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Operant Conditioning for ACL Injury

N/A
Recruiting
Led By Chandramouli Krishnan, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suffered an acute, complete ACL rupture
Aged 18-45 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 weeks after the start of intervention (mid-time point evaluation)
Awards & highlights

Study Summary

This trial will study if operant conditioning can improve thigh muscle weakness and lack of muscle activation after an ACL injury.

Who is the study for?
This trial is for individuals aged 18-45 who have had an ACL rupture and subsequent reconstructive surgery. Participants must be willing to follow the study's procedures. Those pregnant, with previous major knee surgeries, on certain drugs, with fainting spells, uncontrolled diabetes or hypertension, ear/heart devices, recurrent headaches, seizures or recent significant knee injuries cannot join.Check my eligibility
What is being tested?
The study tests if thigh muscle weakness post-ACL injury can be improved using mental coaching (operant conditioning) alongside Single Pulse Transcranial Magnetic Stimulation versus a control group without these interventions.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site from Transcranial Magnetic Stimulation and fatigue due to participation in operant conditioning sessions. No severe side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent, complete tear in my ACL.
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I am between 18 and 45 years old.
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I have had ACL reconstructive surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 weeks after the start of intervention (mid-time point evaluation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 weeks after the start of intervention (mid-time point evaluation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Structure of quadriceps femoris muscle
Secondary outcome measures
Changes in voluntary activation
Other outcome measures
Changes in International Knee Documentation Committee Score
Changes in Knee Injury and Osteoarthritis Outcome Score
Changes in Lysholm Knee Score
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Operant ConditioningExperimental Treatment2 Interventions
Participants will receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks.
Group II: ControlExperimental Treatment2 Interventions
Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Operant Conditioning
2022
N/A
~30
Control
2011
Completed Phase 4
~15780

Find a Location

Who is running the clinical trial?

National Center of Neuromodulation for RehabilitationUNKNOWN
10 Previous Clinical Trials
199 Total Patients Enrolled
Medical University of South CarolinaOTHER
931 Previous Clinical Trials
7,393,979 Total Patients Enrolled
University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,502 Total Patients Enrolled
4 Trials studying Anterior Cruciate Ligament Injury
250 Patients Enrolled for Anterior Cruciate Ligament Injury

Media Library

Operant Conditioning (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03209531 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Control, Operant Conditioning
Anterior Cruciate Ligament Injury Clinical Trial 2023: Operant Conditioning Highlights & Side Effects. Trial Name: NCT03209531 — N/A
Operant Conditioning (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03209531 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for individuals to qualify for this trial?

"This clinical trial is being conducted with 32 individuals that have sustained anterior cruciate ligament injury and are between 18-45 years old. To be considered, applicants must meet the outlined criteria which specify age range, a full rupture of their ACL, and an agreement to comply with testing protocol."

Answered by AI

Is this research program open to people aged 45 and above?

"This clinical trial is searching for candidates aged 18 to 45 years old."

Answered by AI

How many participants are being accepted for inclusion in this trial?

"Affirmative. According to the clinicaltrials.gov website, this trial is actively seeking participants and has been doing so since September 21st 2017. Currently, 32 individuals need to be recruited from one medical facility for the study's completion."

Answered by AI

Is this research project currently recruiting participants?

"According to the information on clinicaltrials.gov, this study is actively seeking volunteers and has been since it was first posted in September of 2017. The trial's particulars were most recently updated on August 19th 2022."

Answered by AI
~9 spots leftby Sep 2026