The Effect of a New Biomechanical Device

NCT00767780 | Completed

• 1 other identifier: 141/08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Joint Replacement; Fractures

Outcome Measures

Primary Outcomes (1)

• Gait spatio-temporal parameters

Secondary Outcomes (1)

• WOMAC, SF-36, Oswestry and FAOS questionnaires

Study Arms (5)

3

Patients suffering from ankle fractures and instability

Device: APOS biomechanical gait system

4

Patients suffering from hip osteoarthritis

Device: APOS biomechanical gait system

5

Patients who underwent total knee replacement or total hip replacement

Device: APOS biomechanical gait system

1

Patients suffering from bilateral knee osteoarthritis

Device: APOS biomechanical gait system

2

Patients suffering fron non specific low back pain

Device: APOS biomechanical gait system

Interventions

APOS biomechanical gait system DEVICE

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; 2; 3; 4; 5

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• knee\\hip OA
• knee\\hip joint replacement
• ankle fractures\\instability
• NSLBP

You may not qualify if:

• neurological disorders
• lack of balance (2 falls in the last year)
• incapable to complete a questionnaire

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

APOS Medical and Sport Thechnologies LTD

Herzliya, 46733, Israel

Location

Related Publications (7)

• 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.

  PMID: 27842560 DERIVED

• 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.

  PMID: 25604319 DERIVED

• 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.

  PMID: 22555568 DERIVED

• 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.

  PMID: 22406298 DERIVED

• 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.

  PMID: 21839981 DERIVED

• 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.

  PMID: 20637534 DERIVED

• 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.

  PMID: 19564755 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Fractures, Bone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Wounds and Injuries

Study Officials

• Ronen Debbi, MD

  Assaf Harophe Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 7, 2008

Record last verified: 2008-10

Locations

IL (1)