Orthotics for Treatment of Symptomatic Flat Feet in Children

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.

Conditions

• Pes Planus

Interventions

OTHER

Birthday card

Birthday card sent to participants in the post

DEVICE

Prefabricated orthoses

Prefabricated insole

OTHER

Signposting to multimedia

Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.

OTHER

Usual supportive care - exercises and footwear advice (the comparator)

Active comparator

Sponsors & Collaborators

• University of Leeds

  collaborator OTHER

• University of Salford

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of Warwick

  collaborator OTHER

• University of York

  lead OTHER

Principal Investigators

• David Torgerson, PhD · University of York

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-21

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• United Kingdom

Study Locations