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
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
Treatments tested in this trial
- EXOPULSE Suit in Active mode
- EXOPULSE Suit in Sham mode
Treatment groups
77 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov