Effectiveness of customised pre-formed foot orthoses in reducing lower limb pain, swollen and tender joints, and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised control trial.

The University of Newcastle0 sites66 target enrollmentAugust 11, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Diagnosed with JIA according to ILAR (International League of Associations for Rheumatology) criteria.
•2\. Age 5 to 18 years old.
•3\. Active lower\-limb joint arthritis involvement.
•4\. No previous use of foot orthoses, or previous failure of foot orthotic management, where the patient has not worn any FOs for a period of at least 3 months.
•5\. Ability to walk a minimum of 15 meters without assistive devices.
•6\. If DMARD and/or Biological therapy are used, not having started these drug therapies within 6 months of enrolling in the trial.

•1\. Inability to walk barefoot or shod.
•2\. Concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders, including Diabetes Mellitus.
•3\. History of lower limb surgery that required general anaesthetic.
•4\. Currently using FOs.
•5\. Where prescription of FOs is contraindicated: for example, less than 12 degrees at sub\-talar joint (STJ) range of motion; fully compensated ankle equinus; significant osseous abnormalities noted in the lower limbs and/or vertebrae during the physical evaluation. Unwillingness to wear appropriate footwear for fitting orthoses.