EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)

Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.

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.

• Having a Berg Balance Scale score ≤46 associated across 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 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 ".)