Anterior Cruciate Ligament InjuriesNCT04069520
Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training
A study testing aNMT Biofeedback in people with Anterior Cruciate Ligament Injuries, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the neural mechanisms of augmented neuromuscular training (aNMT). Participants will complete a 6-week course of neuromuscular training with either aNMT biofeedback or sham biofeedback. An MRI will be performed before and after the training program. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- aNMT Biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2019to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- enrolled in parent study "Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality"
Who cannot join
- contraindications to MRI scan
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Childrens Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Emory Healthcare Sports Performance And Research Center (SPARC)
Flowery Branch, Georgia, 30542
About this study
The purpose of this study is to determine the neural mechanisms of augmented neuromuscular training (aNMT). Participants will complete a 6-week course of neuromuscular training with either aNMT biofeedback or sham biofeedback. An MRI will be performed before and after the training program.
Read the detailed description
Anterior cruciate ligament (ACL) injury is a common and debilitating knee injury affecting over 350,000 children or young adults each year, drastically reducing their chances for an active and healthy life. Annual direct costs exceed $13 billion, and the long-term indirect costs far exceed that figure, as ACL injury is also linked to accelerated development of disabling osteoarthritis within a few years after injury. The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence-based ACL injury prevention to reduce this burden. The investigators have identified modifiable risk factors that predict ACL injury in young female athletes. This neuromuscular training targets those factors and shows statistical efficacy in high-risk athletes, but meaningful transfer of low-risk mechanics to the field of play has been limited, as current approaches are not yet decreasing national ACL injury rates in young female athletes. The key gap is how to target mechanisms that allow transfer of risk-reducing motor control strategies from the intervention to the athletic field. The mechanisms that ultimately make such transfer possible are neural, but thus far injury prevention training focusing on neuromuscular control has not utilized neural outcomes. The investigators published and new preliminary data on neuroplasticity related to injury and neuromuscular training demonstrate the proficiency to capture these neural outcomes and future capability to target these neural mechanisms to improve the rate of motor transfer. The data support this proposal's central hypothesis that increased sensory, visual and motor planning activity to improve motor cortex efficiency is the neural mechanism of adaptation transfer to realistic scenarios. The ability to target the neural mechanisms to increase risk-reducing motor transfer from the clinic to the world could revolutionize ACL injury prevention. The transformative, positive impact of such innovative strategies will enhance the delivery of biofeedback to optimize training and increase the potential for sport transfer. This contribution will be significant for ACL injury prevention and associated long-term sequelae in young females. This unique opportunity to enhance ACL injury prevention by targeting neural mechanisms of neuromuscular adaptation and transfer will reduce the incidence of injuries that cause costly and long-term disabling osteoarthritis.
Participants from the parent study "Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality" will be eligible to participate in this study. In the parent study, participants are randomized to receive augmented neuromuscular training (aNMT) or sham biofeedback training that will be evaluated using 3D biomechanical assessments. Enrolled participants into the current ancillary project will complete MRI testing before and after the study training program. The MRI protocol will include high resolution T1-weighted 3D images, motor task-based functional magnetic resonance imaging (fMRI). The fMRI tasks will be focused on motor function, participants will be asked to complete lower extremity movements including knee flexion and extension and a combined hip and knee flexion and extension.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- aNMT Biofeedback, Sham Biofeedback
- 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.
aNMT BiofeedbackOther
aNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine real-time transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create ("animate") a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention. The aNMT biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks.
Sham BiofeedbackOther
Sham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases. The sham biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| aNMT Biofeedback | Experimental | Participants randomized to receive a neuromuscular training intervention that incorporates biofeedback training. Receives: Other: aNMT Biofeedback |
| Sham Biofeedback | Sham comparator | Participants randomized to receive a neuromuscular training intervention with sham feedback training. Receives: Other: Sham Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Mechanisms for Injury-resistant Movement Pattern Acquisition
Sensorimotor brain activity was measured in task-based fMRI (% Blood Oxygen Level Dependent (BOLD) Signal change of knee sensorimotor network regions from baseline between rest and move blocks at each respective time point- the standard measure to determine brain activity during a condition is to contrast to rest to remove confounds make the data interpretable across conditions and individuals) and was associated with knee joint biomechanics (knee sagittal and frontal plane angle and moments) captured during landing task during standard laboratory landing assessment pre- and post-intervention.
Measured: Baseline (pre-training testing), Week 7 (post-training testing)
Knee Joint Biomechanics During Landing Task
Knee joint biomechanics (knee angle) captured during a standard laboratory landing task assessment was reported pre- and post-intervention. The degree of knee angle is the peak knee flexion angle during drop vertical jump landing.
Measured: Baseline (pre-training testing), Week 7 (post-training testing)
Secondary outcomes (2)
Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport
Sensorimotor brain activity during task-based fMRI (% Blood Oxygen Level Dependent (BOLD) Signal change of knee sensorimotor network regions from baseline between rest and move blocks at each respective time point- the standard measure to determine brain activity during a condition is to contrast to rest to remove confounds make the data interpretable across conditions and individuals) was assessed and compared to biomechanical movement patterns (knee angle) measured during VR-simulated sport.
Measured: Baseline (pre-training testing), Week 7 (post-training testing)
Knee Joint Biomechanics During VR-simulated Sport
Biomechanical movement patterns (knee angle) were measured during VR-simulated sport at pre- and post-intervention. The degree of knee angle is the peak knee flexion angle during a sport specific landing task.
Measured: Baseline (pre-training testing), Week 7 (post-training testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jun 2019
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Greg Myer, Emory University
- Investigators
- Gregory D Myer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069520
- Sponsor's protocol ID
- STUDY00001772
- Other IDs
- 1R01AR076153, 2019-0245
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2019
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training
- ClinicalTrials.gov ID
- NCT04069520
- Acronym / sponsor ID
- STUDY00001772
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 25 Jul 2024
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 determine the neural mechanisms of augmented neuromuscular training (aNMT). Participants will complete a 6-week course of neuromuscular training with either aNMT biofeedback or sham biofeedback. An MRI will be performed before and after the training program.
Detailed description
Anterior cruciate ligament (ACL) injury is a common and debilitating knee injury affecting over 350,000 children or young adults each year, drastically reducing their chances for an active and healthy life. Annual direct costs exceed $13 billion, and the long-term indirect costs far exceed that figure, as ACL injury is also linked to accelerated development of disabling osteoarthritis within a few years after injury. The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence-based ACL injury prevention to reduce this burden. The investigators have identified modifiable risk factors that predict ACL injury in young female athletes. This neuromuscular training targets those factors and shows statistical efficacy in high-risk athletes, but meaningful transfer of low-risk mechanics to the field of play has been limited, as current approaches are not yet decreasing national ACL injury rates in young female athletes. The key gap is how to target mechanisms that allow transfer of risk-reducing motor control strategies from the intervention to the athletic field. The mechanisms that ultimately make such transfer possible are neural, but thus far injury prevention training focusing on neuromuscular control has not utilized neural outcomes. The investigators published and new preliminary data on neuroplasticity related to injury and neuromuscular training demonstrate the proficiency to capture these neural outcomes and future capability to target these neural mechanisms to improve the rate of motor transfer. The data support this proposal's central hypothesis that increased sensory, visual and motor planning activity to improve motor cortex efficiency is the neural mechanism of adaptation transfer to realistic scenarios. The ability to target the neural mechanisms to increase risk-reducing motor transfer from the clinic to the world could revolutionize ACL injury prevention. The transformative, positive impact of such innovative strategies will enhance the delivery of biofeedback to optimize training and increase the potential for sport transfer. This contribution will be significant for ACL injury prevention and associated long-term sequelae in young females. This unique opportunity to enhance ACL injury prevention by targeting neural mechanisms of neuromuscular adaptation and transfer will reduce the incidence of injuries that cause costly and long-term disabling osteoarthritis.
Participants from the parent study "Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality" will be eligible to participate in this study. In the parent study, participants are randomized to receive augmented neuromuscular training (aNMT) or sham biofeedback training that will be evaluated using 3D biomechanical assessments. Enrolled participants into the current ancillary project will complete MRI testing before and after the study training program. The MRI protocol will include high resolution T1-weighted 3D images, motor task-based functional magnetic resonance imaging (fMRI). The fMRI tasks will be focused on motor function, participants will be asked to complete lower extremity movements including knee flexion and extension and a combined hip and knee flexion and extension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aNMT Biofeedback | Experimental | Other: aNMT BiofeedbackParticipants randomized to receive a neuromuscular training intervention that incorporates biofeedback training. |
| Sham Biofeedback | Sham comparator | Other: Sham BiofeedbackParticipants randomized to receive a neuromuscular training intervention with sham feedback training. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- enrolled in parent study "Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality"
Key exclusion criteria (1 listed)
- contraindications to MRI scan
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 |
|---|---|---|
| aNMT BiofeedbackaNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine real-time transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create ("animate") a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention. The aNMT biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks. | Other | aNMT Biofeedback |
| Sham BiofeedbackSham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases. The sham biofeedback occurs during neuromuscular training sessions. The neuromuscular training is a 18 session, pre-season training program occurring over 6 weeks. | Other | Sham Biofeedback |
Primary outcome
Neural Mechanisms for Injury-resistant Movement Pattern Acquisition
Time frame: Baseline (pre-training testing), Week 7 (post-training testing)
Sensorimotor brain activity was measured in task-based fMRI (% Blood Oxygen Level Dependent (BOLD) Signal change of knee sensorimotor network regions from baseline between rest and move blocks at each respective time point- the standard measure to determine brain activity during a condition is to contrast to rest to remove confounds make the data interpretable across conditions and individuals) and was associated with knee joint biomechanics (knee sagittal and frontal plane angle and moments) captured during landing task during standard laboratory landing assessment pre- and post-intervention.
Knee Joint Biomechanics During Landing Task
Time frame: Baseline (pre-training testing), Week 7 (post-training testing)
Knee joint biomechanics (knee angle) captured during a standard laboratory landing task assessment was reported pre- and post-intervention. The degree of knee angle is the peak knee flexion angle during drop vertical jump landing.
2 secondary outcomes
Neural Mechanisms for Injury-resistant Movement Pattern Transfer to VR-simulated Sport
Time frame: Baseline (pre-training testing), Week 7 (post-training testing)
Knee Joint Biomechanics During VR-simulated Sport
Time frame: Baseline (pre-training testing), Week 7 (post-training testing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gregory D Myer, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aNMT Biofeedback in people with Anterior Cruciate Ligament Injuries, run by Emory University at 2 sites 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 1 inclusion and 1 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neural Mechanisms for Injury-resistant Movement Pattern Acquisition (time frame: Baseline (pre-training testing), Week 7 (post-training testing)). The study lists 2 primary outcomes in all. 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 25 Jul 2024.