EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
EXO-MOBILITY
Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial
1 other identifier
interventional
77
1 country
11
Brief Summary
The EXOPULSE Suit is medical device composed of 50 electrods that can stimulate up to 43 main muscle groups of the body. The multisite electrical stimulation relaxes tens and spastic muscles, thus enhance mobility and balance. This non-invasive body garment is a home-use device which should be used for 1 hour every other day. This research aims at confirming the benefits of EXOPULSE Suit in persons with Multiple Sclerosis, including the walking ability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Feb 2026
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
November 28, 2025
November 1, 2025
1 year
November 19, 2025
November 19, 2025
Conditions
Keywords
Outcome Measures
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.
28 days
Secondary Outcomes (8)
10 Meters Walk Test (10MWT)
28 days
2-minute Walk Test (2MWT)
28 days
Timed-up and go Test (TUG)
28 days
Visual Analog Scale - Fatigue (VAS - Fatigue)
28 days
The Modified Ashworth Scale (MAS)
28 days
- +3 more secondary outcomes
Other Outcomes (2)
Feeling during the stimulation
28 days
Satisfaction with the suit
28 days
Study Arms (2)
EXOPULSE Suit Active then EXOPUSLE Suit sham
OTHERThe participant is fist using the EXOPULSE Suit in Active mode for 4 weeks, then he has a 4-weeks wash-out period, then he is using the EXOPULSE Suit in a sham mode for 4 weeks.
EXOPULSE Suit in sham mode then EXOPULSE Suit in Active mode
OTHERThe participant is first using the EXOPUISE Suit in sham mode for 4 weeks, then he has a 4-weeks wash-out phase, the he is using the EXOPULSE Suit in Active mode for 4 weeks.
Interventions
The EXOPULSE Suit in Active mode stimulates the targeted muscles during the whole 60-minutes cession
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.
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Centre Jacques Calvé Fondation Hopale
Berck, 62 608, France
CHU Henri Mondor
Créteil, 94000, France
CHU Dijon
Dijon, 21 079, France
Clinique Verdaich
Gaillac-Toulza, 31 550, France
Hôpital Raymond-Poincaré
Garches, 92380, France
Hopital Saint Philibert
Lomme, 59462, France
Centre Médical Germaine REVEL
Lyon, 69 440, France
Hôpital L'Archet
Nice, 62 000, France
Pole MPR Saint Hélier
Rennes, 35000, France
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69 230, France
Hôpital de Hautepierre
Strasbourg, 67200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Samar AYACHE, Pr
CHU Henri Mondor
- STUDY CHAIR
Djamel BENSMAIL, Pr
Hôpital Raymond Poincaré
- STUDY CHAIR
Jérôme DE SEZE, Pr
Hôpital de Hautepierre
- STUDY CHAIR
Volker LIMMROTH, Pr
Klinik für Neurologie Köln-Merheim
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share