The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.
Clin Rehabil
; 33(7): 1150-1162, 2019 Jul.
Article
in En
| MEDLINE
| ID: mdl-30974955
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). OUTCOMEMEASURES:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Electric Stimulation Therapy
/
Peroneal Neuropathies
/
Foot Orthoses
/
Multiple Sclerosis
Type of study:
Clinical_trials
/
Etiology_studies
/
Health_economic_evaluation
Aspects:
Patient_preference
Limits:
Adult
/
Aged
/
Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Clin Rehabil
Journal subject:
REABILITACAO
Year:
2019
Document type:
Article
Affiliation country: