Efficacy Of Custom-Fitted Footwear To Increase Physical Activity In Children And Adolescents With Down Syndrome (Shoefit): Randomised Pilot Study

Purpose: To determine the feasibility of conducting a definitive randomised trial to evaluate the efficacy of custom-fitted footwear for increasing physical activity in children and adolescents with Down syndrome. Methods: Assessor-blinded, parallel-group randomised pilot study. Thirty-three children and adolescents with Down syndrome were randomly allocated to a custom-fitted footwear group (Clarks (R) footwear) or a wait-list control group. Six feasibility domains were evaluated at baseline, 6 and 12 weeks; demand (recruitment), implementation (co-interventions and adherence), acceptability, practicality (adverse events), limited efficacy testing (physical activity, disability associated with foot and ankle problems, and gait parameters), and adaptation (shoe-fit). Results: Three participants were recruited per month. The use of co-interventions was common with six control group participants purchasing new footwear during the study. Mean adherence was 35 h/week in the custom-fitted footwear group, and there were few minor adverse events. There were trends for differences in physical activity favouring the custom-fitted footwear, but no trends for differences in disability associated with foot and ankle problems or gait parameters. The fit of the custom-fitted footwear was no better than participants' regular footwear. Conclusions: A definitive randomised trial is feasible. However, recruitment, use of co-interventions and footwear fit need further consideration.