健常な小児の足底挿板による身体機能および心理的幸福感の改善効果：無作為化比較試験

This study aimed to evaluate the short-term effects of customized arch-support insoles on physical functional performance, physical function, and psychological well-being in asymptomatic, healthy children. In this randomized controlled trial, 45 healthy, asymptomatic children were assigned to a treatment group (customized arch-support insoles) or a control group (no insoles) for 12 weeks. Physical functional performance was assessed by walking speed, stair ascent and descent time, chair rise time, and the Timed Up and Go test. Physical function and psychological well-being were measured using the Pediatric Outcome Data Collection Instrument-Parent and the Child Health Questionnaire-Parent Form 28 (CHQ-PF28). Adverse events related to insole use were monitored. All 45 participants (25 boys and 20 girls; mean age: 5.6 ± 2.5 years) completed the study, and no adverse events were reported. Baseline characteristics were comparable between groups. At 12 weeks, significant between-group differences favored the treatment group for stair ascent (mean difference: 2.01; P = 0.007) and stair descent (mean difference: 2.23; P = 0.007). The treatment group also showed greater improvement in the Pediatric Outcome Data Collection Instrument-Sports and Physical Function subscale (mean difference: 4.5; P = 0.031). No significant between-group differences were observed for the Child Health Questionnaire-Parent Form 28 well-being scores. Customized arch-support insoles were associated with improvements limited to stair-climbing performance, with no measurable effects on overall physical function or psychological well-being over 12 weeks. Although no adverse effects were observed, the additional time and financial costs do not support routine use of customized arch-support insoles in healthy, asymptomatic children.