The effects of Customized Arch Support Insoles for Children with developmental delays: A Prospective, Single-blind, Randomized Controlled Study

Abstract

Abstract Using arch support insoles for children with motor developmental delays requires further evidence. This study aims to evaluate the short-term effects of customized arch support insoles on these children, adopting the International Classification of Functioning, Disability, and Health (ICF) framework for our analysis. Participants were randomly assigned to either the treatment group, which received customized insoles, or the control group (waitlisted), which did not receive any insoles during a 12-week intervention. The primary outcome focused on physical health, measured using the Pediatric Outcome Data Collection Instrument-Parent (PODCI). Secondary outcomes included balance (measured via the Berg Balance Scale), physical functional performance (10-meter walking test, stair climbing test, and Timed Up and Go test), and health-related quality of life (assessed using the Pediatric Quality of Life Inventory, PedsQL). A significant improvement was observed in the regular walking speed of the treatment group compared to the control group (0.13 m/s vs. 0.013 m/s, P < .001), and nearly met the criteria for minimal clinically important difference. However, no significant differences were noted between the groups regarding changes in scores from the PODCI, Berg Balance Scale, Timed Up and Go test, most physical functional performance, and PedsQL. Conclusion: The 12-week use of customized arch support insoles in children with motor developmental delays showed a marginal improvement in regular walking speed, and the improvement did not extend to physical health status, most physical functional performance, or health-related quality of life. Thus, we do not recommend arch support insoles for children with motor developmental delays. Trial registration ClinicalTrials.gov: NCT03191006 (Registered June 22, 2017).