Clinical trial NCT06341868: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: knee
Anterior Cruciate Ligament
Gait
Neuromuscular electric stimulation
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
Collaborators: name: Medical Technology Enterprise Consortium
First posted: 2024-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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..

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous ligamentous surgery in ipsilateral knee
2. Concomitant or prior high tibial osteotomy (HTO)
3. Concomitant or prior cartilage restoration procedure
4. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)
5. 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
6. Meniscus tear precluding weight bearing for 6 weeks.

Primary outcomes:
measure: Change in gait post-operatively assessed by the KneeStimTM Device
timeFrame: 6 weeks;3, 6, 9, 12 months post-operative
Secondary outcomes:
measure: change in gait post-operatively assessed by 3D Motion capture
timeFrame: 3, 6, 9, 12 months post-operative
measure: change in gait post-operatively assessed by force plate instrumented treadmill
timeFrame: 3, 6, 9, 12 months post-operative
measure: change in muscle volume assessed by MRI
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: ACL graft healing assessed by MRI
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change in isometric muscle strength assessed by CSMi HUMAC NORM
timeFrame: 3, 6, 9, 12 months post-operative
measure: Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA)
timeFrame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
measure: Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA)
timeFrame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
measure: Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA)
timeFrame: pre-operative, 4, 8 weeks; 3, 6, 9, 12 months post-operative
measure: Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change in knee function assessed by the Marx Activity Rating Scale (MARS)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: pre-operative, 3, 6, 9, 12 months post-operative
measure: Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS)
timeFrame: Weekly from 1-week post-operative until 3 months; monthly from 4-12 months
measure: Time to return to full duty
timeFrame: 12 months post-operative
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital
state: New York
Study officials:
affiliation: Keller Army Community Hospital
name: Shawn M Gee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerra ON, Coyle TE. Dentistry and the Ellis Fischel State Cancer Hospital. J Mo Dent Assoc. 1978 Jun-Jul;58(6):54-9. No abstract available.
citation: Nemcok JC. An analysis of 353 vaginal deliveries: natural versus anesthesia. J Am Osteopath Assoc. 1980 Dec;80(4):247-53. No abstract available.
citation: Hixon JE, Pijanowski GJ, Weston PG, Shanks RD, Wagner WC. Evidence for an oscillator other than luteinizing hormone controlling the secretion of progesterone in cattle. Biol Reprod. 1983 Dec;29(5):1155-62. doi: 10.1095/biolreprod29.5.1155.
citation: Matsushita N, Kato Y, Shimatsu A, Katakami H, Yanaihara N, Imura H. Effects of VIP, TRH, GABA and dopamine on prolactin release from superfused rat anterior pituitary cells. Life Sci. 1983 Mar 14;32(11):1263-9. doi: 10.1016/0024-3205(83)90196-0.
citation: 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.
citation: Herron P, Dykes R. The ventroposterior inferior nucleus in the thalamus of cats: a relay nucleus in the Pacinian pathway to somatosensory cortex. J Neurophysiol. 1986 Dec;56(6):1475-97. doi: 10.1152/jn.1986.56.6.1475.
citation: 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.
citation: Pietrowa N, Jaczynowska Z, Duchowska H. [Treatment of uveitis in the course of rheumatoid arthritis in children]. Reumatologia. 1973;11(4):355-62. No abstract available. Polish.
citation: 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.
citation: 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.
citation: Behrend EI, Craig AM, Wilson SM, Denhardt DT, Chambers AF. Expression of antisense osteopontin RNA in metastatic mouse fibroblasts is associated with reduced malignancy. Ann N Y Acad Sci. 1995 Apr 21;760:299-301. doi: 10.1111/j.1749-6632.1995.tb44640.x. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.