protocolSection identificationModule nctId: NCT06381440, orgStudyIdInfo id: PROGR-EX_MNESYS, briefTitle: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability, acronym: PROGR-EX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, collaborators name: Universita di Verona, collaborators name: Università degli Studi di Ferrara, descriptionModule briefSummary: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lokomat device (Hocoma AG, Volketswil, Switzerland)., interventions name: Conventional walking training, outcomesModule primaryOutcomes measure: Walking function, secondaryOutcomes measure: Mobility, secondaryOutcomes measure: Walking endurance, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Spasticity, secondaryOutcomes measure: Perceived quality of life, secondaryOutcomes measure: Perceived walking ability, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Adaptation to medical condition, secondaryOutcomes measure: Coping strategies, secondaryOutcomes measure: Muscle oxygen consumption, secondaryOutcomes measure: Hemodynamic cortical activation, secondaryOutcomes measure: Electrical brain activity, secondaryOutcomes measure: miRNA expression, secondaryOutcomes measure: Acceptability of robot intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, status: RECRUITING, city: Ferrara, state: Emilia Romagna, zip: 44124, country: Italy, contacts name: Sofia Straudi, MD, PhD, role: CONTACT, phone: 0532236185, email: s.straudi@ospfe.it, contacts name: Sofia Straudi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Fabio Manfredini, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nicola Lamberti, PhD, role: SUB_INVESTIGATOR, contacts name: Andrea Baroni, PhD, role: SUB_INVESTIGATOR, contacts name: Giulia Fregna, MSc, role: SUB_INVESTIGATOR, contacts name: Michela Rimondini, PhD, role: SUB_INVESTIGATOR, contacts name: Marialuisa Gandolfi, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Luigi Zerbinati, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.83804, lon: 11.62057, hasResults: False