The Effect of a New Biomechanical Device

NCT ID: NCT00767780

Last Updated: 2008-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Joint Replacement Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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3

Patients suffering from ankle fractures and instability

APOS biomechanical gait system

Intervention Type 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

4

Patients suffering from hip osteoarthritis

APOS biomechanical gait system

Intervention Type 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

5

Patients who underwent total knee replacement or total hip replacement

APOS biomechanical gait system

Intervention Type 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

Patients suffering from bilateral knee osteoarthritis

APOS biomechanical gait system

Intervention Type 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

2

Patients suffering fron non specific low back pain

APOS biomechanical gait system

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ronen Debbi, MD

Role: STUDY_DIRECTOR

Assaf Harophe Medical Center

Locations

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APOS Medical and Sport Thechnologies LTD

Herzliya, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 27842560 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25604319 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22555568 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22406298 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21839981 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20637534 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19564755 (View on PubMed)

Other Identifiers

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141/08

Identifier Type: -

Identifier Source: org_study_id