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

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ClinicalTrials.gov Identifier: NCT03209531
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Medical University of South Carolina
National Center of Neuromodulation for Rehabilitation
Information provided by (Responsible Party):
Chandramouli Krishnan, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Behavioral: Operant Conditioning Behavioral: Control Device: Single Pulse Transcranial Magnetic Stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Operant Conditioning
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.

Experimental: Control
Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209531


Contacts
Contact: Chandramouli Krishnan, PhD 734.936.4031 mouli@umich.edu
Contact: Riann Palmieri-Smith, PhD 734-615-3154 riannp@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Chandramouli Krishnan, PhD    734-232-0898    neurrolab@umich.edu   
Principal Investigator: Chandramouli Krishnan, PhD         
Sub-Investigator: Riann Palmieri-Smith, PhD         
Sponsors and Collaborators
University of Michigan
Medical University of South Carolina
National Center of Neuromodulation for Rehabilitation
Investigators
Principal Investigator: Chandramouli Krishnan, PhD Assistant Professor

Responsible Party: Chandramouli Krishnan, Director of Neuromuscular and Rehabilitation Robotics Laboratory, University of Michigan
ClinicalTrials.gov Identifier: NCT03209531     History of Changes
Other Study ID Numbers: HUM00130845
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chandramouli Krishnan, University of Michigan:
Quadriceps activation deficits
ACL
Surgery
Quadrcieps weakness
Operant conditioning
Cortical excitability

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries