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Recruiting Phase 2 NCT07020312

NCT07020312 Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery

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Clinical Trial Summary
NCT ID NCT07020312
Status Recruiting
Phase Phase 2
Sponsor Rush University Medical Center
Condition Anterior Cruciate Ligament Reconstruction
Study Type INTERVENTIONAL
Enrollment 240 participants
Start Date 2025-08-14
Primary Completion 2028-05

Trial Parameters

Condition Anterior Cruciate Ligament Reconstruction
Sponsor Rush University Medical Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-14
Completion 2028-05
Interventions
Visualization training with neurofeedbackStandard post-surgical rehabilitation therapy

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Brief Summary

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: 1. Anterior cruciate ligament reconstruction (ACLR) 2. Total knee arthroplasty (TKA) 3. Total hip arthroplasty (THA) 4. Hip arthroscopy (HA) for femoroacetabular impingement (FAI) The 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. The hope is that combining brain training with physical therapy will lead to faster, more complete recoveries and improve how patients move after surgery.

Eligibility Criteria

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 * Pa

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