The Effect of a New Biomechanical Device

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00767780
Collaborator
(none)
200
1
22
9.1

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Gait spatio-temporal parameters []

Secondary Outcome Measures

  1. WOMAC, SF-36, Oswestry and FAOS questionnaires []

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00767780
Other Study ID Numbers:
  • 141/08
First Posted:
Oct 7, 2008
Last Update Posted:
Oct 7, 2008
Last Verified:
Oct 1, 2008
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2008