteria

Inclusion

Inclusion Criteria:

United States Military Academy cadet between ages of 17-27 years
undergoing anterior cruciate ligament reconstruction

Exclusion

Exclusion Criteria:

Previous ligamentous surgery in ipsilateral knee
Concomitant or prior high tibial osteotomy (HTO)
Concomitant or prior cartilage restoration procedure
Concomitant ligamentous reconstruction (lateral collateral ligament; posteriorcruciate ligament; medial collateral ligament)
Contraindications to using the KneeStim device

Use of pacemaker, defibrillators, or other implanted electronic devices, as thismay cause electric shock, burns, electrical interference, or death Unstable anginaor decompensated heart failure Epilepsy or history of seizure disorder Pregnancy orplanning to become pregnant (Self reported) Critical ischemia of lower limbsModerate to severe dementia Altered sensation at the knee such that the user cannotfeel a pinprick Undiagnosed pain syndromes

Meniscus tear precluding weight bearing for 6 weeks.

Study Design

KneeStim

September 19, 2024

September 30, 2026

Study Description

Anterior cruciate ligament (ACL) tears have a recovery time of nearly 6-12 months with operative treatment. While most service members return to full duty after ACL reconstruction, it is delayed by quadriceps activation, muscle weakness, and abnormal gait patterns. Neuromuscular electric stimulation devices are already being used in physical therapy to complement gains in muscle strength and size. The innovation of KneeStim, is that it can be used to stimulate knee muscles while the individual is engaging in their daily activities. This study looks at the effects of 12 weeks of post-operative use of the KneeStim on biomechanical function (gait) in United States Military Academy Cadets aged 17-27 years of age. The investigators hypothesize that using the KneeStim will accelerate normalization of the biomechanical function parameters of gait and thus return to full duty.

Connect with a study center

Keller Army Community Hospital
West Point, New York 10996
United States
Site Not Available
Keller Army Community Hospital
West Point 5143966, New York 5128638 10996
United States
Active - Recruiting

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