NCT07706114Enrolling by invitation
FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.
Functional Electrical Stimulation: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 9 Jul 2026
- Start date
- 31 Aug 2026
- Primary completion date
- 2 Jul 2029
- Lead sponsor
- University of California, San Francisco
- Diseases
- Multiple sclerosis
- NCT number
- NCT07706114
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 31 Aug 2026 to the primary completion date, 2 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive, dexterity or visual impairment that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to comply with the study protocol.
Other
- Inability to provide informed consent
- FES use in the last 6 months
- Musculoskeletal / cardiovascular comorbidities that in the opinion of the study physical therapists (VB, JB), places the patient at risk.
- Recent (last 30 days) relapse affecting gait
- \>2/4 on the Ashworth scale (3= passive movement difficult)
Who the study is looking for
- Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria79
- Ages 22-75 years old
- EDSS 2 - 6.5 (wide range of impairment, 6.5 = ambulation requires walker or 2 canes)
- ≥ 1/5 (and \<5/5 on manual muscle test) of affected leg muscles
- Any MS therapy, or no disease modifying treatment.
- Technological criteria: availability of Wi-Fi in the home or workspace for connectivity.
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco, Weill Institute for Neurosciences Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.