- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773317
Can Neuromuscular Training Alter Movement Patterns
Can Neuromuscular Training Alter Movement Patterns After Anterior Cruciate Ligament Injury?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Delaware
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Newark, Delaware, United States, 19716
- University of Delaware, Physical Therapy Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
At this time, subjects have been enrolled and we are no longer recruiting for this study.
Inclusion Criteria:
- 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
Exclusion Criteria:
- concomitant Grade III ligament tears
- osteochondral defects >1cm2
- history of previous Anterior Cruciate Ligament Reconstruction or other major lower extremity injury/surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perturbation
Subjects complete the training protocol and peturbation training exercises
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All subjects complete study protocol.
Subjects randomized to the perturbation group will complete the additional perturbation exercises
Other Names:
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Experimental: Control
Subjects will complete the training protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
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Subjects will complete the study protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Motion analysis data of gait patterns will be collected to analyze gait movement patterns of individuals after anterior cruciate ligament reconstruction and over time.
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
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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
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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
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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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lynn Snyder-Mackler, PT,ATC,ScD, University of Delaware
Publications and helpful links
General 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.
- Zarzycki 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.
- Capin 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.
- Capin 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.
- Arundale 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.
- White 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 225014-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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