The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial

Objective: Compare the clinical and cost effectiveness of ankle-foot orthoses (AFO) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop.Design: Multi-centre, powered, non-blinded, randomised trial.Setting: Seven multiple sclerosis out-patient centres across Scotland. Subjects: 85 treatment-naïve people with Multiple Sclerosis with persistent (> 3 months) foot drop. Interventions: Participants randomised to receive a custom-made, ankle-foot orthosis (n=43) or functional electrical stimulation device (n=42). Outcome measures: Assessed at 0,3,6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, EQ–5D-5L, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, equipment and NHS staff time costs of interventions. Results: Groups were similar for age (AFO, 51.4(11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). 38 % dropped out by 12 months (AFO, n=21; FES, n=11). Both groups walked faster at 12 months with device (p<0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores for FES for Competence (p=0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (p=0.001; AFO,0.38(0.97); FES 1.53(0.98)) and Self-Esteem (p=0.006; AFO, 0.45(0.67); FES 1(0.68)). Effects were comparable for other measures. Functional electrical stimulation may offer value for money alternative to usual care. Conclusion: Ankle-foot orthoses and functional electrical stimulation have comparable effects on walking performance and patient reported outcomes, however high drop outs introduces uncertainty.