The Effect of a New Biomechanical Device

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00767780
First received: October 2, 2008
Last updated: October 5, 2008
Last verified: October 2008

October 2, 2008
October 5, 2008
October 2006
August 2008   (final data collection date for primary outcome measure)
Gait spatio-temporal parameters [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00767780 on ClinicalTrials.gov Archive Site
WOMAC, SF-36, Oswestry and FAOS questionnaires [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of a New Biomechanical Device
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The purpose of this study is to examine (retrospectively) the effect of a new biomechanical device on gait patterns of patients suffering from musculoskeletal disorders. The analysis is conducted on an existing database of the therapy center.

Patients treated in the therapy center undergo a computerized gait test and complete several pain and function questionnaires at fixed time point. We examined the effect of the treatment on the level of pain, function and quality of life as well as on the gait patterns of these patients. Measurements were taken at baseline, after 3 months, and after 6 months.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

Patients suffering from one of the following conditions: knee\hip OA, knee\hip joint replacement, ankle fractures\instability, NSLBP

  • Osteoarthritis
  • Joint Replacement
  • Fractures
Device: APOS biomechanical gait system
a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase
  • 3
    Patients suffering from ankle fractures and instability
    Intervention: Device: APOS biomechanical gait system
  • 4
    Patients suffering from hip osteoarthritis
    Intervention: Device: APOS biomechanical gait system
  • 5
    Patients who underwent total knee replacement or total hip replacement
    Intervention: Device: APOS biomechanical gait system
  • 1
    Patients suffering from bilateral knee osteoarthritis
    Intervention: Device: APOS biomechanical gait system
  • 2
    Patients suffering fron non specific low back pain
    Intervention: Device: APOS biomechanical gait system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • knee\hip OA
  • knee\hip joint replacement
  • ankle fractures\instability
  • NSLBP

Exclusion Criteria:

  • neurological disorders
  • lack of balance (2 falls in the last year)
  • incapable to complete a questionnaire
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00767780
141/08
No
Not Provided
Assaf-Harofeh Medical Center
Not Provided
Study Director: Ronen Debbi, MD Assaf Harophe Medical Center
Assaf-Harofeh Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP