protocolSection identificationModule nctId: NCT06341868, orgStudyIdInfo id: KACH.2023.0067, secondaryIdInfos id: 23KACH008, type: OTHER, domain: Keller Army Community Hospital, briefTitle: Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Keller Army Community Hospital, class: FED, collaborators name: Medical Technology Enterprise Consortium, 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:* 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.., conditionsModule conditions: Anterior Cruciate Ligament Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: KneeStim, outcomesModule primaryOutcomes measure: Change in gait post-operatively assessed by the KneeStimTM Device, secondaryOutcomes measure: change in gait post-operatively assessed by 3D Motion capture, secondaryOutcomes measure: change in gait post-operatively assessed by force plate instrumented treadmill, secondaryOutcomes measure: change in muscle volume assessed by MRI, secondaryOutcomes measure: ACL graft healing assessed by MRI, secondaryOutcomes measure: Change in isometric muscle strength assessed by CSMi HUMAC NORM, secondaryOutcomes measure: Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA), secondaryOutcomes measure: Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA), secondaryOutcomes measure: Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA), secondaryOutcomes measure: Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS), secondaryOutcomes measure: Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), secondaryOutcomes measure: Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29), secondaryOutcomes measure: Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE), secondaryOutcomes measure: Change in knee function assessed by the Marx Activity Rating Scale (MARS), secondaryOutcomes measure: Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL), secondaryOutcomes measure: Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI), secondaryOutcomes measure: Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS), secondaryOutcomes measure: Time to return to full duty, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 27 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Keller Army Community Hospital, status: RECRUITING, city: West Point, state: New York, zip: 10996, country: United States, contacts name: Natalia B Prando, BA, role: CONTACT, phone: 845-938-5325, email: natalia.b.prando.ctr@health.mil, contacts name: Paige A McHenry, MS, role: CONTACT, phone: 845-938-2630, email: paige.a.mchenry.ctr@health.mil, geoPoint lat: 41.39148, lon: -73.95597, hasResults: False