Actively Recruiting
EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
Led by Otto Bock France SNC · Updated on 2026-04-06
77
Participants Needed
11
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Multiple Sclerosis according to the 2017 McDonald criteria for at least 3 months
- Expanded Disability Status Scale (EDSS) score between 4 and 6
- Stable walking ability for at least two weeks prior to inclusion (variation in MSWS-12 questionnaire less than 8/100)
- Not currently treated with Fampridine due to contraindications, adverse events, lack of response, loss of response, or reluctance to take drugs
- Presence of spasticity in lower limb muscles with a Modified Ashworth Scale score of 1+ or higher in quadriceps, hamstrings, triceps surae, or tibialis anterior
- Never used the EXOPULSE Suit before
You will not qualify if you...
- Under 18 years old
- Contraindications to using the EXOPULSE Suit
- Use of electronic life-support equipment such as pacemakers or high-frequency surgical equipment, or ECG equipment
- Other somatic or neuropsychiatric diagnoses like arrhythmias, uncontrolled epilepsy, or diseases causing osteoarticular and muscular pain
- Relapses within the last 3 months before inclusion
- Medical treatment changes for Multiple Sclerosis or motor performance within 3 months before inclusion
- Botulinum toxin injections in main lower limb muscles within 4 months before inclusion
- Planning to use a new medical device (e.g., ankle-foot orthosis) during the study
- Undergoing or planning intensive rehabilitation
- Participation in another study
- Unsuitable size for the EXOPULSE Suit (e.g., BMI over 35, height under 100 cm or over 205 cm)
- No smartphone or unable/unwilling to use smartphone for the EXOPULSE app
- Unavailable for all medical visits during the study
- Unable to understand verbal and written French instructions
- Pregnancy
- Under juridical protection
- Prisoner
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Centre Jacques Calvé Fondation Hopale
Berck, France, 62 608
Actively Recruiting
2
CHU Henri Mondor
Créteil, France, 94000
Actively Recruiting
3
CHU Dijon
Dijon, France, 21 079
Actively Recruiting
4
Clinique Verdaich
Gaillac-Toulza, France, 31 550
Actively Recruiting
5
Hôpital Raymond-Poincaré
Garches, France, 92380
Actively Recruiting
6
Hopital Saint Philibert
Lomme, France, 59462
Active, Not Recruiting
7
Centre Médical Germaine REVEL
Lyon, France, 69 440
Actively Recruiting
8
Hôpital L'Archet
Nice, France, 62 000
Not Yet Recruiting
9
Pole MPR Saint Hélier
Rennes, France, 35000
Actively Recruiting
10
Hôpital Henry Gabrielle
Saint-Genis-Laval, France, 69 230
Actively Recruiting
11
Hôpital de Hautepierre
Strasbourg, France, 67200
Actively Recruiting
Research Team
A
Aurelie LACROIX, Ing.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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