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Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Trial Foot Orthoses (FOs)
placebo foot orthoses (FOs)
Sponsored by
University of Newcastle, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

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).

Sites / Locations

  • Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
  • University of Newcastle, Podiatry, School of Health & Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Trial Group

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.

Secondary Outcome Measures

gait parameters when barefoot
gait parameters with shoes
gait parameters with shoes and foot orthoses (FOs)

Full Information

First Posted
November 25, 2013
Last Updated
December 3, 2013
Sponsor
University of Newcastle, Australia
Collaborators
Queen Margaret University
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1. Study Identification

Unique Protocol Identification Number
NCT02001844
Brief Title
Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA
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).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Newcastle, Australia
Collaborators
Queen Margaret University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Trial Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Trial Foot Orthoses (FOs)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
placebo foot orthoses (FOs)
Intervention Description
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.
Primary Outcome Measure Information:
Title
effects of pre-formed semi-rigid FOs on Pain in Paediatric Rheumatology.
Time Frame
6 months
Title
effects of pre-formed semi-rigid FOs on Quality of Life in Paediatric Rheumatology.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
gait parameters when barefoot
Time Frame
6 months
Title
gait parameters with shoes
Time Frame
6 months
Title
gait parameters with shoes and foot orthoses (FOs)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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).
Facility Information:
Facility Name
Dr Andrea Coda - Lecturer Podiatry , School of Health & Science
City
Ourimbah
State/Province
New South Wales
ZIP/Postal Code
2258
Country
Australia
Facility Name
University of Newcastle, Podiatry, School of Health & Science
City
Ourimbah
State/Province
New South Wales
ZIP/Postal Code
2258
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24636956
Citation
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.
Results Reference
derived

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Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA

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