EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)

Launched by SHEIKH SHAKHBOUT MEDICAL CITY · Jan 17, 2024

Keywords

ClinConnect Summary

The EXOSTROKE 2 clinical trial is studying the use of the Exopulse Mollii suit, a special device designed to help improve movement and balance in adults who have had a stroke and experience muscle stiffness, known as spasticity. The researchers want to see if wearing this suit can make a difference in how well participants can move, their balance, and their overall quality of life, including any pain or fatigue they might feel.

To participate, individuals need to be between 18 and 75 years old and have had a stroke for at least three months. They should be able to walk, even with some support, and have some level of muscle stiffness. The trial involves a few visits over several weeks, including sessions where participants will either use the suit or a placebo (a dummy version that doesn’t have any active effects). After the initial sessions, participants will wear the suit at home for four weeks. Throughout the trial, researchers will check in to see how the participants are doing and if the suit is helping them. It's important to note that certain health conditions or treatments may exclude someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 75 years.
• • Having a clinical diagnosis of stroke since at least three months.
• • Being able to walk freely or with the need of support (modified Rankin score ≤ 4).
• • 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 stroke 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/m2.
• • In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period.
• • Patients under juridical protection.
• • Prisoners.