Operant Conditioning After ACL Reconstruction

Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Behavioral: Operant Conditioning; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operant Conditioning; Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks	Behavioral: Operant Conditioning; Active encouragement and feedback to increase motor evoked response during stimulation.
Experimental: Control; Motor evoked responses will be elicited without operant conditioning training for about 2 weeks	Behavioral: Control; Absence of active encouragement and feedback to increase motor evoked response when stimulated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in corticospinal excitability	Corticospinal excitability will be measured using transcranial magnetic stimulation at baseline and post-intervention and will be compared between groups.	Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quadriceps strength	Isometric quadriceps strength will be measured using an isokinetic dynamometer. Quadriceps strength will be measured prior to the intervention and immediately following the intervention.	Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Changes in quadriceps voluntary activation	Voluntary activation will be measured using an electrical superimposition technique. Voluntary activation will be measured prior to the intervention and immediately following the intervention.	Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ACL; Quadriceps
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: HUM00166442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No