Clinical trial NCT03209531: Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction
Official title: Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Quadriceps activation deficits
ACL
Surgery
Quadrcieps weakness
Operant conditioning
Cortical excitability
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Center of Neuromodulation for Rehabilitation
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-07-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Thigh muscle weakness is a common result after anterior cruciate ligament (ACL) injury and reconstruction surgery. Therefore, reducing thigh muscle weakness after ACL injury and reconstructive surgery is important as the quadriceps muscles act as shock absorbers that protect the knee joint. If significant weakness is present in the quadriceps, the knee is exposed to increased forces and often results in degeneration of the structures in the joint leading to osteoarthritis. Thus, it is important to investigate activation and strength rehabilitation methods for the quadriceps muscles. This research study is being done to learn if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved by conditioning brain responses (elicited by non-invasive transcranial magnetic stimulation) using a form of training called as operant conditioning.

Eligibility criteria: Inclusion Criteria:

* aged 18-45 years
* suffered an acute, complete ACL rupture
* have undergone ACL reconstructive surgery
* willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria:

* have suffered a previous ACL injury;
* have undergone previous major surgery to either knee;
* have a history of recent significant knee injury (other than ACL) or lower-extremity fracture;
* have a history of uncontrolled diabetes or hypertension;
* be pregnant or plan to become pregnant;
* have metal implants in the head;
* have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers);
* have unexplained recurrent headaches;
* have a recent history of seizures;
* be taking drugs that reduce seizure threshold;
* have a history of repeated fainting spells;

Primary outcomes:
measure: Changes in Quadriceps muscle strength
timeFrame: Approximately 8 weeks after the start of intervention
Secondary outcomes:
measure: Changes in voluntary activation
timeFrame: Approximately 8 weeks after the start of intervention
Other outcomes:
measure: Changes in mid-point quadriceps muscle strength
timeFrame: Approximately 4 weeks after the start of intervention (mid-time point evaluation)
measure: Changes in mid-point voluntary activation as measured by percentage activation deficit
timeFrame: Approximately 4 weeks after the start of intervention (mid-time point evaluation)
measure: Changes in motor cortical excitability measures
timeFrame: Approximately after 8 weeks after the start of intervention
measure: Changes in Knee Injury and Osteoarthritis Outcome Score
timeFrame: Approximately after 8 weeks after the start of intervention
measure: Changes in International Knee Documentation Committee Score
timeFrame: Approximately after 8 weeks after the start of intervention
measure: Changes in Lysholm Knee Score
timeFrame: Approximately after 8 weeks after the start of intervention
measure: Changes in Tegner Activity Score
timeFrame: Approximately after 8 weeks after the start of intervention
measure: Changes in Marx Activity Rating Score
timeFrame: Approximately after 8 weeks after the start of intervention
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Assistant Professor
name: Chandramouli Krishnan, PhD
role: PRINCIPAL_INVESTIGATOR
References: