Anterior Cruciate Ligament InjuryNCT03080402
Mechanical Perturbation Training for ACL Injury Prevention
A study testing Mechanical Perturbation Training in people with Anterior Cruciate Ligament Injury and ACL, run by University of Delaware at 1 site in United States.
Trial summary
A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury, ACL
- What is being tested?
- Mechanical Perturbation Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 31 Dec 2017
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female athletes will be eligible if they are: 1) regular participants in Level 1 and 2 sports (cutting and pivoting type sports, and 2) ages 15-30 years
Who cannot join
- History of major injury or surgery to the legs.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Delaware, Physical Therapy Department
Newark, Delaware, 19716
Martha Callahan, 302-831-6202, mcall@udel.edu
Lynn Snyder-Mackler, PT ATC ScD
About this study
A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Using a prospective risk stratification design, female athletes with knee abduction moment (KAM) > 25.25 Nm from drop jump motion analysis will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM < 25.25 Nm from drop jump motion analysis will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
Read the detailed description
Anterior cruciate ligament (ACL) injuries are prevalent in sports with female athletes at particularly high risk. Female athletes have 2-4x higher risk of ACL injury compared to their male counterparts in the same high-risk sports. Modifiable and non-modifiable risk factors play a role in the high incidence of ACL injuries in female athletes. High knee abduction moment (KAM), is a known modifiable risk factor for ACL injury risk. Female athletes with a KAM greater than 25.25 Nm have been identified as at high risk for an ACL injury. The ability to classify female athletes who are at a high risk for an ACL injury, highlights the importance of identifying modifiable risk factors that can be readily addressed by physical therapists and developing targeted treatments to potentially reduce ACL injury risk while improving functional performance.
Neuromuscular training programs are treatments designed to help improve coordination, strength, and control. Such training programs have been designed to alter biomechanical and neuromuscular measures, in particular high KAM, in order to improve performance and function and thereby reduce the risk of ACL injury. Neuromuscular training programs involving plyometric exercises can reduce dynamic lower extremity valgus and limb-to-limb asymmetries in healthy female athletes. Despite the reductions in injury rates seen with performance of neuromuscular training programs, incidence of ACL injuries is remains higher than acceptable. Novel training methods are currently in development to optimize these current ACL injury prevention programs. As unanticipated perturbations may contribute to ACL injury risk, incorporating a mechanical platform device that provides unanticipated surface compliance changes (i.e. the floor lowering down below a subject's feet) into an ACL injury prevention program has the potential to optimize knee biomechanics and neuromuscular performance, including during unanticipated perturbations.
Mechanical perturbation has been advocated for as an effective training method to modify the sensorimotor system and restore normal neuromuscular coordination through exposing the subjects to controlled, progressive perturbations. Furthermore, mechanical perturbation has the potential to improve dynamic postural stability and control, and enhance muscle activation patterns. One advantage of mechanical perturbation devices is that they can be utilized while performing a variety of dynamic tasks such as hopping and jumping compared to static loading tasks such as standing and balancing activities. Dynamic tasks may place a greater demand on the knee joint, promoting joint stability as the subject overcomes the perturbation. Additionally, mechanical perturbation may allow physical therapists to administer random perturbations at different phases of the activities (i.e. as the subject is landing from a hop, or taking-off from a jump) that simulate real-life perturbations which occur during different functional or sporting activities.
The goal of this study is to assess the effectiveness of an intensive neuromuscular training program to reduce risk factors associated with ACL injury
- Conditions
- Anterior Cruciate Ligament Injury, ACL
- Being tested
- Mechanical Perturbation Training
- Keywords
- Anterior Cruciate Ligament, ACL injury, Injury prevention, Perturbation training, Risk factors
- 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.
Mechanical Perturbation TrainingDevice
Also called Reactive Agility Platform Trainer 2.0, RAPTr
The training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing. The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane. The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks. The final four sessions will incorporate rotational and pivoting activities with the maneuvers. The resultant protocol has been derived and optimized from previous published research studies and prevention techniques.
| Study group | Role | What they receive |
|---|---|---|
| High KAM | Experimental | Mechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training Receives: Device: Mechanical Perturbation Training |
| Normal KAM | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak knee abduction moment
Peak knee abduction moment during a drop jump landing task as assessed via motion analysis
Measured: baseline and 6 weeks after baseline testing
Secondary outcomes (8)
Peak Quadriceps torque 60 degrees/sec
Peak Quadriceps torque 60 degrees/sec
Measured: baseline and 6 weeks after baseline testing
Peak Quadriceps torque 240 degrees/sec
Peak Quadriceps torque 240 degrees/sec
Measured: baseline and 6 weeks after baseline testing
Peak Hamstrings torque 60 degrees/sec
Peak Hamstrings torque 60 degrees/sec
Measured: baseline and 6 weeks after baseline testing
Peak Hamstrings torque 240 degrees/sec
Peak Hamstrings torque 240 degrees/sec
Measured: baseline and 6 weeks after baseline testing
Single hop for distance LSI
Single hop for distance limb symmetry index
Measured: baseline and 6 weeks after baseline testing
Crossover hop for distance LSI
Crossover hop for distance limb symmetry index
Measured: baseline and 6 weeks after baseline testing
Triple hop for distance LSI
Triple hop for distance limb symmetry index
Measured: baseline and 6 weeks after baseline testing
6m Timed Hop LSI
6 meter Timed Hop limb symmetry index
Measured: baseline and 6 weeks after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start20 Feb 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- 24 female athletes (12 with high KAM; 12 with normal KAM) will be recruited into the intervention/ testing phase of this study. Female athletes with KAM \> 25.25 Nm will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM \< 25.25 Nm will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Simbex, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lynn Snyder-Mackler, University of Delaware
- Investigators
- Lynn Snyder-Mackler, PT, ATC, ScD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080402
- Sponsor's protocol ID
- R44HD068054
- Other IDs
- 5R44HD068054
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Perturbation Training for ACL Injury Prevention
- ClinicalTrials.gov ID
- NCT03080402
- Acronym / sponsor ID
- R44HD068054
- Conditions
- Anterior Cruciate Ligament Injury, ACL
- Keywords
- Anterior Cruciate Ligament, ACL injury, Injury prevention, Perturbation training, Risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Simbex, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 15 Mar 2017 (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.
A prospective trial will be used to evaluate the efficacy of prophylactic mechanical perturbation training program. 24 female athletes who are regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 15-30 year are eligible. Using a prospective risk stratification design, female athletes with knee abduction moment (KAM) > 25.25 Nm from drop jump motion analysis will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM < 25.25 Nm from drop jump motion analysis will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
Detailed description
Anterior cruciate ligament (ACL) injuries are prevalent in sports with female athletes at particularly high risk. Female athletes have 2-4x higher risk of ACL injury compared to their male counterparts in the same high-risk sports. Modifiable and non-modifiable risk factors play a role in the high incidence of ACL injuries in female athletes. High knee abduction moment (KAM), is a known modifiable risk factor for ACL injury risk. Female athletes with a KAM greater than 25.25 Nm have been identified as at high risk for an ACL injury. The ability to classify female athletes who are at a high risk for an ACL injury, highlights the importance of identifying modifiable risk factors that can be readily addressed by physical therapists and developing targeted treatments to potentially reduce ACL injury risk while improving functional performance.
Neuromuscular training programs are treatments designed to help improve coordination, strength, and control. Such training programs have been designed to alter biomechanical and neuromuscular measures, in particular high KAM, in order to improve performance and function and thereby reduce the risk of ACL injury. Neuromuscular training programs involving plyometric exercises can reduce dynamic lower extremity valgus and limb-to-limb asymmetries in healthy female athletes. Despite the reductions in injury rates seen with performance of neuromuscular training programs, incidence of ACL injuries is remains higher than acceptable. Novel training methods are currently in development to optimize these current ACL injury prevention programs. As unanticipated perturbations may contribute to ACL injury risk, incorporating a mechanical platform device that provides unanticipated surface compliance changes (i.e. the floor lowering down below a subject's feet) into an ACL injury prevention program has the potential to optimize knee biomechanics and neuromuscular performance, including during unanticipated perturbations.
