Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001082493
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
11/08/2016
Date last updated
28/01/2020
Date data sharing statement initially provided
28/01/2020
Date results information initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of foot orthoses in children with juvenile idiopathic arthritis: a randomised control trial.
Scientific title
Effectiveness of customised pre-formed foot orthoses in reducing lower limb pain, swollen and tender joints, and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised control trial.
Secondary ID [1] 289865 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 299809 0
Condition category
Condition code
Inflammatory and Immune System 299738 299738 0 0
Other inflammatory or immune system disorders
Musculoskeletal 299771 299771 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those patients that meet all the inclusion and exclusion criteria, wishing to participate in the study will be asked to sign the consent form and a study participation number will be assigned. Only for those patients who require foot orthoses (FOs) intervention (as per inclusion criteria) will be allowed to take part to the study, and they will be asked to agree to wear the FOs for twelve months. Any participant may withdraw from the study at anytime without giving any reasons.
Following gait analysis examination, those in the trial group will receive a unique customised semi-rigid pre-formed functional device with the same Dual Opulex performance 1.5mm material made from a neoprene base and a stretch nylon top cover (same as control FOs). The prescription of the FOs will be customised according to each individual biomechanical need, and supplied on the same day of the initial assessment. To customise the foot orthoses the research clinician will conduct a full biomechanical analysis that will involve both walking gait analysis and physical examination of lower limb joints, particularly of the foot and ankle. Once information is gathered to justify what type of customisation is needed, the same research clinician will use an on-site orthoses lab to make the necessary modifications.
One chief investigator (PhD student + 3 years experience as clinical podiatrist) will be responsible for the prescription of the trial intervention during the data collection period. All participants will be required to wear the FOs for 12 months, with follow-up consultations of 3 and 6 months. At 4 weeks; participants and parents will be required to complete the self-reported primary outcome pain. At 12 months participants and parents will be required to complete all self-reported outcomes including pain, quality of life and foot disability. As these outcomes are self-assessed, they do not require a research consultation.
To monitor adherence to the intervention the chief researcher will check the integrity of the top-cover (at follow-up intervals) which will give an indication of compliance as it starts to produce a dynamic foot pressure indicative of usage after approximately 1 week of wear. In addition; participants will be required to fill out a simple diary each week to indicate how many days per week they wore their allocated foot orthoses.

The prescription of the trial foot orthoses will occur at any of the following sites:

- Sydney Children's Network Hospital (Randwick and Westmead)
Randwick - High Street Randwick NSW 2031
Westmead - Cnr Hawkesbury Road and Hainsworth Street, Westmead

- John Hunter Children's Hospital
Kookaburra Circuit, New Lambton Heights NSW 2305
Intervention code [1] 295551 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will receive a flat insole without rearfoot or forefoot corrections, and without any modifications that may impact on plantar pressure distribution.The control device top cover will be made from Dual Opulex performance 1.5mm material consisting of a neoprene base and a stretch nylon top. The base of the control device will be made from a 1mm leather board.
The top cover is representative of standard insole appearance regularly supplied by podiatrists.
With regards to compliance the top-cover will also give an indication of compliance as it starts to produce a dynamic foot pressure indicative of usage after approximately 1 week of wear. In addition; participants will be required to fill out a simple diary each week to indicate how many days per week they wore their allocated foot orthoses.
Control group
Placebo

Outcomes
Primary outcome [1] 299206 0
PAIN: 100mm Visual Analogue Scale (VAS). The 100mm VAS will be used to measure the primary outcome in this RCT. Participants will be asked to rate their level of pain by drawing a vertical line on a 100mm horizontal scale. The left end point of the scale represents no pain, and the right end point represents the worst pain imaginable. The higher the score indicates more pain and vice versa for a lower score. The participant's pain levels will be scored out of 100 each time it's measured. A clinically important difference is considered when there is a difference of more than 8mm between each interval. Dhanani S, Quenneville J, Perron M, et al. Minimal difference in pain associated with change in quality of life in children with rheumatic disease. Arthritis Rheum 2002;47:501–5.
Timepoint [1] 299206 0
Pain will be measured using the VAS for the following follow-ups:
1. Baseline, prescription/allocation of foot orthoses
2. 4 weeks post prescription/allocation of foot orthoses
3. 3 months post prescription/allocation of foot orthoses (Primary Timepoint)
4. 6 months post prescription/allocation of foot orthoses.
5. 12 months post prescription/allocation of foot orthoses
Secondary outcome [1] 326506 0
SWELLING and TENDERNESS: The first of the secondary outcomes measured in this study will be the count of swollen and tender joints. No research currently exists that explores the effectiveness of a mechanical therapy alone in the reduction of lower limb swollen and tender joints in children with JIA. The assessment tool that will be used to measure swollen and tender joints will be the tool that was developed by Helliwell et al (2007) for the assessment of swollen and tender joints in adult rheumatoid arthritis. This tool will be modified and will include the: hip; knee; ankle; sub-talar; talo-navicular; calcaneo-cuboid; metatarsophalangeal; and finally the proximal and distal interphalangeal joints. Each side of the lower limb will have twenty individual joints to count for both swelling and tenderness. Joint count for swelling and tenderness will be recorded at baseline and 6 month follow-up assessments.
Timepoint [1] 326506 0
1. Baseline, prescription/allocation of foot orthoses
2. 6 months post prescription/allocation of foot orthoses
Secondary outcome [2] 326509 0
Gait Analysis

For both groups, secondary outcome data (gait analysis) will be collected at baseline, 3 months and 6 months using F-Scan insole and HR Mat (Tekscan Trademark, Boston, USA). Both systems are equipped with exactly the same sensors resolution allowing for data analysis comparison.
A randomised sequence of the gait analysis state will be recorded, amongst barefoot, shoes alone, and shoes and control/trial FOs. This procedure will account for fatigue potentially exhibited by symptomatic JIA children during acquisition of gait data in both groups.
The equipment will be set up according to the manufacturer instructions before the start of the trial. The equipment will be calibrated before each recording is taken for each participant.
Timepoint [2] 326509 0
1. Baseline, prescription/allocation of foot orthoses

2. 3 months post prescription/allocation of foot orthoses

3. 6 months post prescription/allocation of foot orthoses
Secondary outcome [3] 342416 0
Quality of life is another secondary outcome and will be measured using the Pediatric Quality of Life 3.0 Questionnare (PedsQL), a validated tool for use in children with arthritis and their parents/guardians. There are two PedsQL questionnaires that can be used for children with rheumatic disease. The PedsQL 3.0 Rheumatology Module scales which is more specific for children with JIA by measuring their pain and hurt, daily activities, treatment, worry, and communication. In this clinical trial only the PedsQL 3.0 Rheumatology Module will be used. Both participants and parents are required to complete this questionnaire. The PedsQL questionnaire is scored out of 100 points. A clinical important difference is considered when there is a 5 point difference between time intervals. Unlike the 100mm VAS pain score, a higher score on the PedsQL indicates a better quality of life, and therefore a more favourable outcome. The PedsQL will be self-reported by both the participants and parents/guardians, therefore assessors will be blinded to this outcome.
Timepoint [3] 342416 0
Measured at:
1. Baseline
2. 3-months
3. 6-months
4. 12-months
Secondary outcome [4] 342417 0
FOOT DISABILITY. The Juvenile Arthritis Foot Disability Index (JAFI) will be used to assess foot disability. The JAFI questionnaire comprises of 3 sections (27 responses) focusing on foot related questions regarding impairment, activity limitation and participation restriction. The JAFI is only completed by the child or adolescent with JIA.
Timepoint [4] 342417 0
1. Baseline
2. 3-months
3. 6-months
4. 12-months

