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
What it found
No result yet.
What was tested
Treatment tested
- Cionic Neural Sleeve NS-100
- Walking Program
What it measured
Main measures
Change in Gait Speed
Day 0, Week 6, Week 12
Disability progressionWalking and mobilityChange in Perceived Walking Ability
Day 0, Week 6, Week 12
Walking and mobilityChange in MS Disability
Day 0, Week 6, Week 12
Amount of Daily Walking/Activity Level
During allocation to receive the functional electrical stimulation arm
Walking and mobilityPhysical functionDuration of Daily Walking/Activity Level
During allocation to receive the functional electrical stimulation arm
Walking and mobility
Who could take part
Relapsing and progressive · 22 to 75 · EDSS 4 to 6.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Loading reviews and guidelines…
History
Started
Sept 2023
Main results due
Jun 2026
Finished
Jul 2026