The Effect of a New Biomechanical Device

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767780
• Other study ID #: 141/08
• Status: Completed
• Phase: N/A
• First received: October 2, 2008
• Last updated: October 5, 2008
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fractures
• Joint Replacement
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Israel	APOS Medical and Sport Thechnologies LTD	Herzlia

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait spatio-temporal parameters			No
Secondary	WOMAC, SF-36, Oswestry and FAOS questionnaires			No