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

NCT07706114 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: CionicInMSR01HD118065
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

functional electrical stimulation; multi-modal stimulation; gait impairment; multiple sclerosis; implementation science; physical activity monitoring

Outcome Measures

Primary Outcomes (7)

• Adherence

  Adherence will be measured by monitoring compliance with prescribed use (at least ½ of prescribed FES use = success).

  4 months

• Retention

  Retention will be assessed by the proportion of participants in each group, who remain in the study till the end of Epoch A

  4 months

• Peak Step Rate

  Peak step rate will be calculated per literature using minute-by-minute step count

  4 months

• PROMIS - Participation satisfaction

  We will evaluate changes in participation from baseline to 4 months using Wilcoxon signed rank test.

  4 months

• Dorsiflexion angle

  Assess changes in ankle dorsiflexion angle from pre to post by a paired t-test or Wilcoxon signed rank test

  baseline

• Spatiotemporal gait metrics

  A linear mixed model with random intercepts for participants will assess the relationship between muscle function changes (i.e., Manual muscle testing, sEMG activation) and unassisted (no FES) gait.To compare FES vs. Sham in Epoch A, we will use an LMM with fixed effects for group, time (baseline, 4M), and interaction, adjusting for covariates

  4 months

• Dynamometer muscle strength

  To compare FES vs. Sham in Epoch A, we will use an linear mixed model with fixed effects for group, time (baseline, 4M), and interaction, adjusting for covariates

  4 months

Secondary Outcomes (5)

• Persistence (prolonged adherence to FES)

  4 months

• Adoption

  4 months

• Daily Step count

  4 months

• Dorsiflexion angle change

  8 months

• Spatiotemporal gait metrics

  8 months

Other Outcomes (2)

• Retention (prolonged)

  8 months

• Persistence

  8 months

Study Arms (2)

Group 2: FES Sham

SHAM COMPARATOR

This group will receive 4 months of sham stimulation followed by 4 months of functional electrical stimulation.

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

Group 1: FES Full

ACTIVE COMPARATOR

This group will receive 8 months of functional electrical stimulation.

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

Interventions

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

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.

Group 1: FES Full; Group 2: FES Sham

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California San Francisco, Weill Institute for Neurosciences

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Valerie Block, DPTSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie J Block, DPTSc

CONTACT

415-502-7208; valerie.block@ucsf.edu

Jeannine Bradsby

CONTACT

415-353-4612; jeannine.bradsby@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study coordinators, assessors, and participants will be blinded to group assignment to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): July 2, 2029
• Study Completion (Estimated): October 30, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)