None listed
Conditions
Brief summary
This randomised control trial will aim to explore the effectiveness of pre-formed, semi-rigid, customised foot orthoses (FOs) in reducing pain; improving quality of life; reducing swelling and tenderness; and improving gait parameters in children suffering from active lower limb involvement in juvenile idiopathic arthritis (JIA). Hypotheses: Primary Outcomes 1. Pre-formed FOs will reduce lower limb pain using visual analogue scale (VAS) in children with JIA Secondary Outcomes 1. Pre-formed FOs will improve quality of life in children with JIA using the Pediatric Quality of Life Questionnaire™ (PedsQL) Rheumatology Module – version 3.0 for children and parents. 2. Pre-formed FOs will improve foot disability in children with JIA using the Juvenile Arthritis Foot Disability Index (JAFI). 3. Pre-formed FOs will reduce localised swelling and tenderness of lower limb joints in children with JIA by visual inspection and palpation. 4. Pre-formed FOs will have an effect on quantitative kinematic and kinetic parameters of gait in children with JIA when barefoot, with shoes alone, and with shoes and FOs. Participant's who are eligible and consent to partake in the research based on the study's inclusion and exclusion criteria will be randomised into two groups. Thirty-three participants will be allocated to the trial intervention group, and the remaining thirty-three will be allocated to the control group. The trial group will receive a pre-formed, semi-rigid, customised foot orthoses, while the control group will receive a placebo device made from basic materials. The control orthoses will be made to resemble standard innersoles in athletic-style footwear. To help prevent participant's on knowing their allocated interventions, the top covers of both the trial and control groups will be made from the same materials. The participant's will be required to wear their allocated interventions for a maximum of 12 months. Primary outcome will be assessed at baseline,4-weeks, 3,6 and 12 months, Quality of life and foot disability will be assessed at baseline, 3,6 and 12 months. Joint swelling and tenderness, and gait parameters will be assessed at baseline, 3 and 6 months. Please note that one previous study was done with a similar methodological approach.(which was given a Clinical Trial ID with Clinicaltrials.gov: NCT02001844) [1]. This particular randomised control trial is unique to this previous study as it will investigate the effectiveness of foot orthoses in the treatment of swollen and tender lower limb joints. It will also be the first study to investigate any type of foot orthoses beyond 6 months in children with JIA. 1. Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.
Interventions
Those patients that meet all the inclusion and exclusion criteria, wishing to participate in the study will be asked to sign the consent form and a study participation number will be assigned. Only for those patients who require foot orthoses (FOs) intervention (as per inclusion criteria) will be allowed to take part to the study, and they will be asked to agree to wear the FOs for twelve months. Any participant may withdraw from the study at anytime without giving any reasons.
Following gait a
Those patients that meet all the inclusion and exclusion criteria, wishing to participate in the study will be asked to sign the consent form and a study participation number will be assigned. Only for those patients who require foot orthoses (FOs) intervention (as per inclusion criteria) will be allowed to take part to the study, and they will be asked to agree to wear the FOs for twelve months. Any participant may withdraw from the study at anytime without giving any reasons. Following gait analysis examination, those in the trial group will receive a unique customised semi-rigid pre-formed functional device with the same Dual Opulex performance 1.5mm material made from a neoprene base and a stretch nylon top cover (same as control FOs). The prescription of the FOs will be customised according to each individual biomechanical need, and supplied on the same day of the initial assessment. To customise the foot orthoses the research clinician will conduct a full biomechanical analysis that will involve both walking gait analysis and physical examination of lower limb joints, particularly of the foot and ankle. Once information is gathered to justify what type of customisation is needed, the same research clinician will use an on-site orthoses lab to make the necessary modifications. One chief investigator (PhD student + 3 years experience as clinical podiatrist) will be responsible for the prescription of the trial intervention during the data collection period. All participants will be required to wear the FOs for 12 months, with follow-up consultations of 3 and 6 months. At 4 weeks; participants and parents will be required to complete the self-reported primary outcome pain. At 12 months participants and parents will be required to complete all self-reported outcomes including pain, quality of life and foot disability. As these outcomes are self-assessed, they do not require a research consultation. To monitor adherence to the intervention the chief researcher will check the integrity of the top-cover (at follow-up intervals) which will give an indication of compliance as it starts to produce a dynamic foot pressure indicative of usage after approximately 1 week of wear. In addition; participants will be required to fill out a simple diary each week to indicate how many days per week they wore their allocated foot orthoses. The prescription of the trial foot orthoses will occur at any of the following sites: - Sydney Children's Network Hospital (Randwick and Westmead) Randwick - High Street Randwick NSW 2031 Westmead - Cnr Hawkesbury Road and Hainsworth Street, Westmead - John Hunter Children's Hospital Kookaburra Circuit, New Lambton Heights NSW 2305
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed