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

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-naïve 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 (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

An exploration of the experiences and utility of functional electrical stimulation for foot drop in people with multiple sclerosis

Purpose: Functional electrical stimulation (FES) is effective in improving walking in people with multiple sclerosis (MS) with foot drop. There is limited research exploring people’s experiences of using this device. This study aims to explore the utility, efficacy, acceptability, and impact on daily life of the device in people with MS. Methods: An interpretative phenomenological approach was employed. Ten participants who had used FES for 12 months were interviewed. Transcripts were analysed, and emergent themes identified. Results: Nine participants continued to use the device. Three relevant super-ordinate themes were identified; impact of functional electrical stimulation, sticking with functional electrical stimulation, and autonomy and control. Participants reported challenges using the device; however, all reported positive physical and psychological benefits. Intrinsic and external influences such as; access to professional help, the influence of others, an individual’s ability to adapt, and experiences using the device, influenced their decisions to continue with the device. A thematic model of these factors was developed. Conclusions: This study has contributed to our understanding of people with MS experiences of using the device and will help inform prescribing decisions and support the continued, appropriate use of FES over the longer term

A comparison of the initial orthotic effects of functional electrical stimulation and ankle-foot orthoses on the speed and oxygen cost of gait in multiple sclerosis

Foot drop affects walking in people with multiple sclerosis (pwMS). This study compares the initial orthotic effects of two treatments for foot drop: ankle-foot orthoses (AFO) and functional electrical stimulation (FES), on the speed and oxygen cost of walking in MS. Method and materials: Seventy-eight pwMS were randomised to receive AFO or FES (ODFS PACE (OML, Salisbury, UK)). Participants completed the 25-ft walk test (25ftWT) and 5-min self-selected walk test (5minSSWT), from which oxygen cost was determined, with and without their device. Between-, within- and sub-group analyses (based on baseline walking speed of <0.8 m/s (slow) or ≥0.8 m/s (fast)) were undertaken. Results: No significant differences between baseline measures were observed. The AFO group walked significantly slower than the FES group (5minSSWT, p = 0.037, 0.11 m/s). The AFO group walked significantly slower with than without AFO (25ftWT, p = 0.037), particularly in the fast-walking group ( p = 0.011). The slow-walking FES group walked significantly faster with FES than without (25ftWT; p = 0.029, 5minSSWT; p = 0.037). There were no differences in the fast-walking FES group or in the oxygen cost for either device. Conclusion: AFO reduced walking speed, particularly in fast walkers. FES increased walking speed in slow, but not fast walkers