Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

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.

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.

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.

Collected by the usage log of the device, measured in steps per day

Collected by the usage log of the device, measured in duration of activity.

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.

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.

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.

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.

Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.

Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.

Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.

Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.

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.

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.

Measured by changes in dose intensities of prescribed medication(s).

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.

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.