Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
Conditions
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.
Interventions
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
Sponsors
Cionic, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed | 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 | 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 | 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 | 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 | During allocation to receive the functional electrical stimulation arm | Collected by the usage log of the device, measured in duration of activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankle Plantarflexor Strength | Day 0, 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 | Day 0, 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 | Day 0, 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 | Day 0, 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 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 Medication(s) and Dosage | Day 0, Week 6, Week 12 | Measured by changes in dose intensities of prescribed medication(s). |
| Change in Pain | Day 0, 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 | 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. |
| Change in Incidence of Falls | From enrollment to end of treatment at 12 weeks | 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 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 | Day 0, 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 | Day 0, 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. |
Countries
United States
Contacts
Primary ContactDouglas A Wajda, PhD
Backup ContactRebecca Webster, PhD
Outcome results
None listed