[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Steadman Philippon Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623528","home-based-leg-dexterity-trainer-for-management-of-knee-osteoarthritis-100623528",false,"NCT07397806","Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis","INCLUSION CRITERIA:\n\n1. Age 40 to 85 years\n2. Ambulatory in home and community settings\n3. History of knee osteoarthritis in one or both knees (Kellgren-Lawrence grade II-IV)\n4. Baseline pain of 3-10 points on the target (i.e., more-affected) knee and a pain differential of at least -2 points on the contralateral knee as exhibited by the worst pain score for the previous week (on the 11-point Numeric Rating Scale, NRS\u002FVisual Analog Scale VAS).\n5. Capacity to personally give informed consent (consent via a legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments\n\nEXCLUSION CRITERIA:\n\n1. Previous or Planned Knee Surgeries, Procedures, and\u002For Treatments:\n\n   1. Planned surgery on either the contralateral or target knee at any time during the Study period, including pre-and post-training assessments.\n   2. Within 6 months of signing informed consent has received diagnostic arthroscopy of the target knee or arthroscopic surgery (including microfracture and meniscectomy) on the target knee;\n   3. Within 12 weeks of signing informed consent has received intra-articular treatment of the target knee with steroids or hyaluronic acid derivatives;\n   4. Planned intra-articular treatment of the target knee with steroids or hyaluronic acid derivatives on either the contralateral or target knee at any time during the Study period including pre-and post-training assessments.\n   5. History of previous total or partial arthroplasty in the target knee. Partial or total arthroplasty in the contralateral knee is acceptable as long as the surgery was performed at least 6 months prior to enrollment and the operative knee is asymptomatic\n2. Current and\u002For Previous Medical Conditions, Surgeries, and\u002For Procedures:\n\n   1. Within 2 years of signing informed consent, history of active blood disorders (i.e., DVTs, chronic blood clotting, hemophilia, leukemia, myeloma, etc.); or active malignancy of any type or history of a malignancy (with the exception of subjects with a history of treated basal or squamous cell carcinoma).\n   2. Current diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria.\n   3. Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis.\n   4. Current or prior history of other joint diseases including but not limited to joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and\u002For radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler syndrome, joint infection, hemochromatosis, or neuropathic arthropathy of any cause.\n   5. Any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Investigator or his designee) constitutes a risk or contraindication for participation in the Study or that could interfere with the Study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the Study.\n3. Within 8 weeks of signing informed consent, has used opioid analgesics and is not willing to discontinue these medications through the duration of the study.","ALL","40 Years","85 Years",{"count":19,"type":20},82,"ESTIMATED","INTERVENTIONAL",[23],"NA","Rationale:\n\nRoughly 14 million adults aged 60 or older (10% male\u002F13% female) in the United States experience symptoms of knee osteoarthritis (OA). Knee OA pain progressively impacts aging, reducing mobility and increasing morbidity. Nonsurgical self-management of knee OA includes exercise to promote proper knee mechanics, non-steroidal anti-inflammatory drugs (NSAIDs), cortisone injections, and weight loss to reduce pain and retain function. As OA has no cure, self-management progresses to \\~1 million joint replacements per year. Critically, home-based devices are lacking for specifically training the low-level proprioceptive and neuromuscular circuitry for proper knee mechanics in a safe, focused, mechanistic way. Such devices would supplement exercises for strength, mobility, and whole-body loading and movement.\n\nInitially considered a wear-and-tear condition, knee OA is now understood as a complex disease involving inflammatory responses to mechanical loading and neuromuscular feedback loops among pain, joint damage, and dynamic loading. Home-based exercises remain a primary nonpharmacological and nonsurgical approach to managing chronic pain in OA that fundamentally disrupts proprioception and neuromuscular control of the joint, which accelerates articular degeneration.\n\nNeuromuscular Dynamics, LLC has developed a simple, safe, quick, and effective Leg Dexterity System that is portable, wireless, and coupled to HIPAA-compliant cloud analytics. A seated participant uses their foot to compress a platform atop a slender spring, which becomes unstable as it begins to buckle at low forces. The participant must then control their leg dexterity (i.e., via short-latency sensorimotor circuits) to stabilize the unstable dynamic foot-ground interactions. A tablet computer connected to the device provides feedback during use and uploads the participant's activity data to the server for analysis and reporting, accessible to users and clinicians.\n\nThe investigators have successfully tested Leg Dexterity in control participants in multiple publications. The Leg Dexterity test is safe and poses minimal risk as the forces needed to do it are very low, does not involve full weight- bearing maneuvers, and is performed while seated without the risk of falling.\n\nStudy:\n\nThe investigators will conduct a randomized home-based clinical trial in knee OA to demonstrate the efficacy of leg dexterity training to reduce pain and improve function compared to currently prescribed dynamic exercise on a wobble board (a commonly used approach for improving proprioception and balance). Successful completion of this study will justify the adoption of the Leg Dexterity System as an effective at-home supplement to any nonsurgical management of knee OA.\n\nThe investigators propose a longitudinal double-blind dose-matched trial comparing 8 weeks of leg dexterity training (Treatment using a slender, unstable spring system that engages short-latency sensorimotor control, 42 participants) vs. at-home wobble board exercises (Control, 42 participants) at the Steadman Philippon Research Institute.",[26],"Osteo Arthritis of the Knee",[28,29,30,31],"osteoarthritis","knee","exercise","dexterity","RECRUITING","2026-02-02",{"date":35,"type":36},"2026-02-09","ACTUAL",{"date":38,"type":36},"2025-09-11",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"Steadman Philippon Research Institute","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100524387","phase-1-mitigation-of-arthrofibrosis-after-total-knee-arthroplasty-using-losartan-100524387","NCT06108063","Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan","Inclusion Criteria:\n\n1. Planned primary total knee arthroplasty of a single knee;\n2. Male or female ≥ 18 years of age;\n3. Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.\n\nExclusion Criteria:\n\n1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study;\n2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;\n3. Previous knee arthroplasty on the study knee;\n4. Previous infection affecting the study knee;\n5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;\n6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;\n7. Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;\n8. Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;\n9. Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;\n10. Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period);\n11. Allergic to any active or inactive ingredient of Losartan;\n12. Taking medication with known adverse Losartan interaction;\n13. Subjects that have any medical condition, including malignancies, laboratory findings, and\u002For findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects of the study.","18 Years",{"count":53,"type":20},120,[55,56],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.",[59],"Knee Arthroplasty, Total",[61],"TKA Losartan Arthrofibrosis","2024-03-07",{"date":64,"type":36},"2024-03-12",{"date":66,"type":36},"2024-03-06",{"date":68,"type":20},"2027-06-30",{"name":42,"class":43},""]