Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 2:38 AM
Study NCT ID:
NCT07252895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis
Sponsor:
Otto Bock France SNC
Organization:
Study Overview
Official Title:
Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXO-MOBILITY
Brief Summary:
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.
This research aims at confirming the benefits of EXOPULSE Suit in persons with Multiple Sclerosis, including the walking ability.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: