AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Study Overview
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Brief Summary
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Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of the disease are pain and functional disability. This study has two aims: To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment. To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from symptomatic bilateral knee osteoarthritis at the medial compartment for at least six months, fulfilling the ACR clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale. Patients with an overall WOMAC score of >2cm (as measured at baseline). Males and females between the ages of 50-70. Exclusion Criteria: Patients suffering from acute septic arthritis. Patients suffering from inflammatory arthritis. Patients who received a corticosteroid injection within 3 months of the study. Patients suffering from avascular necrosis of the knee. Patients with a history of knee buckling or recent knee injury. Patients who have had a joint replacement. Patients suffering from neuropathic arthropathy. Patients with an increased tendency to fall. Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. Patients with a history of pathological osteoporotic fracture. Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees. Patients with referred pain in the knees from back or hip joint symptoms.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research<br> | Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-evaluation questionnaires between baseline and after 6 months of therapy | Western Ontario and MacMaster osteoarthritis questionnaire (WOMAC) and SF-36 Health Survey will be evaluated. The WOMAC questionnaire is measured on a 10cm visual analogue scale (VAS) and the SF-36 is scored between 0-100. | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in spatio-temporal gait parameters between basline and after 6 months of therapy |  | Baseline, 6 months |