Operant Conditioning After ACL Reconstruction

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Behavioral: Control; Behavioral: Operant Conditioning

• Registration Number: NCT05519345
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2022-12-28
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Motor evoked responses will be elicited without operant conditioning training for about 2 weeks
Operant Conditioning	Operant Conditioning	Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States