AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

March 23, 2012 updated by: Apos Medical and Sports Technology Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 248649
        • AposTherapy center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-evaluation questionnaires between baseline and after 6 months of therapy
Time Frame: Baseline, 6 months

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
Time Frame
Changes in spatio-temporal gait parameters between basline and after 6 months of therapy
Time Frame: Baseline, 6 months
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apos Medical and Sports Technology Ltd.

Investigators

  • Principal Investigator: Yoav Aloni, AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apos_Sing_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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