Impact of Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The randomized within-participants crossover 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 an Actigraph; 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 hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.
Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Control Participants will follow the walking program. |
Device: Actigraph accelerometer
Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.
|
| Experimental: Functional electrical stimulation Participants will follow the walking program and receive stimulation assistance during the walking sessions. |
Device: 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.
Device: Actigraph accelerometer
Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.
|
Outcome Measures
Primary Outcome Measures
- Change in Gait Speed [Week 1, 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 [Week 1, 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 [Day 0, Week 6, Week 12]
Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability.
- Change in Fall Risk [Week 1, Week 6, Week 12]
Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent.
- Amount of Daily Walking/Activity Level [Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16]
Collected by the usage log of the device(s), measured in steps per day
- Duration of Daily Walking/Activity Level [Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16]
Collected by the usage log of the device(s), measured in duration of activity.
Other Outcome Measures
- Change in Health-Related Quality of Life [Day 0, Week 6, Week 12]
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 [Day 0, Week 6, Week 12]
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 [Day 0, Week 6, Week 12]
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 [Week 1, Week 6, Week 12]
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.
- Change in Lower Limb Strength [Week 1, Week 6, Week 12]
Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.
- Change in Ankle Plantarflexor Strength [Week 1, Week 6, Week 12]
Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.
- Change in Lower Limb Range of Motion [Week 1, Week 6, Week 12]
Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.
- Change in Walking Endurance [Week 1, Week 6, Week 12]
Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.
- Change in Balance [Week 1, Week 6, Week 12]
Measured using force platform posturography in standing to quantify postural sway. There will be four 30-second trials with eyes open standing as still as possible.
- Change in Blood Lipids [Week 1, Week 6, Week 12]
Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care lipid profile and cholesterol testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
- Change in Blood Glucose [Week 1, Week 6, Week 12]
Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care glucose testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
- Change in Incidence of Falls [From enrollment to end of treatment at 12 weeks, post-intervention at Week 16]
Measured using a self-reported fall diary and a survey, the Hopkins Fall Grading Scale, a 4-point scale to grade the nature and severity of a fall. Higher grades represent increased severity and impact of injurious falls.
- Change in Medication(s) and Dosage [Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16]
Measured by changes in dose intensities of prescribed medication(s).
- Change in Pain [Week 1, Week 6, Week 12]
Measured using the questionnaire, the Numeric Pain Rating Scale (NPRS), an 11-point numeric scale ranging from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.
- Change in Self-Reported Physical Activity [From enrollment to end of treatment at 12 weeks, post-intervention at Week 16]
Subjects will record their weekly physical activity using the Godin-Leisure Time Exercise Questionnaire (GLTEQ), measured by score. Scores less than 14 units are interpreted as insufficiently active/sedentary, while scores between 14 and 23 are interpreted as moderately active, and scores greater than 24 units are interpreted as active.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75
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Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device
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Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia
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Able to tolerate the Neural Sleeve device for up to 8 hours per day
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T25FWT time between 8 and 45 seconds
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No recent change in medication or recent exacerbation of symptoms over the last 60 days
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Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5
Exclusion Criteria:
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Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
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Absent sensation in the impacted or more impacted leg
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Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
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Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
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History of falls greater than once a week
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No use of FES devices in the past year
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Demand-type cardiac pacemaker or defibrillator
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Malignant tumor in the impacted or more impacted leg
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Existing thrombosis in the impacted or more impacted leg
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Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland State University | Cleveland | Ohio | United States | 44115 |
Sponsors and Collaborators
- Cionic, Inc.
Investigators
- Principal Investigator: Douglas A Wajda, PhD, Cleveland State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIONIC-06-001