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NOT YET RECRUITING
NCT07706114
NA

FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

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. Study objectives are 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 randomized controlled trial (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.

Official title: Functional Electrical Stimulation: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-08-31

Completion Date

2030-10-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DEVICE

Use of functional electrical stimulation for extended duration on the participants' weaker limb

Participants will be randomized into two groups. Group 1: will receive FES during EPOCH A (4 months) and EPOCH B (4 months). Group 2 (delayed start): will receive 4 months of Sham stimulation during EPOCH A, and FES during EPOCH B. Follow-up: After Epoch B, all participants will be followed for 1 month with no FES sleeve or stimulation to assess carryover.

Locations (1)

University of California San Francisco, Weill Institute for Neurosciences

San Francisco, California, United States