Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
Single Blinded RCT to Investigate the Clinical Effectiveness of Pre-formed Semi-rigid Foot Orthoses (FOs) on Pain, Quality of Life and Dynamic of Gait With Children Diagnosed With Juvenile Idiopathic Arthritis (JIA).
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedDecember 5, 2013
December 1, 2013
3.5 years
November 25, 2013
December 3, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
6 months
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.
6 months
Secondary Outcomes (3)
gait parameters when barefoot
6 months
gait parameters with shoes
6 months
gait parameters with shoes and foot orthoses (FOs)
6 months
Study Arms (2)
Control
PLACEBO COMPARATORThe 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
EXPERIMENTALTrial 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Newcastle, Australialead
- Queen Margaret Universitycollaborator
Study Sites (2)
Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
Ourimbah, New South Wales, 2258, Australia
University of Newcastle, Podiatry, School of Health & Science
Ourimbah, New South Wales, 2258, Australia
Related Publications (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. Arch Dis Child. 2014 Jul;99(7):649-51. doi: 10.1136/archdischild-2013-305166. Epub 2014 Mar 17.
PMID: 24636956DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 5, 2013
Study Start
May 1, 2009
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
December 5, 2013
Record last verified: 2013-12