Clinical trial NCT04104555: Orthotics for Treatment of Symptomatic Flat Feet in Children
Official title: Orthotics for Treatment of Symptomatic Flat Feet in Children the OSTRICH Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pes Planus
Keywords: Pes planus
Randomised controlled trial
Orthoses
Exercise
Children
Lead sponsor: University of York
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: University of Salford
name: University of Oxford
name: King's College London
name: University of Warwick
First posted: 2019-09-26
Enrollment: 134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Update 13.12.2021 To mitigate the effects the COVID-19 pandemic, and due to difficulties in sites setting up the custom orthoses arm of the protocol an amendment was approved to change the design of the study from a 3 to a 2 arm trial. The amendment drops the custom orthoses arm and was implemented prior to the start of recruitment.

As a child grows the shape of their foot changes and most develop an arch in their foot. For some, however, the arch does not fully form or it might be flat against the ground. This is known as having flat feet and it can cause pain in the feet, legs, or back. At the moment, we are not sure what the best treatment for flat feet is, so the purpose of this research is to conduct a trial to compare two of the most common treatments. The first is exercise and advice about things like which types of shoes might help. The second of the treatment is a type of insole, which is put inside the shoe.

Participants will receive their treatment as part of their normal National Health System care. We would like 478 children and young people aged between 6 and 14 years old to take part in the study. Everyone will receive advice about the type of shoes to wear, ankle exercises and things to look out for when children have painful flat feet. In addition to this, half of the participants will receive a pre-made insole that is the right size. We will ask for their help for 12 months. During this time, we will track their progress by sending them 3 questionnaires in the post to fill in and weekly text messages to find out how painful their feet are during the first few months. We also want to learn more about the problems that flat feet cause, and children's experiences of the treatments delivered as part of this clinical trial. We will explore this through in-depth conversations with children and their parent(s) or the person who looks after them. Once we have finished the trial, we will work with the people who took part in the trial, and clinicians, to make sure that our results can be used by as many people as possible.

We will run 3 additional studies. The first will find out if having information about the study in the form of a video in addition to information in a paper booklet will increase recruitment rates. The second will find out if sending participants a birthday card will increase the response rates to postal questionnaires. The third study will take a 3D impression of the participant's foot and see if it changes over the course of the study.

Detailed description: The aim of the study is to undertake a large, pragmatic, multi-armed, randomised controlled trial to assess the clinical and cost-effectiveness of prefabricated orthoses in addition to exercises and advice compared with exercises and advice alone on the physical functioning of children with symptomatic flat feet. We will aim to recruit 478 children with flat feet. They will be allocated to one of two groups, in a 1:1 ratio to either (a) prefabricated orthoses plus exercises and footwear advice or (b) exercises and footwear advice only. We will follow the participants up for 12 months after randomisation to assess their physical functioning, levels of pain and quality of life. We will undertake qualitative interviews with approximately 30 children and their parents, to find out about their experiences of having flat feet, and of being in the trial.

In addition to the main OSTRICH study we will undertake two additional trial methodological Studies within a Trial (SWAT) and a sub-study.

The multimedia trial information SWAT: This SWAT will evaluate the effectiveness of including signposting to multimedia trial information in the patient information sheet, which is sent to participants in their recruitment pack.

The birthday card SWAT: This SWAT will evaluate the effectiveness of sending a birthday card to participants on response rates to postal questionnaires.

Foot scan sub-study: This embedded observational sub-study will assess the capability of a 3D scanning approach to identify and stratify severity of pes planus and to assess change in foot shape over the duration of the trial. We will investigate the associations between aspects of foot shape and score on the physical domain scale of the OxAFQ-C.

Eligibility criteria: OSTRICH main trial inclusion criteria:

Potential participants will be included in the trial if they fulfil all of the following criteria:

* Are aged between six and 14 years, inclusive
* Have one or both symptomatic pes planus\*
* The child and/or parent/legal guardian is able to speak, write and understand English
* The parent/legal guardian is able to give informed consent \*Symptomatic pes planus is described as the manifestation of foot and lower limb symptoms, secondary to altered foot alignment (reduced medial longitudinal arch, everted rearfoot and abducted forefoot). The diagnosis will be made pragmatically, by treating clinicians in line with current practice

OSTRICH main trial exclusion criteria:

Potential participants will be excluded from the study if they fulfil any of the following criteria:

* Have a history of major trauma or fracture of the lower leg (below knee)
* Have pes planus secondary to any systematic condition/syndrome\*\* /malignancy
* Have a history of foot and/or ankle surgery
* Require an ankle-foot orthoses or other lower limb device or have received treatment previously for their flat feet

  * This does not exclude children with hypermobility spectrum disorder (HSD) where the manifestation is non-syndromic and isolated (L-HSD), peripheral (P-HSD) or generalised hypermobility (G-HSD)(14).

OSTRICH signposting to multimedia trial information SWAT: inclusion criteria any potential participant identified as eligible to be sent trial information from a site taking part in the SWAT, will be eligible for the study.

OSTRICH birthday card SWAT Inclusion criteria: All participants recruited into the host trial will be eligible to take part in this SWAT. Exclusion criteria: Any participant who has withdrawn from the main OSTRICH study or is not due a follow up questionnaire will be excluded.

Primary outcomes:
measure: Physical domain subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) over the 12 month follow-up period.
timeFrame: For the primary comparison the physical domain subscale will be compared between the groups using a linear covariance pattern mixed model to estimate the effect over the whole 12 month followup, incorporating data from all available time points
Secondary outcomes:
measure: The 'School and Play' domain of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
measure: The 'Emotional' subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
measure: Footwear item of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
timeFrame: Collected at baseline, 3, 6 and 12 months post randomisation
measure: EuroQoL-Five Dimension Youth
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
measure: Child Health Utility 9D (CHU9D)
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
measure: Foot pain score measured by numeric rating scale
timeFrame: Collected once a week for 12 weeks and at baseline, 3, 6 and 12 months post randomisation
measure: Healthcare resource use
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
measure: Foot pain over past week measured by Wong-Baker Faces pain rating scale
timeFrame: Collected at baseline, 3,6 and 12 months post randomisation
Other outcomes:
measure: Proportion of participants who go on to be randomised to the OSTRICH trial.
timeFrame: Post randomisation
measure: Retention to main OSTRICH trial
timeFrame: 3, 6 and 12 months post randomisation
measure: Response rate to the participant follow-up questionnaire at the first time point following receipt of the birthday card
timeFrame: Next followup either , 3, 6 or 12 months post randomisation
measure: Response rate to the participant follow-up paper questionnaire at the 12-month follow-up
timeFrame: 12 months post randomisation
measure: Completeness of host-trial primary outcome measure
timeFrame: 12 months post randomisation
measure: Time to return postal questionnaire
timeFrame: 3, 6 and 12 months post randomisation
measure: Need for questionnaire reminder
timeFrame: 3, 6 and 12 months post randomisation
measure: Qualitative interviews
timeFrame: Interviews will be conducted throughout the study
measure: 3D foot scan
timeFrame: Baseline and at 12 months
Locations:
city: Macclesfield
country: United Kingdom
facility: East Cheshire NHS Trust
state: Cheshire
city: Birmingham
country: United Kingdom
facility: Birmingham Community Healthcare NHS Foundation Trust
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Local Health Board
city: Gillingham
country: United Kingdom
facility: Medway Community Healthcare
city: Goole
country: United Kingdom
facility: North Lincolnshire & Goole NHS Foundation Trust
city: Harrogate
country: United Kingdom
facility: Harrogate and District Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Community Healthcare NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Maidstone
country: United Kingdom
facility: Kent Community Health NHS Foundation Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Lancashire & South Cumbria Nhs Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Solent NHS Trust
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
city: Walsall
country: United Kingdom
facility: Walsall Healthcare NHS Trust
Study officials:
affiliation: University of York
name: David Torgerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.