EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
Recruiting · NCT07252895 · Interventional (participants receive a specific treatment) · Lead sponsor: Otto Bock France SNC
View the official record on ClinicalTrials.gov →Interventions studied
EXOPULSE Suit in Active modeEXOPULSE Suit in Sham mode
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
11 locations listed.
- Centre Jacques Calvé Fondation Hopale - Berck, France
- CHU Henri Mondor - Créteil, France
- CHU Dijon - Dijon, France
- Clinique Verdaich - Gaillac-Toulza, France
- Hôpital Raymond-Poincaré - Garches, France
- Hopital Saint Philibert - Lomme, France
- Centre Médical Germaine REVEL - Lyon, France
- Hôpital L'Archet - Nice, France
- Pole MPR Saint Hélier - Rennes, France
- Hôpital Henry Gabrielle - Saint-Genis-Laval, France
- Hôpital de Hautepierre - Strasbourg, France