Customized Arch Support Insoles Improve Physical Functional Performance in Children: A Randomized Controlled Study
Abstract The effectiveness of arch-support insoles on children remains controversial. We evaluated the short-term therapeutic effects of arch-support insoles on the physical functional performance, physical function, and psychological well-being of healthy children under the International Classification of Functioning, Disability, and Health (ICF) framework. It was a prospective double-blind randomized controlled study. The participants were randomized into 2 groups, the treatment group (with customized arch-support insoles) and the control group (without insoles) for a 12-week intervention period. The walking speed test, stairs ascent and descent tests, the Five Times Sit-to-Stand test, and the Timed Up and Go test for physical functional performance, and the Pediatric Outcome Data Collection Instrument-Parent (PODCI) and the Child Health Questionnaire-Parent Form (CHQ-PF28) for the physical function and psychological well-being of children were assessed. Forty-five children completed the study. Compared with the control group, after 12 weeks of wearing customized insoles, the treatment group exhibited significant improvement in physical functional performance in terms of fastest walking speed (effect size: .515, P = .046), stairs ascent time (effect size: .658, P = .023), and stairs descent time (effect size: .718, P = .012). No significant difference was found between PODCI and CHQ-PF28 scores.Conclusions: Children wearing customized arch-support insoles for 12 weeks improved their physical functional performance which belonged to the domain of activity in the ICF. However, using insoles did not affect the physical function and psychological well-being of children.ClinicalTrials.gov (NCT03198299), date of registration: June 2017, retrospectively registered.