Recruiting
Phase 2

Neurofeedback Visualization

Sponsor:

Rush University Medical Center

Code:

NCT07020312

Conditions

Anterior Cruciate Ligament Reconstruction

Total Hip Arthroplasty (THA)

Total Knee Arthroplasty

Hip Arthroscopy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visualization training with neurofeedback

Standard post-surgical rehabilitation therapy

Study Details

Brief 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

Study ID

NCT07020312

Start date

Aug 14, 2025

Status verified date

Jun, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Participants

  • Inclusion Criteria:

  • Patient age >18 years
  • Ability to complete neurofeedback training and follow study follow-ups
  • Indicated for one of the four investigated orthopedic procedures
  • Exclusion Criteria:

  • Inability to participate in neurofeedback training
  • Lack of decisional capability
  • History of stroke, movement disorder (e.g. Parkinson's), peripheral neuropathy
  • Cardiac pacemaker or other internal electronic device
  • BMI >35
  • Previous surgery or specific pathology on the affected joint (refer to procedure specific indications below)

Procedure Specifics:

Anterior cruciate ligament reconstruction (ACLR) Procedure-specific Inclusion Criteria

  • Patients undergoing primary ACLR with autograft or allograft tissue
  • Adjunct lateral Extra-articular tenodesis will be included
  • Additional meniscus debridement and repair will be included Procedure-specific exclusion criteria
  • Revision ACL surgery
  • Moderate to Severe arthritis - Kellgren-Lawerence (KL) Grade > 3
  • Patients with meniscus root repair
  • Non-weight-bearing status exceeding 1 week postoperatively

Total knee arthroplasty (TKA) Procedure specific inclusion criteria

  • Patients undergoing primary TKA
  • Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension)
  • Prior extensor mechanism tendon repair, quadriceps or patella tendon. Procedure specific exclusion criteria
  • Revision surgery
  • Hinged implant
  • Any open procedure involving the knee joint
  • Symptomatic arthritis in the contralateral knee with planned or expected total knee arthroplasty within 6 months
  • Inflammatory Arthritis

Total hip arthroplasty (THA) Procedure Specific Inclusion Criteria

  • Patients undergoing primary THA Procedure Specific Exclusion Criteria
  • Revision Surgery
  • Any open procedure involving the hip joint
  • Bilateral THA procedures
  • Inflammatory Arthritis

Hip arthroscopy (HA) for femoroacetabular impingement syndrome (FAIS) Procedure Specific Inclusion Criteria

· Patients undergoing HA for FAIS Procedure Specific Exclusion Criteria

  • Revision Surgery
  • Diagnosis of hip dysplasia

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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.

Primary outcome measure

  • Knee extensor strength [ Time Frame: 2, 4 and 6 months ]
  • Hip Abductor Strength [ Time Frame: 2, 4 and 6 months ]

Central Contacts and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carla Edwards, Ph.D., MPH, MLS(ASCP)CMCCRP

312.563.5735carla_edwards@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-06-18.