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| Sponsors and Collaborators: |
Ullevaal University Hospital University of Delaware |
|---|---|
| Information provided by: | Ullevaal University Hospital |
| ClinicalTrials.gov Identifier: | NCT00696319 |
Purpose
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:
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 Orthopadeic Centre, Ullevaal University Hospital and part of The Norwegian Reserach 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 | Intervention |
|---|---|
|
Knee Injury |
Other: Exercise protocol with perturbation exercises. Other: Exercise protocol with traditional exercises for stability and balance. |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Dynamic Stability of the ACL Deficient Knee - a Prospective Cohort Study |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Arm 1 will go through a rehabilitation protocol with perturbation training exercises.
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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).
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2: Experimental
Arm 2 will go through a rehabilitation protocol with traditional exercises for balance and stability training.
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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.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 13 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ingrid Eitzen, PT, MSc, PhD student | +4790709965 | ingrid.eitzen@hjelp24.no |
| Contact: May Arna Risberg, PT, PhD | +4741312776 | mayarna.risberg@hjelp24.no |
| Norway | |
| Orthopaedic Centre, Ullevaal University Hospital | Recruiting |
| Oslo, Norway, 0407 | |
| Principal Investigator: May Arna Risberg, PT, PhD | |
| Principal Investigator: | May Arna Risberg, PT, PhD | Ullevaal University Hospital |
More Information
| Responsible Party: | NAR/Ullevaal University Hospital ( May Arna Risberg, PT, PhD ) |
| Study ID Numbers: | 01-2008-NAR, NIH grant #2RO1HD37985-05 |
| Study First Received: | June 9, 2008 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00696319 |
| Health Authority: | Norway: The Regional Committees for Medical Research Ethics in Norway (REK) |
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Rupture of the anterior cruciate ligament of the knee |
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Wounds and Injuries Disorders of Environmental Origin Knee Injuries Rupture Leg Injuries |
