NCT07252895 EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

Trial Parameters

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Brief 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 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 equip

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