Skip to main content
OpenTrials
Completed

NCT Number: NCT05519345

Operant Conditioning 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operant Conditioning

Behavioral

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

Control

Behavioral

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

Primary outcomes

  1. Changes in corticospinal excitability

    Time frame: 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.

Other outcomes

  1. Changes in quadriceps strength

    Time frame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)

    Isometric quadriceps strength will be measured using an isokinetic dynamometer. Quadriceps strength will be measured prior to the intervention and immediately following the intervention.

  2. Changes in quadriceps voluntary activation

    Time frame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)

    Voluntary activation will be measured using an electrical superimposition technique. Voluntary activation will be measured prior to the intervention and immediately following the intervention.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.