[R01] Functional Electrical Stimulation: Effect on Walking in the Real World and Participation in Daily Life in People with Multiple Sclerosis
Ente: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Scadenza: 2031-06-30
Importo max: 638.608 EUR
Paese: US
Descrizione
PROJECT SUMMARY
Background: Multiple sclerosis (MS) is a chronic, neurodegenerative disease and the most common cause of
non-traumatic disability in young adults. Foot drop, arising from MS-induced muscle weakness, leads to impaired
mobility, increased fall risk, reduced overall physical activity and reduced health-related quality of life. Functional
electrical stimulation (FES) represents a revolutionary approach for addressing gait mobility challenges in MS
and evolution in the technology has greatly improved its design, comfort, and functionality. Despite its proven
benefits, FES is underutilized in MS clinical practice and lacks a comprehensive assessment of its long-term
effectiveness and impact in real-world applications. Overarching Plan: To evaluate the utility of FES for
improving function and real-world outcomes in people with MS (PwMS) who have gait impairments. Study
design: 4-month RCT (n=70 PwMS) evaluating FES efficacy. Group 1: 4M FES; Group 2: 4M sham stimulation,
followed by both groups: 4M FES, then 1M (no-FES) follow-up assessing carryover. We will assess gait quality,
muscle function, physical activity, and FES adoption factors, with covariates including age, sex, MS severity, MS
symptoms, biomechanical factors, and device usage patterns. Aim 1: Functional Improvements. Evaluate the
immediate and sustained effects of FES on gait, ankle kinematics, and muscle function. Immediate effects of
FES will be assessed via changes in dorsiflexion angle (digital goniometer) and instrumented walkway gait
parameters using paired comparisons. Over 4M, the effects of FES vs sham stimulation on unassisted gait quality
and muscle function will be assessed using spatiotemporal gait, strength (dynamometer, manual muscle testing),
and motor unit activation - via mixed-effects models. Aim 2: Real-world Impact. Evaluate the effect of FES vs.
sham on ambulatory activity, daily participation and quality of life using validated remote (wearable) and in-clinic
(6-minute walk test) metrics to monitor ambulatory capacity (i.e., peak step count and daily steps), as well as
robust surveys of daily life participation and quality of life. Linear mixed models will explore the differences using
FES vs. sham, and FES duration (4M vs. 8M). Aim 3: Implementation. Characterize barriers and facilitators
influencing real-world FES use, to understand implementation approaches and the heterogeneity of responses
to FES. Using a combination of validated surveys, device usage data, and qualitative exit interviews, we will
comprehensively characterize the barriers and facilitators influencing FES utilization over 4M and 8M. Participant
experiences, including perceived ease of use, immediate walking effects, adherence, and satisfaction levels, will
be explored to generate insights for future clinical implementation strategies and personalized rehabilitation
approaches. Impact: This innovative trial is the first to rigorously assess FES on real-world outcomes in terms
of p
Istituzione: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
PI: Valerie J Block
Progetto: 1R01HD118065-01A1
Settori: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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