Dynamic Stability of the Anterior Cruciate Ligament (ACL) Deficient Knee

NCT00696319 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-07-01

No results posted yet for this study

Summary

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:

1. 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
2. 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.

Conditions

  • Knee Injury

Interventions

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).

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.

Sponsors & Collaborators

  • University of Delaware

    collaborator OTHER
  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • May Arna Risberg, PT, PhD · Ullevaal University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696319 on ClinicalTrials.gov