Eligibility
Key inclusion criteria
1. Diagnosed with JIA according to ILAR (International League of Associations for Rheumatology) criteria.
2. Age 5 to 18 years old.
3. Active lower-limb joint arthritis involvement.
4. No previous use of foot orthoses, or previous failure of foot orthotic management, where the patient has not worn any FOs for a period of at least 3 months.
5. Ability to walk a minimum of 15 meters without assistive devices.
6. If DMARD and/or Biological therapy are used, not having started these drug therapies within 6 months of enrolling in the trial.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to walk barefoot or shod.
2. Concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders, including Diabetes Mellitus.
3. History of lower limb surgery that required general anaesthetic.
4. Currently using FOs.
5. Where prescription of FOs is contraindicated: for example, less than 12 degrees at sub-talar joint (STJ) range of motion; fully compensated ankle equinus; significant osseous abnormalities noted in the lower limbs and/or vertebrae during the physical evaluation. Unwillingness to wear appropriate 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)
Allocation concealment will be achieved by using sequentially numbered, opaque and sealed envelopes. Both sequence generation and allocation concealment will be conducted by a research team member. During this independent allocation process, the research team member will not be involved at any stage as part of the recruitment process, orthotic prescription of the control or trial intervention; data collection and will not have any prior or ongoing contact with enrolled participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Immediately after consent is obtained; participants will be randomly allocated in blocks of 10, to either a control or trial group. Their allocation to each group will be achieved with a pre-determined generated list. This will be achieved using a computer random number generator (https://www.random.org/sequences/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Currently, there are insufficient data to conduct power calculations for each outcome. However, sufficient data are available with regards to pain outcome. Power calculations are therefore based on the outcome of pain measured on a 100mm VAS, with a minimal clinical significance of 8mm (Dhanani et al. 2002). For a 2-sided t-test with a=0.05 and power 80% for a randomised control trial design with baseline and primary outcome of difference between the groups at 12 months, and a moderate effect size of 0.6, it was estimated that a total of 90 participants would be required (45 controls and 45 trial) on a ratio of 1:1 allocation (Noordzij et. al 2010; Cohen 1988). This was adjusted with an ANCOVA using an assumed correlation of 0.6 giving an adjusted total number of participants required of 60 (30 controls and 30 trial). The study will be overpowered to an estimated 66 (that is, 33 participants per group) to allow for 10% dropouts during the 12 months’ data collection period.

Data Analysis
All data collected during the study from baseline, 3, 6 and 12 months will be represented graphically using the histograms and/or box-plots. Normality will be checked using the Shapiro Wilks test. Where the variable presents ordinal data, the appropriate non-parametric test will be used. A series of between and within group analyses will be carried out. Analyses will be conducted with intention to treat.
Comparison between control and trial Group
To test the hypothesis, the control group will be compared with the trial group. Pair wise statistical analysis will be carried out using an unpaired t-test or Mann Whitney U test, depending on the distribution of the data.
Within each individual Group Analysis
To investigate the relationships between the groups at baseline, 3, 6 and 12 months, a repeated measures ANOVA will be carried out for parametric data where sphericity exist; or a Friedman test where non-parametric and/or no-sphericity exists.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
1/02/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
24/06/2019
Date of last data collection
Anticipated
24/06/2020
Actual
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6429 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 6430 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 6431 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 13973 0
2145 - Westmead
Recruitment postcode(s) [2] 13974 0
2031 - Randwick
Recruitment postcode(s) [3] 13975 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 294252 0
University
Name [1] 294252 0
The University of Newcastle
Country [1] 294252 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan
NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 293084 0
None
Name [1] 293084 0
Address [1] 293084 0
Country [1] 293084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295682 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295682 0
Lookout Road
New Lambton NSW 2305
Postal address:
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 295682 0
Australia
Date submitted for ethics approval [1] 295682 0
22/08/2016
Approval date [1] 295682 0
01/11/2016
Ethics approval number [1] 295682 0
HNEHREC Reference No: 16/09/21/4.03

Summary
Brief summary
This randomised control trial will aim to explore the effectiveness of pre-formed, semi-rigid, customised foot orthoses (FOs) in reducing pain; improving quality of life; reducing swelling and tenderness; and improving gait parameters in children suffering from active lower limb involvement in juvenile idiopathic arthritis (JIA).
Hypotheses:
Primary Outcomes
1. Pre-formed FOs will reduce lower limb pain using visual analogue scale (VAS) in children with JIA
Secondary Outcomes
1. Pre-formed FOs will improve quality of life in children with JIA using the Pediatric Quality of Life Questionnaire™ (PedsQL) Rheumatology Module – version 3.0 for children and parents.
2. Pre-formed FOs will improve foot disability in children with JIA using the Juvenile Arthritis Foot Disability Index (JAFI).
3. Pre-formed FOs will reduce localised swelling and tenderness of lower limb joints in children with JIA by visual inspection and palpation.
4. Pre-formed FOs will have an effect on quantitative kinematic and kinetic parameters of gait in children with JIA when barefoot, with shoes alone, and with shoes and FOs.

