[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604137":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":34,"centralContacts":43,"locations":49,"responsibleParty":104,"collaborators":34,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":34,"eligibilityCriteria":113,"healthyVolunteers":110,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":34,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":140,"whyStopped":34,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Haute Ecole ARC Sante","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Rehabilitation","ACTIVE_COMPARATOR","Participants receive the standardized postoperative ACL rehabilitation program only. Sessions are supervised approximately 3 times per week for 6 weeks, starting about 2 weeks after surgery. Content includes progressive range of motion, quadriceps activation and strengthening, functional tasks, and return-to-activity progressions delivered per protocol.",[13],"Behavioral: Standard Rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Rehabilitation + Blood Flow Restriction (BFR)","EXPERIMENTAL","Participants receive the standardized postoperative ACL rehabilitation plus low-load BFR training. BFR is applied with individualized limb occlusion pressure during prescribed isometric and then dynamic exercises. Sessions are supervised \\~3 times per week for 6 weeks beginning \\~2 weeks postoperatively.",[19],"Behavioral: Blood Flow Restriction (BFR) Training",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard Rehabilitation + sEMG Biofeedback","Participants receive the standardized postoperative ACL rehabilitation plus surface EMG biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions and functional movements). Real-time visual and\u002For auditory feedback is provided during supervised sessions \\~3 times per week for 6 weeks starting \\~2 weeks after surgery.",[24],"Behavioral: sEMG Biofeedback",{"label":26,"type":16,"description":27,"interventionNames":28},"Standard Rehabilitation + Combined BFR and sEMG Biofeedback","Participants receive the standardized postoperative ACL rehabilitation with both adjuncts delivered concurrently: individualized low-load BFR training and sEMG biofeedback during targeted tasks. Sessions are supervised \\~3 times per week for 6 weeks beginning \\~2 weeks postoperatively.",[19,24],[30,35,39],{"type":31,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Standardized postoperative ACL rehabilitation only. Begins \\~2 weeks after surgery; supervised \\~3 sessions\u002Fweek for 6 weeks. Includes progressive range of motion, quadriceps activation\u002Fstrengthening, functional drills, and return-to-activity progressions delivered per protocol.",[9],null,{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Blood Flow Restriction (BFR) Training","Low-load resistance exercises performed with individualized limb occlusion pressure (LOP) determined each session; target %LOP per protocol. Progresses from isometric to dynamic open\u002Fclosed-chain tasks. Delivered under supervision \\~3 sessions\u002Fweek for 6 weeks; monitoring of tolerance and adverse events per safety LOP.",[15,26],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"sEMG Biofeedback","Real-time surface electromyography biofeedback to optimize quadriceps recruitment during targeted tasks (e.g., isometric contractions, straight-leg raise, sit-to-stand, mini-squat, gait drills). Visual and\u002For auditory feedback with progressive targets. Supervised \\~3 sessions\u002Fweek for 6 weeks; outcome assessors remain blinded.",[26,21],[44],{"name":45,"role":46,"phone":47,"phoneExt":34,"email":48},"Florian Forelli, PhD","CONTACT","0041329301654","florian.forelli@he-arc.ch",[50,66,81,94],{"facility":51,"status":34,"city":52,"state":34,"zip":34,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Orthosport","Domont","France","FR",{"type":56,"coordinates":57},"Point",[58,59],2.32638,49.02782,{"lat":59,"lon":58},[62],{"name":63,"role":46,"phone":64,"phoneExt":34,"email":65},"Ayrton Moiroux -- Sahraoui","+33634099012","ayrton.moirouxsahraoui@gmail.com",{"facility":67,"status":34,"city":68,"state":34,"zip":34,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Movare","Bulle","Switzerland","CH",{"type":56,"coordinates":72},[73,74],7.0569,46.61797,{"lat":74,"lon":73},[77],{"name":78,"role":46,"phone":79,"phoneExt":34,"email":80},"Loic Bel, MSc","+41792749573","bel.loic.pt@gmail.com",{"facility":82,"status":34,"city":83,"state":34,"zip":34,"country":69,"countryCode":70,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Centre de l'Appareil Locomoteur et du Sport, Hôpitaux Universitaires de Genève (HUG)","Geneva",{"type":56,"coordinates":85},[86,87],6.14569,46.20222,{"lat":87,"lon":86},[90],{"name":91,"role":46,"phone":92,"phoneExt":34,"email":93},"Anna Stitelmann, MSc","+4122372 33 