Effectiveness of Custom-Made Foot Orthoses Versus Standard Footwear in Children with Symptomatic Flexible Flatfoot: A Randomized Controlled Trial

Abstract

Background: Flexible flatfoot is a common musculoskeletal condition in children, often asymptomatic but in some cases associated with pain, gait abnormalities, and functional limitations. Conservative management strategies remain debated, with standard footwear frequently recommended under the assumption of natural arch development, while orthoses are widely prescribed to provide support and symptom relief. High-quality evidence comparing these interventions in symptomatic pediatric populations remains limited. Objective: To evaluate the effectiveness of custom-made foot orthoses compared with standard footwear in reducing pain and improving function in children with symptomatic flexible flatfoot. Methods: A randomized controlled trial was conducted at a rehabilitation clinic involving 50 children aged 7–12 years diagnosed with symptomatic flexible flatfoot. Participants were randomly assigned to receive either custom-made orthoses (n=25) or standard footwear (n=25) for 12 weeks. Pain was assessed using the Visual Analog Scale (VAS) and function with the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C). Secondary outcomes included gait observations and parental satisfaction. Data were analyzed using t-tests and chi-square tests, with p<0.05 considered significant. Results: The orthoses group showed greater reductions in pain (−4.7 vs −2.4, mean difference −2.3, 95% CI −3.0 to −1.6, p<0.001) and larger functional improvements (+26.3 vs +14.8, mean difference 11.5, 95% CI 7.9–15.1, p=0.003). Parental satisfaction was higher in the orthoses group (84% vs 64%, p=0.02). Conclusion: Custom-made foot orthoses provided superior short-term pain reduction, functional improvement, and caregiver satisfaction compared with standard footwear. Orthoses should be considered a first-line conservative intervention for symptomatic flexible flatfoot in children.