Participant's who are eligible and consent to partake in the research based on the study's inclusion and exclusion criteria will be randomised into two groups. Thirty-three participants will be allocated to the trial intervention group, and the remaining thirty-three will be allocated to the control group. The trial group will receive a pre-formed, semi-rigid, customised foot orthoses, while the control group will receive a placebo device made from basic materials. The control orthoses will be made to resemble standard innersoles in athletic-style footwear. To help prevent participant's on knowing their allocated interventions, the top covers of both the trial and control groups will be made from the same materials.

The participant's will be required to wear their allocated interventions for a maximum of 12 months. Primary outcome will be assessed at baseline,4-weeks, 3,6 and 12 months, Quality of life and foot disability will be assessed at baseline, 3,6 and 12 months. Joint swelling and tenderness, and gait parameters will be assessed at baseline, 3 and 6 months.

Please note that one previous study was done with a similar methodological approach.(which was given a Clinical Trial ID with Clinicaltrials.gov: NCT02001844) [1]. This particular randomised control trial is unique to this previous study as it will investigate the effectiveness of foot orthoses in the treatment of swollen and tender lower limb joints. It will also be the first study to investigate any type of foot orthoses beyond 6 months in children with JIA.
1. Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.
Trial website
Trial related presentations / publications
The protocol for this randomised control trial has been accepted for publication in BMJ Open Paediatrics.

Full Citation: Fellas A, Singh-Grewal D, Chaitow J, Santos D, Coda A. Effectiveness of preformed foot orthoses in reducing lower limb pain, swollen and tender joints and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised controlled trial (Protocol). BMJ Paediatrics Open. 2017 Nov 1;1(1):e000121.
Public notes

Contacts
Principal investigator
Name 68066 0
Mr Antoni Fellas
Address 68066 0
The University of Newcastle, University Drive, Callaghan
NSW 2308, Australia
Country 68066 0
Australia
Phone 68066 0
+61402134787
Fax 68066 0
Email 68066 0
[email protected]
Contact person for public queries
Name 68067 0
Mr Antoni Fellas
Address 68067 0
The University of Newcastle, University Drive, Callaghan
NSW 2308, Australia
Country 68067 0
Australia
Phone 68067 0
+61402134787
Fax 68067 0
Email 68067 0
[email protected]
Contact person for scientific queries
Name 68068 0
Mr Antoni Fellas
Address 68068 0
The University of Newcastle, University Drive, Callaghan
NSW 2308, Australia
Country 68068 0
Australia
Phone 68068 0
+61402134787
Fax 68068 0
Email 68068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any raw data that was collected from participants that researchers wish to access within good reason will be shared. This includes all primary and secondary outcome data acquired.
When will data be available (start and end dates)?
Data will be made available following publication, with no end date determined.
Available to whom?
Data will only be shared to researchers who require it for studies including but not limited to systematic reviews with or without meta-analysis, scoping reviews.
Available for what types of analyses?
Raw data can be available for any purpose but will most likely be suitable for meta-analyses in systematic reviews.
How or where can data be obtained?
Principle investigator - Antoni Fellas - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6632Study protocolFellas A, Singh-Grewal D, Chaitow J, Santos D, Coda A. Effectiveness of preformed foot orthoses in reducing lower limb pain, swollen and tender joints and in improving quality of life and gait parameters in children with juvenile idiopathic arthritis: a randomised controlled trial (Protocol). BMJ paediatrics open. 2017;1(1).   371252-(Uploaded-06-01-2020-10-10-20)-Study-related document.pdf



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