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New treatment option for Anterior Cruciate Ligament Reconstruction
Official title Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
ClinicalTrials.gov ID: NCT07020312
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants
- Patient age \>18 years
- Ability to complete neurofeedback training and follow study follow-ups
- Indicated for one of the four investigated orthopedic procedures
You likely can't join 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: Anterior cruciate...
See the full eligibility criteria
- Participants
- Patient age \>18 years
- Ability to complete neurofeedback training and follow study follow-ups
- Indicated for one of the four investigated orthopedic procedures
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.