No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
77 (estimated)
Sponsor
Otto Bock France SNC · Industry
Who this trial is looking for
This trial is looking for individuals diagnosed with Multiple Sclerosis to test a special suit that can help improve walking ability. Participants will wear the suit at home for an hour every other day.
Are You a Good Fit for This Trial?
Rules you outUncontrolled epilepsy
You may be able to join if
I have been diagnosed with Multiple Sclerosis for at least 3 months.
I have an EDSS score between 4 and 6.
I have stable walking ability for at least two weeks before the study.
I have spasticity in my lower limbs.
I have never tried the EXOPULSE Suit.
You may not be able to join if
I am under 18 years old.
I have a medical condition that prevents me from using the EXOPULSE Suit.
I use electronic life-support equipment.
I have had relapses in the last 3 months.
I have had changes to my MS treatment in the last 3 months.
I cannot use the EXOPULSE Suit due to my size.
I do not have a smartphone or cannot use the EXOPULSE App.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 t…
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.
Trial Locations
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City
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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 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
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