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

Official title

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

Overview

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..

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.

Interventions

• Device KneeStim
  Participant will be randomized to either be in control or experimental group

Primary outcome measures

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

Secondary outcome measures (12)

• change in gait post-operatively assessed by 3D Motion capture [Time frame: 3, 6, 9, 12 months post-operative]
• change in gait post-operatively assessed by force plate instrumented treadmill [Time frame: 3, 6, 9, 12 months post-operative]
• change in muscle volume assessed by MRI [Time frame: pre-operative, 3, 6, 9, 12 months post-operative]
• ACL graft healing assessed by MRI [Time frame: pre-operative, 3, 6, 9, 12 months post-operative]
• Change in isometric muscle strength assessed by CSMi HUMAC NORM [Time frame: 3, 6, 9, 12 months post-operative]
• Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA) [Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative]
• Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA) [Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative]
• Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA) [Time frame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative]
• Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS) [Time frame: 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) [Time frame: pre-operative, 3, 6, 9, 12 months post-operative]
• Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29) [Time frame: pre-operative, 3, 6, 9, 12 months post-operative]
• Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE) [Time frame: pre-operative, 3, 6, 9, 12 months post-operative]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Keller Army Community Hospital — West Point

Publications

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64. PMID 14613558
• Jacobson RP, Kang D, Houck J. Can Patient-Reported Outcomes Measurement Information System(R) (PROMIS) measures accurately enhance understanding of acceptable symptoms and functioning in primary care? J Patient Rep Outcomes. 2020 May 20;4(1):39. doi: 10.1186/s41687-020-00206-9. PMID 32436001
• O'Connor CM, Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019 Jul;7(4):303-306. PMID 31448305
• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar. PMID 30211382
• Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601. PMID 11292048
• Winterstein AP, McGuine TA, Carr KE, Hetzel SJ. Comparison of IKDC and SANE Outcome Measures Following Knee Injury in Active Female Patients. Sports Health. 2013 Nov;5(6):523-9. doi: 10.1177/1941738113499300. PMID 24427427
• 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
• 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

Identifiers

NCT: NCT06341868 · KACH.2023.0067 · 23KACH008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