The shape of a child’s foot changes as they grow, with most developing an arch in their foot. However, when the arch does not fully form or it is flat against the ground, this is called pes planus, or flat feet. Pes planus can result in pain in the feet, ankles, legs, or back, with it being one of the most common conditions seen in paediatric practice. Currently, it is not clear what the most effective management for pes planus is, with it being debated as to whether there should be intervention provided or whether symptoms will resolve without intervention. Common management options for pes planus are orthoses (insoles), which can be custom-made or pre-fabricated, and exercise and advice about shoe types.
The OSTRICH study is investigating the effectiveness of custom-made and prefabricated orthoses in addition to exercise and advice compared with exercise and advice alone on the physical functioning of children with symptomatic pes planus. We aim to recruit 1085 children/young people aged 6 to 14 years of age, who will be randomised in a 2:2:1 ratio in favour of the orthoses groups (i.e. 423 will receive prefabricated orthoses plus exercise and advice, 423 will receive custom-made orthoses plus exercise and advice, and 239 will receive exercise and advice alone). The primary outcome is the physical domain of the Oxford Ankle Foot Questionnaire for Children over the 12 month follow-up period.
The study is being coordinated by researchers at the York Trials Unit at the University of York, in collaboration with researchers at the University of Salford, University of Oxford, University of Brighton, University of Leeds and Leeds Teaching Hospitals NHS Trust, in addition to input from our patient representatives. The research is funded by the National Institute for Health Research Health Technology Assessment Programme, with Professor David Torgerson as the Chief Investigator.
Two methodological studies are also embedded – Studies Within A Trial (SWATs).
NIHR Health Technology Assessment (HTA)
(Project number: NIHR127510)
University of York
|Start Date:||June 2019|
|End Date:||December 2022|