Arthritis, Juvenile RheumatoidNCT02001844
Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
A study testing Trial Foot Orthoses (FOs) in people with Arthritis, Juvenile Rheumatoid, run by University of Newcastle, Australia at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- What is being tested?
- Trial Foot Orthoses (FOs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- May 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
Ourimbah, New South Wales, 2258
University of Newcastle, Podiatry, School of Health & Science
Ourimbah, New South Wales, 2258
About this study
Official 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).
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.
Read the detailed description
Introduction - Currently there is limited evidence supporting podiatric treatment of children with JIA. The foot orthoses (FOs) prescribed to JIA children so far appeared to be very expensive and required long time to manufacture before the fitting. This randomised controlled trial (RCT) aimed to determine whether pre-formed FOs that can be prescribed at chair side, impacted on pain, quality of life (primary outcomes) and/or gait-parameters (secondary outcomes) in children affected by JIA.
Methods - The study took place at the Gait Analysis laboratory at Queen Margaret University - Edinburgh and at the TORT Centre, Ninewells Hospital-Dundee. Children with JIA were diagnosed according to the ILAR criteria. Intervention was blinded to the patients. The trial group received Slimflex-plus FOs, with the addition of chair side corrections and the control FOs supplied were made with leather board (1mm thick) only. Both FOs had the same black EVA top cover. Primary outcomes were investigated using validated questionnaires (VAS, CHAQ and PedsQL). Tekscan™ equipment (F-Scan™ and HR Walkway®) 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.
- Conditions
- Arthritis, Juvenile Rheumatoid
- Being tested
- Trial Foot Orthoses (FOs), placebo foot orthoses (FOs)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial Foot Orthoses (FOs)Device
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.
placebo foot orthoses (FOs)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Device: placebo foot orthoses (FOs) |
| Trial Group | Experimental | 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. Receives: Device: Trial Foot Orthoses (FOs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
Measured: 6 months
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.
Measured: 6 months
Secondary outcomes (3)
gait parameters when barefoot
Measured: 6 months
gait parameters with shoes
Measured: 6 months
gait parameters with shoes and foot orthoses (FOs)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMay 2009
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Newcastle, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Margaret University
- Responsible party
- Principal investigator, Dr Andrea Coda, University of Newcastle, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001844
- Sponsor's protocol ID
- JIA - FOs intervention
- Status last verified
- Dec 2013
- First submitted
- 25 Nov 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24636956
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT02001844
- Acronym / sponsor ID
- JIA - FOs intervention
- Conditions
- Arthritis, Juvenile Rheumatoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Newcastle, AustraliaUniversity, hospital or other
- Collaborators
- Queen Margaret University
- Study start
- May 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction - Currently there is limited evidence supporting podiatric treatment of children with JIA. The foot orthoses (FOs) prescribed to JIA children so far appeared to be very expensive and required long time to manufacture before the fitting. This randomised controlled trial (RCT) aimed to determine whether pre-formed FOs that can be prescribed at chair side, impacted on pain, quality of life (primary outcomes) and/or gait-parameters (secondary outcomes) in children affected by JIA.
Methods - The study took place at the Gait Analysis laboratory at Queen Margaret University - Edinburgh and at the TORT Centre, Ninewells Hospital-Dundee. Children with JIA were diagnosed according to the ILAR criteria. Intervention was blinded to the patients. The trial group received Slimflex-plus FOs, with the addition of chair side corrections and the control FOs supplied were made with leather board (1mm thick) only. Both FOs had the same black EVA top cover. Primary outcomes were investigated using validated questionnaires (VAS, CHAQ and PedsQL). Tekscan™ equipment (F-Scan™ and HR Walkway®) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: 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. |
| Trial Group | Experimental | Device: Trial Foot Orthoses (FOs)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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Trial Group |
| 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. | Device | Control |
Primary outcome
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
Time frame: 6 months
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.
Time frame: 6 months
3 secondary outcomes
gait parameters when barefoot
Time frame: 6 months
gait parameters with shoes
Time frame: 6 months
gait parameters with shoes and foot orthoses (FOs)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Derived from this study: PubMed 24636956Coda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial Foot Orthoses (FOs) in people with Arthritis, Juvenile Rheumatoid, run by University of Newcastle, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.