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 (ClarksVR 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.

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