The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
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
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
Crossover
Cionic Neural Sleeve NS-100
DeviceThe 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.
Walking Program
Behavioral15 minutes of walking for 5 days per week for 6 weeks
Change in Gait Speed
The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.
Change in Perceived Walking Ability
Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.
Change in MS Disability
A 9-item survey, Patient-Determined Disease Steps (PDDS), will measure of disability status in individuals with MS. The PDDS ranges from 0 to 8, with higher values indicative of higher levels of disability.
Amount of Daily Walking/Activity Level
Collected by the usage log of the device, measured in steps per day
Change in Health-Related Quality of Life
The Euroqol 5 Dimension 5 Level (EQ-5D-5L) questionnaire describes health profiles using different domains, measured by a 5-digit code. Single-digit numbers of the dimensions range from 1 to 5, with 1 indicative of no problem and 5 indicative of extreme problems in that domain.
Change in Impact of MS
Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaire to measure the physical and psychological impact of MS, measured by score. Scores on the MSIS-29 are transformed into a score out of 100, with higher scores indicative of greater degree of disability.
Change in Perceived Fatigue
Modified Fatigue Impact Scale (MFIS) survey to measure the effects of fatigue in physical, cognitive, and psychosocial functioning. MFIS score ranges from 0 to 84, with high scores indicative of a greater impact of fatigue on activities.
Change in Spasticity
A trained clinician will administer the Modified Ashworth Scale (MAS) to assess for muscle tone and spasticity. Scores of the MAS range from 0 to 4, with high scores representative of increased muscle tone and spasticity.
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