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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02001844




Registration number
NCT02001844
Ethics application status
Date submitted
25/11/2013
Date registered
5/12/2013
Date last updated
5/12/2013

Titles & IDs
Public title
Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
Scientific title
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).
Secondary ID [1] 0 0
JIA - FOs intervention
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Juvenile Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Trial Foot Orthoses (FOs)
Treatment: Devices - placebo foot orthoses (FOs)

Placebo Comparator: Control - 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.

Experimental: Trial Group - Trial 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.


Treatment: Devices: Trial Foot Orthoses (FOs)
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.

Treatment: Devices: placebo foot orthoses (FOs)
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
gait parameters when barefoot
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
gait parameters with shoes
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
gait parameters with shoes and foot orthoses (FOs)
Timepoint [3] 0 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 equines; 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dr Andrea Coda - Lecturer Podiatry , School of Health & Science - Ourimbah
Recruitment hospital [2] 0 0
University of Newcastle, Podiatry, School of Health & Science - Ourimbah
Recruitment postcode(s) [1] 0 0
2258 - Ourimbah

Funding & Sponsors
Primary sponsor type
Other
Name
University of Newcastle, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queen Margaret University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02001844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02001844