A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cionic, Inc.
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Change in Gait Speed
Study Overview
Brief Summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Detailed Description
The randomized within-participants crossover 12-week 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 the Cionic Neural Sleeve; 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 Cionic Neural Sleeve on the most impacted leg for 6 weeks, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Cionic Neural Sleeve will be worn for 6 weeks of the study while following the walking program.
Participants will be randomized to one of two groups: A or B. Group A will follow the walking program and wear the Neural Sleeve to receive stimulation assisted walking from the Neural Sleeve for 6 weeks. Group B will follow the walking program for 6 weeks. After 6 weeks, participants in each group will cross over to the other group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 22 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Gait Speed
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in steps per day
Duration of Daily Walking/Activity Level
Time Frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in duration of activity.
Change in Gait Speed
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: Day 0, Week 6, Week 12
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
Time Frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in steps per day
Duration of Daily Walking/Activity Level
Time Frame: During allocation to receive the functional electrical stimulation arm
Collected by the usage log of the device, measured in duration of activity.
Secondary Outcomes
No secondary outcomes reported