11","anna.stitelmann@outlook.com",{"facility":95,"status":34,"city":83,"state":34,"zip":34,"country":69,"countryCode":70,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Exotherapie",{"type":56,"coordinates":97},[86,87],{"lat":87,"lon":86},[100],{"name":101,"role":46,"phone":102,"phoneExt":34,"email":103},"Maxime Gard","+41796518623","m.gard@exotherapie.ch",{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Forelli Florian","Assistant Professor ; PhD","100604137","effects-of-early-rehabilitation-using-blood-flow-restriction-andor-surface-electromyography-biofeedback-on-quadriceps-activation-and-strength-after-anterior-cruciate-ligament-reconstruction-a-multicenter-randomized-controlled-trial-100604137",false,"NCT07145606","Effects of Early Rehabilitation Using Blood Flow Restriction and\u002For Surface Electromyography Biofeedback on Quadriceps Activation and Strength After Anterior Cruciate Ligament Reconstruction: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18-35 years.\n\nFirst-time anterior cruciate ligament (ACL) reconstruction.\n\nPre-injury activity level Tegner ≥ 6.\n\nMarx activity scale ≥ 12.\n\nBody mass index \\\u003C 35.\n\nWith or without associated meniscal injury.\n\nExclusion Criteria:\n\n* Revision ACL surgery.\n\nConcurrent repair of other knee ligaments.\n\nNeurological or systemic musculoskeletal disorders.\n\nContraindications to blood flow restriction (BFR) or surface EMG monitoring\u002Fbiofeedback.\n\nPregnancy or lactation.\n\nLanguage barrier or cognitive impairment preventing valid informed consent; vulnerable populations not enrolled.","ALL","18 Years","35 Years",{"count":118,"type":119},200,"ESTIMATED","INTERVENTIONAL",[122],"NA","Many patients experience quadriceps inhibition after anterior cruciate ligament (ACL) reconstruction, delaying strength recovery, hindering return to sport, and potentially increasing the risk of re-injury. Two rehabilitation strategies-low-load blood flow restriction (BFR) training and surface electromyography (sEMG) biofeedback-aim to enhance neuromuscular activation and strength while limiting joint load. However, comparative and combined evidence in pragmatic, multicenter settings remains limited.\n\nAMIRACL is a multicenter, prospective, randomized, controlled, parallel-group trial with four arms enrolling 200 adults (18-35 years) undergoing a first-time ACL reconstruction. Participants are randomized with center stratification; outcome assessors are blinded to allocation. The four groups are: (1) standard rehabilitation; (2) standard + early BFR; (3) standard + early sEMG biofeedback; and (4) standard + combined BFR and sEMG biofeedback. Interventions begin about 2 weeks postoperatively, are delivered over 6 weeks at three supervised sessions per week, and are integrated into contemporary ACL rehabilitation. BFR uses individualized, auto-regulated cuff pressure during low-load isometric and then dynamic exercises. sEMG biofeedback provides real-time visual and\u002For auditory feedback to optimize quadriceps recruitment during targeted tasks. The combined arm receives both modalities concurrently.\n\nThe primary objective is to compare quadriceps activation (sEMG) and maximal isometric knee extensor strength between groups at 3 and 6 months. Secondary objectives include return-to-sport readiness and patient-reported function (e.g., ACL-RSI, IKDC), broader knee outcomes (e.g., KOOS, Lysholm), adherence and adverse events across arms, and ACL re-injury (ipsilateral graft rupture or contralateral ACL injury) within 2 years. Longer-term patient-reported quality of life is explored up to 5 years.\n\nKey eligibility criteria include age 18-35 years, first ACL reconstruction, and preinjury sport participation; major exclusions include revision ACL surgery, concomitant multi-ligament repair, neuromuscular disorders, and contraindications to BFR or sEMG. The planned sample size is 200 (50 per arm), powered to detect a clinically meaningful between-group difference in quadriceps activation. Analyses will follow the intention-to-treat principle using mixed-effects models for repeated measures. The study is conducted under Good Clinical Practice and applicable Swiss regulations; all participants provide written informed consent. Overall, AMIRACL will determine whether early BFR, sEMG biofeedback, or their combination meaningfully improves quadriceps activation, strength, and clinical recovery after ACL reconstruction compared with standard rehabilitation alone.",[125,126,127],"Anterior Cruciate Ligament Injuries","Knee Injuries","Muscle Weakness",[129,130,126,131,132,133,134,135,136,137,138,139],"Anterior Cruciate Ligament","ACL Reconstruction","Rehabilitation","Quadriceps Muscle","Quadriceps Activation","Muscle Strength","Arthrogenic Muscle Inhibition","Blood Flow Restriction Training","Surface Electromyography","Biofeedback","Return to Sport","NOT_YET_RECRUITING","2025-08-21",{"date":143,"type":144},"2025-08-28","ACTUAL",{"date":146,"type":119},"2026-01-02",{"date":148,"type":119},"2031-01-02",{"name":5,"class":6},4]