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

NCT07020312 | Recruiting Phase 2 FDA Device

• 1 other identifier: 24021101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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. 1.Anterior cruciate ligament reconstruction (ACLR)
2. 2.Total knee arthroplasty (TKA)
3. 3.Total hip arthroplasty (THA)
4. 4.Hip arthroscopy (HA) for femoroacetabular impingement (FAI)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Knee extensor strength

  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.

  2, 4 and 6 months

• Hip Abductor Strength

  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.

  2, 4 and 6 months

Secondary Outcomes (23)

• Joint Kinematics During Functional Tasks (Walk, Lunge, Bilateral Squats, Single Leg Vertical Jump)

  2, 4 and 6 months

• Joint Kinetics During Functional Tasks (Walk, Lunge, Bilateral Squats, Single Leg Vertical Jump)

  2, 4 and 6 months

• EMG Amplitude of Lower Limb Muscles During Functional Tasks

  2, 4 and 6 months

• Flexibility

  2, 4 and 6 months

• International Knee Documentation Committee (IKDC) Subjective Knee Form

  Pre-operative, 2, 4 and 6 months, 1 year, 2 years

Other Outcomes (5)

• Knee AMI Classification

  2, 4 and 6 months

• Digital Avatar Performance Metrics

  0 to 8 weeks of training

• Spatiotemporal Gait Parameters

  2, 4, and 6 months

Study Arms (8)

Anterior cruciate ligament reconstruction (ACLR) - Experimental

EXPERIMENTAL

Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training

Other: Visualization training with neurofeedback; Other: Standard post-surgical rehabilitation therapy

Anterior cruciate ligament reconstruction (ACLR) - Control

ACTIVE COMPARATOR

Control group: Standard post-surgical rehabilitation therapy

Other: Standard post-surgical rehabilitation therapy

Total knee arthroplasty (TKA) - Experimental

EXPERIMENTAL

Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training

Other: Visualization training with neurofeedback; Other: Standard post-surgical rehabilitation therapy

Total knee arthroplasty (TKA) - Control

ACTIVE COMPARATOR

Control group: Standard post-surgical rehabilitation therapy

Other: Standard post-surgical rehabilitation therapy

Total hip arthroplasty (THA) - Experimental

EXPERIMENTAL

Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training

Other: Visualization training with neurofeedback; Other: Standard post-surgical rehabilitation therapy

Total hip arthroplasty (THA) - Control

ACTIVE COMPARATOR

Control group: Standard post-surgical rehabilitation therapy

Other: Standard post-surgical rehabilitation therapy

Hip arthroscopy (HA) - Experimental

EXPERIMENTAL

Intervention Group: Standard post-surgical rehabilitation therapy + iBrainTech neurofeedback training

Other: Visualization training with neurofeedback; Other: Standard post-surgical rehabilitation therapy

Hip arthroscopy (HA) - Control

ACTIVE COMPARATOR

Control group: Standard post-surgical rehabilitation therapy

Other: Standard post-surgical rehabilitation therapy

Interventions

Visualization training with neurofeedback OTHER

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.

Anterior cruciate ligament reconstruction (ACLR) - Experimental; Hip arthroscopy (HA) - Experimental; Total hip arthroplasty (THA) - Experimental; Total knee arthroplasty (TKA) - Experimental

Standard post-surgical rehabilitation therapy OTHER

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.

Anterior cruciate ligament reconstruction (ACLR) - Control; Anterior cruciate ligament reconstruction (ACLR) - Experimental; Hip arthroscopy (HA) - Control; Hip arthroscopy (HA) - Experimental; Total hip arthroplasty (THA) - Control; Total hip arthroplasty (THA) - Experimental; Total knee arthroplasty (TKA) - Control; Total knee arthroplasty (TKA) - Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Patients undergoing primary ACLR with autograft or allograft tissue
• Adjunct lateral Extra-articular tenodesis will be included
• 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
• Patients undergoing primary TKA
• Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Neurofeedback

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Jorge Chahla, MD, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Forsythe, MD

CONTACT

708-236-2782; Brian.forsythe@rushortho.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and physicians will be blinded to group allocation to minimize bias in clinical decision-making and post-operative care. Patients will not be blinded due to the nature of the neurofeedback intervention, which cannot be masked. Both study groups will receive standard rehabilitation, with the only difference being the addition of NFVT in the intervention arm. The neurofeedback sessions will take place within the physical therapy clinic, immediately prior to scheduled physical therapy appointments. The team delivering the neurofeedback intervention will be the only personnel aware of group allocation. Treating physicians, physical therapists, outcome assessors, and the statistical analysis team will remain blinded to participant allocation throughout the trial. Statistical analyses will be performed by the Rush Statistical Analysis team, an independent third-party ancillary resource, using a coded dataset to ensure blinding is maintained during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will have two arms - a 1:1 allocation ratio for the control group and for the intervention group- stratified into four orthopedic surgeries: * Anterior Cruciate Ligament Reconstruction (ACLR) * Total Knee Arthroplasty (TKA) * Total Hip Arthroplasty (THA) * Hip Arthroscopy (HA) for Femoroacetabular Impingement Syndrome (FAIS) There will be 30 participants per cohort arm for each procedure, totaling 240 participants for the project.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)