Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaed… (NCT07020312) | Clinical Trial Compass
RecruitingPhase 2
Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
United States240 participantsStarted 2025-08-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.