MedTrace Logo

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

NCT07706114 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Valerie Block, DPTSc · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-07-02
Completion
2030-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706114 on ClinicalTrials.gov