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AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01562652
Enrollment
60
Registered
2012-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

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: 1. To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment. 2. To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.

Interventions

DEVICEAposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)

Sponsors

Apos Medical and Sports Technology Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in self-evaluation questionnaires between baseline and after 6 months of therapyBaseline, 6 monthsWestern 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.

Secondary

MeasureTime frame
Changes in spatio-temporal gait parameters between basline and after 6 months of therapyBaseline, 6 months

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026