Multiple Sclerosis Clinical Trial
Impact of Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Full Description
The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.
Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by an Actigraph; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS.
All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.
Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.
Eligibility Criteria
Inclusion Criteria:
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) to identify persons with dementia
Able to tolerate the Neural Sleeve device for up to 8 hours per day
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
Exclusion Criteria:
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 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
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