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

NCT06341868 | Recruiting FDA Device

• 2 other identifiers: KACH.2023.006723KACH008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

knee; Anterior Cruciate Ligament; Gait; Neuromuscular electric stimulation

Outcome Measures

Primary Outcomes (1)

• Change in gait post-operatively assessed by the KneeStimTM Device

  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)

  6 weeks;3, 6, 9, 12 months post-operative

Secondary Outcomes (19)

• change in gait post-operatively assessed by 3D Motion capture

  3, 6, 9, 12 months post-operative

• change in gait post-operatively assessed by force plate instrumented treadmill

  3, 6, 9, 12 months post-operative

• change in muscle volume assessed by MRI

  pre-operative, 3, 6, 9, 12 months post-operative

• ACL graft healing assessed by MRI

  pre-operative, 3, 6, 9, 12 months post-operative

• Change in isometric muscle strength assessed by CSMi HUMAC NORM

  3, 6, 9, 12 months post-operative

Study Arms (2)

Standard of Care + KneeStim controlled low intensity

SHAM COMPARATOR

Low intensity range

Device: KneeStim

Standard of Care + KneeStim flexible intensity

EXPERIMENTAL

Flexible to high intensity range

Device: KneeStim

Interventions

KneeStim DEVICE

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

Standard of Care + KneeStim controlled low intensity; Standard of Care + KneeStim flexible intensity

Eligibility Criteria

• Age: 17 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• United States Military Academy cadet between ages of 17-27 years
• Undergoing a Primary ACL Reconstruction, or Revision ACL Reconstruction

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Technology Enterprise Consortium: collaborator
• Keller Army Community Hospital: lead

Study Sites (1)

Keller Army Community Hospital

West Point, New York, 10996, United States

RECRUITING

Related Publications (15)

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  PMID: 30211382 BACKGROUND

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  PMID: 11292048 BACKGROUND

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  PMID: 24427427 BACKGROUND

• Cobian DG, Koch CM, Amendola A, Williams GN. Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, With Analysis of Neuromuscular Mechanisms. J Orthop Sports Phys Ther. 2017 Dec;47(12):945-956. doi: 10.2519/jospt.2017.7310. Epub 2017 Oct 9.

  PMID: 28992769 BACKGROUND

• Kline PW, Morgan KD, Johnson DL, Ireland ML, Noehren B. Impaired Quadriceps Rate of Torque Development and Knee Mechanics After Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft. Am J Sports Med. 2015 Oct;43(10):2553-8. doi: 10.1177/0363546515595834. Epub 2015 Aug 14.

  PMID: 26276828 BACKGROUND

• Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.

  PMID: 17888709 BACKGROUND

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  PMID: 23756076 BACKGROUND

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  PMID: 32866081 BACKGROUND

• Aguero AD, Irrgang JJ, MacGregor AJ, Rothenberger SD, Hart JM, Fraser JJ. Sex, military occupation and rank are associated with risk of anterior cruciate ligament injury in tactical-athletes. BMJ Mil Health. 2023 Nov 22;169(6):535-541. doi: 10.1136/bmjmilitary-2021-002059.

  PMID: 35165197 BACKGROUND

• Hauret KG, Jones BH, Bullock SH, Canham-Chervak M, Canada S. Musculoskeletal injuries description of an under-recognized injury problem among military personnel. Am J Prev Med. 2010 Jan;38(1 Suppl):S61-70. doi: 10.1016/j.amepre.2009.10.021.

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  PMID: 32107561 BACKGROUND

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  PMID: 23464951 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Shawn M Gee, MD

  Keller Army Community Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia B Prando, MA

CONTACT

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

Madison Mach, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: request can be made to study contacts and will be reviewed by the study principal investigator and human research protections office.

Locations

US (1)