The Effect of a New Biomechanical Device - Full Text View

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00767780

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

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Study ID Numbers:	141/08
Study First Received:	October 2, 2008
Last Updated:	October 5, 2008
ClinicalTrials.gov Identifier:	NCT00767780
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Fractures, Bone
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009