Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
NCT ID: NCT02001844
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-05-31
2013-05-31
Brief Summary
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Detailed Description
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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 month's period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
The control FOs, or placebo FOs was supplied to patients who were randomly included in the control group. The control FOs was made of leather board (1mm), grey Poron (1mm), and black EVA (0.75mm) as covering. This thin inner sole did not have any sort of biomechanical support, nor had it any effect on the distribution of pressure, as it was completely flat. In addition, the placebo FOs did not present with any intrinsic or extrinsic correction underneath the sub-talar-joint (STJ).
The use of black EVA as the covering material and the leather-board as a base, allowed for gathering of a dynamic impression over the 6 months of the trial.
placebo foot orthoses (FOs)
The control FOs, or placebo FOs was supplied to patients who were randomly included in the control group. The control FOs was made of leather board (1mm), grey Poron (1mm), and black EVA (0.75mm) as covering. This thin inner sole did not have any sort of biomechanical support, nor had it any effect on the distribution of pressure, as it was completely flat. In addition, the placebo FOs did not present with any intrinsic or extrinsic correction underneath the sub-talar-joint (STJ).
The use of black EVA as the covering material and the leather-board as a base, allowed for gathering of a dynamic impression over the 6 months of the trial.
Trial Group
Trial Group:
children who were randomly introduced into this group received the pre-formed semi-rigid FOs. The FOs were used as an off the-shelf device and subsequently customised with chair side modifications. In order to reproduce the exact same aesthetical appearance as the control FOs, grey poron (1mm) and black EVA (0.75mm) was used as well to cover the trial FOs.
Furthermore, depending on the type of correction applied to the trial patient, the black EVA also allowed the correction applied on the surface of the device to be masked.
Trial Foot Orthoses (FOs)
Trial Group:
The children who were randomly introduced into this group received the pre-formed semi-rigid FOs. The FOs were used as an off the-shelf device and subsequently customised with chair side modifications. In order to reproduce the exact same aesthetical appearance as the control FOs, grey poron (1mm) and black EVA (0.75mm) was used as well to cover the trial FOs.
Furthermore, depending on the type of correction applied to the trial patient, the black EVA also allowed the correction applied on the surface of the device to be masked.
Interventions
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Trial Foot Orthoses (FOs)
Trial Group:
The children who were randomly introduced into this group received the pre-formed semi-rigid FOs. The FOs were used as an off the-shelf device and subsequently customised with chair side modifications. In order to reproduce the exact same aesthetical appearance as the control FOs, grey poron (1mm) and black EVA (0.75mm) was used as well to cover the trial FOs.
Furthermore, depending on the type of correction applied to the trial patient, the black EVA also allowed the correction applied on the surface of the device to be masked.
placebo foot orthoses (FOs)
The control FOs, or placebo FOs was supplied to patients who were randomly included in the control group. The control FOs was made of leather board (1mm), grey Poron (1mm), and black EVA (0.75mm) as covering. This thin inner sole did not have any sort of biomechanical support, nor had it any effect on the distribution of pressure, as it was completely flat. In addition, the placebo FOs did not present with any intrinsic or extrinsic correction underneath the sub-talar-joint (STJ).
The use of black EVA as the covering material and the leather-board as a base, allowed for gathering of a dynamic impression over the 6 months of the trial.
Eligibility Criteria
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Inclusion Criteria
* All subjects with lower extremity joint involvement with disease onset ranging from 5 to 18 years old.
* Previous failure of orthotic management, where the patient has not worn any FOs for a period of at least 3 months.
* Ability to walk a minimum of 15 metres without assistive devices.
* Six months after start of DMARD therapy.
Exclusion Criteria
* Concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders, especially Diabetes Mellitus.
* Previous foot surgery.
* Currently using foot orthosis.
* Where supply of orthotics are contraindicated: (Less than 12 degrees at subtler joint; Fully compensated ankle equines; Osseous anomaly noted in the lower limbs and/or vertebrae during the physical evaluation; Inappropriate footwear for fitting orthoses).
5 Years
18 Years
ALL
No
Sponsors
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Queen Margaret University
OTHER
University of Newcastle, Australia
OTHER
Responsible Party
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Dr Andrea Coda
Dr
Locations
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Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
Ourimbah, New South Wales, Australia
University of Newcastle, Podiatry, School of Health & Science
Ourimbah, New South Wales, Australia
Countries
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References
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Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial. Arch Dis Child. 2014 Jul;99(7):649-51. doi: 10.1136/archdischild-2013-305166. Epub 2014 Mar 17.
Other Identifiers
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JIA - FOs intervention
Identifier Type: -
Identifier Source: org_study_id