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Trial registered on ANZCTR


Registration number
ACTRN12613001336774
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
6/12/2013
Date last updated
6/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Foot Orthoses (FOs) on Pain, Quality of Life and Gait with Children Diagnosed with Juvenile Idiopathic Arthritis (JIA).
Scientific title
A single blinded randomised controlled trial, to investigate the clinical effectiveness of preformed semi-rigid foot orthoses, on pain, quality of life and the dynamics of gait of patients diagnosed with juvenile idiopathic arthritis (JIA)
Secondary ID [1] 283691 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis (JIA) 290656 0
Condition category
Condition code
Inflammatory and Immune System 291035 291035 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288391 0
Treatment: Devices
Comparator / control treatment
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.
Control group
Placebo

Outcomes
Primary outcome [1] 291020 0
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology using the Visual Analogue Scale (VAS)
Timepoint [1] 291020 0
6 months
Primary outcome [2] 291021 0
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology using the questionnaires PedsQL.
Timepoint [2] 291021 0
6 months
Secondary outcome [1] 305854 0
JIA gait parameters when barefoot such as plantar pressure analysis, stance time and velocity, utilising the HR Walkway system.
Timepoint [1] 305854 0
6 months
Secondary outcome [2] 305855 0
JIA gait parameters with shoes (without FOs) such as plantar pressure analysis utilizing the F-Scan system
Timepoint [2] 305855 0
6 months
Secondary outcome [3] 305856 0
JIA gait parameters with shoes and with FOs, such as plantar pressure analysis utilizing the F-Scan system.
Timepoint [3] 305856 0
6 months

Eligibility
Key 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.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants were recruited from the Paediatric Rheumatology Department of the Royal Hospital for Sick Children, Edinburgh; and from the Paediatric Rheumatology Clinic in Ninewells Hospital, Dundee in 2011 and 2012. The Paediatric Rheumatologists identified the patients who were eligible and met all the inclusion and exclusion criteria. After obtaining informed consent, children were randomised in blocks by online computer random number generator (www.randomization.com) to wear fitted FOs or control FOs.
Verbal and written consent was sought both from the child and parent (carer). Each participant was able to withdraw from the study at any time without providing any explanation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
children were randomised by online computer random number generator to wear fitted FOs or control FOs. Given uncertainty around the potential for recruiting to the trial, block randomisation was used to limit the risk of biased allocation in the light of either poor recrutiment or the study finishing early.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical differences between the control and trial groups were compared at 3 time points (baseline, 3 and 6 months). All data showed a non-parametric distribution hence a Mann-Whitney U test was used for the pairwise comparisons.
For a 5% 2-sided t-test with a=0.05 and power 80% for a RCT design with baseline and 2 post-intervention observations, and a moderate effect size, it was estimated that a total of 46 JIA children would be required (23 controls and 23 trial).
The study was overpowered to an estimated 30 participants per group to allow for potential dropouts during the 6 months data collection period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2009
Actual
30/10/2009
Date of last participant enrolment
Anticipated
29/10/2010
Actual
29/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5664 0
United Kingdom
State/province [1] 5664 0
Scotland

Funding & Sponsors
Funding source category [1] 288378 0
University
Name [1] 288378 0
University of Newcastle - NSW, Australia
Country [1] 288378 0
Australia
Primary sponsor type
University
Name
University of Newcastle (NSW)
Address
Dr Andrea Coda
Lecturer Podiatry
School of Health & Science
PO Box 127 - Ourimbah
NSW 2258 - Australia
Country
Australia
Secondary sponsor category [1] 287082 0
Individual
Name [1] 287082 0
Dr Andrea Coda
Address [1] 287082 0
Dr Andrea Coda
Lecturer Podiatry
School of Health & Science
PO Box 127 - Ourimbah
NSW 2258 - Australia
Country [1] 287082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290261 0
NHS Lothian (Scotland)
Ethics committee address [1] 290261 0
Ethics committee country [1] 290261 0
United Kingdom
Date submitted for ethics approval [1] 290261 0
08/05/2009
Approval date [1] 290261 0
12/05/2009
Ethics approval number [1] 290261 0
REC no: 09/S1101/21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44730 0
Dr Andrea Coda
Address 44730 0
Lecturer Podiatry
School of Health & Science
University of Newcastle
PO Box 127 - Ourimbah
NSW 2258 - Australia
Country 44730 0
Australia
Phone 44730 0
+61456444842
Fax 44730 0
Email 44730 0
Andrea.Coda@newcastle.edu.au
Contact person for public queries
Name 44731 0
Andrea Coda
Address 44731 0
Lecturer Podiatry
School of Health & Science
University of Newcastle
PO Box 127 - Ourimbah
NSW 2258 - Australia
Country 44731 0
Australia
Phone 44731 0
+61456444842
Fax 44731 0
Email 44731 0
Andrea.Coda@newcastle.edu.au
Contact person for scientific queries
Name 44732 0
Andrea Coda
Address 44732 0
Lecturer Podiatry
School of Health & Science
University of Newcastle
PO Box 127 - Ourimbah
NSW 2258 - Australia
Country 44732 0
Australia
Phone 44732 0
+61456444842
Fax 44732 0
Email 44732 0
Andrea.Coda@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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