Text Size

AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apos Medical and Sports Technology Ltd.
ClinicalTrials.gov Identifier:
NCT01562652
First received: March 14, 2012
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

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.

Condition Intervention
Knee Osteoarthritis
 Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS—Medical and Sports Technologies Ltd. Herzliya, Israel)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Apos Medical and Sports Technology Ltd.:

Primary Outcome Measures:
  • Changes in self-evaluation questionnaires between baseline and after 6 months of therapy [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Changes in spatio-temporal gait parameters between basline and after 6 months of therapy [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Arms Assigned Interventions
Experimental: Research Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS—Medical and Sports Technologies Ltd. Herzliya, Israel)

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562652

Locations
Singapore
AposTherapy center
Singapore, Singapore, 248649
Sponsors and Collaborators
Apos Medical and Sports Technology Ltd.
Investigators
Principal Investigator: Yoav Aloni AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649
  More Information

No publications provided

Responsible Party: Apos Medical and Sports Technology Ltd.
ClinicalTrials.gov Identifier: NCT01562652     History of Changes
Other Study ID Numbers: Apos_Sing_01
Study First Received: March 14, 2012
Last Updated: March 23, 2012
Health Authority: Singapore: Ministry of Health

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 13, 2013