- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03209531
Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction
August 1, 2023 updated by: Chandramouli Krishnan, University of Michigan
Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chandramouli Krishnan, PhD
- Phone Number: 734.936.4031
- Email: mouli@umich.edu
Study Contact Backup
- Name: Riann Palmieri-Smith, PhD
- Phone Number: 734-615-3154
- Email: riannp@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48108
- Recruiting
- University of Michigan
-
Contact:
- Chandramouli Krishnan, PhD
- Phone Number: 734-232-0898
- Email: neurrolab@umich.edu
-
Sub-Investigator:
- Riann Palmieri-Smith, PhD
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Principal Investigator:
- Chandramouli Krishnan, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Operant Conditioning
Participants will receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks.
|
Active encouragement and feedback to increase motor evoked response when stimulated.
Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.
|
Experimental: Control
Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.
|
Absence of active encouragement and feedback to increase motor evoked response when stimulated.
Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Quadriceps muscle strength
Time Frame: 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.
|
Approximately 8 weeks after the start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in voluntary activation
Time Frame: 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.
|
Approximately 8 weeks after the start of intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in mid-point quadriceps muscle strength
Time Frame: 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.
|
Approximately 4 weeks after the start of intervention (mid-time point evaluation)
|
Changes in mid-point voluntary activation as measured by percentage activation deficit
Time Frame: 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.
|
Approximately 4 weeks after the start of intervention (mid-time point evaluation)
|
Changes in motor cortical excitability measures
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Changes in Knee Injury and Osteoarthritis Outcome Score
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Changes in International Knee Documentation Committee Score
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Changes in Lysholm Knee Score
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Changes in Tegner Activity Score
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Changes in Marx Activity Rating Score
Time Frame: 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.
|
Approximately after 8 weeks after the start of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chandramouli Krishnan, PhD, assistant professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2017
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
June 30, 2017
First Submitted That Met QC Criteria
July 3, 2017
First Posted (Actual)
July 6, 2017
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
August 1, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00130845
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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