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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341868
• Other study ID #: KACH.2023.0067
• Secondary ID: 23KACH008
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: March 2024
• Source: Keller Army Community Hospital
• Contact: Natalia B Prando, BA
• Phone: 845-938-5325
• Email: natalia.b.prando.ctr[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Keller Army Community Hospital	West Point	New York

Sponsors (2)

Lead Sponsor	Collaborator
Keller Army Community Hospital	Medical Technology Enterprise Consortium

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Lepley LK, Davi SM, Burland JP, Lepley AS. Muscle Atrophy After ACL Injury: Implications for Clinical Practice. Sports Health. 2020 Nov/Dec;12(6):579-586. doi: 10.1177/1941738120944256. Epub 2020 Aug 31. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative
Secondary	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, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative
Secondary	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, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months post-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 9 months; monthly from 9-12 months
Secondary	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