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Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery

RecruitingPhase 2Ages 18 Years - anyAllRush University Medical Center
NCT07020312 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. In 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. The study includes patients recovering from one of four surgeries:

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📋 Eligibility rules (as published)
Participants * Inclusion Criteria: * Patient age \>18 years * Ability to complete neurofeedback training and follow study follow-ups * Indicated for one of the four investigated orthopedic procedures * Exclusion Criteria: * Inability to participate in neurofeedback training * Lack of decisional capability * History of stroke, movement disorder (e.g. Parkinson's), peripheral neuropathy * Cardiac pacemaker or other internal electronic device * BMI \>35 * Previous surgery or specific pathology on the affected joint (refer to procedure specific indications below) Procedure Specifics: Anterior cruciate ligament reconstruction (ACLR) Procedure-specific Inclusion Criteria * Patients undergoing primary ACLR with autograft or allograft tissue * Adjunct lateral Extra-articular tenodesis will be included * Additional meniscus debridement and repair will be included Procedure-specific exclusion criteria * Revision ACL surgery * Moderate to Severe arthritis - Kellgren-Lawerence (KL) Grade \> 3 * Patients with meniscus root repair * Non-weight-bearing status exceeding 1 week postoperatively Total knee arthroplasty (TKA) Procedure specific inclusion criteria * Patients undergoing primary TKA * Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension) * Prior extensor mechanism tendon repair, quadriceps or patella tendon. Procedure specific exclusion criteria * Revision surgery * Hinged implant * Any open procedure involving the knee joint * Symptomatic arthritis in the contralateral knee with planned or expected total knee arthroplasty within 6 months * Inflammatory Arthritis Total hip arthroplasty (THA) Procedure Specific Inclusion Criteria * Patients undergoing primary THA Procedure Specific Exclusion Criteria * Revision Surgery * Any open procedure involving the hip joint * Bilateral THA procedures * Inflammatory Arthritis Hip arthroscopy (HA) for femoroacetabular impingement syndrome (FAIS) Procedure Specific Inclusion Criteria · Patients undergoing HA for FAIS Procedure Specific Exclusion Criteria * Revision Surgery * Diagnosis of hip dysplasia
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What it tests

  • Visualization training with neurofeedback
  • Standard post-surgical rehabilitation therapy
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Where

1 site
Rush University Medical Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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