Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

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) and/or 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 month's period.
    

Intervention name(s): Trial Foot Orthoses (FOs); placebo foot orthoses (FOs)
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment