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

Keller Army Community Hospital

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: KneeStim

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT06341868

KACH.2023.0067

23KACH008 (Other Identifier)

Details and patient eligibility

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..

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 17 to 27 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard of Care + KneeStim controlled low intensity

Sham Comparator group

Description:

Low intensity range

Treatment:

Device: KneeStim

Standard of Care + KneeStim flexible intensity

Experimental group

Description:

Flexible to high intensity range

Treatment:

Device: KneeStim