A new clinical trial aimed at improving mobility for patients with Multiple Sclerosis (MS) is set to commence. Sponsored by Otto Bock France SNC, the study evaluates the effectiveness of the EXOPULSE Suit, a medical device designed to enhance walking performance. As of November 2025, the study status is officially listed as “Not yet recruiting.” This trial could offer groundbreaking insights for MS treatment, particularly for clinical, quality, and regulatory teams monitoring device innovation.
In this article:
- What is the study about?
- How does the EXOPULSE Suit work?
- What are the implications for MS patients?
- FAQs about the study
- Key takeaways
- Disclaimer
- Study reference link
What is the study about?
The primary objective of this upcoming trial is to investigate the roles of active and sham modes of the EXOPULSE Suit in improving walking ability among MS patients. The trial uses a comparative intervention model, dividing participants into two groups: one using the device in active mode and another using it in sham mode. By collecting data on performance and safety, the study seeks to validate the device’s therapeutic potential and compliance with regulatory standards.
How does the EXOPULSE Suit work?
The EXOPULSE Suit is a wearable medical device designed to assist individuals with neurological disorders in regaining mobility. Operating in active mode involves functional stimulation that targets specific muscle groups. Meanwhile, the sham mode serves as a control mechanism, allowing researchers to assess the device’s true effects against a placebo equivalent. Otto Bock France SNC emphasizes that safety, performance, and intended therapeutic benefits align with MDR Annex XIV regulatory expectations.
What are the implications for MS patients?
Multiple Sclerosis often leads to mobility loss, severely impacting patient independence and quality of life. Devices like the EXOPULSE Suit represent a critical innovation by leveraging functional stimulation as a therapeutic approach. The upcoming trial’s findings could determine whether this device becomes widely recommended for MS management. Positive data could also signal advancements in wearable medical technologies tailored for neurological conditions.
FAQs about the study
1. What is the anticipated recruitment timeline?
As of November 2025, recruitment has not yet begun. Updates on recruitment phases are expected once the study officially moves forward.
2. Who is overseeing this trial?
The trial sponsor is Otto Bock France SNC, a medical technology company focused on adaptive solutions for neurological challenges.
3. Where can regulatory professionals find more details?
Further information is available on ClinicalTrials.gov, accessible through the provided reference link.
Key takeaways
This trial introduces promising developments for MS care and wearable medical technologies. However, clinical, quality, and regulatory teams should monitor results to determine device efficacy and compliance with safety standards. Professionals engaged in related fields may find significant value in observing ongoing progress.
Disclaimer
This article is for informational purposes only, based on publicly available data. It is not a substitute for professional legal or regulatory guidance.
Study reference link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07252895?term=medical+device