CompletedNot Applicable

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

France30 participantsStarted 2022-12-20

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) judic…

What they're measuring

Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation

Timeframe: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)

Trial details

NCT IDNCT06702163

SponsorInstitut De La Colonne Vertebrale Et Des Neurosciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Spasticity as Sequela of Stroke trials