Operant Conditioning After ACL Reconstruction
Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedJanuary 23, 2024
January 1, 2024
10 months
August 17, 2022
January 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in quadriceps strength
Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Changes in quadriceps voluntary activation
Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Study Arms (2)
Operant Conditioning
EXPERIMENTALMotor evoked responses will be elicited along with operant conditioning training for about 2 weeks
Control
EXPERIMENTALMotor evoked responses will be elicited without operant conditioning training for about 2 weeks
Interventions
Active encouragement and feedback to increase motor evoked response during stimulation.
Absence of active encouragement and feedback to increase motor evoked response when stimulated.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 29, 2022
Study Start
December 28, 2022
Primary Completion
October 10, 2023
Study Completion
October 10, 2023
Last Updated
January 23, 2024
Record last verified: 2024-01