Feasibility study of a novel, low-cost splint device for children with foot drop

Importance: Foot drop impairs mobility for many children globally, causing life-long health issues. Existing treatments are costly, custom-made, and require frequent clinical visits. A new, low-cost, off-the-shelf splint (OrthoPed) could improve access and user experience. Objective: To determine the feasibility of recruiting children (4-17 years) with moderate foot drop and collecting biomechanical, clinical, and patient-reported outcomes to compare OrthoPed with existing treatments. Design: Single-centre cross-sectional feasibility and pilot study informing a future randomised clinical trial. Participants: Twelve children (target=20; mean age=10.6 {+/-} 3.5 years; 2 females) with moderate foot drop and prescribed orthotic support were recruited via physiotherapy. Intervention: The new OrthoPed splint was compared against existing treatments: ankle foot orthoses (AFOs) and Lycra socks. Main outcome measures: Primary outcome: recruitment and retention rates. Secondary outcomes: biomechanical and clinical gait measures, alongside useability and performance questionnaires. Results: Recruitment reached 22% of eligible participants (an "amber" rating for future trials). Despite four dropouts due to treatment burden, all outcome measures were successfully collected. Preliminarily, OrthoPed supported more natural gait mechanics than AFOs and offered better usability and comfort than AFOs and Lycra socks, potentially enhancing adherence. Conclusions: Recruiting children for orthotic trials is feasible, though coordinating gait testing with routine clinical appointments could improve future recruitment. Importantly, low-cost orthotic devices may provide better usability, accessibility and adherence than existing prescribed options.