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Recruiting Not applicable

EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

NCT07252895 · tracked via the Priya Life Science France tracker
Sponsor
Otto Bock France SNC
Phase
Not applicable
Started
2026-03-30
Last updated
2026-04-06

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

EXOPULSE Suit in Active modeEXOPULSE Suit in Sham mode

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

EXOPULSE Suit in Sham mode: 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * Person with spasticity at the lower limb(s), attested by a Modified Ashworth Scale ≥ 1+ of at least one of the following muscle groups: quadriceps, hamstrings, triceps surae, tibialis anterior * Person who never tried EXOPULSE SUIT Exclusion Criteria: * 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). * Person with relapses over the last 3 months before the inclusion * Person who had a modification of his/her medical treatments of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion * Person who had a new medical treatment of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion * Person who had an injection of botulinum toxin in at least one of the main muscle groups of the lower limbs over the last 4 months before the inclusion * Person planning to use a new medical device during the study (ex: ankle-foot orthosis…) * Person undergoing or planning to undergo an intensive rehabilitation phase * Person that is part of another study * Person who cannot be fitted with EXOPULSE SUIT due to inexistent Suitable size of the Suit (eg: BMI\>35; user height \< 100 cm or \> 205cm) * Person who does not have a smartphone or who cannot or does not want to use his/her smartphone for operating the EXOPULSE App * Person not available to undergo all medical visits during the study * Person unable to understand verbal and written instructions in french * Pregnant person * Persons under juridical protection * Prisoners

Primary outcome measure(s)

  • The Multiple Sclerosis Walking Scale 12 (MSWS-12) — 28 days
    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.

Trial sites (11)

FacilityCityRegionStatus
Centre Jacques Calvé Fondation Hopale Berck France Recruiting
CHU Henri Mondor Créteil France Recruiting
CHU Dijon Dijon France Recruiting
Clinique Verdaich Gaillac-Toulza France Recruiting
Hôpital Raymond-Poincaré Garches France Recruiting
Hopital Saint Philibert Lomme France Active Not Recruiting
Centre Médical Germaine REVEL Lyon France Recruiting
Hôpital L'Archet Nice France Not Yet Recruiting
Pole MPR Saint Hélier Rennes France Recruiting
Hôpital Henry Gabrielle Saint-Genis-Laval France Recruiting
Hôpital de Hautepierre Strasbourg France Recruiting

More Otto Bock France SNC trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252895 on ClinicalTrials.gov ↗ ← All trials in France