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

This study has suspended participant recruitment.
(Study was suspended due to lack of resources.)
Sponsor:
Collaborator:
University of Delaware
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00696319
First received: June 9, 2008
Last updated: June 30, 2011
Last verified: June 2011
  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:

  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.


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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Stability of the ACL Deficient Knee - a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Biomechanical changes during walking and one-legged hop tests. [ Time Frame: Before and after a six week intervention. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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).
Experimental: 2
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified unilateral total rupture of the ACL
  • Age 13-55 years
  • Date of injury within 3 months prior to inclusion
  • Activity level 1 or 2 (regular participation in pivoting sports)

Exclusion Criteria:

  • Concomitant ligamentous injury
  • Bilateral involvement
  • Symptomatic meniscal damage
  • Fractures
  • Full-thickness articular cartilage damage larger than 1 cm in diameter
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696319

Locations
Norway
Orthopaedic Centre, Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Delaware
Investigators
Principal Investigator: May Arna Risberg, PT, PhD Ullevaal University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: May Arna Risberg, PT, PhD, NAR/Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00696319     History of Changes
Other Study ID Numbers: 01-2008-NAR, NIH grant #2RO1HD37985-05
Study First Received: June 9, 2008
Last Updated: June 30, 2011
Health Authority: Norway: The Regional Committees for Medical Research Ethics in Norway (REK)

Keywords provided by Oslo University Hospital:
Rupture of the anterior cruciate ligament of the knee

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 21, 2014