Every year, roughly 1,085 children with symptomatic flat feet will be randomly assigned to receive either off-the-shelf orthoses, customised orthoses, or standard supportive care alone. This matters because flat feet in children are common, but there is no clear evidence on which treatment—if any—actually reduces pain and improves daily function. GPs and paediatricians currently prescribe orthoses based on habit rather than data, wasting NHS resources and potentially subjecting children to unnecessary devices. If the trial shows that off-the-shelf orthoses work as well as expensive custom ones, the NHS could save significant money on manufacturing and fitting. If neither orthosis outperforms exercise and footwear advice alone, clinical guidelines could shift away from prescribing any orthotic device. The embedded qualitative interviews will also reveal how flat feet affect children’s participation in school and play—information that rarely appears in clinical records. The trial is a pragmatic, multi-centre randomised controlled trial with an internal pilot phase, running for 42 months from June 2019. It includes a process evaluation to understand why clinicians and families do or do not take part.
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Design: A multi-centre, three-armed, pragmatic individually randomised controlled trial. Setting: Any primary or secondary care outpatient clinic providing care for children with symptomatic flat feet (pes planus). Target population: Children aged between six and 16 who have symptomatic pes planus. 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. 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. 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. Primary outcome: Physical domain subscale of the Oxford Ankle Foot Questionnaire for children (OxAFQ-C). 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). 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. Sample size: 1085 in a ratio of 2:2:1 (423:423:239). 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. 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. SWAT: We will undertake at least one recruitment and three retention SWATs. The proposed start date of the trial is the 01.06.2019, and it will be 42 months in duration. Months 1-6 Preparation and submission of documentation for ethics and R&D approval etc. Months 1-3 consensus development phase Months 3-12 Recruitment to internal pilot. To set up four to five sites, recruiting two or more participants a month Continuation to be agreed with funders Month 13- 24 Recruitment to the main trial (based on 30 sites recruiting 3 participants per month each) Month 25-36 follow up Month 37-42 statistical analysis and report writing 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.
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