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

Linda Renfrew, Lorna Paul, Angus McFadyen, Danny Rafferty, Owen Mosley, Anna C. Lord, Roy Bowers, Paul Mattison

Research output: Contribution to journalArticle

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Abstract

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.
Original languageEnglish
Pages (from-to)1150-1162
Number of pages13
JournalClinical Rehabilitation
Volume33
Issue number7
Early online date11 Apr 2019
DOIs
Publication statusPublished - 1 Jul 2019

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Foot Orthoses
Ankle
Electric Stimulation
Multicenter Studies
Multiple Sclerosis
Cost-Benefit Analysis
Foot
Walking
Self-Help Devices
Equipment and Supplies
Psychology
Costs and Cost Analysis
Scotland
Self Concept
Mental Competency
Uncertainty
Fatigue

Keywords

  • multiple sclerosis
  • patient-centred outcome measure
  • functional electrical stimulation
  • walking
  • orthoses

Cite this

@article{32623618bc254b76afff24cb4ee9203f,
title = "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: 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-na{\"i}ve 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.",
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The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial. / Renfrew, Linda; Paul, Lorna; McFadyen, Angus; Rafferty, Danny; Mosley, Owen; Lord, Anna C.; Bowers, Roy; Mattison, Paul.

In: Clinical Rehabilitation, Vol. 33, No. 7, 01.07.2019, p. 1150-1162.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial

AU - Renfrew, Linda

AU - Paul, Lorna

AU - McFadyen, Angus

AU - Rafferty, Danny

AU - Mosley, Owen

AU - Lord, Anna C.

AU - Bowers, Roy

AU - Mattison, Paul

N1 - Acceptance in SAN

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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.

AB - 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.

KW - multiple sclerosis

KW - patient-centred outcome measure

KW - functional electrical stimulation

KW - walking

KW - orthoses

U2 - 10.1177/0269215519842254

DO - 10.1177/0269215519842254

M3 - Article

VL - 33

SP - 1150

EP - 1162

JO - Clinical Rehabilitation

JF - Clinical Rehabilitation

SN - 0269-2155

IS - 7

ER -