Study of the Cionic Neural Sleeve to Improve Walking and Activity in Adults with Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis MS. This 12-week randomized crossover study focuses on people with relapsing-remitting or progressive forms of MS, measuring how the device affects mobility, disability, fall risk, and physical activity. The study collects physical measurements, performance tests, and questionnaire responses to assess walking ability, quality of life, and the physical and psychological effects of MS. Participants will follow a home-based walking program of 15 minutes per day, 5 days a week for 12 weeks. They will be randomly assigned to two groups one group will wear the Cionic Neural Sleeve on the most affected leg and receive functional electrical stimulation to assist walking for 6 weeks, while the other group will follow the walking program without stimulation for 6 weeks. After 6 weeks, participants will switch to the other group, allowing comparison within individuals. During the study, researchers will record physical activity using the Neural Sleeve, and conduct in-person tests to measure disability, spasticity, and balance. Participants will complete questionnaires about their walking ability and quality of life at the start, midpoint, and end of the study. The primary outcomes include changes in gait speed, perceived walking ability, MS disability, and daily walking activity. The total study duration for each participant is 12 weeks.

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis