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

Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction

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..

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Device: KneeStim

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia B Prando, MA; Phone Number: 315-774-8368; Email: natalia.b.prando.ctr@health.mil
• Study Contact Backup: Name: Madison Mach, PhD; Phone Number: 315-774-8368; Email: madison.s.mach.ctr@health.mil

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10996
      • Recruiting
      • Keller Army Community Hospital
      • Contact: Natalia B Prando, MA; Phone Number: 315-774-8368; Email: natalia.b.prando.ctr@health.mil
      • Contact: Madison Mach, PhD; Phone Number: 315-774-8368; Email: madison.s.mach.ctr@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Standard of Care + KneeStim controlled low intensity; Low intensity range	Device: KneeStim; Participant will be randomized to either be in control or experimental group
Experimental: Standard of Care + KneeStim flexible intensity; Flexible to high intensity range	Device: KneeStim; Participant will be randomized to either be in control or experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in gait post-operatively assessed by 3D Motion capture	Kinetic and kinematic biomechanical data will be monitored throughout the return to run phases of rehabilitation in knee and hip joints (walking and running); changes in gait speed (walking and running); changes in join angle range of motion (walking and running); changes in stride length (walking and running)	3, 6, 9, 12 months post-operative
change in gait post-operatively assessed by force plate instrumented treadmill	Ground reaction forces will be recorded simultaneously with the motion capture system via force plates on an instrumented treadmill to determine force output between limbs during walking and running trials.	3, 6, 9, 12 months post-operative
change in muscle volume assessed by MRI	Summation of the cross-sectional area and volumetric measurements	pre-operative, 3, 6, 9, 12 months post-operative
ACL graft healing assessed by MRI	Signal intensity will be used to monitor tissue quality throughout healing process	pre-operative, 3, 6, 9, 12 months post-operative
Change in isometric muscle strength assessed by CSMi HUMAC NORM	Rate of torque development (in ms) over time.	3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)	The KOOS is a self-reported outcome measure assessing the patient's perspective about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, activities of daily living, function in sports/recreation, and quality of life. A likert scale is used and all items have five possible answers ranging from 0 (no problems) to 4 (extreme problems). The five subscale scores are calculated as the sum of the items for each subscale. Scores are then transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.	pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)	The IKDC is a self-reported outcome measure that assesses knee disability and function before and after treatment. It consists of 18 items that measure symptoms, function, and sports activity. Response types include 5-point Likert Scales, 11-point Likert scales, and dichotomous "yes-no" responses.	pre-operative, 3, 6, 9, 12 months post-operative
Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)	PROMIS-29 is a self-reported outcome measure assessing for the patient's pain intensity. It is a 28-item questionnaire, which includes 7 subscales of four items each: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. A likert scale is used for all domain response scales, however they vary in responses.	pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)	Participants will provide a numerical rating from 0 (least normal) to 100 (most normal) of the perceived improvement in knee health in relation to their pre-injury baseline.	pre-operative, 3, 6, 9, 12 months post-operative
Change in knee function assessed by the Marx Activity Rating Scale (MARS)	MARS includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year". Each item is scored on a 5-point ordinal scale ranging from 0 (less than 1 time in a month) to 4 (4 or more times in a week), and the total scale score is obtained by summing the individual items' scores (range, 0-16). A higher score indicates more functional demand on the knee joint and potentially a higher risk of injury.	pre-operative, 3, 6, 9, 12 months post-operative
Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)	The questionnaire consists of 32 equally weighted questions that are answered using a 100 mm visual analog scale and is scored of 100. It comprises 5 domains, including (1) symptoms and physical complaints (5 items); (2) work-related concerns (4 items); (3) recreational activity and sport participation or competition (12 items); (4) lifestyle (6 items); and (5) social and emotional (5 items).	pre-operative, 3, 6, 9, 12 months post-operative
Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)	The 9-item UWRI assesses running ability following a running related injury, with the maximum score of 36 indicating a return to preinjury running ability.	pre-operative, 3, 6, 9, 12 months post-operative
Time to return to full duty	Measured by the time from post-operative timepoint to time of full clearance for military tasks	12 months post-operative
Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)	Skeletal muscle mass will be measured (in kg) to monitor rate of muscle hypertrophy/atrophy over rehabilitation timeline.	pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)	Muscle mass, bone mass, and body fluid (kg/m2) will be measured to contribute to Body Mass Index (BMI) scores.	pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)	Fat mass (kg/m2) will be measured to contribute to body mass index (BMI) scores.	pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)	Will measure average knee pain over a given timeframe from 0 to 10 cm visual analogue scale where 0 cm equals no pain and 10 cm indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.	Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.	Peak isometric extensor torque (nm/kg).	At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.
Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.	Rate of torque development (nm/s)	At either month 3, 6, 9, or 12, Tindeq testing will occur 24-72 hours after the bilateral strength assessment using the CSMi HUMAC NORM.

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital
• Collaborators: Medical Technology Enterprise Consortium
• Investigators: Principal Investigator: Shawn M Gee, MD, Keller Army Community Hospital

Publications and helpful links

General Publications

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• 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.
• 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.
• Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.
• Hill OT, Bulathsinhala L, Scofield DE, Haley TF, Bernasek TL. Risk factors for soft tissue knee injuries in active duty U.S. Army soldiers, 2000-2005. Mil Med. 2013 Jun;178(6):676-82. doi: 10.7205/MILMED-D-13-00049.
• 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.
• 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.
• Molloy JM, Pendergrass TL, Lee IE, Hauret KG, Chervak MC, Rhon DI. Musculoskeletal Injuries and United States Army Readiness. Part II: Management Challenges and Risk Mitigation Initiatives. Mil Med. 2020 Sep 18;185(9-10):e1472-e1480. doi: 10.1093/milmed/usaa028.
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Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament; Gait; knee; Neuromuscular electric stimulation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: KACH.2023.0067; 23KACH008 (Other Identifier: Keller Army Community Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all individual participant data (IPD) that underlie results in a publication.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: request can be made to study contacts and will be reviewed by the study principal investigator and human research protections office.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes