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

Study acronym: iBrainTechRCT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: May 2028 to May 1, 2028
    • Study completion date: Aug 2028 to Aug 1, 2028
    v6
  2. Minor Start date changed from estimate of Sep 2025 to Aug 14, 2025v5
  3. Notable Start date: Jul 2025 to Sep 2025v4
  4. Minor Start date: Jun 2025 to Jul 2025v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07020312
Lead Sponsor Rush University Medical Center
Conditions
(from sponsor)
Anterior Cruciate Ligament Reconstruction, Total Hip Arthroplasty (THA), Total Knee Arthroplasty, Hip Arthroscopy
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov