EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial
What it found
No result yet.
What was tested
Treatment tested
- EXOPULSE Suit in Active mode
Placebo
- EXOPULSE Suit in Sham mode
What it measured
Main measures
The Multiple Sclerosis Walking Scale 12 (MSWS-12)
28 days
Walking and mobility
Other measures (8)
10 Meters Walk Test (10MWT)
28 days
Walking and mobility2-minute Walk Test (2MWT)
28 days
Walking and mobilityTimed-up and go Test (TUG)
28 days
Walking and mobilityVisual Analog Scale - Fatigue (VAS - Fatigue)
28 days
FatigueThe Modified Ashworth Scale (MAS)
28 days
MRI lesionsSpasticityThe Multiple Sclerosis Impact Scale 29-items (MSIS-29)
28 days
Quality of life (reported by participants)The EuroQol - 5 Dimensions -5 levels (EQ-5D-5L)
28 days
Walking and mobilityPainMood and sleepQuality of life (reported by participants)Visual Analog Scale - Pain (VAS - Pain)
28 days
Pain
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Mar 2026
Main results due
Mar 2027
Finished
Mar 2027