Dynamic Stability of the Anterior Cruciate Ligament (ACL) Deficient Knee
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|ClinicalTrials.gov Identifier: NCT00696319|
Recruitment Status : Suspended (Study was suspended due to lack of resources.)
First Posted : June 12, 2008
Last Update Posted : July 1, 2011
The study that is registered in ClinicalTrials is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The aim of the overall study is to prospectively follow a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee, in order to document results from different rehabilitation regimes after the injury.
The title of the part study is 'Neuromuscular changes in ACL-deficient individuals before and after an intensive perturbation training program. A case-control study.' The aims of the part study are:
- To describe muscle activation patterns, joint angles and forces during gait and one-legged hop in newly injured ACL-deficient individuals before and after execution of an intensive training program consisting of either perturbation training or conventional balance- and stability training
- To describe eventual changes between the two groups that may indicate superiority of either one of the methods
The study will include 25 subjects in each group. The intervention consists of two different rehabilitation protocols for neuromuscular training. Subjects will be tested in a biomechanical laboratory before and after intervention, with use of 3D camera systems, force plates and electromyographic measurements (EMG). Main outcomes are eventual differences in muscle activation patterns, joint angles and forces during selected phases of walking and one-legged hopping. Secondary outcomes of interest are self-assessment of knee function, isokinetic strength and functional one-legged hop tests.
Status: Inclusion to the main study started in January 2007. Data collection for the case-control part study will take place in 2008-2009. The part study study should be finished in 2010, where results will be included in a PhD dissertation. The PhD student responsible, Ingrid Eitzen, is enrolled in the Doctoral program at the Faculty of Medicine, University of Oslo. She is employed at Orthopaedic Centre, Ullevaal University Hospital and part of The Norwegian Research Center for Active Rehabilitation (NAR). The project is included in the NAR research program. In addition, the overall study is organized as a formalized collaboration with the University of Delaware, US, where they also will follow a cohort of 150 subjects.
|Condition or disease||Intervention/treatment||Phase|
|Knee Injury||Other: Exercise protocol with perturbation exercises. Other: Exercise protocol with traditional exercises for stability and balance.||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynamic Stability of the ACL Deficient Knee - a Prospective Cohort Study|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2013|
Arm 1 will go through a rehabilitation protocol with perturbation training exercises.
Other: Exercise protocol with perturbation exercises.
Perturbation exercises are exercises for balance and stability that involves perturbations of the surface through use of custom made equipment (a rollerboard, a rockerboard and a platform).
Arm 2 will go through a rehabilitation protocol with traditional exercises for balance and stability training.
Other: Exercise protocol with traditional exercises for stability and balance.
The exercise protocol will consist of exercises for balance and stability that do not include sudden disturbances or perturbations to the surface.
- Biomechanical changes during walking and one-legged hop tests. [ Time Frame: Before and after a six week intervention. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696319
|Orthopaedic Centre, Ullevaal University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||May Arna Risberg, PT, PhD||Ullevaal University Hospital|