Foot orthoses for children with flat feet (the OSTRICH trial)
Research type
Research Study
Full title
Orthotics for Treatment of Symptomatic Flat Feet in Children - The OSTRICH study
IRAS ID
282832
Contact name
David Torgerson
Contact email
Sponsor organisation
University of York
ISRCTN Number
ISRCTN14602568
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
79, SWAT MRC Northern Ireland Hub for Trials Methodology Research Effect of birthday cards with or without nudge on retention and data completion rates in trials involving children
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Research Summary:
Orthotics and exercises for the treatment of flat feet: the OSTRICH TRIAL
Background
As a child grows the shape of their feet changes and most develop an arch. For some children, the arch does not fully form or may be flat against the ground. If this happens, it is known as having flat feet. Having flat feet can cause pain in the feet, legs or back. At the moment we're not sure what the best treatment is for people with this condition.Aims
We are going to run a trial to compare three of the most common treatments for children with flat feet used in the NHS to find out which is the best. Two of these treatments will test two different types of insoles, which are put inside the shoe. The third treatment involves some exercises and advice about which types of shoes might help.Methods
We would like 1055 children and young people aged between six and 14 years old to take part in the study. Everyone will receive advice about the type of shoes to wear, ankle exercises and routine monitoring. 422 participants will receive a pre-made insole that is the right size and 422 will receive an insole which is individually made for them. We will ask participants for their help for 12 months. During this time they will be asked to fill in some questionnaires and reply to some text messages asking how painful their feet are. We also want to learn more about the problems that flat feet cause and children's experiences of the treatments. We will invite some children/young people and their parents to take part in some in-depth conversations. Once we have finished the trial we will work with the people who provided the trial treatments to get their views on the study treatments.Lay Summary of Results:
Why did we do this trial?
Some children and young people with flat feet seek treatment because their feet cause them problems such as pain. However, we are unsure what the best treatment is. We wanted to find out which of two commonly used treatments is most helpful.What did we do?
One hundred and thirty-four children and young people aged six to 14 years took part in the study. Half were given exercises, advice and insoles to wear in their shoes, and the other half were given exercises and advice. We collected information about any problems they had with their feet or ankles, including pain, for 12 months. We interviewed children and young people, their parents, and healthcare professionals who delivered the treatment to find out their experiences of being in the study.What did we find?
Due to the COVID-19 pandemic there were significant delays in setting up the study and starting recruitment. We planned to enrol 478 people, but this was not possible in the timeframe and it would have cost too much money to recruit for longer, so we had to stop the study. In the interviews people told us that they expected to be given insoles and thought these would work better than the exercises. People who had been given insoles said they thought insoles were easy to use and worked better than exercises. Hardly anyone liked the exercises or thought they worked well. However, healthcare professionals said people had very high expectations of what insoles could do and could be disappointed with the results from insoles.What does this mean?
We do not have enough information to be able to tell which treatment was most helpful. The lessons learned from running the study will help other researchers plan future research studies with similar people.REC name
North East - York Research Ethics Committee
REC reference
20/NE/0173
Date of REC Opinion
6 Aug 2020
REC opinion
Further Information Favourable Opinion