protocolSection identificationModule nctId: NCT06312046, orgStudyIdInfo id: 2018 374-31, briefTitle: Motor-cognitive Performance in People With Multiple Sclerosis, acronym: HiBalance-MS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life., conditionsModule conditions: Multiple Sclerosis, conditions: Postural Balance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and Outcome assessor will not participate in the provided training program. Care provider will not perform the analyses., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: HiBalance-MS, outcomesModule primaryOutcomes measure: Mini Balance Evaluation Systems test., secondaryOutcomes measure: 10-Meter Walk Test, maximum speed., secondaryOutcomes measure: 10-Meter Walk Test, self-selected speed., secondaryOutcomes measure: 2-Minute Walk Test, self-selected speed., secondaryOutcomes measure: Gait speed during simultaneous dual task performance., secondaryOutcomes measure: Stride length during dual task gait performance., secondaryOutcomes measure: Step time during dual task gait performance., secondaryOutcomes measure: Response errors in dual task cognitive performance, secondaryOutcomes measure: Reaction time in dual task cognitive performance, secondaryOutcomes measure: Six-Spot Step Test., secondaryOutcomes measure: Completion time in the Trail Making Test., secondaryOutcomes measure: Number of errors in the Trail Making Test., secondaryOutcomes measure: Immediate and delayed recall in the Ray Auditory Verbal Learning Test., secondaryOutcomes measure: Cognitive processing speed in the Symbol Digit Modalities Test., secondaryOutcomes measure: Cognitive function - composite measure of three cognitive tests., secondaryOutcomes measure: Physical activity level., secondaryOutcomes measure: Physical activity level, self-reported., secondaryOutcomes measure: Physical exercise habits, self-reported., secondaryOutcomes measure: The generic Walk-12 questionnaire., secondaryOutcomes measure: Falls Efficacy Scale - International., secondaryOutcomes measure: Assesment of anxiety with the Hospital Anxiety and Depression Scale., secondaryOutcomes measure: Assesment of depression with the Hospital Anxiety and Depression Scale., secondaryOutcomes measure: Modified Fatigue Impact Scale., secondaryOutcomes measure: Occupational Gap Questionnaire., secondaryOutcomes measure: Acceptance of Chronic Health Condition scale., secondaryOutcomes measure: Multiple Sclerosis Impact Scale - physical impact., secondaryOutcomes measure: Multiple Sclerosis Impact Scale - psychological impact., secondaryOutcomes measure: Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L)., secondaryOutcomes measure: Euroqol Visual Analogue Scale (EQ VAS)., secondaryOutcomes measure: World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, zip: 17177, country: Sweden, contacts name: Sverker Johansson, Ph.D, role: CONTACT, phone: +46702861260, email: sverker.johansson@ki.se, contacts name: Andreas Wallin, Ph.D, role: CONTACT, phone: +46735137604, email: andreas.wallin@ki.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False