protocolSection identificationModule nctId: NCT06384729, orgStudyIdInfo id: 123, briefTitle: Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: Abstract:Background:Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions.Objective:To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS.Methods:A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS, aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0.Results:Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests.Conclusion:This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: EXOPULSE Mollii Ⓡ, outcomesModule primaryOutcomes measure: referred pain, primaryOutcomes measure: Balance, primaryOutcomes measure: gait speed and distance, secondaryOutcomes measure: fall risk, secondaryOutcomes measure: perception of walking difficulties, secondaryOutcomes measure: perceived quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cecilia Estrada Barranco, status: RECRUITING, city: Villaviciosa De Odón, state: Madrid, zip: 28670, country: Spain, contacts name: Cecilia Estrada Barranco, PhD, role: CONTACT, phone: 686166483, email: cecilia.estrada@universidadeuropea.es, geoPoint lat: 40.35692, lon: -3.90011, hasResults: False