RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07020312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age \>18 years
  2. * Ability to complete neurofeedback training and follow study follow-ups
  3. * Indicated for one of the four investigated orthopedic procedures
  4. *
  1. * Inability to participate in neurofeedback training
  2. * Lack of decisional capability
  3. * History of stroke, movement disorder (e.g. Parkinson's), peripheral neuropathy
  4. * Cardiac pacemaker or other internal electronic device
  5. * BMI \>35
  6. * Previous surgery or specific pathology on the affected joint (refer to procedure specific indications below)
  7. * Patients undergoing primary ACLR with autograft or allograft tissue
  8. * Adjunct lateral Extra-articular tenodesis will be included
  9. * Additional meniscus debridement and repair will be included Procedure-specific exclusion criteria
  10. * Revision ACL surgery
  11. * Moderate to Severe arthritis - Kellgren-Lawerence (KL) Grade \> 3
  12. * Patients with meniscus root repair
  13. * Non-weight-bearing status exceeding 1 week postoperatively
  14. * Patients undergoing primary TKA
  15. * Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension)
  16. * Prior extensor mechanism tendon repair, quadriceps or patella tendon. Procedure specific exclusion criteria
  17. * Revision surgery
  18. * Hinged implant
  19. * Any open procedure involving the knee joint
  20. * Symptomatic arthritis in the contralateral knee with planned or expected total knee arthroplasty within 6 months
  21. * Inflammatory Arthritis
  22. * Patients undergoing primary THA Procedure Specific Exclusion Criteria
  23. * Revision Surgery
  24. * Any open procedure involving the hip joint
  25. * Bilateral THA procedures
  26. * Inflammatory Arthritis
  27. * Revision Surgery
  28. * Diagnosis of hip dysplasia

Contacts and Locations

Study Contact

Brian Forsythe, MD
CONTACT
708-236-2782
Brian.forsythe@rushortho.com

Principal Investigator

Jorge Chahla, MD, PhD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Jorge Chahla, MD, PhD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-06
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • ACLR
  • THA
  • TKA
  • Hip Arthroscopy
  • Arthrogenic muscle inhibition
  • Electroencephalography
  • Gait
  • Motion Analysis
  • Biomechanics
  • Strength

Additional Relevant MeSH Terms

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