[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":31,"responsibleParty":43,"collaborators":31,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":31,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":31,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":73,"whyStopped":31,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":31},{"fullName":5,"class":6},"Jouf University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KEA Device Group","EXPERIMENTAL","Participants in this arm will perform quadriceps setting exercises using the Knee Extensors Activation (KEA) device. The device includes an inflatable cushion, pressure gauge, and digital repetition counter. Beginning on postoperative Day 1, participants will complete two supervised sessions daily for five days. Each session includes 3 sets of 10 isometric contractions of the quadriceps, with each contraction held for 5 seconds. The KEA device provides real-time visual feedback, encouraging full-effort contractions. A repetition is only counted when the pressure exceeds a preset threshold and returns to baseline, ensuring correct performance. All sessions are supervised by a physiotherapist.",[13],"Device: Knee Extensors Activation (KEA) Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Towel Group","ACTIVE_COMPARATOR","Participants in this arm will perform the same quadriceps setting exercises using a conventional rolled towel placed under the knee. This represents the current standard of care. Beginning on postoperative Day 1, participants will complete two supervised sessions daily for five days. Each session consists of 3 sets of 10 isometric quadriceps contractions with 5-second holds. The physiotherapist provides verbal cues and manually counts repetitions. There is no objective feedback or automated monitoring of contraction effort or repetition quality. All other rehabilitation care is consistent between groups.",[19],"Other: Conventional Towel-Based Exercise",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Knee Extensors Activation (KEA) Device","A portable, non-electric device consisting of an inflatable cushion, pressure gauge, and digital counter. It provides objective feedback during isometric quadriceps exercises after ACL reconstruction. The device encourages full contraction by only counting repetitions that exceed a preset pressure threshold and return to baseline.",[9],[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Conventional Towel-Based Exercise","Standard rehabilitation method using a rolled towel under the knee during quadriceps setting exercises. Patients perform isometric contractions without feedback or objective measurement. Repetitions are manually counted by the physiotherapist.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Abdulmajeed Alfayyadh","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","+966500568065","abalfayyadh@ju.edu.sa",{"name":42,"role":38,"phone":31,"phoneExt":31,"email":31},"Sulaiman Alanezi",{"type":35,"investigatorFullName":34,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Assistant Professor","100596048","kea-vs-towel-for-early-quad-activation-post-anterior-cruciate-ligament-reconstruction-100596048",false,"NCT07040384","KEA vs Towel for Early Quad Activation Post Anterior Cruciate Ligament Reconstruction","Knee Extensors Activation Device Versus Rolled Towel for Early Quadriceps Activation After ACL Reconstruction: Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 45 years\n* Undergoing primary unilateral anterior cruciate ligament (ACL) reconstruction (any graft type, any surgical technique)\n* Able and willing to participate in postoperative rehabilitation\n* Able to provide written informed consent\n* Able to comply with study procedures and complete the 5-day inpatient exercise program\n\nExclusion Criteria:\n\n* Bilateral knee surgeries (e.g., simultaneous ACL reconstruction on both knees)\n* Significant neuromuscular disorders that may affect rehabilitation or EMG readings\n* Cognitive impairment that would interfere with understanding or performing exercises\n* History of major lower limb surgery within the past year (excluding the current ACL surgery)\n* Concomitant injuries requiring extensive repair (e.g., complex ligament reconstructions beyond minor meniscal or collateral work)\n* Any medical condition or postoperative complication that would prevent safe participation in the exercise program","ALL","18 Years","45 Years",{"count":56,"type":57},40,"ESTIMATED","INTERVENTIONAL",[60],"NA","The goal of this clinical trial is to learn if a novel Knee Extensors Activation (KEA) device can improve quadriceps muscle activation in adults after anterior cruciate ligament (ACL) reconstruction surgery. The study focuses on adults aged 18-45 years undergoing primary unilateral ACL reconstruction, a population commonly affected by this injury.\n\nThe main questions it aims to answer are:\n\nDoes using the KEA device lead to greater quadriceps muscle activation (measured via EMG) by postoperative Day 5 compared to standard care using a rolled towel?\n\nDoes the KEA device improve early knee function, reduce pain, and decrease fear of movement compared to the towel method?\n\nResearchers will compare participants using the KEA device versus a control group using the conventional rolled towel during early postoperative rehabilitation to see if the KEA device provides better outcomes.\n\nParticipants will:\n\nBegin quadriceps strengthening exercises on the first day after ACL surgery.\n\nBe randomly assigned to use either the KEA device or a rolled towel for isometric quadriceps exercises.\n\nPerform 3 sets of 10 repetitions of knee extension exercises, twice daily for 5 consecutive days.\n\nUndergo assessment of quadriceps EMG activation and complete questionnaires (KOOS, IKDC, TSK, and VAS) on Day 5.",[63,64],"ACL Surgery","Quadriceps Strength",[66,67,68,69,70,71,72],"Anterior cruciate ligament","quadriceps activation","biofeedback","rehabilitation","electromyography","knee","randomized controlled trial","NOT_YET_RECRUITING","2025-06-25",{"date":76,"type":77},"2025-06-27","ACTUAL",{"date":79,"type":57},"2025-08-25",{"date":81,"type":57},"2026-12-10",{"name":5,"class":6}]