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

NCT02001844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-12-05

No results posted yet for this study

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.

Conditions

  • Arthritis, Juvenile Rheumatoid

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Queen Margaret University

    collaborator OTHER

  • University of Newcastle, Australia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001844 on ClinicalTrials.gov