Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209531
• Other study ID #: HUM00130845
• Secondary ID: P2CHD086844
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Chandramouli Krishnan, PhD
• Phone: 734.936.4031
• Email: mouli[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

Behavioral:
• Operant Conditioning
Active encouragement and feedback to increase motor evoked response when stimulated.
• Control
Absence of active encouragement and feedback to increase motor evoked response when stimulated.

Device:
• Single Pulse Transcranial Magnetic Stimulation
Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Medical University of South Carolina, National Center of Neuromodulation for Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in mid-point quadriceps muscle strength	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.	Approximately 4 weeks after the start of intervention (mid-time point evaluation)
Other	Changes in mid-point voluntary activation as measured by percentage activation deficit	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.	Approximately 4 weeks after the start of intervention (mid-time point evaluation)
Other	Changes in motor cortical excitability measures	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.	Approximately after 8 weeks after the start of intervention
Other	Changes in Knee Injury and Osteoarthritis Outcome Score	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.	Approximately after 8 weeks after the start of intervention
Other	Changes in International Knee Documentation Committee Score	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.	Approximately after 8 weeks after the start of intervention
Other	Changes in Lysholm Knee Score	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.	Approximately after 8 weeks after the start of intervention
Other	Changes in Tegner Activity Score	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.	Approximately after 8 weeks after the start of intervention
Other	Changes in Marx Activity Rating Score	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.	Approximately after 8 weeks after the start of intervention
Primary	Changes in Quadriceps muscle strength	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.	Approximately 8 weeks after the start of intervention
Secondary	Changes in voluntary activation	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.	Approximately 8 weeks after the start of intervention