Clinical trial NCT00767780: The Effect of a New Biomechanical Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Joint Replacement
Fractures
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Gait spatio-temporal parameters
Secondary outcomes:
measure: WOMAC, SF-36, Oswestry and FAOS questionnaires
Other outcomes:
Locations:
city: Herzlia
country: Israel
facility: APOS Medical and Sport Thechnologies LTD
Study officials:
affiliation: Assaf Harophe Medical Center
name: Ronen Debbi, MD
role: STUDY_DIRECTOR
References:
citation: Atoun E, Mor A, Segal G, Debi R, Grinberg D, Benedict Y, Rozen N, Beer Y, Elbaz A. A non-invasive, home-based biomechanical therapy for patients with spontaneous osteonecrosis of the knee. J Orthop Surg Res. 2016 Nov 14;11(1):139. doi: 10.1186/s13018-016-0472-0.
citation: Herman A, Chechik O, Segal G, Kosashvili Y, Lador R, Salai M, Mor A, Elbaz A, Haim A. The correlation between radiographic knee OA and clinical symptoms--do we know everything? Clin Rheumatol. 2015 Nov;34(11):1955-60. doi: 10.1007/s10067-015-2871-8. Epub 2015 Jan 22.
citation: 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.
citation: 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). 2012 Jul;27(6):584-7. doi: 10.1016/j.clinbiomech.2012.02.002. Epub 2012 Mar 9.
citation: 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. doi: 10.1016/j.apmr.2011.05.009. Epub 2011 Aug 12.
citation: 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). 2010 Nov;25(9):920-5. doi: 10.1016/j.clinbiomech.2010.06.017. Epub 2010 Jul 16.
citation: 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 (Phila Pa 1976). 2009 Jul 1;34(15):E507-12. doi: 10.1097/BRS.0b013e3181a98d3f.