EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis (EXO-MOBILITY)

Otto Bock Healthcare (Ottobock)

Status: Begins enrollment in 1 month

Conditions: Multiple Sclerosis

Treatments: Device: EXOPULSE Suit in Sham mode; Device: EXOPULSE Suit in Active mode

Study type: Interventional

Funder types: Industry

Identifiers

NCT07252895

BP-11-PT-010

Details and patient eligibility

About

The EXOPULSE Suit is medical device composed of 50 electrods that can stimulate up to 43 main muscle groups of the body. The multisite electrical stimulation relaxes tens and spastic muscles, thus enhance mobility and balance. This non-invasive body garment is a home-use device which should be used for 1 hour every other day.

This research aims at confirming the benefits of EXOPULSE Suit in persons with Multiple Sclerosis, including the walking ability.

Full description

Lower limb function is perceived as being essential by persons with multiple sclerosis (pwMS). The loss of walking ability is a major physical manifestation among MS patients with EDSS between 4 and 7, that negatively impacts activities of daily living and employment. Different therapeutic means can be proposed to maintain or improve mobility such as rehabilitation, that is an essential and irreplaceable element of the patient's journey, or the im-plementation of treatments aiming at decreasing symptoms like spasticity, fatigue or pain.

The only treatment exclusively aiming at improving walking ability is the Fampridine medicine . Nevertheless, all patients cannot benefit from it due to contra-indications, side effects or because they are not responders or no longer responders to Fampridine. Some others simply do not want to take drugs.

The EXOPULSE Suit is a class IIa certified electrical medical device composed of 50 electrods that can stimulate up to 43 main muscle groups of the body. The multi-site electrical stimulation relaxes tens and spastic muscles, thus enhance mobility and balance. This non-invasive body garment is a home-use device which should be used for 1 hour every other day.

EXOPULSE Suit could be an alternative for improving walking ability of patients who cannot be treated with Fampridine medicine.

This research aims at confirming the benefits of EXOPULSE Suit in pwMS. It should highlight an improved walking ability with the EXOPULSE Suit when compared to sham condition.

Enrollment: 77 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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77 participants in 2 patient groups

EXOPULSE Suit Active then EXOPUSLE Suit sham

Other group

Description:

The participant is fist using the EXOPULSE Suit in Active mode for 4 weeks, then he has a 4-weeks wash-out period, then he is using the EXOPULSE Suit in a sham mode for 4 weeks.

Treatment:

Device: EXOPULSE Suit in Active mode

Device: EXOPULSE Suit in Sham mode

EXOPULSE Suit in sham mode then EXOPULSE Suit in Active mode

Other group

Description:

The participant is first using the EXOPUISE Suit in sham mode for 4 weeks, then he has a 4-weeks wash-out phase, the he is using the EXOPULSE Suit in Active mode for 4 weeks.

Treatment:

Device: EXOPULSE Suit in Active mode

Device: EXOPULSE Suit in Sham mode