Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02001844
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2013-11-25
Brief Title:
Foot Orthoses FOs on Pain Quality of Life and the Gait With Children Diagnosed With JIA
Sponsor:
University of Newcastle Australia
Organization:
University of Newcastle Australia
Study Overview
Official Title:
Single Blinded RCT to Investigate the Clinical Effectiveness of Pre-formed Semi-rigid Foot Orthoses FOs on Pain Quality of Life and Dynamic of Gait With Children Diagnosed With Juvenile Idiopathic Arthritis JIA
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Modern modular foot-orthoses systems allow an integration of the cost and efficiency benefits afforded by the use of pre-formed semi-rigid FOs components while simultaneously allowing a high degree of individualisation of prescription Such systems while popular still remain unproven Recent studies in paediatric rheumatology have made a contribution in developing guidelines with regards to pharmacological intervention in arthritic children In addition specific drug therapy protocols have been published to effectively help general practitioners physiotherapists and ophthalmologists to successfully treat children with JIA patients BSPAR 2006 Hull 2001 NICE guidelines 2002 A Cochrane systematic review on treatment of pes planus highlighted that children with JIA were excluded as a group from most of the studies Ashford et al 2005 At present little evidence exists for the podiatric management of children affected by this disabling pathology especially for orthotic management This research has provided evidence to support the use of readily available off-the-shelf FOs in treating JIA children
Detailed Description:
Introduction - Currently there is limited evidence supporting podiatric treatment of children with JIA The foot orthoses FOs prescribed to JIA children so far appeared to be very expensive and required long time to manufacture before the fitting This randomised controlled trial RCT aimed to determine whether pre-formed FOs that can be prescribed at chair side impacted on pain quality of life primary outcomes andor gait-parameters secondary outcomes in children affected by JIA
Methods - The study took place at the Gait Analysis laboratory at Queen Margaret University - Edinburgh and at the TORT Centre Ninewells Hospital-Dundee Children with JIA were diagnosed according to the ILAR criteria Intervention was blinded to the patients The trial group received Slimflex-plus FOs with the addition of chair side corrections and the control FOs supplied were made with leather board 1mm thick only Both FOs had the same black EVA top cover Primary outcomes were investigated using validated questionnaires VAS CHAQ and PedsQL Tekscan equipment F-Scan and HR Walkway measured secondary outcomes in-shoe pressure and force data with and without FOs intervention Multiple foot strikes and repetitive gait patterns were compared pre and post-treatment Primary and secondary outcome measures were recorded at baseline 3rd and 6th months period
Methods - The study took place at the Gait Analysis laboratory at Queen Margaret University - Edinburgh and at the TORT Centre Ninewells Hospital-Dundee Children with JIA were diagnosed according to the ILAR criteria Intervention was blinded to the patients The trial group received Slimflex-plus FOs with the addition of chair side corrections and the control FOs supplied were made with leather board 1mm thick only Both FOs had the same black EVA top cover Primary outcomes were investigated using validated questionnaires VAS CHAQ and PedsQL Tekscan equipment F-Scan and HR Walkway measured secondary outcomes in-shoe pressure and force data with and without FOs intervention Multiple foot strikes and repetitive gait patterns were compared pre and post-treatment Primary and secondary outcome measures were recorded at baseline 3rd and 6th months period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None