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.

Clinical Trial Registration number

NCT05587010

Contribution of the Paper

• The OrthoPed splint is a safe, feasible, low-cost alternative for paediatric foot drop, balancing gait support with natural ankle mobility.

• A definitive study will addresses a critical gap in neurorehabilitation research for children.

• Findings suggest OrthoPed supports more natural mechanics and preserved movement compared to motion-restricting rigid AFOs.

• The off-the-shelf design improves patient experience through superior comfort and footwear compatibility, likely enhancing treatment adherence.

• By eliminating bespoke fitting and frequent clinic visits, OrthoPed can reduce healthcare costs and clinical workloads, offering a transformative global solution for foot drop management.