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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT07020312
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Reconstruction
  • Hip Arthroscopy
  • Total Hip Arthroplasty (THA)
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Visualization training with neurofeedback — OTHER
    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.
  • Standard post-surgical rehabilitation therapy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anterior cruciate ligament reconstruction (ACLR) - Experimental
    Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training
  • Active Comparator: Anterior cruciate ligament reconstruction (ACLR) - Control
    Control group: Standard post-surgical rehabilitation therapy
  • Experimental: Total knee arthroplasty (TKA) - Experimental
    Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training
  • Active Comparator: Total knee arthroplasty (TKA) - Control
    Control group: Standard post-surgical rehabilitation therapy
  • Experimental: Total hip arthroplasty (THA) - Experimental
    Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training
  • Active Comparator: Total hip arthroplasty (THA) - Control
    Control group: Standard post-surgical rehabilitation therapy
  • Experimental: Hip arthroscopy (HA) - Experimental
    Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training
  • Active Comparator: Hip arthroscopy (HA) - Control
    Control group: Standard post-surgical rehabilitation therapy

Primary Outcome Measure

Knee extensor strength [ Time Frame: 2, 4 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Carla Edwards, Ph.D., MPH, MLS(ASCP)CMCCRP
[email protected]
312.563.5735

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Rush University Medical Center· Chicago, IL

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