AposTherapy for Singaporean Patients With Knee Osteoarthr... | NCT01562652

Studies
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)

NCT01562652

Sponsor

Apos Medical and Sports Technology Ltd.

Status

Completed

Last Update Posted

Mar 26, 2012Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

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

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 14, 2012

First Submission Date that Met QC Criteria

Mar 23, 2012

First Posted Date

Mar 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Research	Experimental		Device: AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)	Device		Research

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoav Aloni	AposTherapy Singapore Pte Ltd. #05-07, 1 Orchard Boulevard Singapore 248649	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AposTherapy center		Singapore		248649	Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24383821	Derived	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.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases