EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)

Launched by SHEIKH SHAKHBOUT MEDICAL CITY · May 10, 2023

Keywords

ClinConnect Summary

The EXOSEP 2 clinical trial is studying how the EXOPULSE Mollii suit can help improve movement and comfort for adults with Multiple Sclerosis (MS) who experience muscle stiffness, also known as spasticity. The main focus is to see if wearing this suit can enhance balance, mobility, and overall quality of life while also reducing pain and fatigue. Participants will take part in several sessions over a few weeks, where they will either use the active suit or a non-active version (sham) to help researchers understand its effects.

To be eligible for this study, participants need to be between 18 and 75 years old, have a confirmed diagnosis of MS, and be able to walk with or without assistance. They should also have noticeable muscle stiffness and a risk of falling. Throughout the trial, participants will attend a few visits for evaluations, wear the suit at home for a month, and then return for a final assessment. It's essential to know that individuals who are pregnant, have specific health conditions, or are currently involved in other research studies may not be able to participate. This trial aims to find new ways to support those living with MS and improve their daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
• • Age between 18 and 75 years.
• • Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) \< 7).
• • Being free of relapses in the last three months.
• • Being able to understand verbal instructions.
• • Having spasticity with a score of at least 1+ on the MAS.
• • Having a BBS score ≤46 associated in the literature with a risk of fall.
• Exclusion Criteria:
• • Being included in another research protocol during the study period.
• • Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
• • Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
• • Being pregnant.
• • Having a change in their pharmacological therapy in the last three months.
• • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
• • Having a body mass index above 35 kg/m\^2.
• • In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period.
• • Patients under juridical protection.
• • Prisoners.