The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study
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|ClinicalTrials.gov Identifier: NCT00457132|
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : June 27, 2007
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 or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: APOS biomechanical gait system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dynamic Wedging: A Novel Treatment for Knee Osteoarthritis|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||February 2006|
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)
- Aggregated Locomotor Function (ALF)
- SF-36 health survey
- Knee Society Score
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
|Assaf-Harofeh Medical Center|
|Zerifin, Israel, 70600|
|Principal Investigator:||Nahum Halperin, MD||Asaf-Harofeh Medical Center|