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The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457132
First Posted: April 5, 2007
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

Context: The many treatments and devices developed to unload the diseased articular surface in knee osteoarthritis have provided limited solutions. A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of such unloading during standing and walking, simultaneously strengthening dynamic stabilizers and training neuromuscular control by controlled biomechanical perturbations.

Objective: To asses the effectiveness of this device in reducing pain and improving function in patients with knee osteoarthritis.

Design and Setting: Randomized, controlled and double blind prospective trial, conducted from September 2005 to February 2006, in the Department of Orthopedics, Asaf Harofeh Medical Center (Zerifin, Israel).

Patients: Sixty-one patients with diagnosed knee osteoarthritis who self-reported moderate-to-severe level pain.

Interventions: Patients were randomly assigned into active and control groups and underwent 8 weeks of treatment. The active group was treated with the device and its four biomechanical elements that had been individually calibrated to accommodate a pain-free joint alignment. The control group was treated with the device’s platforms without the biomechanical elements.

Primary Outcome Measures: The patients were evaluated three times during the study: at baseline, after 4 weeks and at the 8 week endpoint. Primary outcomes were the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and the Aggregated Locomotor Function (ALF) assessment.


Condition Intervention
Knee Osteoarthritis Device: APOS biomechanical gait system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dynamic Wedging: A Novel Treatment for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)
  • Aggregated Locomotor Function (ALF)

Secondary Outcome Measures:
  • SF-36 health survey
  • Knee Society Score

Estimated Enrollment: 60
Study Start Date: September 2005
Study Completion Date: February 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • radiographically assessed osteoarthritis of the knee graded 1 to 4 according to the Kellgren and Lawrence scale
  • self reported moderate to severe level pain

Exclusion Criteria:

  • acute septic arthritis
  • predisposition to a tendency to fall
  • lack of physical or mental ability to perform or comply with the treatment procedure
  • diabetes mellitus
  • history of pathological osteoporotic fracture
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00457132


Locations
Israel
Assaf-Harofeh Medical Center
Zerifin, Israel, 70600
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Nahum Halperin, MD Asaf-Harofeh Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00457132     History of Changes
Other Study ID Numbers: 44/05
First Submitted: April 4, 2007
First Posted: April 5, 2007
Last Update Posted: June 27, 2007
Last Verified: April 2007

Keywords provided by Assaf-Harofeh Medical Center:
Knee
Osteoarthritis
WOMAC
ALF
Wedging

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases