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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00767780
Other study ID # 141/08
Secondary ID
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


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
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