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

Not Yet RecruitingNA

Sponsor: University of California, San Francisco

Conditions: Multiple Sclerosis

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

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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)

Locations (1)

San Francisco, California, United States