Health TrialsbyHealthPanel

EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOtto Bock France SNC

About this trial

The EXOPULSE Suit is a medical device composed of 50 electrodes capable of stimulating up to 43 major muscle groups throughout the body. The multisite electrical stimulation relaxes tense and spastic muscles, thereby enhancing mobility and balance. This non-invasive body garment is intended for home use and should be used for 1 hour every other day.

This research aims to confirm the benefits of the EXOPULSE Suit in individuals with Multiple Sclerosis, including improvements in walking ability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Person with a clear Multiple Sclerosis diagnosis according to the 2017 revision of the McDonald criteria since at least 3 months.

Person with an Expanded Disability Status Scale (EDSS) score ≥ 4 and ≤ 6

Person with stable walking ability for at least two weeks prior to the inclusion visit (variation at the MSWS-12 questionnaire < 8/100 points)

Person not treated with fampridine due to contra-indication or adverse events or not respondent or no longer respondent or reluctant to taking drugs

Disqualifiers

Person under 18 years old

Person having a contraindication to using EXOPULSE SUIT

Person using an electronic life-support equipment, e.g. pacemakers or hight-frequency surgical equipment and person using an ECG equipment

Person affected by other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).

Trial design

Design model

Crossover

Treatments tested in this trial

  • EXOPULSE Suit in Active mode

    Device

    The EXOPULSE Suit in Active mode stimulates the targeted muscles during the whole 60-minutes cession

  • EXOPULSE Suit in Sham mode

    Device

    The EXOPULSE Suit in Sham mode stimulates the targeted muscles during the first minute of the cession then is off during the 59 minutes left.

Treatment groups

77 Participants
are divided into 2 treatment groups
Group A: EXOPULSE Suit Active then EXOPUSLE Suit shamOther 2 interventions
Group B: EXOPULSE Suit in sham mode then EXOPULSE Suit in Active modeOther 2 interventions

Trial outcomes

Primary outcomes

1

The Multiple Sclerosis Walking Scale 12 (MSWS-12)

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.

Time frame
28 days

Secondary outcomes

1

10 Meters Walk Test (10MWT)

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.

Time frame
28 days
2

2-minute Walk Test (2MWT)

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.

Time frame
28 days
3

Timed-up and go Test (TUG)

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.

Time frame
28 days
4

Visual Analog Scale - Fatigue (VAS - Fatigue)

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.

Time frame
28 days

Other outcomes

1

Feeling during the stimulation

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.

Time frame
28 days
2

Satisfaction with the suit

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.

Time frame
28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Otto Bock France SNC

Lead sponsor

Source ClinicalTrials.gov
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