Acute Injury of Anterior Cruciate LigamentNCT01773317
Can Neuromuscular Training Alter Movement Patterns
A study testing Perturbation in people with Acute Injury of Anterior Cruciate Ligament, run by Lynn Snyder-Mackler at 1 site in United States.
Trial summary
A prospective randomized controlled trial will be used to evaluate the efficacy of post-operative perturbation training. 80 patients who were regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 13-55 at the time of injury are eligible. Read more about this study
- Who is it for?
- Ages 13 to 55 years
- Conditions the study is for
- Acute Injury of Anterior Cruciate Ligament
- What is being tested?
- Perturbation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 28 Aug 2018
- 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 13 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury
- ages 13-55 at the time of injury
- undergo primary Anterior Cruciate Ligament reconstruction
Who cannot join
- concomitant Grade III ligament tears
- osteochondral defects >1cm2
- history of previous Anterior Cruciate Ligament Reconstruction or other major lower extremity injury/surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Delaware, Physical Therapy Department
Newark, Delaware, 19716
About this study
Official title: Can Neuromuscular Training Alter Movement Patterns After Anterior Cruciate Ligament Injury?
A prospective randomized controlled trial will be used to evaluate the efficacy of post-operative perturbation training. 80 patients who were regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 13-55 at the time of injury are eligible. All eligible subjects must undergo primary anterior cruciate ligament reconstruction. Using a prospective randomized design, 40 subjects who will be block randomized by sex to 40 patients who will receive 10 sessions of post-operative perturbation training in addition to standard agility and return to activity progression and forty who receive only standard agility and return to activity progression. Post-operative perturbation training will be initiated when the athlete is at least 12 weeks post-anterior cruciate ligament reconstruction, has full range of motion and achieves 80% quadriceps strength symmetry, the criteria we currently use for beginning return to activity progression.
Read the detailed description
For many years, our laboratory has been examining the functional capabilities and movement strategies of individuals who sustain anterior cruciate ligament injuries of the knee. Using a battery of clinical tests and measures with these athletes, we have learned that not all of these individuals respond similarly to injury. Some athletes, called potential copers, experience a high level of function after their injury. Rehabilitation that involves specialized training called perturbation training allows the majority of potential copers to be successful in returning to sports in the short-term. Non-copers, however, are a group of anterior cruciate ligament-injured athletes with poor knee stability during daily activities. The capability of these individuals to return to sport is limited, and anterior cruciate ligament reconstruction is typically recommended.
Over the last five years, we have begun to investigate the effects of perturbation training on non-copers. Non-copers represent the majority of anterior cruciate ligament-injured athletes, and they are of great interest not only because of their distinct functional limitations, but also the large variability within this group. Abnormal movement patterns are common following anterior cruciate ligament injury, but strategies differ between potential copers and non-copers. During an activity as basic as walking, non-copers reduce the motion of the injured knee and increase the work done at the hip and ankle, perhaps in an effort to avoid knee instability. Non-copers limit the motion of the knee by activating several muscles around the knee simultaneously. So while this may be effective in stabilizing the knee in the short term, this strategy may cause altered and potentially harmful loading patterns within the knee joint.
The abnormal movement and altered muscle firing patterns of anterior cruciate ligament-injured athletes are believed to be a mechanism for knee osteoarthritis. Though anterior cruciate ligament reconstruction restores knee stability, surgery does not fully address the faulty movement of these individuals. Pre-operative perturbation training is effective in improving function and normalizing knee motion in some non-copers. Perturbation training does not improve the ability of all non-copers to return to sport, suggesting other patient factors may be related to post-surgical outcomes. Women are known to be at greater risk for anterior cruciate ligament injury than men, but recently poorer outcomes in women following surgery have also been found. In response to pre-operative training, women demonstrate improved function and gait symmetry, but recover much more slowly after surgery and demonstrate abnormal patterns and knee joint loads. Persistent faulty patterns in women warrants further study and our research can help us find ways for us to address these abnormalities.
This goal of this work is to determine whether perturbation training can improve knee function and reduce faulty adaptations after anterior cruciate ligament reconstruction. Specifically, the aims of this project are to investigate whether the addition of post-operative perturbation training results in lower loading, better movement patterns and better functional outcomes than standard care.
- Being tested
- Perturbation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerturbationOther
Also called Intervention
All subjects complete study protocol. Subjects randomized to the perturbation group will complete the additional perturbation exercises
ControlOther
Also called Intervention
Subjects will complete the study protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
| Study group | Role | What they receive |
|---|---|---|
| Perturbation | Experimental | Subjects complete the training protocol and peturbation training exercises Receives: Other: Perturbation |
| Control | Experimental | Subjects will complete the training protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gait patterns from baseline to completion of intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction and 2 years after anterior cruciate ligament reconstruction
Motion analysis data of gait patterns will be collected to analyze gait movement patterns of individuals after anterior cruciate ligament reconstruction and over time.
Measured: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 year after anterior cruciate ligament reconstruction
Secondary outcomes (3)
Quadriceps Strength
Measured: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery),1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
Patient reported outcomes (Knee Outcomes Survey-Activity of Daily Living Scale, Global Rating Score of Perceived Knee Function, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000 Subjective Knee Form)
Measured: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
Single-legged hop measures
Measured: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startNov 2011
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Injury of Anterior Cruciate LigamentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Snyder-Mackler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT01773317
- Sponsor's protocol ID
- 225014-1
- Status last verified
- Jul 2019
- First submitted
- 13 Jun 2012
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ito N, Capin JJ, Khandha A, Buchanan TS, Silbernagel KG, Snyder-Mackler L. Bone-Patellar Tendon-Bone Autograft Harvest Prolongs Extensor Latency during Gait 2 yr after ACLR. Med Sci Sports Exerc. 2022 Dec 1;54(12):2109-2117. doi: 10.1249/MSS.0000000000003009. Epub 2022 Aug 6.
PubMed 35941514Zarzycki R, Arhos E, Failla M, Capin J, Smith AH, Snyder-Mackler L. Association of the Psychological Response to the ACL-SPORTS Training Program and Self-reported Function at 2 Years After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Nov;49(13):3495-3501. doi: 10.1177/03635465211045388. Epub 2021 Oct 8.
PubMed 34623939Capin JJ, Khandha A, Buchanan TS, Snyder-Mackler L. Partial medial meniscectomy leads to altered walking mechanics two years after anterior cruciate ligament reconstruction: Meniscal repair does not. Gait Posture. 2019 Oct;74:87-93. doi: 10.1016/j.gaitpost.2019.08.017. Epub 2019 Aug 27.
PubMed 31491565Capin JJ, Failla M, Zarzycki R, Dix C, Johnson JL, Smith AH, Risberg MA, Huston LJ, Spindler KP, Snyder-Mackler L. Superior 2-Year Functional Outcomes Among Young Female Athletes After ACL Reconstruction in 10 Return-to-Sport Training Sessions: Comparison of ACL-SPORTS Randomized Controlled Trial With Delaware-Oslo and MOON Cohorts. Orthop J Sports Med. 2019 Aug 1;7(8):2325967119861311. doi: 10.1177/2325967119861311. eCollection 2019 Aug.
PubMed 31413963Arundale AJH, Capin JJ, Zarzycki R, Smith A, Snyder-Mackler L. Functional and Patient-Reported Outcomes Improve Over the Course of Rehabilitation: A Secondary Analysis of the ACL-SPORTS Trial. Sports Health. 2018 Sep/Oct;10(5):441-452. doi: 10.1177/1941738118779023. Epub 2018 Jun 20.
PubMed 29924719White K, Di Stasi SL, Smith AH, Snyder-Mackler L. Anterior cruciate ligament- specialized post-operative return-to-sports (ACL-SPORTS) training: a randomized control trial. BMC Musculoskelet Disord. 2013 Mar 23;14:108. doi: 10.1186/1471-2474-14-108.
PubMed 23522373
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Neuromuscular Training Alter Movement Patterns After Anterior Cruciate Ligament Injury?
- ClinicalTrials.gov ID
- NCT01773317
- Acronym / sponsor ID
- 225014-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lynn Snyder-MacklerUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 23 Jan 2013 (estimated)
- 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 randomized controlled trial will be used to evaluate the efficacy of post-operative perturbation training. 80 patients who were regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in age from 13-55 at the time of injury are eligible. All eligible subjects must undergo primary anterior cruciate ligament reconstruction. Using a prospective randomized design, 40 subjects who will be block randomized by sex to 40 patients who will receive 10 sessions of post-operative perturbation training in addition to standard agility and return to activity progression and forty who receive only standard agility and return to activity progression. Post-operative perturbation training will be initiated when the athlete is at least 12 weeks post-anterior cruciate ligament reconstruction, has full range of motion and achieves 80% quadriceps strength symmetry, the criteria we currently use for beginning return to activity progression.
Detailed description
For many years, our laboratory has been examining the functional capabilities and movement strategies of individuals who sustain anterior cruciate ligament injuries of the knee. Using a battery of clinical tests and measures with these athletes, we have learned that not all of these individuals respond similarly to injury. Some athletes, called potential copers, experience a high level of function after their injury. Rehabilitation that involves specialized training called perturbation training allows the majority of potential copers to be successful in returning to sports in the short-term. Non-copers, however, are a group of anterior cruciate ligament-injured athletes with poor knee stability during daily activities. The capability of these individuals to return to sport is limited, and anterior cruciate ligament reconstruction is typically recommended.
Over the last five years, we have begun to investigate the effects of perturbation training on non-copers. Non-copers represent the majority of anterior cruciate ligament-injured athletes, and they are of great interest not only because of their distinct functional limitations, but also the large variability within this group. Abnormal movement patterns are common following anterior cruciate ligament injury, but strategies differ between potential copers and non-copers. During an activity as basic as walking, non-copers reduce the motion of the injured knee and increase the work done at the hip and ankle, perhaps in an effort to avoid knee instability. Non-copers limit the motion of the knee by activating several muscles around the knee simultaneously. So while this may be effective in stabilizing the knee in the short term, this strategy may cause altered and potentially harmful loading patterns within the knee joint.
The abnormal movement and altered muscle firing patterns of anterior cruciate ligament-injured athletes are believed to be a mechanism for knee osteoarthritis. Though anterior cruciate ligament reconstruction restores knee stability, surgery does not fully address the faulty movement of these individuals. Pre-operative perturbation training is effective in improving function and normalizing knee motion in some non-copers. Perturbation training does not improve the ability of all non-copers to return to sport, suggesting other patient factors may be related to post-surgical outcomes. Women are known to be at greater risk for anterior cruciate ligament injury than men, but recently poorer outcomes in women following surgery have also been found. In response to pre-operative training, women demonstrate improved function and gait symmetry, but recover much more slowly after surgery and demonstrate abnormal patterns and knee joint loads. Persistent faulty patterns in women warrants further study and our research can help us find ways for us to address these abnormalities.
This goal of this work is to determine whether perturbation training can improve knee function and reduce faulty adaptations after anterior cruciate ligament reconstruction. Specifically, the aims of this project are to investigate whether the addition of post-operative perturbation training results in lower loading, better movement patterns and better functional outcomes than standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation | Experimental | Other: PerturbationSubjects complete the training protocol and peturbation training exercises |
| Control | Experimental | Other: ControlSubjects will complete the training protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps) |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- regular participants in activities that involve cutting, pivoting, jumping, and lateral movements prior to injury
- ages 13-55 at the time of injury
- undergo primary Anterior Cruciate Ligament reconstruction
Key exclusion criteria (3 listed)
- concomitant Grade III ligament tears
- osteochondral defects >1cm2
- history of previous Anterior Cruciate Ligament Reconstruction or other major lower extremity injury/surgery
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 |
|---|---|---|
| PerturbationAlso: InterventionAll subjects complete study protocol. Subjects randomized to the perturbation group will complete the additional perturbation exercises | Other | Perturbation |
| ControlAlso: InterventionSubjects will complete the study protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps) | Other | Control |
Primary outcome
Changes in gait patterns from baseline to completion of intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction and 2 years after anterior cruciate ligament reconstruction
Time frame: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 year after anterior cruciate ligament reconstruction
Motion analysis data of gait patterns will be collected to analyze gait movement patterns of individuals after anterior cruciate ligament reconstruction and over time.
3 secondary outcomes
Quadriceps Strength
Time frame: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery),1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
Patient reported outcomes (Knee Outcomes Survey-Activity of Daily Living Scale, Global Rating Score of Perceived Knee Function, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000 Subjective Knee Form)
Time frame: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
Single-legged hop measures
Time frame: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 years after anterior cruciate ligament reconstruction
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 25 Jul 2019.
- Derived from this study: PubMed 35941514Ito N, Capin JJ, Khandha A, Buchanan TS, Silbernagel KG, Snyder-Mackler L. Bone-Patellar Tendon-Bone Autograft Harvest Prolongs Extensor Latency during Gait 2 yr after ACLR. Med Sci Sports Exerc. 2022 Dec 1;54(12):2109-2117. doi: 10.1249/MSS.0000000000003009. Epub 2022 Aug 6.
- Derived from this study: PubMed 34623939Zarzycki R, Arhos E, Failla M, Capin J, Smith AH, Snyder-Mackler L. Association of the Psychological Response to the ACL-SPORTS Training Program and Self-reported Function at 2 Years After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Nov;49(13):3495-3501. doi: 10.1177/03635465211045388. Epub 2021 Oct 8.
- Derived from this study: PubMed 31491565Capin JJ, Khandha A, Buchanan TS, Snyder-Mackler L. Partial medial meniscectomy leads to altered walking mechanics two years after anterior cruciate ligament reconstruction: Meniscal repair does not. Gait Posture. 2019 Oct;74:87-93. doi: 10.1016/j.gaitpost.2019.08.017. Epub 2019 Aug 27.
- Derived from this study: PubMed 31413963Capin JJ, Failla M, Zarzycki R, Dix C, Johnson JL, Smith AH, Risberg MA, Huston LJ, Spindler KP, Snyder-Mackler L. Superior 2-Year Functional Outcomes Among Young Female Athletes After ACL Reconstruction in 10 Return-to-Sport Training Sessions: Comparison of ACL-SPORTS Randomized Controlled Trial With Delaware-Oslo and MOON Cohorts. Orthop J Sports Med. 2019 Aug 1;7(8):2325967119861311. doi: 10.1177/2325967119861311. eCollection 2019 Aug.
- Derived from this study: PubMed 29924719Arundale AJH, Capin JJ, Zarzycki R, Smith A, Snyder-Mackler L. Functional and Patient-Reported Outcomes Improve Over the Course of Rehabilitation: A Secondary Analysis of the ACL-SPORTS Trial. Sports Health. 2018 Sep/Oct;10(5):441-452. doi: 10.1177/1941738118779023. Epub 2018 Jun 20.
- Derived from this study: PubMed 23522373White K, Di Stasi SL, Smith AH, Snyder-Mackler L. Anterior cruciate ligament- specialized post-operative return-to-sports (ACL-SPORTS) training: a randomized control trial. BMC Musculoskelet Disord. 2013 Mar 23;14:108. doi: 10.1186/1471-2474-14-108.
- 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.
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 Perturbation in people with Acute Injury of Anterior Cruciate Ligament, run by Lynn Snyder-Mackler 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 3 inclusion and 3 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 2019. 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 gait patterns from baseline to completion of intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction and 2 years after anterior cruciate ligament reconstruction (time frame: At enrollment (baseline), After protocol intervention (approximately 6 months after surgery), 1 year after anterior cruciate ligament reconstruction, 2 year after anterior cruciate ligament reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773317, which also lists 6 linked publications.
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 2019.