AzTrials
AzTrials

Multiple SclerosisEXO-MOBILITYNCT07252895

EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

A study testing EXOPULSE Suit in Active mode in people with Multiple Sclerosis, run by Otto Bock France SNC at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
EXOPULSE Suit in Active mode
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
11 sitesFrance
Study dates
30 Mar 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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 locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

France11 sites, 10 recruiting
  • Centre Jacques Calvé Fondation Hopale

    Berck, 62 608

    Pascal RIGAUX, Dr.

    Pascal RIGAUX, Dr.

    Recruiting
  • CHU Henri Mondor

    Créteil, 94000

    Samar AYACHE, Pr.

    Samar AYACHE, Pr.

    Recruiting
  • CHU Dijon

    Dijon, 21 079

    Paul ORNETTI, Pr.

    Paul ORNETTI, Pr.

    Recruiting
  • Clinique Verdaich

    Gaillac-Toulza, 31 550

    Elsa MAURUC-SOUBIRAC, Dr.

    Elsa MAURUC-SOUBIRAC, Dr.

    Recruiting
  • Hôpital Raymond-Poincaré

    Garches, 92380

    Djamel BENSMAIL, Pr.

    Djamel BENSMAIL, Pr.

    Recruiting
  • Hopital Saint Philibert

    Lomme, 59462

    Active, not recruiting
  • Centre Médical Germaine REVEL

    Lyon, 69 440

    Vivien RAYNAUD, Dr.

    Vivien RAYNAUD, Dr.

    Recruiting
  • Hôpital L'Archet

    Nice, 62 000

    Audrey ALLAMANDI, Dr.

    Audrey ALLAMANDI, Dr.

    Not yet recruiting
  • Pole MPR Saint Hélier

    Rennes, 35000

    Philippe GALLIEN, Dr.

    Philippe GALLIEN, Dr.

    Recruiting
  • Hôpital Henry Gabrielle

    Saint-Genis-Laval, 69 230

    Sophie JACQUIN COURTOIS, Dr.

    Sophie JACQUIN COURTOIS, Dr.

    Recruiting
  • Hôpital de Hautepierre

    Strasbourg, 67200

    Jérôme DE SEZE, Pr.

    Jérôme DE SEZE, Pr.

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
EXOPULSE Suit in Active mode, EXOPULSE Suit in Sham mode
Keywords
Multiple Sclerosis, neuromodulation, suit, walking ability, multi-site electrical stimulation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXOPULSE Suit in Active modeDevice

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

  • EXOPULSE Suit in Sham modeDevice

    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.

Study groups in NCT07252895
Study groupRoleWhat they receive
EXOPULSE Suit Active then EXOPUSLE Suit shamOtherThe 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.
Receives: Device: EXOPULSE Suit in Active mode; Device: EXOPULSE Suit in Sham mode
EXOPULSE Suit in sham mode then EXOPULSE Suit in Active modeOtherThe 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.
Receives: Device: EXOPULSE Suit in Active mode; Device: EXOPULSE Suit in Sham mode

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

Secondary outcomes (8)
  1. 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.

    Measured: 28 days

  2. 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.

    Measured: 28 days

  3. 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.

    Measured: 28 days

  4. 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.

    Measured: 28 days

  5. 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

    Measured: 28 days

  6. 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).

    Measured: 28 days

  7. 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.

    Measured: 28 days

  8. 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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start30 Mar 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Each participant is his/her own control
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252895
Sponsor's protocol ID
BP-11-PT-010
Acronym
EXO-MOBILITY
Status last verified
Mar 2026
First submitted
19 Nov 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EXOPULSE Suit in Active mode in people with Multiple Sclerosis, run by Otto Bock France SNC at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurelie LACROIX, Ing. (0033 (0)7 86 29 52 03, aurelie.lacroix@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Multiple Sclerosis Walking Scale 12 (MSWS-12) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in