Actively Recruiting
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Led by Cionic, Inc. · Updated on 2025-09-24
14
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75
- Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device
- Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS)
- Able to tolerate the Neural Sleeve device for up to 8 hours per day
- Timed 25-Foot Walk Test (T25FWT) time between 8 and 45 seconds
- No recent change in medication or recent exacerbation of symptoms over the last 60 days
- Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5
You will not qualify if you...
- Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
- Absent sensation in the impacted or more impacted leg
- Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
- Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
- History of falls greater than once a week
- No use of functional electrical stimulation (FES) devices in the past year
- Demand-type cardiac pacemaker or defibrillator
- Malignant tumor in the impacted or more impacted leg
- Existing thrombosis in the impacted or more impacted leg
- Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 weeks
Participants follow a home-based walking program for 12 weeks. During this period, participants will wear the Cionic Neural Sleeve on their most impacted leg for 6 weeks while receiving stimulation-assisted walking, and for 6 weeks they will follow the walking program without the device. Participants are randomized to start with either the device-assisted walking or walking alone, then cross over to the other condition after 6 weeks.
Assessments on Day 0, Week 6, and Week 12 (in-person visits)
Trial Site Locations
Total: 1 location
1
Cleveland State University
Cleveland, Ohio, United States, 44115
Actively Recruiting
Research Team
D
Douglas A Wajda, PhD
R
Rebecca Webster, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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