Actively Recruiting
Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery A Blinded Randomized Controlled Trial
Led by Rush University Medical Center · Updated on 2025-08-17
240
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients undergoing orthopedic surgeries such as anterior cruciate ligament reconstruction, total knee arthroplasty, total hip arthroplasty, or hip arthroscopy for femoroacetabular impingement often face challenges with muscle activation post-surgery due to Arthrogenic Muscle Inhibition (AMI). This condition can limit muscle strength and slow recovery despite standard physical therapy. The study evaluates whether adding neurofeedback visualization training, which uses brain signals to provide real-time feedback during imagined movements, can improve muscle activation and enhance recovery outcomes compared to standard therapy alone. Participants will be randomly assigned to either a control group receiving standard post-surgical rehabilitation or an intervention group receiving the same therapy plus neurofeedback visualization training using the i-BrainTech2 platform. The neurofeedback sessions occur twice weekly for eight weeks post-surgery and involve wearing an EEG cap that measures brain activity while patients visualize rehabilitation exercises. This feedback is presented as a video game controlled by brain signals, encouraging focused mental rehearsal of movements to potentially reduce AMI and improve muscle control. During the study, participants will attend assessments at 2, 4, and 6 months after surgery involving strength testing, motion analysis using markerless 3D motion capture, electromyography (EMG) of specific muscles, and questionnaires about recovery and function. Strength tests will focus on knee extension or hip abduction depending on surgery type. The study tracks changes in muscle strength and movement quality over time to compare outcomes between groups. Follow-up visits and standard clinical care continue throughout the study, which will enroll 240 adults and last up to six months postoperatively.
CONDITIONS
Brief Title
Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age over 18 years
- Ability to complete neurofeedback training and attend all study follow-ups
- Scheduled for one of the following orthopedic surgeries: anterior cruciate ligament reconstruction, total knee arthroplasty, total hip arthroplasty, or hip arthroscopy for femoroacetabular impingement
- Undergoing primary ACL reconstruction with autograft or allograft tissue (including adjunct lateral extra-articular tenodesis and meniscus debridement/repair)
- Undergoing primary total knee arthroplasty with preoperative knee range of motion of at least 100 degrees
- Undergoing primary total hip arthroplasty
- Undergoing hip arthroscopy for femoroacetabular impingement syndrome
You will not qualify if you...
- Inability to participate in neurofeedback training
- Lack of decisional capacity
- History of stroke, movement disorders such as Parkinson's disease, or peripheral neuropathy
- Presence of cardiac pacemaker or other internal electronic device
- Body mass index (BMI) greater than 35
- Previous surgery or specific pathology on the affected joint
- Revision ACL surgery or moderate to severe arthritis (Kellgren-Lawrence Grade above 3)
- Meniscus root repair or non-weight-bearing status over 1 week postoperatively
- Revision total knee arthroplasty, hinged implant, open knee joint procedures, symptomatic arthritis in the opposite knee with planned surgery, or inflammatory arthritis
- Revision total hip arthroplasty, open hip joint procedures, bilateral hip replacements, or inflammatory arthritis
- Revision hip arthroscopy or diagnosis of hip dysplasia on the affected side
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are screened before surgery to determine eligibility and complete baseline assessments.
Duration - Day of surgery
Participants undergo one of four orthopedic surgical procedures: anterior cruciate ligament reconstruction, total knee arthroplasty, total hip arthroplasty, or hip arthroscopy for femoroacetabular impingement.
1 visit (in-person) for surgery
Duration - 8 weeks postoperatively
Participants receive standard post-surgical rehabilitation therapy. Those in the intervention group also participate in brain-computer interface visualization training with neurofeedback using EEG twice a week for 8 weeks postoperatively to enhance muscle activation and recovery.
Twice weekly visits for neurofeedback training and physical therapy sessions during the first 8 weeks; control group attends physical therapy sessions only
Duration - 2 to 6 months postoperatively
Participants attend scheduled study visits for motion analysis, strength testing, and patient-reported outcome assessments to track recovery progress and muscle strength improvements after surgery.
3 visits (in-person) at approximately 2, 4, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
B
Brian Forsythe, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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