Operant Conditioning After ACL Reconstruction

NCT ID: NCT05519345

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-28
• Study Completion Date: 2023-10-10

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.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Operant Conditioning

Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks

Group Type: EXPERIMENTAL

Operant Conditioning

Intervention Type: BEHAVIORAL

Active encouragement and feedback to increase motor evoked response during stimulation.

Control

Motor evoked responses will be elicited without operant conditioning training for about 2 weeks

Group Type: EXPERIMENTAL

Control

Intervention Type: BEHAVIORAL

Absence of active encouragement and feedback to increase motor evoked response when stimulated.

Interventions

Operant Conditioning

Active encouragement and feedback to increase motor evoked response during stimulation.

Intervention Type: BEHAVIORAL

Control

Absence of active encouragement and feedback to increase motor evoked response when stimulated.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Riann Palmieri-Smith

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00166442

Identifier Type: -

Identifier Source: org_study_id