Operant Conditioning After ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519345
• Other study ID #: HUM00166442
• Status: Completed
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Behavioral:
• Operant Conditioning
Active encouragement and feedback to increase motor evoked response during stimulation.
• Control
Absence of active encouragement and feedback to increase motor evoked response when stimulated.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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)