NCT07252895

EXOPULSE Suit and Walking Ability of Patients With Multiple Sclerosis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Otto Bock France SNC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-11-28
• Last updated: 2026-04-06

Locations

11 sites across 1 country: France