EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

Официальное название

Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial

Обзор

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.

Подробное описание

Lower limb function is perceived as essential by individuals with multiple sclerosis. The loss of walking ability is a major physical manifestation among individuals with an EDSS score between 4 and 7 and negatively impacts activities of daily living and employment. Various therapeutic options can be proposed to maintain or improve mobility, such as rehabilitation-which is an essential and irreplaceable component of the clinical care pathway-or treatments aimed at reducing symptoms such as spasticity, fatigue, or pain.

Fampridine is the only treatment exclusively intended to improve walking ability. However, not all individuals can benefit from this medication due to contraindications, side effects, lack of response, or loss of response over time. Some individuals also prefer to avoid drug-based treatments.

The EXOPULSE Suit is a class IIa-certified electrical 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.

The EXOPULSE Suit may represent an alternative for improving walking ability in individuals who cannot be treated with Fampridine.

This research aims to confirm the benefits of the EXOPULSE Suit in individuals with Multiple Sclerosis and to demonstrate improved walking ability with the EXOPULSE Suit compared with a sham condition.

Вмешательства

• Устройство EXOPULSE Suit in Active mode
  The EXOPULSE Suit in Active mode stimulates the targeted muscles during the whole 60-minutes cession
• Устройство EXOPULSE Suit in Sham mode
  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.

Первичные конечные точки

• The Multiple Sclerosis Walking Scale 12 (MSWS-12) [Срок оценки: 28 days]

Вторичные конечные точки (8)

• 10 Meters Walk Test (10MWT) [Срок оценки: 28 days]
• 2-minute Walk Test (2MWT) [Срок оценки: 28 days]
• Timed-up and go Test (TUG) [Срок оценки: 28 days]
• Visual Analog Scale - Fatigue (VAS - Fatigue) [Срок оценки: 28 days]
• The Modified Ashworth Scale (MAS) [Срок оценки: 28 days]
• The Multiple Sclerosis Impact Scale 29-items (MSIS-29) [Срок оценки: 28 days]
• The EuroQol - 5 Dimensions -5 levels (EQ-5D-5L) [Срок оценки: 28 days]
• Visual Analog Scale - Pain (VAS - Pain) [Срок оценки: 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 11 центров

• Centre Jacques Calvé Fondation Hopale — Berck
• CHU Henri Mondor — Créteil
• CHU Dijon — Dijon
• Clinique Verdaich — Gaillac-Toulza
• Hôpital Raymond-Poincaré — Garches
• Hopital Saint Philibert — Lomme
• Centre Médical Germaine REVEL — Lyon
• Hôpital L'Archet — Nice
• … и ещё 3 центра

Идентификаторы

NCT: NCT07252895 · BP-11-PT-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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