[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06208631":3,"trial-entities:NCT06208631":106,"trial-summary:NCT06208631":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":51,"minimum_age":52,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":71,"locations":74,"central_contacts":90,"overall_officials":93,"references":97,"see_also_links":105},"NCT06208631","34928","Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis","Effects of Haptic Movement Retraining on Osteoarthritis Progression","RECRUITING","2026-12","2025-10","2026-06-23","2024-01-18","Stanford University","OTHER",false,"This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading.\n\nPrior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Some participants will train on a treadmill in the laboratory for up to two sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. Other participants will train outside the laboratory for one session with 30 minutes of walking with feedback to investigate changes in knee loading while using the new walking strategy during over-ground walking.\n\nThe movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.",null,[19],"Osteoarthritis, Knee",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},31,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Gait retraining","Changing muscle coordination while walking",[33],"Gait modification",[35],{"measure":36,"description":37,"timeFrame":38},"Change from baseline in knee contact force","Knee contact force will be evaluated using motion capture data and musculoskeletal modeling and simulations, for participants that are able to reduce gastrocnemius activation.","Evaluated during the 30 minutes of feedback walking in the second in-lab session and out-of-lab session",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Change from baseline in gastrocnemius activation","Gastrocnemius activation measured through EMG signals.","Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session",{"measure":45,"description":46,"timeFrame":43},"Proportion of participants that reduce gastrocnemius activation","Gastrocnemius activation will be measured through electromyography (EMG) signals, and the muscle activation during gait retraining will be compared to baseline walking. Participants that can reduce gastrocnemius activation 10% or more from baseline within 30 minutes of gait retraining will be counted as participants that can reduce gastrocnemius activation out of the total number of participants who try the gait retraining.",{"measure":48,"description":49,"timeFrame":50},"Proportion of participants that reduce knee contact force","For the participants who can successfully reduce gastrocnemius activation from baseline, knee contact force will be calculated using motion capture data and musculoskeletal modeling and simulations. The proportion of participants that reduce knee contact force from baseline during gait retraining out of the total participants that reduce gastrocnemius activation will be evaluated.","Evaluated during the 30 minutes of feedback walking in the second in-lab session and the out-of-lab session","ALL","18 Years",{"inclusion":54,"exclusion":61,"raw_text":70},[55,56,57,58,59,60],"Medial and\u002For lateral compartment knee osteoarthritis","Diagnosed with knee osteoarthritis of at least six months duration","Ambulatory without aids","Able to walk for at least 60 minutes","Typical pain rating of 1-4 on scale of 0-10","Able to reduce gastrocnemius muscle activation by 10% from baseline",[62,63,64,65,66,67,68,69],"History of symptomatic arthritis in lower limb joints other than the knees","Replacement of any lower extremity joint","Symptoms originating from the patellofemoral joint","Body mass index equal to or greater than 35","Nerve or muscle disease associated with walking difficulty","History of rheumatoid arthritis, gout, or autoimmune disease","History of lower limb fracture or surgery requiring hospitalization","Pregnant","Inclusion Criteria:\n\n* Medial and\u002For lateral compartment knee osteoarthritis\n* Diagnosed with knee osteoarthritis of at least six months duration\n* Ambulatory without aids\n* Able to walk for at least 60 minutes\n* Typical pain rating of 1-4 on scale of 0-10\n* Able to reduce gastrocnemius muscle activation by 10% from baseline\n\nExclusion Criteria:\n\n* History of symptomatic arthritis in lower limb joints other than the knees\n* Replacement of any lower extremity joint\n* Symptoms originating from the patellofemoral joint\n* Body mass index equal to or greater than 35\n* Nerve or muscle disease associated with walking difficulty\n* History of rheumatoid arthritis, gout, or autoimmune disease\n* History of lower limb fracture or surgery requiring hospitalization\n* Pregnant",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"Stanford Human Performance Lab","Stanford","California","94305","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Scott D Uhlrich, PhD","CONTACT","650-721-2547","oawalking@lists.stanford.edu",{"lat":88,"lon":89},37.42411,-122.16608,[91],{"name":92,"role":84,"phone":85,"email":86},"Study Team",[94],{"name":95,"affiliation":13,"role":96},"Scott L Delp, PhD","PRINCIPAL_INVESTIGATOR",[98,102],{"pmid":99,"type":100,"citation":101},"35798755","BACKGROUND","Uhlrich SD, Jackson RW, Seth A, Kolesar JA, Delp SL. Muscle coordination retraining inspired by musculoskeletal simulations reduces knee contact force. Sci Rep. 2022 Jul 7;12(1):9842. doi: 10.1038\u002Fs41598-022-13386-9.",{"pmid":103,"type":100,"citation":104},"24615885","Demers MS, Pal S, Delp SL. Changes in tibiofemoral forces due to variations in muscle activity during walking. J Orthop Res. 2014 Jun;32(6):769-76. doi: 10.1002\u002Fjor.22601. Epub 2014 Feb 26.",[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Osteoarthritis of knee",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study with a planned enrollment of 31 participants.","completed","Movement Retraining for Knee Osteoarthritis","This study is looking at how a walking exercise called gait retraining can help people with knee osteoarthritis (a condition where cartilage in the knee wears down). Researchers want to see if you can learn to change how you use your calf muscles while walking, and if this change can reduce the stress on your knee. You might be able to join if you are an adult with knee osteoarthritis for at least six months, can walk without help for an hour, and have typical knee pain between 1 and 4 on a 0-10 scale. The main goal is to measure how much the force on your knee changes after learning this new walking technique.","Knee contact force will be evaluated during feedback walking in the second in-lab session and out-of-lab session.",115,"You would learn to change your muscle coordination while walking, receiving feedback after each step during in-lab and out-of-lab sessions.","Not stated in the trial record.",[30],"v2"]