Study on Dual-Task Balance Training in Humans with MS

subjectsParticipants who interrupt the training for more than one week, or who have a relapse between T0 and T1, are withdrawn.\n\nOUTCOME MEASURES Primary endpoints (feasibility)\n\n* Process metrics: recruitment rate, retention rate, session adherence (sessions completed out of 14).\n* Resource/management metrics: assessment burden (time per session), protocol compliance, data completeness.\n* Scientific feasibility: ability of the selected outcome measures to detect change, to inform sample size of a future trial.\n* Patient-reported: Global Impression of Change, ABC scale, MSWS-12.

sample size basisSecondary endpoints (preliminary effect)\n* Change (T0→T1) in motor DT costs for TUG and 2MWT, compared between intervention and no-treatment group.\n* Change in IMU-based gait kinematic parameters.\n* Change in EEG-based prefrontal activation and TLI during the ST motor conditions.\n* Change in Clinical, functional, cognitive functions, quality of life outcomes: Motricity Index, Dynamic Gait Index, Mini Best Test, Multiple Sclerosis Functional Composite, Hospital Anxiety and Depression Scale (HADS), Fatigue Severity Scale, Activities-specific balance confidence (ABC), the Manual Ability Measure-36 (MAM-36), Brief Pain Inventory (BPI), Multiple Sclerosis Quality Of Life-54, Five Levels EQ-5D, Paced Auditory Serial Addition Task (PASAT), number of falls in the last month.\n\nExpected outcomes\n\n* The protocol will prove feasible in terms of recruitment, retention and adherence.\n* The intervention group will show reduced prefrontal activation and mental workload (TLI) during TUG and 2MWT in the single-task condition.\n* Reduced DT cost, expected primarily for TUG (and less for 2MWT, since endurance is not specifically targeted by the training).\n* Preliminary effect-size estimates to power a future randomized controlled trial.\n\nSTATISTICAL ANALYSIS.

randomized"briefSummary": "The goal of this randomized controlled feasibility study is to assess whether a balance training program that includes dual-task exercises is feasible in people with multiple sclerosis (MS).

controlled"briefSummary": "The goal of this randomized controlled feasibility study is to assess whether a balance training program that includes dual-task exercises is feasible in people with multiple sclerosis (MS).

research categories"description": "No additional rehabilitation during the study period (about 7 weeks).

interventionThe main questions it aims to answer are:\n\n* Is the training feasible in terms of recruitment, retention, adherence, data completeness, and assessment burden?\n* What are the preliminary effects of the training on dual-task costs during the Timed Up and Go test (TUG) and the 2-Minute Walk Test (2MWT), on prefrontal activation and mental workload during walking, and on clinical outcomes?\n\nResearchers will compare participants who receive the training with participants who receive no additional rehabilitation during the study period.\n\nParticipants will:\n\n* receive 14 in-hospital sessions of balance and dual-task training (60 minutes, 2 sessions per week, about 7 weeks) if allocated to the intervention group, or no new rehabilitation if allocated to the control group;\n* perform a dual-task walking assessment (TUG, 2MWT, backward digit span) while wearing an 8-channel wearable EEG headset and 3 inertial sensors, before (T0) and after (T1) the study period;\n* complete clinical scales and questionnaires on balance, gait, cognition, fatigue, mood, pain, and quality of life.",

comparator"description": "No additional rehabilitation during the study period (about 7 weeks).

primary endpointParticipants who interrupt the training for more than one week, or who have a relapse between T0 and T1, are withdrawn.\n\nOUTCOME MEASURES Primary endpoints (feasibility)\n\n* Process metrics: recruitment rate, retention rate, session adherence (sessions completed out of 14).\n* Resource/management metrics: assessment burden (time per session), protocol compliance, data completeness.\n* Scientific feasibility: ability of the selected outcome measures to detect change, to inform sample size of a future trial.\n* Patient-reported: Global Impression of Change, ABC scale, MSWS-12.

findingsThe main questions it aims to answer are:\n\n* Is the training feasible in terms of recruitment, retention, adherence, data completeness, and assessment burden?\n* What are the preliminary effects of the training on dual-task costs during the Timed Up and Go test (TUG) and the 2-Minute Walk Test (2MWT), on prefrontal activation and mental workload during walking, and on clinical outcomes?\n\nResearchers will compare participants who receive the training with participants who receive no additional rehabilitation during the study period.\n\nParticipants will:\n\n* receive 14 in-hospital sessions of balance and dual-task training (60 minutes, 2 sessions per week, about 7 weeks) if allocated to the intervention group, or no new rehabilitation if allocated to the control group;\n* perform a dual-task walking assessment (TUG, 2MWT, backward digit span) while wearing an 8-channel wearable EEG headset and 3 inertial sensors, before (T0) and after (T1) the study period;\n* complete clinical scales and questionnaires on balance, gait, cognition, fatigue, mood, pain, and quality of life.",

limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.