Mechanical perturbation has been advocated for as an effective training method to modify the sensorimotor system and restore normal neuromuscular coordination through exposing the subjects to controlled, progressive perturbations. Furthermore, mechanical perturbation has the potential to improve dynamic postural stability and control, and enhance muscle activation patterns. One advantage of mechanical perturbation devices is that they can be utilized while performing a variety of dynamic tasks such as hopping and jumping compared to static loading tasks such as standing and balancing activities. Dynamic tasks may place a greater demand on the knee joint, promoting joint stability as the subject overcomes the perturbation. Additionally, mechanical perturbation may allow physical therapists to administer random perturbations at different phases of the activities (i.e. as the subject is landing from a hop, or taking-off from a jump) that simulate real-life perturbations which occur during different functional or sporting activities.
The goal of this study is to assess the effectiveness of an intensive neuromuscular training program to reduce risk factors associated with ACL injury
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 24 female athletes (12 with high KAM; 12 with normal KAM) will be recruited into the intervention/ testing phase of this study. Female athletes with KAM > 25.25 Nm will be classified as high KAM and will receive 12 sessions of mechanically-driven perturbation training and female athletes with KAM < 25.25 Nm will be classified as normal KAM and only participate in baseline performance testing, followed 6 weeks later by another session of drop jump motion analysis and performance testing.
| Arm | Type | Receives |
|---|---|---|
| High KAM | Experimental | Device: Mechanical Perturbation TrainingMechanically-driven neuromuscular training. 2 times per week for 6 weeks for a total of 12 sessions. Perturbation training |
| Normal KAM | No intervention | –No intervention |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female athletes will be eligible if they are: 1) regular participants in Level 1 and 2 sports (cutting and pivoting type sports, and 2) ages 15-30 years
Key exclusion criteria (1 listed)
- History of major injury or surgery to the legs.
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 |
|---|---|---|
| Mechanical Perturbation TrainingAlso: Reactive Agility Platform Trainer 2.0, RAPTrThe training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing. The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane. The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks. The final four sessions will incorporate rotational and pivoting activities with the maneuvers. The resultant protocol has been derived and optimized from previous published research studies and prevention techniques. | Device | High KAM |
Primary outcome
Peak knee abduction moment
Time frame: baseline and 6 weeks after baseline testing
Peak knee abduction moment during a drop jump landing task as assessed via motion analysis
8 secondary outcomes
Peak Quadriceps torque 60 degrees/sec
Time frame: baseline and 6 weeks after baseline testing
Peak Quadriceps torque 240 degrees/sec
Time frame: baseline and 6 weeks after baseline testing
Peak Hamstrings torque 60 degrees/sec
Time frame: baseline and 6 weeks after baseline testing
Peak Hamstrings torque 240 degrees/sec
Time frame: baseline and 6 weeks after baseline testing
Single hop for distance LSI
Time frame: baseline and 6 weeks after baseline testing
Crossover hop for distance LSI
Time frame: baseline and 6 weeks after baseline testing
Triple hop for distance LSI
Time frame: baseline and 6 weeks after baseline testing
6m Timed Hop LSI
Time frame: baseline and 6 weeks after baseline testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: No. There is currently no IPD sharing plan.
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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.
Lynn Snyder-Mackler, PT, ATC, ScD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Perturbation Training in people with Anterior Cruciate Ligament Injury and ACL, run by University of Delaware 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 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: status not confirmed, as of the sponsor's last update on 15 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha Callahan ((302) 831-6202, mcall@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak knee abduction moment (time frame: baseline and 6 weeks after baseline testing). 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 15 Mar 2017.