The Effect of a New Biomechanical Device

October 5, 2008 updated by: Assaf-Harofeh Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Herzlia, Israel, 46733
        • APOS Medical and Sport Thechnologies LTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Gait spatio-temporal parameters

Secondary Outcome Measures

Outcome Measure
WOMAC, SF-36, Oswestry and FAOS questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: Ronen Debbi, MD, Assaf Harophe Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 5, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 5, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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