EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

The Multiple Sclerosis Walking Scale 12 (MSWS-12) is a 12-item assessment tool designed to measure the impact of multiple sclerosis (MS) symptoms on patients' walking and balance ability, through a series of questions about various daily activities performed over the previous two weeks. Patients are asked to rate the impact of MS on their mobility using a five-point Likert scale, ranging from 1, indicating "no im-pact", to 5, meaning "extremely significant impact". The final score is obtained by adding the responses to the 12 questions (with a sum ranging from 12 to 60). This sum is then converted to a scale of 0 to 100, where a higher score reflects a greater impact of symptoms on the patient's walking ability.

The 10MWT is a performance measure that assesses walking speed in meters per second over a short dis-tance. A high score indicates a fast-walking speed. At a comfortable speed, the patient is asked to walk over 10 meters, plus 2 meters at the beginning and at the end for acceleration and deceleration.

The 2-minute Walk test is a measurement of endurance that assesses the maximum walking distance over 2 minutes. A long walking distance reflects good endurance.

The Timed Up and Go (TUG) test is a validated tool in people with MS to assess functional mobility. It measures the time it takes a person to get up from a chair (without the help of the hands), walk 3 meters, turn around a cone / mark on the floor, return to the chair, and sit back down. Patients are instructed to complete the course as safely and quickly as possible. If needed, patients are allowed to use assistive devices while performing the task. They are given 2 trials to complete the TUG test and the computed time across the 2 trials is the final score.

A high value reflects an increased risk of falling.

The VAS is a measurement tool where the patient rates his fatigue level by marking a point on a 10 cm line that represents a continuum between "no fatigue" and "worst possible fatigue". The measurement (in mm) between the left end of the line and the mark done by the patient represents the level of fatigue perceived by the patient. The score is then expressed by a note between 0 and 10, 10 being the worst pos-sible fatigue.

The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system.

MAS measures the increase in muscle tone by assigning a grade of spasticity from 0 to 4. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.

MAS grades:

0 : No increase in muscle tone

1 : Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension

1+ : Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 : More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 : Considerable increase in muscle tone passive, movement difficult 4 : Affected part(s) rigid in flexion or extension

The Multiple Sclerosis Impact Scale 29-items (MSIS-29) is 29-items' self-questionnaires that measure the physical and psychological impact of MS on day-to-day life in the past two weeks. . It comprises 20 items associated with a physical scale and a 9-items scale with a psychological scale. Each item has 5 response options going from 1 "not at all" to 5 "extremely". Each of the two scales are scored by summing the response across items, then converting to a 0-100 scale where 100 indicates a greater impact of disease on daily function.

The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 using this formula: (100*(observed score-20))/(100-20).

The psychological impact score is computed by summing items number 21-29 inclusive. This score can then be transformed to a score on a scale of 0 -100 using this formula: (100*(observed score-9)/(45-9).

The EuroQol - 5 Dimensions -5 levels (EQ-5D-5L) is a scale developed by the EuroQol group that assesses quality of life through 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxie-ty/depression. Each dimension has 5 levels going from "no problems" to "extreme problems". Health status can be defined by an index value that goes between 0 and 1. It expresses how is the health status, according to preferences of the general population of a given country. Health status is also expressed by the EQ VAS (Visual Analogue Scale). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgment.

The VAS is a measurement tool where the patient rates his perceived general pain level by marking a point on a 10 cm line that represents a continuum between "no pain" and "worst possible pain". The measurement (in mm) between the left end of the line and the mark done by the patient represents the level of pain perceived by the patient. The score is then expressed by a note between 0 and 10, 10 being the worst possible pain.

4 additional questions related to the feeling during the stimulation will be asked: pain, tingling, burning, fatigue.

Data considered are with EXOPULSE Suit in active mode.

4 additional questions related to the satisfaction with the suit will be asked: ease for putting on and off, ease of use, comfort with the suit, efficacy.

Data considered are with EXOPULSE Suit in active mode.