Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
NCT ID: NCT05964829
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
14 participants
INTERVENTIONAL
2023-09-04
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Control
Participants will follow the walking program.
Walking Program
15 minutes of walking for 5 days per week for 6 weeks
Functional electrical stimulation
Participants will follow the walking program and receive stimulation assistance during the walking sessions.
Cionic 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.
Walking Program
15 minutes of walking for 5 days per week for 6 weeks
Interventions
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Cionic 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.
Walking Program
15 minutes of walking for 5 days per week for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
75 Years
ALL
No
Sponsors
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Cionic, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas A Wajda, PhD
Role: PRINCIPAL_INVESTIGATOR
Cleveland State University
Locations
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Cleveland State University
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Douglas A Wajda
Role: primary
Other Identifiers
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CIONIC-06-001
Identifier Type: -
Identifier Source: org_study_id
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