Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
Arthritis, Juvenile Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with JIA according to ILAR 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:
- Inability to walk barefoot or shod.
- 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).
Sites / Locations
- Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
- University of Newcastle, Podiatry, School of Health & Science
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control
Trial Group
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: 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.