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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: EXOPULSE Suit in Active mode; Device: EXOPULSE Suit in Sham mode

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelie LACROIX, Ing.; Phone Number: 0033 (0)7 86 29 52 03; Email: aurelie.lacroix@ottobock.com

Study Locations

• France
  • Berck, France, 62 608
    • Recruiting
    • Centre Jacques Calvé Fondation Hopale
    • Contact: Pascal RIGAUX, Dr.
    • Principal Investigator: Pascal RIGAUX, Dr.
  • Créteil, France, 94000
    • Recruiting
    • CHU Henri Mondor
    • Contact: Samar AYACHE, Pr.
    • Principal Investigator: Samar AYACHE, Pr.
  • Dijon, France, 21 079
    • Recruiting
    • CHU Dijon
    • Principal Investigator: Paul ORNETTI, Pr.
    • Contact: Paul ORNETTI, Pr.
  • Gaillac-Toulza, France, 31 550
    • Recruiting
    • Clinique Verdaich
    • Contact: Elsa MAURUC-SOUBIRAC, Dr.
    • Principal Investigator: Elsa MAURUC-SOUBIRAC, Dr.
  • Garches, France, 92380
    • Recruiting
    • Hôpital Raymond-Poincaré
    • Contact: Djamel BENSMAIL, Pr.
    • Principal Investigator: Djamel BENSMAIL, Pr.
    • Sub-Investigator: Nicolas ROCHE, Dr.
    • Sub-Investigator: Jonathan LEVY, Dr.
  • Lomme, France, 59462
    • Active, not recruiting
    • Hopital Saint Philibert
  • Lyon, France, 69 440
    • Recruiting
    • Centre Médical Germaine REVEL
    • Contact: Vivien RAYNAUD, Dr.
    • Principal Investigator: Vivien RAYNAUD, Dr.
  • Nice, France, 62 000
    • Not yet recruiting
    • Hôpital l'Archet
    • Contact: Audrey ALLAMANDI, Dr.
    • Principal Investigator: Audrey ALLAMANDI, Dr.
  • Rennes, France, 35000
    • Recruiting
    • Pole MPR Saint Hélier
    • Contact: Philippe GALLIEN, Dr.
    • Principal Investigator: Philippe GALLIEN, Dr.
  • Saint-Genis-Laval, France, 69 230
    • Recruiting
    • Hôpital Henry Gabrielle
    • Contact: Sophie JACQUIN COURTOIS, Dr.
    • Principal Investigator: Sophie JACQUIN COURTOIS, Dr.
  • Strasbourg, France, 67200
    • Recruiting
    • Hopital de Hautepierre
    • Contact: Jérôme DE SEZE, Pr.
    • Principal Investigator: Jérôme DE SEZE, Pr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EXOPULSE Suit Active then EXOPUSLE Suit sham; 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.	Device: EXOPULSE Suit in Active mode; The EXOPULSE Suit in Active mode stimulates the targeted muscles during the whole 60-minutes cession; Device: 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.
Other: EXOPULSE Suit in sham mode then EXOPULSE Suit in Active mode; 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.	Device: EXOPULSE Suit in Active mode; The EXOPULSE Suit in Active mode stimulates the targeted muscles during the whole 60-minutes cession; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Multiple Sclerosis Walking Scale 12 (MSWS-12)	The Multiple Sclerosis Walking Scale 12 (MSWS-12) is a 12-item assessment tool designed to measure the impact of multiple sclerosis (MS) symptoms on patients' walking and balance ability, through a series of questions about various daily activities performed over the previous two weeks. Patients are asked to rate the impact of MS on their mobility using a five-point Likert scale, ranging from 1, indicating "no im-pact", to 5, meaning "extremely significant impact". The final score is obtained by adding the responses to the 12 questions (with a sum ranging from 12 to 60). This sum is then converted to a scale of 0 to 100, where a higher score reflects a greater impact of symptoms on the patient's walking ability.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 Meters Walk Test (10MWT)	The 10MWT is a performance measure that assesses walking speed in meters per second over a short dis-tance. A high score indicates a fast-walking speed. At a comfortable speed, the patient is asked to walk over 10 meters, plus 2 meters at the beginning and at the end for acceleration and deceleration.	28 days
2-minute Walk Test (2MWT)	The 2-minute Walk test is a measurement of endurance that assesses the maximum walking distance over 2 minutes. A long walking distance reflects good endurance.	28 days
Timed-up and go Test (TUG)	The Timed Up and Go (TUG) test is a validated tool in people with MS to assess functional mobility. It measures the time it takes a person to get up from a chair (without the help of the hands), walk 3 meters, turn around a cone / mark on the floor, return to the chair, and sit back down. Patients are instructed to complete the course as safely and quickly as possible. If needed, patients are allowed to use assistive devices while performing the task. They are given 2 trials to complete the TUG test and the computed time across the 2 trials is the final score. A high value reflects an increased risk of falling.	28 days
Visual Analog Scale - Fatigue (VAS - Fatigue)	The VAS is a measurement tool where the patient rates his fatigue level by marking a point on a 10 cm line that represents a continuum between "no fatigue" and "worst possible fatigue". The measurement (in mm) between the left end of the line and the mark done by the patient represents the level of fatigue perceived by the patient. The score is then expressed by a note between 0 and 10, 10 being the worst pos-sible fatigue.	28 days
The Multiple Sclerosis Impact Scale 29-items (MSIS-29)	The Multiple Sclerosis Impact Scale 29-items (MSIS-29) is 29-items' self-questionnaires that measure the physical and psychological impact of MS on day-to-day life in the past two weeks. . It comprises 20 items associated with a physical scale and a 9-items scale with a psychological scale. Each item has 5 response options going from 1 "not at all" to 5 "extremely". Each of the two scales are scored by summing the response across items, then converting to a 0-100 scale where 100 indicates a greater impact of disease on daily function. The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100 using this formula: (100*(observed score-20))/(100-20). The psychological impact score is computed by summing items number 21-29 inclusive. This score can then be transformed to a score on a scale of 0 -100 using this formula: (100*(observed score-9)/(45-9).	28 days
The EuroQol - 5 Dimensions -5 levels (EQ-5D-5L)	The EuroQol - 5 Dimensions -5 levels (EQ-5D-5L) is a scale developed by the EuroQol group that assesses quality of life through 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxie-ty/depression. Each dimension has 5 levels going from "no problems" to "extreme problems". Health status can be defined by an index value that goes between 0 and 1. It expresses how is the health status, according to preferences of the general population of a given country. Health status is also expressed by the EQ VAS (Visual Analogue Scale). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgment.	28 days
Visual Analog Scale - Pain (VAS - Pain)	The VAS is a measurement tool where the patient rates his perceived general pain level by marking a point on a 10 cm line that represents a continuum between "no pain" and "worst possible pain". The measurement (in mm) between the left end of the line and the mark done by the patient represents the level of pain perceived by the patient. The score is then expressed by a note between 0 and 10, 10 being the worst possible pain.	28 days
The Modified Ashworth Scale (MAS)	The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS measures the increase in muscle tone by assigning a grade of spasticity from 0 to 4. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. MAS grades: 0 : No increase in muscle tone 1 : Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ : Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 : More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 : Considerable increase in muscle tone passive, movement difficult 4 : Affected part(s) rigid in flexion or extension	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeling during the stimulation	4 additional questions related to the feeling during the stimulation will be asked: pain, tingling, burning, fatigue. Data considered are with EXOPULSE Suit in active mode.	28 days
Satisfaction with the suit	4 additional questions related to the satisfaction with the suit will be asked: ease for putting on and off, ease of use, comfort with the suit, efficacy. Data considered are with EXOPULSE Suit in active mode.	28 days

Collaborators and Investigators

• Sponsor: Otto Bock France SNC
• Investigators: Study Chair: Samar AYACHE, Pr, CHU Henri Mondor; Study Chair: Djamel BENSMAIL, Pr, Hopital Raymond Poincare; Study Chair: Jérôme DE SEZE, Pr, Hopital de Hautepierre; Study Chair: Volker LIMMROTH, Pr, Klinik für Neurologie Köln-Merheim

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; neuromodulation; walking ability; suit; multi-site electrical stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: BP-11-PT-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No