Orthotics for Treatment of Symptomatic Flat Feet in Children
Condition: Pes Planus
MeSH terms: Flatfoot
Study type: Interventional

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.
    

Intervention name(s): Birthday card; Prefabricated orthoses; Signposting to multimedia; Usual supportive care - exercises and footwear advice (the comparator)
Intervention type(s): Other; Device; Other; Other
Intervention description(s): Birthday card sent to participants in the post; Prefabricated insole; Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.; Active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pes planus; Randomised controlled trial; Orthoses; Exercise; Children