FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis. (NCT07706114)
Functional Electrical Stimulation: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco, Weill Institute for Neurosciences โ San Francisco, California
Age range: 22 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- University of California San Francisco, Weill Institute for Neurosciences โ San Francisco, California
๐ Contact the Study Coordinator
Phone: (415) 502-7208
Email: valerie.block@ucsf.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Sclerosis
- Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis โ Birmingham, Alabama
- MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience โ New Orleans, Louisiana
- A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis โ Phoenix, Arizona
- A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) โ Carlsbad, California
- The Synergistic Effects of AIH and FES in Persons With MS โ Chicago, Illinois
- A Health Action Process Approach Online Intervention for People With Multiple Sclerosis โ Champaign, Illinois
Explore by condition: All Multiple Sclerosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.