protocolSection identificationModule nctId: NCT06303024, orgStudyIdInfo id: RELIABLE Clinical Study, briefTitle: Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis, acronym: RELIABLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-14, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fondazione Don Carlo Gnocchi Onlus, class: OTHER, collaborators name: Careggi Hospital, collaborators name: Sheba Medical Center, collaborators name: Uppsala University, descriptionModule briefSummary: Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: personalized combined physical and cognitive intervention, outcomesModule primaryOutcomes measure: Symbol Digit Modalities Test (SDMT), primaryOutcomes measure: California Verbal Learning Test second edition (CVLT-II), primaryOutcomes measure: Brief Visuo-Spatial Memory Test- Revised (BVMT-R), primaryOutcomes measure: Word list generation (WLG), primaryOutcomes measure: Stroop test, primaryOutcomes measure: Test Intelligenza Breve (TIB), primaryOutcomes measure: 9 hole peg test (9HPT), primaryOutcomes measure: The Hospital Anxiety and Depression Scale (HADS), primaryOutcomes measure: Beck Depression Inventory second edition, primaryOutcomes measure: The Modified Fatigue Impact Scale (MFIS), primaryOutcomes measure: The Multiple Sclerosis Walking Scale (MSWS-12), primaryOutcomes measure: Multiple Sclerosis Impact Scale (MSIS-29-V2), primaryOutcomes measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54), primaryOutcomes measure: six minutes walking test (6MWT), primaryOutcomes measure: Romberg test, primaryOutcomes measure: handgrip test, primaryOutcomes measure: cognitive-motor interference, primaryOutcomes measure: Timed 25-foot walk, primaryOutcomes measure: brain MRI scan, primaryOutcomes measure: International Physical Activity Questionnaire (IPAQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS, status: RECRUITING, city: Firenze, zip: 50143, country: Italy, contacts name: Maria Pia Amato, Prof, role: CONTACT, phone: 0557947836, email: mpamato@dongnocchi.it, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False