protocolSection identificationModule nctId: NCT06341023, orgStudyIdInfo id: 2023-1430, briefTitle: Functional Balance Intervention in Multiple Sclerosis, acronym: FBIinMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2026-01-09, completionDateStruct date: 2027-01-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: This project involves two sub-parts:Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis.Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis.Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Subjects will be blinded to group existence and assignment and outcome assessors will be blinded to group assignment, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Functional Balance Intervention, interventions name: Stretching, outcomesModule primaryOutcomes measure: Change in physical function, primaryOutcomes measure: Change in cognitive function, primaryOutcomes measure: Change in dual task balance performance, primaryOutcomes measure: Change in dual task gait performance, primaryOutcomes measure: Change in measured community mobility, primaryOutcomes measure: Change in self-reported community mobility, primaryOutcomes measure: Change in self-reported quality of Life, secondaryOutcomes measure: Change in walking performance, secondaryOutcomes measure: Change in walking speed, secondaryOutcomes measure: Change in balance confidence, secondaryOutcomes measure: Change in functional independence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Tanvi Bhatt, PhD, role: CONTACT, phone: 312-355-4443, email: tbhatt6@uic.edu, contacts name: Rudri Purohit, MS, role: CONTACT, phone: 3128773640, email: rpuroh2@uic.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False