Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery: A Blinded Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patient age \>18 years

• Ability to complete neurofeedback training and follow study follow-ups

• Indicated for one of the four investigated orthopedic procedures

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Brian Forsythe, MD
Brian.forsythe@rushortho.com
708-236-2782
Time Frame
Start Date: 2025-08-14
Estimated Completion Date: 2028-08
Participants
Target number of participants: 240
Treatments
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
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov