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
  Purpose

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 Intervention
Osteoarthritis
Joint Replacement
Fractures
Device: APOS biomechanical gait system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Gait spatio-temporal parameters [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC, SF-36, Oswestry and FAOS questionnaires [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by Assaf-Harofeh Medical Center

Additional 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
Study First Received: October 2, 2008
Last Updated: October 5, 2008
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fractures, Bone
Osteoarthritis
Wounds and Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014