NCT01773317|Completed
Loading search results
Sponsor study identifier
interventional
80
1 country
1
Study Start
November 2011
Actual (reported)Primary Completion
August 28, 2018
Actual (reported)Study Completion
August 28, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Actual (reported)June 13, 2012
Actual (reported)January 23, 2013
Actual (reported)August 28, 2018
Actual (reported)August 28, 2018
Actual (reported)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.
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
Quadriceps Strength
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)
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
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
Subjects complete the training protocol and peturbation training exercises
Subjects will complete the training protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
All subjects complete study protocol. Subjects randomized to the perturbation group will complete the additional perturbation exercises
Subjects will complete the study protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
University of Delaware, Physical Therapy Department
Newark, Delaware, 19716, United States
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.
Lynn Snyder-Mackler, PT,ATC,ScD
University of Delaware
80 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2012
First Posted
January 23, 2013
Study Start
November 2011
Actual (reported)A Randomized Recruitment Intervention Trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
August 28, 2018
Actual (reported)Study Completion
August 28, 2018
Actual (reported)Last Updated
July 25, 2019
Record last verified: 2019-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: