Operant Conditioning After ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operant Conditioning
Control
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACL, Quadriceps
Eligibility Criteria
Inclusion Criteria:
- aged 14-45 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 on the contralateral leg
- have undergone previous major surgery to the contralateral 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 seizure
- have a history of repeated fainting spells
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Operant Conditioning
Control
Arm Description
Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks
Motor evoked responses will be elicited without operant conditioning training for about 2 weeks
Outcomes
Primary Outcome Measures
Changes in corticospinal excitability
Corticospinal excitability will be measured using transcranial magnetic stimulation at baseline and post-intervention and will be compared between groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT05519345
First Posted
August 17, 2022
Last Updated
January 4, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05519345
Brief Title
Operant Conditioning After ACL Reconstruction
Official Title
Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine if the changes in corticospinal function that accompany ACL reconstruction can be improved through a form of mental coaching and encouragement, known as operant conditioning.
Detailed Description
It is theorized reduced corticospinal excitability contributes to quadriceps dysfunction after knee injury and joint disease. Current rehabilitation does not directly target the alterations in corticospinal excitability, which may limit recovery. Operant conditioning is an emerging approach capable of increasing corticospinal excitability by directly targeting the corticospinal pathways. However, it remains to be determined whether operant conditioning of the corticospinal pathway may improve corticospinal function after knee trauma. Therefore, this study will evaluate the ability of operant up-conditioning of the corticospinal pathway to improve corticospinal function after ACL reconstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
ACL, Quadriceps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operant Conditioning
Arm Type
Experimental
Arm Description
Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks
Arm Title
Control
Arm Type
Experimental
Arm Description
Motor evoked responses will be elicited without operant conditioning training for about 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Operant Conditioning
Intervention Description
Active encouragement and feedback to increase motor evoked response during stimulation.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Absence of active encouragement and feedback to increase motor evoked response when stimulated.
Primary Outcome Measure Information:
Title
Changes in corticospinal excitability
Description
Corticospinal excitability will be measured using transcranial magnetic stimulation at baseline and post-intervention and will be compared between groups.
Time Frame
Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Changes in quadriceps strength
Description
Isometric quadriceps strength will be measured using an isokinetic dynamometer. Quadriceps strength will be measured prior to the intervention and immediately following the intervention.
Time Frame
Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Title
Changes in quadriceps voluntary activation
Description
Voluntary activation will be measured using an electrical superimposition technique. Voluntary activation will be measured prior to the intervention and immediately following the intervention.
Time Frame
Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 14-45 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 on the contralateral leg
have undergone previous major surgery to the contralateral 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 seizure
have a history of repeated fainting spells
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riann M Palmieri-Smith
Phone
734-615-3154
Email
riannp@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chandramouli Krishnan
Phone
734-936-4031
Email
neurrolab@umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riann M Palmieri-Smith, PhD
Phone
734-615-3154
Email
riannp@umich.edu
First Name & Middle Initial & Last Name & Degree
Chandramouli Krishnan, PhD
Phone
734-936-4031
Email
neurrolab@umich.edu
First Name & Middle Initial & Last Name & Degree
Riann M Palmieri-Smith, PhD
First Name & Middle Initial & Last Name & Degree
Chandramouli Krishnan, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Operant Conditioning After ACL Reconstruction
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