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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age >18 years

Ability to complete neurofeedback training and follow study follow-ups

Indicated for one of the four investigated orthopedic procedures

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Visualization training with neurofeedback

    Other intervention

    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

    Other intervention

    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.

Treatment groups

240 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Anterior cruciate ligament reconstruction (ACLR) - ExperimentalExperimental treatment 2 interventions
Group B: Anterior cruciate ligament reconstruction (ACLR) - ControlActive comparator 1 intervention
Group C: Total knee arthroplasty (TKA) - ExperimentalExperimental treatment 2 interventions
Group D: Total knee arthroplasty (TKA) - ControlActive comparator 1 intervention
Group E: Total hip arthroplasty (THA) - ExperimentalExperimental treatment 2 interventions
Group F: Total hip arthroplasty (THA) - ControlActive comparator 1 intervention
Group G: Hip arthroscopy (HA) - ExperimentalExperimental treatment 2 interventions
Group H: Hip arthroscopy (HA) - ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2, 4 and 6 months
2

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.

Time frame
2, 4 and 6 months

Secondary outcomes

1

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

Hip, knee, ankle, trunk, pelvis, thigh, shank, trunk, and foot angles during walk, lunge, bilateral squats, and single-leg vertical jump. Reported as continuous waveforms over the task cycle (angles vs. % of task cycle).

Time frame
2, 4 and 6 months
2

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

External and internal moments at the hip, knee, and ankle in the sagittal, frontal, and transverse planes. Unit of Measure: Joint moment expressed as a percentage of body weight times height (%BW·HT). Reported as continuous waveforms over the task cycle (%BW·HT vs. % of task cycle).

Time frame
2, 4 and 6 months
3

EMG Amplitude of Lower Limb Muscles During Functional Tasks

Normalized EMG amplitude (mean and maximum) of the vastus lateralis, rectus femoris, vastus medialis, semimembranosus, semitendinosus, gluteus maximus and gluteus medius during walking, squats, lunge, single-leg vertical jump and strength tests. Unit of Measure: % Maximum Voluntary Contraction (%MVC)

Time frame
2, 4 and 6 months
4

Flexibility

TKA and ACLR: Passive knee flexion range of motion Passive knee extension range of motion THA and HA: Thomas test Passive internal/external rotation range of motion Unit of measure: degrees

Time frame
2, 4 and 6 months

Other outcomes

1

Knee AMI Classification

Sonnery-Cottet et al. knee AMI classification (Grade 0-3)

Time frame
2, 4 and 6 months
2

Digital Avatar Performance Metrics

Performance metrics generated during the neurofeedback training sessions will be collected directly from the iBrainTech software. Attention, motor imagery, and session scores.

Time frame
0 to 8 weeks of training
3

Spatiotemporal Gait Parameters

Stride length, step length, cadence, gait speed, stance time, swing time, and double support time during walking task.

Time frame
2, 4, and 6 months
4

EMG Timing of Muscle Onset and Offset During Functional Tasks

Onset and offset timing of activation of key muscle groups during walking, squats, lunge, and single-leg vertical jump. Unit of Measure: % of task cycle

Time frame
2, 4 and 6 months

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