RecruitingPhase 2NCT07020312

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


Sponsor

Rush University Medical Center

Enrollment

240 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • Participants
  • Patient age >18 years
  • Ability to complete neurofeedback training and follow study follow-ups
  • Indicated for one of the four investigated orthopedic procedures
  • Patients undergoing primary ACLR with autograft or allograft tissue
  • Adjunct lateral Extra-articular tenodesis will be included
  • Patients undergoing primary TKA
  • Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension)

Exclusion Criteria22

  • 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:
  • 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
  • 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
  • Revision Surgery
  • Any open procedure involving the hip joint
  • Bilateral THA procedures
  • Inflammatory Arthritis
  • Revision Surgery
  • Diagnosis of hip dysplasia

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Interventions

OTHERVisualization 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.

OTHERStandard 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.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT07020312


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