12 Participants Needed

Operant Conditioning for ACL Injury

RP
CK
Overseen ByChandramouli Krishnan, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved through a form of mental coaching and encouragement, known as operant conditioning.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking drugs that reduce the seizure threshold, you may not be eligible to participate.

Is operant conditioning generally safe for humans?

Operant conditioning has been studied in various contexts, including pain modulation and motor performance, and while it can influence pain perception, there is no specific mention of safety concerns in the studies reviewed. However, some studies suggest that operant conditioning can induce changes in pain perception, such as increased sensitivity, which should be considered when evaluating its safety.12345

How is the treatment Operant Conditioning for ACL Injury different from other treatments?

Operant Conditioning for ACL Injury is unique because it uses a learning-based approach to enhance the brain's ability to control muscles by increasing the activity of specific pathways in the nervous system, which can improve movement and recovery. This method focuses on training the brain and muscles to work better together, unlike traditional treatments that might focus more on physical therapy or medication.26789

What data supports the effectiveness of the treatment Operant Conditioning for ACL Injury?

Research suggests that incorporating motor learning principles, which are part of operant conditioning, can enhance neuroplasticity (the brain's ability to reorganize itself) and improve functional performance after ACL injury. This approach may help reduce the risk of a second ACL injury and early onset of osteoarthritis by targeting changes in neural networks.1011121314

Who Is on the Research Team?

CK

Chandramouli Krishnan, PhD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45 who have had an ACL rupture and subsequent reconstructive surgery. Participants must be willing to follow the study's procedures. Those pregnant, with previous major knee surgeries, on certain drugs, with fainting spells, uncontrolled diabetes or hypertension, ear/heart devices, recurrent headaches, seizures or recent significant knee injuries cannot join.

Inclusion Criteria

Willingness to participate in testing and follow-up as outlined in the protocol
I have a recent, complete tear in my ACL.
I have had ACL reconstructive surgery.

Exclusion Criteria

You have had a previous injury to your ACL (a ligament in your knee).
Be pregnant or plan to become pregnant
I have had major surgery on one of my knees.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week

8 weeks
16-24 visits (in-person)

Mid-point Evaluation

Assessment of quadriceps strength and voluntary activation using isokinetic dynamometer and electrical superimposition technique

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Operant Conditioning
Trial Overview The study tests if thigh muscle weakness post-ACL injury can be improved using mental coaching (operant conditioning) alongside Single Pulse Transcranial Magnetic Stimulation versus a control group without these interventions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Operant ConditioningExperimental Treatment2 Interventions
Group II: ControlExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Center of Neuromodulation for Rehabilitation

Collaborator

Trials
4
Recruited
120+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

National Center of Neuromodulation for Rehabilitation

Collaborator

Trials
12
Recruited
240+

Published Research Related to This Trial

Only about 50% of athletes who undergo anterior cruciate ligament reconstruction (ACLR) can return to competitive sports, and there is a significant risk of re-injury, with up to 20% experiencing a second ACL rupture within the first year after surgery.
Current rehabilitation programs may not effectively address the deficits caused by the initial injury and surgery, highlighting the need for new approaches that incorporate motor learning principles to enhance recovery and reduce the risk of re-injury and early osteoarthritis.
Principles of Motor Learning to Support Neuroplasticity After ACL Injury: Implications for Optimizing Performance and Reducing Risk of Second ACL Injury.Gokeler, A., Neuhaus, D., Benjaminse, A., et al.[2020]
After anterior cruciate ligament reconstruction (ACLR), patients showed increased feelings of learned helplessness (LH) as they progressed from 3 months post-surgery to their return to play, indicating a psychological impact during recovery.
The study found that neural excitability and quadriceps strength were inconsistent and linked to feelings of helplessness, suggesting that addressing both physical and psychological factors could improve recovery outcomes for ACLR patients.
Alterations in physical and neurocognitive wellness across recovery after ACLR: A preliminary look into learned helplessness.Burland, JP., Lepley, AS., DiStefano, LJ., et al.[2020]
Traumatic knee injuries, like ACL sprains, can lead to long-term health issues, including chronic pain and disability, highlighting the importance of effective rehabilitation strategies.
The study suggests that psychological factors, particularly learned helplessness, may negatively impact recovery after ACL reconstruction by affecting both neural activity and rehabilitation outcomes.
Learned Helplessness After Anterior Cruciate Ligament Reconstruction: An Altered Neurocognitive State?Burland, JP., Lepley, AS., Cormier, M., et al.[2020]

Citations

Principles of Motor Learning to Support Neuroplasticity After ACL Injury: Implications for Optimizing Performance and Reducing Risk of Second ACL Injury. [2020]
Alterations in physical and neurocognitive wellness across recovery after ACLR: A preliminary look into learned helplessness. [2020]
Learned Helplessness After Anterior Cruciate Ligament Reconstruction: An Altered Neurocognitive State? [2020]
Clinical and Biomechanical Efficacies of Mechanical Perturbation Training After Anterior Cruciate Ligament Rupture. [2021]
Differences in brain structure and theta burst stimulation-induced plasticity implicate the corticomotor system in loss of function after musculoskeletal injury. [2021]
The role of operant conditioning in chronic pain: an experimental investigation. [2022]
Operant and classical learning principles underlying mind-body interaction in pain modulation: a pilot fMRI study. [2021]
Use of multiple-site performance-contingent SEMG reward programming in pediatric rehabilitation: a retrospective review. [2009]
Controlling pain reports through operant conditioning: a laboratory demonstration. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Reward for Pain: Hyperalgesia and Allodynia Induced by Operant Conditioning: Systematic Review and Meta-Analysis. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
The simplest motor skill: mechanisms and applications of reflex operant conditioning. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Operant conditioning of the tibialis anterior motor evoked potential in people with and without chronic incomplete spinal cord injury. [2020]
Targeted neuroplasticity for rehabilitation. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Operant Up-Conditioning of the Tibialis Anterior Motor-Evoked Potential in Multiple Sclerosis: Feasibility Case Studies. [2018]
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