NCT07020312 · Rush University Medical Center
Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
(iBrainTechRCT)
What this study is about
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.
View original scientific 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.
Interventions
OTHER
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.
OTHER
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 measures
Knee extensor strength
Time frame: 2, 4 and 6 months
ACLR and TKA groups: Maximal isokinetic knee extensor strength (Newtons/BMI). Maximal isokinetic knee extensor strength will be assessed using standardized dynamometry procedures with Biodex Isokinetic Dynamometer (Biodex System 3) at 2, 4 and 6 months after surgery. Each participant will perform three to five maximal voluntary isometric contractions of the knee extensors. The average of the peak torque values will be used for analysis. To account for individual differences in body size, values will be normalized to the participant's body mass index (Newtons/BMI). Body Mass Index (BMI) = weight (kg) / \[height (m)\]². The first assessment will occur at 2 months to ensure patient safety and measurement consistency, as early postoperative conditions (e.g., pain, swelling) could compromise the reliability and validity of strength testing.
Hip Abductor Strength
Time frame: 2, 4 and 6 months
Hip arthroscopy and THA: Maximal isokinetic hip abductor strength (Newtons/BMI). Maximal isokinetic hip abductor strength will be assessed using standardized dynamometry procedures with Biodex Isokinetic Dynamometer (Biodex System 3) at 2, 4 and 6 months after surgery. Each participant will perform three to five maximal voluntary isometric contractions of the hip abductors. The average of the peak torque values will be used for analysis. To account for individual differences in body size, values will be normalized to the participant's body mass index (Newtons/BMI). Body Mass Index (BMI) = weight (kg) / \[height (m)\]². The first assessment will occur at 2 months to ensure patient safety and measurement consistency, as early postoperative conditions (e.g., pain, swelling) could compromise the reliability and validity of strength testing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations