Anterior Cruciate Ligament Injury
Conditions
Keywords
Quadriceps activation deficits, ACL, Surgery, Quadrcieps weakness, Operant conditioning, Cortical excitability
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.
Interventions
BEHAVIORALOperant Conditioning
Active encouragement and feedback to increase motor evoked response when stimulated.
BEHAVIORALControl
Absence of active encouragement and feedback to increase motor evoked response when stimulated.
DEVICESingle Pulse Transcranial Magnetic Stimulation
Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.
Sponsors
Medical University of South Carolina
National Center of Neuromodulation for Rehabilitation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quadriceps muscle strength | Approximately 8 weeks after the start of intervention | Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the end of intervention will be assessed and compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in voluntary activation | Approximately 8 weeks after the start of intervention | Voluntary activation will be measured using an electrical superimposition technique. Improvements in voluntary activation from baseline to the end of intervention will be assessed and compared between groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in motor cortical excitability measures | Approximately after 8 weeks after the start of intervention | Motor cortical excitability will be measured using single- and paired-pulse transcranial magnetic stimulation protocols. Improvements in motor cortical excitability from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in Knee Injury and Osteoarthritis Outcome Score | Approximately after 8 weeks after the start of intervention | Knee Injury and Osteoarthritis Outcome Score (KOOS) will be measured using the KOOS questionnaire, which is a self-administered survey of knee function across five domains: pain, symptoms, activities of daily living, sport and recreation function, and knee related quality of life (scores range from 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms). The improvements in KOOS from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in International Knee Documentation Committee Score | Approximately after 8 weeks after the start of intervention | International Knee Documentation Committee (IKDC) score will be measured using the IKDC subjective knee evaluation form, which is a survey of self-reported level of knee functioning across different domains (scores range from 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms).The improvements in IKDC score from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in mid-point quadriceps muscle strength | Approximately 4 weeks after the start of intervention (mid-time point evaluation) | Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the mid-point of intervention will be assessed and compared between groups. |
| Changes in Tegner Activity Score | Approximately after 8 weeks after the start of intervention | Tegner activity score will be measured using the Tegner Activity level scale, which is a self-reported measure of activity level (scores range from 0 to 10, with 0 indicating no activity because of knee problems and 10 indicating extremely active in competitive sports). The improvements in Tegner activity score from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in Marx Activity Rating Score | Approximately after 8 weeks after the start of intervention | Marx activity rating score will be measured using the Marx Activity Rating Scale, which is a self-reported rating scale designed to measure a subject's level of physical activity in four different categories: running, cutting, deceleration and pivoting (scores range from 0 to 16, with 0 indicating very low activity \[\< one time in a month\] because of knee problems and 16 indicating very high activity \[\> 4 times in a week\] in the four categories). The improvements in Marx activity score from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in Lysholm Knee Score | Approximately after 8 weeks after the start of intervention | Lysholm knee score will be measured using the Lysholm Knee Scoring Scale, which is a questionnaire that assesses knee function after conservatively or surgically treated knee ligament injuries based on activities that require knee movement (scores range from 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms). The improvements in Lysholm score from baseline to the end of intervention will be assessed and compared between groups. |
| Changes in mid-point voluntary activation as measured by percentage activation deficit | Approximately 4 weeks after the start of intervention (mid-time point evaluation) | Voluntary activation will be measured using an electrical superimposition technique. Improvements in voluntary activation from baseline to the mid-point of intervention will be assessed and compared between groups. |
Countries
United States
Outcome results
None listed