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The Effect of a New Biomechanical Device

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ClinicalTrials.gov Identifier: NCT00767780
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis Joint Replacement Fractures Device: APOS biomechanical gait system

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : October 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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U.S. FDA Resources

Group/Cohort Intervention/treatment
3
Patients suffering from ankle fractures and instability
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
4
Patients suffering from hip osteoarthritis
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
5
Patients who underwent total knee replacement or total hip replacement
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
1
Patients suffering from bilateral knee osteoarthritis
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
2
Patients suffering fron non specific low back pain
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



Primary Outcome Measures :
  1. Gait spatio-temporal parameters

Secondary Outcome Measures :
  1. WOMAC, SF-36, Oswestry and FAOS questionnaires


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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from one of the following conditions: knee\hip OA, knee\hip joint replacement, ankle fractures\instability, NSLBP
Criteria

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

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): NCT00767780


Locations
Israel
APOS Medical and Sport Thechnologies LTD
Herzlia, Israel, 46733
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: Ronen Debbi, MD Assaf Harophe Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00767780     History of Changes
Other Study ID Numbers: 141/08
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: October 2008

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