RecruitingNot ApplicableNCT05964829
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Sponsor
Cionic, Inc.
Enrollment
14 participants
Start Date
Sep 4, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Eligibility
Min Age: 22 YearsMax Age: 75 Years
Inclusion Criteria7
- 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 Criteria10
- 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
Interventions
DEVICECionic Neural Sleeve NS-100
The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.
BEHAVIORALWalking Program
15 minutes of walking for 5 days per week for 6 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05964829
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