OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naive people with Multiple Sclerosis with persistent (> three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES 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, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service 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). In all, 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 were found 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 1.00 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

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