240 Participants Needed

Visualization Training for Orthopedic Surgery Recovery

(iBrainTechRCT Trial)

BF
Overseen ByBrian Forsythe, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance recovery from surgeries like knee or hip replacements by addressing Arthrogenic Muscle Inhibition (AMI), which can hinder full muscle activation during recovery. Researchers are testing whether neurofeedback visualization training, a special brain training technique, can improve muscle strength and movement. Participants will receive either standard physical therapy or the therapy plus this brain training, which uses a cap to read brain signals and display a virtual avatar performing exercises. This study suits those who have recently undergone one of four specific surgeries: ACL reconstruction, total knee or hip arthroplasty, or hip arthroscopy for femoroacetabular impingement. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative recovery methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this neurofeedback visualization training is safe for orthopedic surgery recovery?

Research shows that neurofeedback visualization training is generally easy for people to handle. This training uses a device that reads brain signals to help patients visualize exercises. In a previous study, individuals who underwent hip surgery and used this training did not report any major side effects. Instead, they experienced improved muscle activity, suggesting the training is safe and effective for muscle recovery after surgery.

Since this trial is in the second phase of testing, earlier studies have already shown that the treatment is generally safe. This phase focuses more on the treatment's effectiveness rather than its safety, indicating that any major safety concerns have likely been addressed. Participants can expect that the visualization training will not cause harmful side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the visualization training with neurofeedback because it offers an innovative approach to enhancing recovery after orthopedic surgeries like knee and hip replacements or ACL reconstruction. Unlike the standard rehabilitation therapies, which mainly focus on physical exercises and manual therapy, this method integrates iBrainTech neurofeedback training, which helps patients visualize movement and improve brain-muscle communication. This technique holds promise for faster and more effective recovery by harnessing the power of the brain to aid physical rehabilitation, potentially leading to better outcomes and quicker returns to normal activity levels.

What evidence suggests that neurofeedback visualization training is effective for improving recovery after orthopedic surgery?

Research has shown that neurofeedback visualization training can enhance recovery after orthopedic surgeries. In this trial, some participants will receive standard post-surgical rehabilitation therapy combined with iBrainTech neurofeedback training. This training uses a brain-computer interface to allow patients to "see" their exercises through a virtual character, helping to activate muscles often inhibited by Arthrogenic Muscle Inhibition (AMI). Early studies suggest that this training might accelerate recovery by improving muscle strength and movement. Additionally, patients may return to daily activities faster compared to those using standard rehabilitation alone.12367

Who Is on the Research Team?

JC

Jorge Chahla, MD, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

Adults over 18 recovering from ACL reconstruction, total knee or hip replacement, or hip arthroscopy can join this trial. They must be able to complete brain training and follow the study's check-ups.

Inclusion Criteria

Participants
* Patient age \>18 years
* Ability to complete neurofeedback training and follow study follow-ups
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard post-surgical rehabilitation therapy with or without i-BrainTech neurofeedback training

8 weeks
2 visits per week for neurofeedback training

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at 2, 4, and 6 months for motion analysis and strength testing

What Are the Treatments Tested in This Trial?

Interventions

  • Visualization training with neurofeedback
Trial Overview The trial is testing if neurofeedback visualization training plus standard therapy after surgery helps muscle activation better than just standard therapy. Participants will use a brain-signal-reading cap and visualize exercises with a virtual avatar.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Total knee arthroplasty (TKA) - ExperimentalExperimental Treatment2 Interventions
Group II: Total hip arthroplasty (THA) - ExperimentalExperimental Treatment2 Interventions
Group III: Hip arthroscopy (HA) - ExperimentalExperimental Treatment2 Interventions
Group IV: Anterior cruciate ligament reconstruction (ACLR) - ExperimentalExperimental Treatment2 Interventions
Group V: Hip arthroscopy (HA) - ControlActive Control1 Intervention
Group VI: Total knee arthroplasty (TKA) - ControlActive Control1 Intervention
Group VII: Total hip arthroplasty (THA) - ControlActive Control1 Intervention
Group VIII: Anterior cruciate ligament reconstruction (ACLR) - ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Citations

Study Details | NCT07020312 | Brain-Computer Interface ...This study aims to investigate the effect of visualization with neurofeedback on postoperative recovery in patients undergoing physical rehabilitation from 4 ...
Brain-Computer Interface Visualization Training to Optimize ...Postoperative recovery following orthopedic surgeries often faces challenges due to Arthrogenic. Muscle Inhibition (AMI), a neurological condition that ...
Poster 83: Neurofeedback Visualization Training Through ...Neurofeedback visualization training (NFVT) utilizes a brain-computer interface, presenting a non-invasive method that may facilitate muscle reactivation by ...
Poster 83: Neurofeedback Visualization Training Through ...Neurofeedback visualization training (NFVT) utilizes a brain-computer interface, presenting a non-invasive method that may facilitate muscle reactivation by ...
Neurofeedback Visualization Training Through a Brain ...Summary: Neurofeedback visualization training (NFVT) may enhance muscle activation and accelerate neuromuscular recovery following femoroacetabular impingement ...
Poster 83: Neurofeedback Visualization Training Through ...Poster 83: Neurofeedback Visualization Training Through a Brain Computer Interface to Optimize Muscle Activation Following Hip Arthroscopy for ...
Orthopaedic Journal of Sports MedicineNeuromuscular training (NMT) can reduce preventable injuries, including anterior cruciate ligament (ACL) rupture, but is susceptible to non- ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security