EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Launched by INSTITUT DE LA COLONNE VERTEBRALE ET DES NEUROSCIENCES · Nov 20, 2024

Keywords

ClinConnect Summary

The EXOSTROKE trial is studying the use of the EXOPULSE Mollii suit, a special wearable device that may help manage spasticity, a condition that causes muscles to become stiff or tight, often affecting stroke survivors. Spasticity can make it hard to move and can significantly lower a person's quality of life. This trial aims to see if this non-invasive treatment can provide relief for those who have experienced a stroke at least three months prior.

To participate in this study, individuals need to be between 18 and 75 years old, have a confirmed diagnosis of stroke, and be able to walk with or without support. Participants should also speak French and be able to understand instructions. They will wear the EXOPULSE Mollii suit during the trial, which is intended to help reduce muscle stiffness and improve mobility. If someone is pregnant, has certain medical devices, or has other specific health conditions, they may not be eligible to join. Overall, the trial offers an opportunity to explore a new way to help manage spasticity for stroke survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 75 years.
• • Having a clinical diagnosis of stroke for at least three months
• • Being able to walk freely or with the need of support (modified Rankin score
• • 4)
• • Being a French speaker, able to understand verbal instructions, and affiliated with the national health insurance (sécurité social).
• • Having spasticity with a score of at least 1+ on the MAS
• 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 contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
• • Being pregnant (confirmed by a blood beta-HCG test).
• • 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/m2.
• • In case of introducing a medical device other than EXOPULSE Mollii suit during the study period.
• • Patients under juridical protection (" mesure de protection) judiciare : tutelle, curatelle, sauvegarde de justice ")
• • Patients deprived of freedom (" personnes privées de liberté ".)