A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Cionic, Inc.
Summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
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,…
Eligibility
- Age range
- 22–75 years
- Sex
- All
- 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 Dis…
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
Location
- Cleveland State UniversityCleveland, Ohio