The Effect of a New Biomechanical Device - Full Text View

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:

MedlinePlus related topics: Fractures Osteoarthritis

U.S. FDA Resources

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

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):

Elbaz A, Beer Y, Rath E, Morag G, Segal G, Debbi EM, Wasser D, Mor A, Debi R. A unique foot-worn device for patients with degenerative meniscal tear. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):380-7. doi: 10.1007/s00167-012-2026-2. Epub 2012 May 4.

Debi R, Mor A, Segal G, Debbi EM, Cohen MS, Igolnikov I, Bar Ziv Y, Benkovich V, Bernfeld B, Rozen N, Elbaz A. Differences in gait pattern parameters between medial and anterior knee pain in patients with osteoarthritis of the knee. Clin Biomech (Bristol, Avon). 2012 Jul;27(6):584-7. Epub 2012 Mar 9.

Elbaz A, Debbi EM, Segal G, Haim A, Halperin N, Agar G, Mor A, Debi R. Sex and body mass index correlate with Western Ontario and McMaster Universities Osteoarthritis Index and quality of life scores in knee osteoarthritis. Arch Phys Med Rehabil. 2011 Oct;92(10):1618-23. Epub 2011 Aug 12.

Elbaz A, Mor A, Segal G, Debbi E, Haim A, Halperin N, Debi R. APOS therapy improves clinical measurements and gait in patients with knee osteoarthritis. Clin Biomech (Bristol, Avon). 2010 Nov;25(9):920-5. Epub 2010 Jul 16.

Elbaz A, Mirovsky Y, Mor A, Enosh S, Debbi E, Segal G, Barzilay Y, Debi R. A novel biomechanical device improves gait pattern in patient with chronic nonspecific low back pain. Spine. 2009 Jul 1;34(15):E507-12.

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 May 21, 2013