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NCT01266382 Clinical Trial

The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01266382
Other study ID # 93/09
Secondary ID
Status Recruiting
Phase N/A
First received December 22, 2010
Last updated December 23, 2010

Study information
Verified date July 2009
Source Assaf-Harofeh Medical Center
Contact Ganit Segal, MA
Email ganitm@apos.co.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of the study is to examine the effect of a new biomechanical device and treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients with musculoskeletal and neurological disorders. Based on previous reports the investigators hypothesis that this therapy will have a positive effect on these measurements.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Primary osteoarthritis

- Lower limb joint replacement

- Lower limbs fractures

- Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis

- ligaments tear

- Meniscal tears

Exclusion Criteria:

- lack of balance (3 falls in the last year)

- incapable to complete a questionnaire •>age 85

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• AposTherapy
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 AposTherapy center Herzliya

Sponsors (2)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center Apos Medical and Sports Technology Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spatio-temporal Gait parameters No
Primary WOMAC No
Primary SF-36 No
Secondary FAOS questionnaire
Secondary Oswestry questionnaire
Secondary Clinical measurements
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