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

Abstract

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.

Research on lower extremity health in patients with multiple sclerosis: a systematic scoping review

“… 5 Remelius et al 2012, USA [ 73 ] To investigate (1) whether previously observed changes in gait parameters in individuals with multiple sclerosis (MS) are the result of slower preferred walking speeds or reflect adaptations independent of gait speed; and (2) the changes in spatiotemporal features of the unstable swing phase of gait in people with MS. Cross-sectional study; n = 19 PwMS, mean age 51.3 Gait analysis Longer dual support time is part of a gait strategy in MS that is apparent even when controlling for the confounding effect of slower preferred speed. 4 Renfrew et al 2019 UK [ 74 ] 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. Multicentre, powered, non-blinded, randomized trial; n = 85 PwMS divided into n = 43 AFO group, n = 42 FES device group Walking speed Both devices demonstrated improvements in walking speed at 12 months, although there were no significant differences in their effects.…”

“…Some interventions aimed to support lower extremity health in patients with MS. Most of the intervention studies ( n = 12) were focused on improving lower extremity muscle strength, [ 52 , 53 , 64 , 83 ] walking, [ 53 , 55 , 65 , 69 , 70 , 74 , 76 , 77 , 83 ] balance, [ 51 , 52 ] mobility [ 52 ] or kinematics in the lower extremities [ 76 ]. The interventions varied from various physical training methods to foot orthoses.…”

Cost-efficiency of specialist inpatient rehabilitation for adults with multiple sclerosis: A multicentre prospective cohort analysis of the UK Rehabilitation Outcomes Collaborative national clinical dataset for rehabilitation centres in England

“…Such evidence is required not only in the context of clinical trials but also in real-life clinical practice. 16,17 Economic analysis of individual interventions such as home-exercise programmes, functional electrical stimulation, and schemes to keep people in work have been reported, [18][19][20][21][22][23][24] but there is no published evaluation of the cost-efficiency of holistic multidisciplinary specialist rehabilitation.…”

A cohort study of functional electrical stimulation in people with multiple sclerosis demonstrating improvements in quality of life and cost-effectiveness

“…Walking speed is increased similar to use of an ankle foot orthosis; however, little is known about the cost-effectiveness of functional electrical stimulation. 1–5…”

“…Walking speed is increased similar to use of an ankle foot orthosis; however, little is known about the cost-effectiveness of functional electrical stimulation. [1][2][3][4][5] Increase in walking speed is most often reported to reflect clinical efficacy and in fact walking speed has previously been used as a surrogate marker of quality of life in determining cost-effectiveness of functional electrical stimulation; 6 however, other effects such as increase in confidence, reduced falls or less effort of walking may all contribute to increased participation and are equally important. 7 Investigators have looked at the effect of functional electrical stimulation on the Psychosocial Impact of Assistive Device Scale, a measure of the impact of an assisted device on the user's self-esteem, adaptability (impact on participation) and competence (aspects of walking).…”