None listed
Conditions
Brief summary
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
Interventions
Children affected by JIA were diagnosed according to the 'International League of Associations for Rheumatology' (ILAR) criteria. Intervention was blinded to the patients. The trial group received pre-formed semi- rigid (Slimflex-plus) FOs, with the addition of customised chair side
corrections at the rear-foot, midfoot and/or forefoot; the control FOs supplied were instead made with leather board (1mm thick) only, without corrections and completely flat. Both FOs had the same black EVA top cove
Children affected by JIA were diagnosed according to the 'International League of Associations for Rheumatology' (ILAR) criteria. Intervention was blinded to the patients. The trial group received pre-formed semi- rigid (Slimflex-plus) FOs, with the addition of customised chair side corrections at the rear-foot, midfoot and/or forefoot; the control FOs supplied were instead made with leather board (1mm thick) only, without corrections and completely flat. Both FOs had the same black EVA top cover which clearly showed the dynamic impression patterns and allowed to monitor how compliant the children were. in addition, the parent/carer were asked to monitor that the child was wearing the FOs daily for a period of 6 months. Primary outcomes were investigated using validated questionnaires (VAS, CHAQ and PedsQL). Tekscan equipment (F-Scan -Trademark) and (HR Walkway - Registered Trademark) 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; each data collection took no more than 1 hour in total.
Sponsors
University of Newcastle (NSW)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No
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 equinus; Osseous anomaly noted in the lower limbs and/or vertebrae during the physical evaluation; Inappropriate footwear for fitting orthoses).
Outcome results
None listed