[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594505":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":77,"collaborators":43,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":43,"enrollmentInfo":89,"targetDuration":43,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":60,"whyStopped":43,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Rush University Medical Center","OTHER",[8,15,20,23,26,29,32,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Anterior cruciate ligament reconstruction (ACLR) - Experimental","EXPERIMENTAL","Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training",[13,14],"Other: Visualization training with neurofeedback","Other: Standard post-surgical rehabilitation therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Anterior cruciate ligament reconstruction (ACLR) - Control","ACTIVE_COMPARATOR","Control group: Standard post-surgical rehabilitation therapy",[14],{"label":21,"type":10,"description":11,"interventionNames":22},"Total knee arthroplasty (TKA) - Experimental",[13,14],{"label":24,"type":17,"description":18,"interventionNames":25},"Total knee arthroplasty (TKA) - Control",[14],{"label":27,"type":10,"description":11,"interventionNames":28},"Total hip arthroplasty (THA) - Experimental",[13,14],{"label":30,"type":17,"description":18,"interventionNames":31},"Total hip arthroplasty (THA) - Control",[14],{"label":33,"type":10,"description":11,"interventionNames":34},"Hip arthroscopy (HA) - Experimental",[13,14],{"label":36,"type":17,"description":18,"interventionNames":37},"Hip arthroscopy (HA) - Control",[14],[39,44],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Visualization training with neurofeedback","This technology uses electroencephalography (EEG) to measure brain activity through passive sensors placed on a cap aligned with the motor and frontal cortices. These sensors detect changes in electrical signals when patients imagine performing rehabilitation movements. The EEG data is sent to a computer, where iBrainTech™ software translates it into a virtual avatar that mimics the imagined actions. This real-time feedback-called neurofeedback-helps patients see how well they are engaging their brain during visualization. By turning the process into a video game controlled by brain signals, the platform motivates patients to focus deeply on visualizing the exercises. Repeated activation of these brain regions may help rebuild neuromuscular pathways, improve muscle control, and reduce the effects of Arthrogenic Muscle Inhibition (AMI), a common issue after orthopedic surgery.",[9,33,27,21],null,{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Standard post-surgical rehabilitation therapy","Patients will follow a standard physical therapy protocol. The protocol will be assigned by their respective surgeon who conducted the procedure and will be specific to the procedure that the patient underwent.",[16,9,36,33,30,27,24,21],[49],{"name":50,"affiliation":5,"role":51},"Jorge Chahla, MD, PhD","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":43,"email":57},"Brian Forsythe, MD","CONTACT","708-236-2782","Brian.forsythe@rushortho.com",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-87.65005,41.85003,{"lat":70,"lon":69},[73],{"name":74,"role":55,"phone":75,"phoneExt":43,"email":76},"Carla Edwards, Ph.D., MPH, MLS(ASCP)CMCCRP","312.563.5735","carla_edwards@rush.edu",{"type":78,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100594505","phase-2-brain-computer-interface-visualization-training-to-optimize-muscle-activation-following-orthopaedic-surgery-100594505",false,"NCT07020312","Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery","Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery: A Blinded Randomized Controlled Trial","iBrainTechRCT","Participants\n\n* Inclusion Criteria:\n\n  * Patient age \\>18 years\n  * Ability to complete neurofeedback training and follow study follow-ups\n  * Indicated for one of the four investigated orthopedic procedures\n* Exclusion Criteria:\n\n  * Inability to participate in neurofeedback training\n  * Lack of decisional capability\n  * History of stroke, movement disorder (e.g. Parkinson's), peripheral neuropathy\n  * Cardiac pacemaker or other internal electronic device\n  * BMI \\>35\n  * Previous surgery or specific pathology on the affected joint (refer to procedure specific indications below)\n\nProcedure Specifics:\n\nAnterior cruciate ligament reconstruction (ACLR) Procedure-specific Inclusion Criteria\n\n* Patients undergoing primary ACLR with autograft or allograft tissue\n* Adjunct lateral Extra-articular tenodesis will be included\n* Additional meniscus debridement and repair will be included Procedure-specific exclusion criteria\n* Revision ACL surgery\n* Moderate to Severe arthritis - Kellgren-Lawerence (KL) Grade \\> 3\n* Patients with meniscus root repair\n* Non-weight-bearing status exceeding 1 week postoperatively\n\nTotal knee arthroplasty (TKA) Procedure specific inclusion criteria\n\n* Patients undergoing primary TKA\n* Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension)\n* Prior extensor mechanism tendon repair, quadriceps or patella tendon. Procedure specific exclusion criteria\n* Revision surgery\n* Hinged implant\n* Any open procedure involving the knee joint\n* Symptomatic arthritis in the contralateral knee with planned or expected total knee arthroplasty within 6 months\n* Inflammatory Arthritis\n\nTotal hip arthroplasty (THA) Procedure Specific Inclusion Criteria\n\n* Patients undergoing primary THA Procedure Specific Exclusion Criteria\n* Revision Surgery\n* Any open procedure involving the hip joint\n* Bilateral THA procedures\n* Inflammatory Arthritis\n\nHip arthroscopy (HA) for femoroacetabular impingement syndrome (FAIS) Procedure Specific Inclusion Criteria\n\n· Patients undergoing HA for FAIS Procedure Specific Exclusion Criteria\n\n* Revision Surgery\n* Diagnosis of hip dysplasia","ALL","18 Years",{"count":90,"type":91},240,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","After orthopedic surgeries like knee or hip replacement, some patients struggle to fully activate their muscles due to a condition called Arthrogenic Muscle Inhibition (AMI). AMI can slow recovery and make physical therapy less effective. This clinical trial is testing whether a special type of brain training-called neurofeedback visualization training-can help improve muscle activation and speed up recovery.\n\nIn this study, patients will receive standard physical therapy after surgery. Half of them will also use a device that helps them \"visualize\" exercises while wearing a cap that reads brain signals (EEG). The cap tracks brain activity when patients imagine doing specific movements. A computer then shows a virtual avatar performing the movements, giving feedback in real time-like a video game controlled by the brain.\n\nThe study includes patients recovering from one of four surgeries:\n\n1. Anterior cruciate ligament reconstruction (ACLR)\n2. Total knee arthroplasty (TKA)\n3. Total hip arthroplasty (THA)\n4. Hip arthroscopy (HA) for femoroacetabular impingement (FAI)\n\nThe goal is to see if this training improves muscle strength, movement, and daily function more than standard therapy alone. The study will take place at Rush University Medical Center in Chicago and enroll 240 adults, with 60 patients per type of surgery. Each participant will be followed for up to 6 months after surgery and complete strength tests, movement assessments, and questionnaires about their recovery.\n\nThe hope is that combining brain training with physical therapy will lead to faster, more complete recoveries and improve how patients move after surgery.",[97,98,99,100],"Anterior Cruciate Ligament Reconstruction","Total Hip Arthroplasty (THA)","Total Knee Arthroplasty","Hip Arthroscopy",[102,103,104,100,105,106,107,108,109,110],"ACLR","THA","TKA","Arthrogenic muscle inhibition","Electroencephalography","Gait","Motion Analysis","Biomechanics","Strength","2026-06-17",{"date":113,"type":114},"2026-06-18","ACTUAL",{"date":116,"type":114},"2025-08-14",{"date":118,"type":91},"2028-08-01",{"name":5,"class":6},1]