Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Participants will follow the walking program. |
|
| Functional electrical stimulation | Experimental | Participants will follow the walking program and receive stimulation assistance during the walking sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cionic Neural Sleeve NS-100 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed | 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. | Day 0, Week 6, Week 12 |
| Change in Perceived Walking Ability | 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. | Day 0, Week 6, Week 12 |
| Change in MS Disability | 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. | Day 0, Week 6, Week 12 |
| Amount of Daily Walking/Activity Level | Collected by the usage log of the device, measured in steps per day | During allocation to receive the functional electrical stimulation arm |
| Duration of Daily Walking/Activity Level | Collected by the usage log of the device, measured in duration of activity. | During allocation to receive the functional electrical stimulation arm |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-Related Quality of Life | 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. | Day 0, Week 6, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas A Wajda, PhD | Contact | 3308837149 | d.a.wajda@csuohio.edu | |
| Rebecca Webster, PhD | Contact | 925-788-6649 | rebecca@cionic.com |
| Name | Affiliation | Role |
|---|---|---|
| Douglas A Wajda, PhD | Cleveland State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland State University | Recruiting | Cleveland | Ohio | 44115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Walking Program | Behavioral | 15 minutes of walking for 5 days per week for 6 weeks |
|
| Change in Impact of MS |
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. |
| Day 0, Week 6, Week 12 |
| Change in Perceived Fatigue | 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. | Day 0, Week 6, Week 12 |
| Change in Spasticity | 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. | Day 0, Week 6, Week 12 |
| Change in Lower Limb Strength | Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons. | Day 0, Week 6, Week 12 |
| Change in Ankle Plantarflexor Strength | Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises. | Day 0, Week 6, Week 12 |
| Change in Lower Limb Range of Motion | Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer. | Day 0, Week 6, Week 12 |
| Change in Walking Endurance | Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters. | Day 0, Week 6, Week 12 |
| Change in Balance | 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. | Day 0, Week 6, Week 12 |
| Change in Incidence of Falls | 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. | From enrollment to end of treatment at 12 weeks |
| Change in Medication(s) and Dosage | Measured by changes in dose intensities of prescribed medication(s). | Day 0, Week 6, Week 12 |
| Change in Pain | 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. | Day 0, Week 6, Week 12 |
| Change in Self-Reported Physical Activity | 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. | From enrollment to end of treatment at 12 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |