Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT06341868
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gait post-operatively assessed by the KneeStimTM Device', 'timeFrame': '6 weeks;3, 6, 9, 12 months post-operative', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'change in gait post-operatively assessed by 3D Motion capture', 'timeFrame': '3, 6, 9, 12 months post-operative', 'description': '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)'}, {'measure': 'change in gait post-operatively assessed by force plate instrumented treadmill', 'timeFrame': '3, 6, 9, 12 months post-operative', 'description': '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.'}, {'measure': 'change in muscle volume assessed by MRI', 'timeFrame': 'pre-operative, 3, 6, 9, 12 months post-operative', 'description': 'Summation of the cross-sectional area and volumetric measurements'}, {'measure': 'ACL graft healing assessed by MRI', 'timeFrame': 'pre-operative, 3, 6, 9, 12 months post-operative', 'description': 'Signal intensity will be used to monitor tissue quality throughout healing process'}, {'measure': 'Change in isometric muscle strength assessed by CSMi HUMAC NORM', 'timeFrame': '3, 6, 9, 12 months post-operative', 'description': 'Rate of torque development (in ms) over time.'}, {'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', 'description': 'Skeletal muscle mass will be measured (in kg) to monitor rate of muscle hypertrophy/atrophy over rehabilitation timeline.'}, {'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', 'description': 'Muscle mass, bone mass, and body fluid (kg/m2) will be measured to contribute to Body Mass Index (BMI) scores.'}, {'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', 'description': 'Fat mass (kg/m2) will be measured to contribute to body mass index (BMI) scores.'}, {'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', 'description': "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."}, {'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', 'description': '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.'}, {'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', 'description': "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."}, {'measure': 'Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE)', 'timeFrame': 'pre-operative, 3, 6, 9, 12 months post-operative', 'description': '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.'}, {'measure': 'Change in knee function assessed by the Marx Activity Rating Scale (MARS)', 'timeFrame': 'pre-operative, 3, 6, 9, 12 months post-operative', 'description': '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.'}, {'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', 'description': '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).'}, {'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', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Time to return to full duty', 'timeFrame': '12 months post-operative', 'description': 'Measured by the time from post-operative timepoint to time of full clearance for military tasks'}, {'measure': 'Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring peak isometric knee extensor torque.', 'timeFrame': '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.', 'description': 'Peak isometric extensor torque (nm/kg).'}, {'measure': 'Difference between the Tindeq Progessor and CSMi HUMAC NORM in measuring knee extensor rate of torque development.', 'timeFrame': '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.', 'description': 'Rate of torque development (nm/s)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['knee', 'Anterior Cruciate Ligament', 'Gait', 'Neuromuscular electric stimulation'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'referencesModule': {'references': [{'pmid': '14613558', 'type': 'BACKGROUND', '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.'}, {'pmid': '32436001', 'type': 'BACKGROUND', '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.'}, {'pmid': '31448305', 'type': 'BACKGROUND', '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."}, {'pmid': '30211382', 'type': 'BACKGROUND', '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.'}, {'pmid': '11292048', 'type': 'BACKGROUND', '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.'}, {'pmid': '24427427', 'type': 'BACKGROUND', '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.'}, {'pmid': '28992769', 'type': 'BACKGROUND', '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.'}, {'pmid': '26276828', 'type': 'BACKGROUND', '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.'}, {'pmid': '17888709', 'type': 'BACKGROUND', '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.'}, {'pmid': '23756076', 'type': 'BACKGROUND', '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.'}, {'pmid': '32866081', 'type': 'BACKGROUND', '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.'}, {'pmid': '35165197', 'type': 'BACKGROUND', '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.'}, {'pmid': '20117601', 'type': 'BACKGROUND', '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.'}, {'pmid': '32107561', 'type': 'BACKGROUND', '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.'}, {'pmid': '23464951', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n* Examine the effects of KneeStim wear on cadets' post-operative gait\n* Examine changes in site-specific skeletal muscle mass\n* Examine the changes in patient-reported outcomes\n* Assess time to return to full duty\n* Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)\n* Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)\n\nParticipants 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.\n\nResearchers 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..", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '27 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. United States Military Academy cadet between ages of 17-27 years\n2. undergoing anterior cruciate ligament reconstruction\n\nExclusion Criteria:\n\n1. Previous ligamentous surgery in ipsilateral knee\n2. Concomitant or prior high tibial osteotomy (HTO)\n3. Concomitant or prior cartilage restoration procedure\n4. Concomitant ligamentous reconstruction (lateral collateral ligament; posterior cruciate ligament; medial collateral ligament)\n5. Contraindications to using the KneeStim device\n\n \\- 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\n6. Meniscus tear precluding weight bearing for 6 weeks.'}, 'identificationModule': {'nctId': 'NCT06341868', 'briefTitle': 'Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets', 'organization': {'class': 'FED', 'fullName': 'Keller Army Community Hospital'}, 'officialTitle': 'Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'KACH.2023.0067'}, 'secondaryIdInfos': [{'id': '23KACH008', 'type': 'OTHER', 'domain': 'Keller Army Community Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Standard of Care + KneeStim controlled low intensity', 'description': 'Low intensity range', 'interventionNames': ['Device: KneeStim']}, {'type': 'EXPERIMENTAL', 'label': 'Standard of Care + KneeStim flexible intensity', 'description': 'Flexible to high intensity range', 'interventionNames': ['Device: KneeStim']}], 'interventions': [{'name': 'KneeStim', 'type': 'DEVICE', 'description': 'Participant will be randomized to either be in control or experimental group', 'armGroupLabels': ['Standard of Care + KneeStim controlled low intensity', 'Standard of Care + KneeStim flexible intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10996', 'city': 'West Point', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalia B Prando, MA', 'role': 'CONTACT', 'email': 'natalia.b.prando.ctr@health.mil', 'phone': '315-774-8368'}, {'name': 'Madison Mach, PhD', 'role': 'CONTACT', 'email': 'madison.s.mach.ctr@health.mil', 'phone': '315-774-8368'}], 'facility': 'Keller Army Community Hospital', 'geoPoint': {'lat': 41.39148, 'lon': -73.95597}}], 'centralContacts': [{'name': 'Natalia B Prando, MA', 'role': 'CONTACT', 'email': 'natalia.b.prando.ctr@health.mil', 'phone': '315-774-8368'}, {'name': 'Madison Mach, PhD', 'role': 'CONTACT', 'email': 'madison.s.mach.ctr@health.mil', 'phone': '315-774-8368'}], 'overallOfficials': [{'name': 'Shawn M Gee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keller Army Community Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'all individual participant data (IPD) that underlie results in a publication.', 'accessCriteria': 'request can be made to study contacts and will be reviewed by the study principal investigator and human research protections office.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keller Army Community Hospital', 'class': 'FED'}, 'collaborators': [{'name': 'Medical Technology Enterprise Consortium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Shawn Gee, MD', 'investigatorAffiliation': 'Keller Army Community Hospital'}}}}