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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

March 14, 2012
March 23, 2012
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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.

Same as current
Complete list of historical versions of study NCT01562652 on ClinicalTrials.gov Archive Site
Changes in spatio-temporal gait parameters between basline and after 6 months of therapy [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Same as current
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AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
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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:

  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.
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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Osteoarthritis
Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS—Medical and Sports Technologies Ltd. Herzliya, Israel)
Experimental: Research
Intervention: Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS—Medical and Sports Technologies Ltd. Herzliya, Israel)
Elbaz A, Mor A, Segal G, Aloni Y, Teo YH, Teo YS, Das-De S, Yeo SJ. Patients with knee osteoarthritis demonstrate improved gait pattern and reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre study on Singaporean population. J Orthop Surg Res. 2014 Jan 2;9:1. doi: 10.1186/1749-799X-9-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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.
Both
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01562652
Apos_Sing_01
Not Provided
Apos Medical and Sports Technology Ltd.
Apos Medical and Sports Technology Ltd.
Not Provided
Principal Investigator: Yoav Aloni AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649
Apos Medical and Sports Technology Ltd.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP