Award Title: Orthotics for Treatment of Symptomatic Flat Feet in Children (OSTRICH)
Funder: Department of Health and Social Care

Abstract: As a child grows the shape of their foot changes, and most develop an arch in their foot. This doesn’t always happen though, and sometimes the arch does not form, or it might be flat against the ground.  When this happens, it is known as having flat feet. Unfortunately, some of these children get pain in their feet, legs, or back because of their ‘flat feet'.  At the moment we are not sure which is the best treatment for them, so we are going to conduct a trial to compare three of the most common treatments that are used today.  Two of the treatments we are going to test are different types of insoles, which are put inside the child’s shoe. The third treatment is some exercises which we will give children along with some advice about which types of shoes help._x000D_
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If a child and their parent or person who looks after them decide that they would like to take part in the trial, they will receive their treatment as part of their normal NHS care.  We would like 1085 children aged between six and 16 years old to take part in the study.  423 children will receive usual care and insoles that are individually customised for them; 423 will receive insoles that are of the right size but not customised (off the shelf) and 239 will receive usual care (advice on foot and ankle exercise and routing monitoring). We will ask for their help for 12 months.  During this time, we will track their progress by sending them three questionnaires in the post to fill in and we will send them some 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 have caused, and children’s experiences of the treatments delivered as part of the clinical trial. We will explore this through in-depth conversations with children and their parents 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.

Lay Abstract: Design: A multi-centre, three-armed, pragmatic individually randomised controlled trial._x000D_
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Setting: Any primary or secondary care outpatient clinic providing care for children with symptomatic flat feet (pes planus)._x000D_
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Target population: Children aged between six and 16 who have symptomatic pes planus. _x000D_
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Inclusion criteria: Children aged between six and 16; Child and/or parents able to speak and understand English; Have one or both symptomatic flat feet; parent/legal guardian are able to give informed consent._x000D_
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Exclusion criteria: History of major trauma to lower limb; Flat feet secondary to any systematic condition/syndrome/malignancy; History of foot and ankle surgery; Children requiring ankle-foot orthoses or other lower limb device._x000D_
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Health technologies being assessed: (i) Pre-fabricated off-the-shelf orthoses plus usual supportive care; (ii) customised foot orthoses plus usual supportive care; (iii) usual supportive care, which will include a standardised exercise programme and footwear advice.  _x000D_
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Primary outcome: Physical domain subscale of the Oxford Ankle Foot Questionnaire for children (OxAFQ-C). _x000D_
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Secondary outcomes: School and Play, Emotional and Footwear subscales of the OxAFQ-C; EQ5D-Y, text message pain scores sent to child’s parents; Child Health Utility (CHU9D). _x000D_
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Measurement of costs and outcomes: Costs and outcomes will be measured at baseline, three, six and 12 months.  These will be collected using a combination of postal questionnaires and medical records. _x000D_
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Sample size: 1085 in a ratio of 2:2:1 (423:423:239)._x000D_
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Qualitative evaluation: An embedded qualitative study will explore parental and child experiences of symptomatic flat feet, approaches to its management pre trial, and the impact of the symptoms on wider health, participation and family issues. Interviews at the start and end points of the study will provide rich narratives on parent and child experiences. Post trial interviews will also cover the experience and impact of the interventions used. _x000D_
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Internal pilot/feasibility study: In the six months after set-up we will establish the feasibility of main trial in a pilot phase, which will include monitoring recruitment, adherence and completion of three month outcome measures. _x000D_
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SWAT: We will undertake at least one recruitment and three retention SWATs._x000D_
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The proposed start date of the trial is the 01.06.2019, and it will be 42 months in duration.  _x000D_
Months 1-6 Preparation and submission of documentation for ethics and R&D approval etc._x000D_
Months 1-3 consensus development phase  _x000D_
Months 3-12 Recruitment to internal pilot.  To set up four to five sites, recruiting two or more participants a month _x000D_
Continuation to be agreed with funders_x000D_
Month 13- 24 Recruitment to the main trial (based on 30 sites recruiting 3 participants per month each)_x000D_
Month 25-36 follow up_x000D_
Month 37-42 statistical analysis and report writing_x000D_
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05.02.2019 update: We will undertake some additional process evaluation work.  This includes: exploring barriers and facilitators to trial recruitment and experiences of being in the trial;  interviewing clinicians about their experiences of trial recruitment and undertaking 30 observations of clinicians delivering the intervention.

Research Activity Codes: 6.3 MEDICAL DEVICES
Health Categories: MUSCULOSKELETAL