Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
NCT07020312 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2025-08-17
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.
Conditions
- Anterior Cruciate Ligament Reconstruction
- Total Hip Arthroplasty (THA)
- Total Knee Arthroplasty
- Hip Arthroscopy
Interventions
- OTHER
-
Visualization 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.
- OTHER
-
Standard 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.
Sponsors & Collaborators
-
Rush University Medical Center
lead OTHER
Principal Investigators
-
Jorge Chahla, MD, PhD · Rush University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-14
- Primary Completion
- 2028-05-31
- Completion
- 2028-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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