Anterior Cruciate Ligament InjuriesNCT05519345
Operant Conditioning After ACL Reconstruction
A study testing Operant Conditioning in people with Anterior Cruciate Ligament Injuries, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Operant Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2022to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conditioning Brain Responses for Modulating Corticospinal Excitability 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.
Read the 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
- Being tested
- Operant Conditioning, Control
- Keywords
- ACL, Quadriceps
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant ConditioningBehavioural
Active encouragement and feedback to increase motor evoked response during stimulation.
ControlBehavioural
Absence of active encouragement and feedback to increase motor evoked response when stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Operant Conditioning | Experimental | Motor evoked responses will be elicited along with operant conditioning training for about 2 weeks Receives: Behavioral: Operant Conditioning |
| Control | Experimental | Motor evoked responses will be elicited without operant conditioning training for about 2 weeks Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in corticospinal excitability
Corticospinal excitability will be measured using transcranial magnetic stimulation at baseline and post-intervention and will be compared between groups.
Measured: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start28 Dec 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519345
- Sponsor's protocol ID
- HUM00166442
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT05519345
- Acronym / sponsor ID
- HUM00166442
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL, Quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operant Conditioning | Experimental | Behavioral: Operant ConditioningMotor evoked responses will be elicited along with operant conditioning training for about 2 weeks |
| Control | Experimental | Behavioral: ControlMotor evoked responses will be elicited without operant conditioning training for about 2 weeks |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operant ConditioningActive encouragement and feedback to increase motor evoked response during stimulation. | Behavioural | Operant Conditioning |
| ControlAbsence of active encouragement and feedback to increase motor evoked response when stimulated. | Behavioural | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operant Conditioning in people with Anterior Cruciate Ligament Injuries, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in corticospinal excitability (time frame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.